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Prozac Safety Reports submitted to FDA
Prozac FDA safety alerts: 2004 2005 2006 .
Reported deaths: 47 Reported hospitalizations: 137.
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Reported Prozac Side Effects: suicidal ideation, depression, completed suicide, fall, loss of consciousness, homicide, suicide attempt, pain in extremity, agitation, aggression, nausea.
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Prozac Side Effects Report #5147035-1Consumer or non-health professional from reported PROZAC problem on Oct 27, 2006. Female patient, 47 years of age, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: hypotension, respiratory depression. PROZAC dosage: unknown. During the same period patient was treated with FENTANYL CITRATE, VICODIN. Patient died on 05/01/2004.
Prozac Side Effects Report #5150135-3
PROZAC problem was reported by a Physician from UNITED STATES on Oct 24, 2002. Male patient, 47 years of age, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: homicide. PROZAC dosage: unknown. During the same period patient was treated with CODEINE, PROSCAR. Patient recovered.
Prozac Side Effects Report #5150569-7
Consumer or non-health professional from UNITED STATES reported PROZAC problem on Mar 31, 2003. Female patient, 37 years of age, weighting 176.4 lb, was diagnosed with dysthymic disorder, pregnancy, headache and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: caesarean section, cows milk free diet, depression, forceps delivery, gestational diabetes, heart rate increased, postpartum depression. PROZAC dosage: 30 MG, DAILY (1/D). During the same period patient was treated with PRENATAL VITAMINS, ATIVAN, TYLENOL, MAGNESIUM SULPHATE, EXCEDRIN. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5151459-6
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 02, 2006. Female patient was diagnosed with major depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: contusion, von willebrand's disease. PROZAC dosage: 20 MG, DAILY (1/D). Patient recovered.
Prozac Side Effects Report #5151736-9
Consumer or non-health professional from FRANCE reported PROZAC problem on Oct 18, 2006. Female patient was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: congenital tracheomalacia, heart disease congenital, hypertonia neonatal, premature baby, premature labour. PROZAC dosage: unknown. During the same period patient was treated with XANAX, ANAFRANIL, LEXOMIL, THERALENE, AMITRIPTYLINE HYDROCHLORIDE, MEPRONIZINE. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5152971-6
PROZAC problem was reported by a Physician from SAUDI ARABIA on Oct 02, 2006. Female patient, 62 years of age, was diagnosed with depression, osteoporosis and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: aspergillosis, balance disorder, gait disturbance, headache, unevaluable event, vomiting projectile. PROZAC dosage: unknown. During the same period patient was treated with FORTEO. Patient was hospitalized. Patient died on 08/15/2006.
Prozac Side Effects Report #5156158-2
Physician from UNITED STATES reported PROZAC problem on Nov 09, 2006. Female patient, 64 years of age, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: multiple myeloma, tremor. PROZAC dosage: unknown. Patient recovered.
Prozac Side Effects Report #5157437-5
PROZAC problem was reported by a Physician from FRANCE on Nov 14, 2006. Female patient, weighting 7.08 lb, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: ventricular septal defect. PROZAC dosage: unknown. Patient recovered.
Prozac Side Effects Report #5157441-7
Physician from FRANCE reported PROZAC problem on Nov 14, 2006. Female patient, 21 years of age, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: brain oedema, cerebral haemorrhage, leukoencephalopathy. PROZAC dosage: 20 MG, DAILY (1/D). During the same period patient was treated with CONTRAMAL, LEXOMIL, POTASSIUM CHLORIDE, CHLORIDE, OMEPRAZOLE, LOVENOX, PERFALGAN. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5157594-0
PROZAC problem was reported by a Physician from NETHERLANDS on Nov 14, 2006. Female patient, weighting 6.61 lb, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: blood ph decreased, caesarean section, foetal distress syndrome, hyperglycaemia, meconium in amniotic fluid, respiratory disorder. PROZAC dosage: 20 MG, UNK. During the same period patient was treated with KYTRIL, OMEPRAZOLE, MAGNESIUM OXIDE. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5159461-5
Consumer or non-health professional from UNITED STATES reported PROZAC problem on Nov 22, 2006. Male patient, 32 years of age, weighting 185.0 lb, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: erectile dysfunction, libido decreased. PROZAC dosage: unknown. Patient recovered.
Prozac Side Effects Report #5163754-5
PROZAC problem was reported by a Pharmacist from UNITED STATES on Nov 27, 2006. Male patient, 14 years of age, weighting 172.0 lb, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: overdose. PROZAC dosage: 20 MG DAILY PO. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5214649-X
Consumer or non-health professional from UNITED STATES reported PROZAC problem on Apr 21, 2006. Male patient, 25 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: anger, completed suicide. PROZAC dosage: unknown. Patient died on 08/16/1998.
Prozac Side Effects Report #5214651-8
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 04, 2006. Male patient, 46 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: depression, insomnia, joint injury, road traffic accident, somnolence, suicidal ideation, thinking abnormal. PROZAC dosage: 80 MG; SEE IMAGE. During the same period patient was treated with CYMBALTA, LORTAB, VISTARIL, SEROQUEL. Patient recovered.
Prozac Side Effects Report #5214671-3
Physician from UNITED STATES reported PROZAC problem on Mar 17, 2006. Female patient, 45 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: glaucoma. PROZAC dosage: 20 MG, ORAL. During the same period patient was treated with TRAZODONE, TRIPTYL, SEROQUEL. Patient recovered.
Prozac Side Effects Report #5214954-7
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 07, 2006. Female patient was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: animal scratch, psychogenic pain disorder, scar, suicidal ideation, wound complication. PROZAC dosage: 20 MG, ORAL. During the same period patient was treated with KLONOPIN. Patient recovered.
Prozac Side Effects Report #5214955-9
Consumer or non-health professional from UNITED STATES reported PROZAC problem on July 31, 2006. Male patient, 53 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: anorgasmia, erectile dysfunction, suicidal behaviour. PROZAC dosage: unknown. During the same period patient was treated with TIMOLOL MALEATE. Patient recovered.
Prozac Side Effects Report #5214956-0
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on July 25, 2006. Male patient, 44 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: asthenia, confusional state, hypersomnia, mood altered, suicidal ideation. PROZAC dosage: unknown. Patient recovered.
Prozac Side Effects Report #5214963-8
Pharmacist from UNITED STATES reported PROZAC problem on July 07, 2006. Male patient, 49 years of age, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: platelet count decreased. PROZAC dosage: 10 MG, DAILY (1/D). Patient recovered.
Prozac Side Effects Report #5214966-3
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on June 26, 2006. Female patient, 38 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: hypersensitivity, throat tightness, urticaria. PROZAC dosage: unknown. Patient recovered.
Prozac Side Effects Report #5214968-7
Consumer or non-health professional from UNITED STATES reported PROZAC problem on June 21, 2006. Female patient, 56 years of age, weighting 302.9 lb, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: constipation, dizziness, dry mouth, limb discomfort, loss of consciousness, muscular weakness, nausea, vomiting, weight decreased. PROZAC dosage: unknown. During the same period patient was treated with CYMBALTA, ATENLOL, ACTOS, AVALIDE, ASPIRIN, ENALAPRIL MALEATE, METFORMIN. Patient recovered.
Prozac Side Effects Report #5214969-9
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on June 12, 2006. Male patient, 17 years of age, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: intentional overdose, serotonin syndrome, suicide attempt. PROZAC dosage: 80 MG, DAILY (1/D). During the same period patient was treated with REMERON, METHYLPHENIDATE. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5215197-3
Health Professional from UNITED STATES reported PROZAC problem on Aug 14, 2006. Female patient, 35 years of age, was diagnosed with anxiety and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: myalgia, postpartum depression, respiratory distress. PROZAC dosage: unknown. During the same period patient was treated with LAMICTAL. Patient recovered.
Prozac Side Effects Report #5215200-0
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 28, 2006. Male patient, 22 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: mania. PROZAC dosage: unknown. During the same period patient was treated with LAMICTAL, ELAVIL, XANAX, VALIUM, DILAUDID, BENEFIBER, VITAMIN. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5162782-3
Consumer or non-health professional from UNITED STATES reported PROZAC problem on Nov 17, 2006. Female patient was diagnosed with depression, pain and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: anaemia, dyspnoea, faeces discoloured, food poisoning, gastric operation, gastritis erosive, haematochezia, pain, transfusion. PROZAC dosage: 30 MG, UNK. During the same period patient was treated with NEXIUM, ALEVE. Patient recovered.
Prozac Side Effects Report #5162784-7
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 17, 2006. Female patient was diagnosed with depression, pain, food poisoning and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: anaemia, dyspnoea, faeces discoloured, food poisoning, gastritis erosive, haematochezia, overweight, pain. PROZAC dosage: 30 MG, UNK. During the same period patient was treated with NEXIUM, ALEVE, PROTONIX. Patient recovered.
Prozac Side Effects Report #5163950-7
Consumer or non-health professional from UNITED STATES reported PROZAC problem on Nov 20, 2006. Female patient, 40 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: caesarean section, cows milk free diet, gestational diabetes, heart rate increased, postpartum depression, premature labour. PROZAC dosage: 20 MG, DAILY (1/D). During the same period patient was treated with PRENATAL VITAMINS, TYLENOL, EXCEDRIN, MAGNESIUM SULPHATE. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5164330-0
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 31, 2003. Female patient, 37 years of age, weighting 176.4 lb, was diagnosed with dysthymic disorder, pregnancy, headache and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: depression, gestational diabetes. PROZAC dosage: 30 MG, DAILY (1/D). During the same period patient was treated with PRENATAL VITAMINS, ATIVAN, TYLENOL, MAGNESIUM SULPHATE, EXCEDRIN. Patient recovered.
Prozac Side Effects Report #5164869-8
Consumer or non-health professional from UNITED STATES reported PROZAC problem on Nov 04, 1996. Male patient, 66 years of age, was diagnosed with myoclonus, gastric disorder, depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, dysarthria, homicide, paranoia. PROZAC dosage: unknown. During the same period patient was treated with KLONOPIN, LIBRIUM, LIBRAX, ZANTAC, BENADRYL, CAPTOPRIL, DOXEPIN. Patient died.
Prozac Side Effects Report #5164872-8
PROZAC problem was reported by a Physician from UNITED STATES on Nov 21, 2006. Male patient, 57 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: catatonia. PROZAC dosage: unknown. Patient recovered.
Prozac Side Effects Report #5164915-1
Physician from UNITED KINGDOM reported PROZAC problem on Oct 20, 1989. Male patient, 47 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: aggression, agitation, fatigue, homicide, insomnia, suicide attempt, tangentiality. PROZAC dosage: unknown. During the same period patient was treated with LITHIUM CARBONATE, TRAZODONE, TEMAZEPAM. Patient died.
Prozac Side Effects Report #5164920-5
PROZAC problem was reported by a Physician from UNITED KINGDOM on Oct 24, 2006. Female patient, 29 years of age, was diagnosed with depressed mood and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: ecchymosis, gingival bleeding. PROZAC dosage: 20 MG, DAILY (1/D). Patient recovered.
Prozac Side Effects Report #5169915-3
Consumer or non-health professional from UNITED STATES reported PROZAC problem on Nov 27, 2006. Male patient, 47 years of age, was diagnosed with major depression, cardiac disorder and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: breast enlargement, cardiac operation, fluid retention, rash, skin discolouration, urine flow decreased. PROZAC dosage: unknown. During the same period patient was treated with KLONOPIN, COREG, LISINOPRIL, SINEQUAN, SIMVASTATIN. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5170203-X
PROZAC problem was reported by a Physician from FRANCE on Nov 29, 2006. Male patient, 47 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: laceration, superinfection. PROZAC dosage: unknown. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5170206-5
Physician from FRANCE reported PROZAC problem on Oct 05, 2006. Female patient, 67 years of age, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: dermatitis bullous. PROZAC dosage: unknown. During the same period patient was treated with SINTROM, VALSARTAN AND HYDROCHLOROTHIAZIDE, EUPRESSYL, FUROSEMIDE, AVLOCARDYL, ALDACTONE, DIGOXIN. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5171170-5
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 07, 2006. Male patient, 24 years of age, weighting 215.0 lb, was diagnosed with bipolar disorder and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: aggression, imprisonment, physical assault, suicidal ideation. PROZAC dosage: 60 MG 1 TIME DAY MOUTH. Patient recovered.
Prozac Side Effects Report #5171310-8
Health Professional from UNITED STATES reported PROZAC problem on Dec 08, 2006. Female patient, 81 years of age, weighting 125.0 lb, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: chronic obstructive pulmonary disease, dyspnoea, hypersensitivity, pruritus, rash, skin disorder, urticaria. PROZAC dosage: unknown. During the same period patient was treated with TYLENOL, CALAMINE LOTION. Patient died on 09/26/2004.
Prozac Side Effects Report #5171716-7
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 29, 2006. Female patient was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: dry mouth, loss of consciousness, road traffic accident. PROZAC dosage: 20 MG, DAILY (1/D). Patient recovered.
Prozac Side Effects Report #5171729-5
Physician from FRANCE reported PROZAC problem on Sept 15, 2006. Female patient, 84 years of age, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: gait disturbance, tremor. PROZAC dosage: 10 MG, DAILY (1/D). During the same period patient was treated with PLAVIX, VERAPAMIL, FONZYLANE, DITROPAN, ACETAMINOPHEN W. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5174335-1
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on May 09, 2006. Male patient, weighting 196.0 lb, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: cardiac disorder, diabetes mellitus, hyperglycaemia, hyperphagia, hypoglycaemia, polydipsia, polyuria. PROZAC dosage: unknown. During the same period patient was treated with ZYPREXA. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5186423-4
Consumer or non-health professional from UNITED STATES reported PROZAC problem on Dec 08, 2006. Female patient was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: diverticulitis, surgery. PROZAC dosage: 20 MG, UNK. During the same period patient was treated with TEMAZEPAM. Patient recovered.
Prozac Side Effects Report #5186436-2
PROZAC problem was reported by a Physician from FRANCE on Aug 21, 2000. Female patient, weighting 5.07 lb, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: agitation neonatal, apgar score low, foetal growth retardation, infantile apnoeic attack, premature baby. PROZAC dosage: unknown. During the same period patient was treated with CLARITIN, SERESTA. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5189051-X
Physician from FRANCE reported PROZAC problem on Dec 12, 2006. Female patient, 48 years of age, weighting 72.75 lb, was diagnosed with hiv infection and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: dyspnoea, pulmonary hypertension. PROZAC dosage: 20 MG, DAILY (1/D). During the same period patient was treated with ZIAGEN, EPIVIR, VIDEX, ATARAX, ESOMEPRAZOLE MAGNESIUM, IMOVANE. Patient was hospitalized. Patient died on 11/20/2006.
Prozac Side Effects Report #5190000-9
PROZAC problem was reported by a Physician from FRANCE on Dec 13, 2006. Female patient, 83 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: fall, hyponatraemia. PROZAC dosage: unknown. During the same period patient was treated with SERETIDE, LEXOMIL, PERSANTINE, ODRIK, EUPANTOL, CACIT D, TEMESTA. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5190433-0
Consumer or non-health professional from UNITED STATES reported PROZAC problem on Dec 14, 2006. Male patient, 58 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: cardiac disorder, cardiac operation, sexual dysfunction. PROZAC dosage: unknown. Patient recovered.
Prozac Side Effects Report #5190435-4
PROZAC problem was reported by a Physician from FRANCE on Dec 15, 2006. Male patient, 79 years of age, weighting 149.9 lb, was diagnosed with tachyarrhythmia and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: bronchitis, haemoptysis, international normalised ratio increased. PROZAC dosage: 20 MG, DAILY (1/D). During the same period patient was treated with PREVISCAN, OGAST, KETEK. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5190450-0
Physician from FRANCE reported PROZAC problem on Dec 15, 2006. Female patient, 58 years of age, weighting 158.7 lb, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: facial bones fracture, fall, hyperthermia, nosocomial infection, pulmonary oedema, serotonin syndrome, ventricular fibrillation, wrist fracture. PROZAC dosage: 20 MG, DAILY (1/D). During the same period patient was treated with TERALITHE, DEFANYL, TROSPIUM CHLORIDE, ZOPICLONE, METFORMIN HYDROCHLORIDE, CIBACENE. Patient was hospitalized. Patient died on 10/01/2006.
Prozac Side Effects Report #5190467-6
PROZAC problem was reported by a Physician from UNITED STATES on Dec 15, 2006. Male patient, 54 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, attention deficit/hyperactivity disorder, carpal tunnel decompression, joint injury, joint reconstruction, spinal fusion surgery, thyroid cyst. PROZAC dosage: 20MG, UNK. During the same period patient was treated with WARFARIN, LEVOXINE, QUINAPRIL. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5193795-3
Physician from FRANCE reported PROZAC problem on Dec 18, 2006. Male patient, 66 years of age, weighting 174.2 lb, was diagnosed with ischaemic cardiomyopathy, hypertension, diabetes mellitus non-insulin-dependent and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, bundle branch block right, cardiomyopathy, disseminated intravascular coagulation, fall, haematoma, hepatic failure, muscular weakness, psychomotor retardation. PROZAC dosage: 40 MG, DAILY (1/D). During the same period patient was treated with PERINDOPRIL ERBUMINE, SECTRAL, CORDARONE, PLAVIX, NOCTRAN, ISOCARD, LOXEN, MEDIATOR. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5338316-7
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 13, 2006. Female patient, 55 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: inflammation, suicidal ideation. PROZAC dosage: 10 MG, 2/D. During the same period patient was treated with CYMBALTA, DIOVAN, PLAQUENIL, PRILOSEC, TRAZODONE, PREDNISONE, XANAX. Patient recovered.
Prozac Side Effects Report #5383279-1
Physician from FRANCE reported PROZAC problem on July 04, 2007. Female patient, 60 years of age, was diagnosed with depression, non-small cell lung cancer, back pain and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: gait disturbance, grand mal convulsion, renal failure, respiratory distress, sciatica. PROZAC dosage: unknown. During the same period patient was treated with GEMZAR, CISPLATIN, VALIUM, STILNOX, XANAX, VOLTAREN, DAFALGAN. Patient was hospitalized. Patient died on 05/08/2007.
Prozac Side Effects Report #5383362-0
PROZAC problem was reported by a Physician from UNITED STATES on June 27, 2007. Female patient was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: foreign body aspiration. PROZAC dosage: unknown. Patient recovered.
Prozac Side Effects Report #5385840-7
Consumer or non-health professional from UNITED STATES reported PROZAC problem on June 29, 2007. Female patient was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: dental caries, dry mouth, mastectomy, overdose, tooth discolouration, tooth loss, toothache. PROZAC dosage: 20 MG, DAILY (1/D). During the same period patient was treated with ZYPREXA, ALPRAZOLAM, LORAZEPAM. Patient recovered.
Prozac Side Effects Report #5390140-5
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on July 16, 2007. Male patient, 37 years of age, weighting 200.0 lb, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, asphyxia, completed suicide, depression. PROZAC dosage: 20 MG 1XDAY CUTANEOUS. Patient died on 05/13/2007.
Prozac Side Effects Report #5390390-8
Consumer or non-health professional from UNITED STATES reported PROZAC problem on July 06, 2007. Female patient, weighting 134.0 lb, was diagnosed with insomnia and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: abnormal sleep-related event, amnesia, back pain, balance disorder, cerebrovascular accident, dysuria, haematoma, lethargy, pharyngolaryngeal pain. PROZAC dosage: unknown. During the same period patient was treated with LISINOPRIL, PROTONIX, LEXAPRO, ASPIRIN, NORVASC, COUMADIN, AMBIEN. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5392126-3
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on July 18, 2007. Male patient, 77 years of age, weighting 190.0 lb, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: completed suicide. PROZAC dosage: unknown. During the same period patient was treated with LUNESTA. Patient died on 06/21/2005.
Prozac Side Effects Report #5394547-1
Physician from UNITED STATES reported PROZAC problem on July 09, 2007. Male patient, 33 years of age, was diagnosed with hiv infection and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: platelet function test abnormal, subdural haematoma. PROZAC dosage: 20 MG, DAILY (1/D). During the same period patient was treated with ZIDOVUDINE, FLUCONAZOLE, DAPSONE, DILANTIN KAPSEAL. Patient was hospitalized. Patient died.
Prozac Side Effects Report #5398067-X
PROZAC problem was reported by a Physician from UNITED KINGDOM on July 16, 2007. Male patient, 18 years of age, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: dyskinesia, epilepsy. PROZAC dosage: unknown. Patient recovered.
Prozac Side Effects Report #5402079-7
Consumer or non-health professional from UNITED STATES reported PROZAC problem on July 05, 2007. Female patient, 65 years of age, was diagnosed with depression, osteoporosis and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: arthralgia, arthritis, arthropathy, bone disorder, bone pain, depression, glaucoma, headache. PROZAC dosage: 10 MG, 2/D AS NEEDED; 10 MG DAILY (1/D) AS NEEDED. During the same period patient was treated with FORTEO, FORTEP PEN. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5406863-5
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on July 23, 2007. Female patient, 14 years of age, weighting 160.0 lb, was diagnosed with anxiety and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: anxiety, conversion disorder, dizziness, dysarthria, dysstasia, headache, hypoxia, loss of consciousness, syncope. PROZAC dosage: 20 MG, 2/D. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5411614-4
Physician from UNITED STATES reported PROZAC problem on July 02, 2007. Female patient, 18 years of age, weighting 119.9 lb, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: convulsion, electroencephalogram abnormal, postictal state, tremor. PROZAC dosage: 40 MG, UNK. During the same period patient was treated with WELLBUTRIN, FOLIC ACID, ASACOL, BACTRIM, MERCAPTOPURINE. Patient was hospitalized and became disabled. Patient recovered.
Prozac Side Effects Report #5412809-6
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on July 31, 2007. Female patient was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: catatonia. PROZAC dosage: 20 MG, UNK. Patient was hospitalized. Patient died.
Prozac Side Effects Report #5413977-2
Physician from FRANCE reported PROZAC problem on Aug 01, 2007. Female patient, 54 years of age, was diagnosed with depression, abnormal behaviour, anxiety, hypotension and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, status epilepticus. PROZAC dosage: 20 MG, DAILY (1/D). During the same period patient was treated with SOLIAN, RISPERDAL, VALIUM. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5413980-2
PROZAC problem was reported by a Physician from FRANCE on July 31, 2007. Female patient, 82 years of age, was diagnosed with depression, cardiac failure and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: asthenia, hyponatraemia. PROZAC dosage: 20 MG, DAILY (1/D). During the same period patient was treated with ALDACTONE, LASIX, ATACAND, BISOPROLOL, IKOREL, PLAVIX, STAGID, AMARYL. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5418466-7
Consumer or non-health professional from UNITED STATES reported PROZAC problem on Aug 06, 2007. Female patient, 37 years of age, was diagnosed with anxiety and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: dysgeusia, dyspepsia, heart rate irregular, palpitations, parosmia, thyroid cancer. PROZAC dosage: 20 MG, UNK. During the same period patient was treated with ATIVAN, TOPROL. Patient recovered.
Prozac Side Effects Report #5421395-6
PROZAC problem was reported by a Consumer or non-health professional from CANADA on Aug 08, 2007. Female patient was diagnosed with depression, feeling abnormal, hypertension, asthma, hernia, red blood cell count decreased and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: amnesia, crying, hydrocephalus. PROZAC dosage: 20 MG, DAILY (1/D). During the same period patient was treated with ATIVAN, ATACAND, SINGULAIR, LOSEC, VITAMIN B. Patient recovered.
Prozac Side Effects Report #5421401-9
Consumer or non-health professional from UNITED STATES reported PROZAC problem on Aug 08, 2007. Male patient, 52 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: neoplasm malignant. PROZAC dosage: unknown. Patient recovered.
Prozac Side Effects Report #5422570-7
PROZAC problem was reported by a Physician from FRANCE on Aug 08, 2007. Female patient, 82 years of age, was diagnosed with depression, cardiac failure and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: asthenia, hyponatraemia. PROZAC dosage: 20 MG, DAILY (1/D). During the same period patient was treated with ALDACTONE, LASIX, ATACAND, BISOPROLOL, IKOREL, PLAVIX, STAGID, AMARYL. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5429138-7
Physician from UNITED KINGDOM reported PROZAC problem on Aug 15, 2007. Female patient, 39 years of age, weighting 196.2 lb, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: hallucination, self-injurious ideation. PROZAC dosage: 20 MG, DAILY (1/D). Patient recovered.
Prozac Side Effects Report #5431616-1
PROZAC problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 17, 2007. Female patient, 58 years of age, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: vein disorder. PROZAC dosage: 20 MG, UNK. During the same period patient was treated with MEPERIDINE, ALPRAZOLAM. Patient was hospitalized. Patient died on 03/27/2007.
Prozac Side Effects Report #5441835-6
Consumer or non-health professional from UNITED STATES reported PROZAC problem on Aug 24, 2007. Female patient, 66 years of age, was diagnosed with depression, sleep disorder, arthritis and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: abnormal sleep-related event, amnesia, impaired driving ability, overdose, road traffic accident, somnambulism. PROZAC dosage: unknown. During the same period patient was treated with AMBIEN, ALEVE. Patient recovered.
Prozac Side Effects Report #5445036-7
PROZAC problem was reported by a Consumer or non-health professional from BRAZIL on Aug 24, 2007. Female patient, weighting 9.82 lb, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: hyperinsulinism, hypoglycaemia, large for dates baby. PROZAC dosage: unknown. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5447835-4
Physician from FRANCE reported PROZAC problem on Aug 30, 2007. Female patient, 84 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: fall, haematoma, hypertension, hyponatraemia, inappropriate antidiuretic hormone secretion, open wound, pain. PROZAC dosage: unknown. During the same period patient was treated with BIPRETERAX, KARDEGIC, PLAVIX, TAHOR, BISOPROLOL, MOLSIDOMINE, INIPOMP, SPAGULAX. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5447837-8
PROZAC problem was reported by a Physician from FRANCE on Aug 30, 2007. Male patient, 60 years of age, was diagnosed with depression, hypertension and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: blood creatinine decreased, hallucination, visual, hypochloraemia, hyponatraemia. PROZAC dosage: 20 MG, EACH MORNING. During the same period patient was treated with LOPRESSOR. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5450070-7
Physician from UNITED KINGDOM reported PROZAC problem on Aug 31, 2007. Female patient, 63 years of age, was diagnosed with anxiety, hypothyroidism and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: heart rate increased, hypoventilation, loss of consciousness, pallor. PROZAC dosage: unknown. During the same period patient was treated with LEVOTHYROXINE. Patient recovered.
Prozac Side Effects Report #5456820-8
PROZAC problem was reported by a Physician from UNITED STATES on Sept 17, 2007. Female patient, 63 years of age, weighting 215.0 lb, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: anxiety, depression, feeling abnormal, nightmare, paranoia. PROZAC dosage: unknown. Patient recovered.
Prozac Side Effects Report #5463441-X
Consumer or non-health professional from UNITED STATES reported PROZAC problem on Sept 07, 2007. Female patient, 37 years of age, was diagnosed with anxiety and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: dysgeusia, dyspepsia, palpitations, parosmia, thyroid cancer. PROZAC dosage: 20 MG, UNK. During the same period patient was treated with ATIVAN, TOPROL. Patient recovered.
Prozac Side Effects Report #5465354-6
PROZAC problem was reported by a Pharmacist from UNITED STATES on Sept 20, 2007. Male patient was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: suicidal ideation. PROZAC dosage: 10 MG DAILY PO. During the same period patient was treated with SEROQUEL. Patient recovered.
Prozac Side Effects Report #5466663-7
Physician from UNITED STATES reported PROZAC problem on Sept 24, 2007. Male patient, child 12 years of age, was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: decreased appetite, fatigue, jaundice, liver disorder, nausea, prothrombin time prolonged. PROZAC dosage: 10 MG PER DAY. Patient recovered.
Prozac Side Effects Report #5468273-4
PROZAC problem was reported by a Physician from on Sept 14, 2007. Male patient, 49 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: cholestasis. PROZAC dosage: 20 MG, DAILY (1/D). During the same period patient was treated with DIAZEPAM, SULPRID. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5470857-4
Physician from FRANCE reported PROZAC problem on Sept 17, 2007. Female patient was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: gastrooesophageal reflux disease, malaise, neonatal respiratory depression, respiratory disorder neonatal, somnolence neonatal. PROZAC dosage: 10 MG, DAILY (1/D). During the same period patient was treated with ANAFRANIL, LOVENOX. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5470858-6
PROZAC problem was reported by a Physician from FRANCE on Sept 17, 2007. Female patient, 54 years of age, was diagnosed with depression and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: dyspnoea, interstitial lung disease. PROZAC dosage: unknown. During the same period patient was treated with DERINOX, RIVOTRIL, IMIGRANE, LEXOMIL. Patient was hospitalized. Patient recovered.
Prozac Side Effects Report #5474095-0
Physician from UNITED STATES reported PROZAC problem on Sept 28, 2007. Female patient, 59 years of age, weighting 183.0 lb, was diagnosed with depression, pain and was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: pain. PROZAC dosage: 20 MG BID PO. During the same period patient was treated with LANTUS, BYETTA, LIPITOR, COZAAR, HYDROCHLOROTHIAZIDE, ASPIRIN, CELEBREX. Patient recovered.
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Drug Information: Fluoxetine
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a689006.html
(floo ox' e teen)IMPORTANT WARNING:
| A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as fluoxetine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant.You should know that your mental health may change in unexpected ways when you take fluoxetine or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor when you are unable to seek treatment on your own.Your healthcare provider will want to see you often while you are taking fluoxetine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fluoxetine. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/cder/drug/antidepressants/antidepressants_MG_2007.pdf.No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you. |
Why is this medication prescribed?
Fluoxetine (Prozac) is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), some eating disorders, and panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks). Fluoxetine (Sarafem) is used to relieve the symptoms of premenstrual dysphoric disorder, including mood swings, irritability, bloating, and breast tenderness. Fluoxetine is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.
How should this medicine be used?
Fluoxetine (Prozac) comes as a capsule, a tablet, a delayed-release (long-acting) capsule, and a solution (liquid) to take by mouth. Fluoxetine may be taken with or without food. Fluoxetine (Sarafem) comes as a capsule to take by mouth. Fluoxetine (Prozac) capsules, tablets, and liquid are usually taken once a day in the morning or twice a day, in the morning and at noon. Fluoxetine delayed-released capsules are usually taken once a week. Fluoxetine (Sarafem) is usually taken once a day, either every day of the month or on certain days of the month. Take fluoxetine at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fluoxetine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may start you on a low dose of fluoxetine and gradually increase your dose.
It may take 4 to 5 weeks or longer before you feel the full benefit of fluoxetine. Continue to take fluoxetine even if you feel well. Do not stop taking fluoxetine without talking to your doctor. If you suddenly stop taking fluoxetine, you may experience withdrawal symptoms such as mood changes, irritability, agitation, dizziness, numbness or tingling in the hands or feet, anxiety, confusion, headache, tiredness, and difficulty falling asleep or staying asleep. Your doctor will probably decrease your dose gradually.
Other uses for this medicine
Fluoxetine is also sometimes used to treat alcoholism, attention-deficit disorder, borderline personality disorder, sleep disorders, headaches, mental illness, posttraumatic stress disorder, Tourette's syndrome, obesity, sexual problems, and phobias. Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking fluoxetine,
- tell your doctor and pharmacist if you are allergic to fluoxetine or any other medications.
- tell your doctor if you are taking pimozide (Orap),thioridazine or monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking a monoamine oxidase inhibitor within the past 2 weeks. Your doctor will probably tell you that you should not take fluoxetine. If you stop taking fluoxetine, you should wait at least 5 weeks before you begin to take thioridazine or a monoamine oxidase inhibitor.
- tell your doctor and pharmacist what other prescription and nonprescription medications and vitamins you are taking or plan to take. Be sure to mention any of the following: alprazolam (Xanax); anticoagulants ('blood thinners') such as warfarin (Coumadin); antidepressants (mood elevators) such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin, imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin), and naproxen (Aleve, Naprosyn); diazepam (Valium); digoxin (Lanoxin); diuretics (water pills), flecainide (Tambocor); insulin or oral medications for diabetes; lithium (Eskalith, Lithobid); medications for anxiety and Parkinson's disease; medications for mental illness such as clozapine (Clozaril), haloperidol (Haldol), and pimozide (Orap); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); medications for seizures such as carbamazepine (Tegretol) and phenytoin (Dilantin); sedatives; sibutramine (Meridia); sleeping pills; tramadol (Ultram); tranquilizers; and vinblastine (Velban). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor what nutritional supplements you are taking, especially products that contain St. John's wort or tryptophan.
- tell your doctor if you are being treated with electroshock therapy (procedure in which small electric shocks are administered to the brain to treat certain mental illnesses), if you have recently had a heart attack and if you have or have ever had diabetes, seizures, or liver or heart disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking fluoxetine, call your doctor.
- you should know that fluoxetine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- remember that alcohol can add to the drowsiness caused by this medication.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Fluoxetine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- nervousness
- nausea
- dry mouth
- sore throat
- drowsiness
- weakness
- uncontrollable shaking of a part of the body
- loss of appetite
- weight loss
- changes in sex drive or ability
- excessive sweating
Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- rash
- hives
- fever
- joint pain
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
- seeing things or hearing voices that do not exist (hallucinating)
- seizures
Fluoxetine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- unsteadiness
- confusion
- unresponsiveness
- nervousness
- uncontrollable shaking of a part of the body
- dizziness
- rapid, irregular, or pounding heartbeat
- seeing things or hearing voices that do not exist (hallucinating)
- fever
- fainting
- coma (loss of consciousness for a period of time)
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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