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Review Tofranil Safety Reports submitted to FDA

Total Tofranil reports: 31.
Tofranil FDA safety alerts: No.
   Reported hospitalizations: 23.
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FDA Reported Tofranil Side Effects: liver disorder, aspartate aminotransferase increased, alanine aminotransferase increased, pyrexia, blood alkaline phosphatase increased, insomnia, somnolence, gamma-glutamyltransferase increased, overdose, blood lactate dehydrogenase increased, glossoptosis.
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Tofranil Side Effects Report #5650738-3
Consumer or non-health professional from BRAZIL reported TOFRANIL problem on Feb 26, 2008. Male patient, 33 years of age, weighting 132.3 lb, was diagnosed with affective disorder and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: asthenopia, scotoma, vision blurred. TOFRANIL dosage: 75 MG/DAY. During the same period patient was treated with RIVOTRIL. Patient recovered.

Tofranil Side Effects Report #5657407-4
TOFRANIL problem was reported by a Pharmacist from JAPAN on Mar 05, 2008. Male patient was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: parkinson's disease. TOFRANIL dosage: 25 MG/DAY. During the same period patient was treated with ANTIHYPERTENSIVES. Patient recovered.

Tofranil Side Effects Report #5659081-X
Pharmacist from JAPAN reported TOFRANIL problem on Mar 05, 2008. Male patient was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: parkinson's disease. TOFRANIL dosage: 25 MG/DAY. During the same period patient was treated with ANTIHYPERTENSIVES. Patient recovered.

Tofranil Side Effects Report #5669713-8
TOFRANIL problem was reported by a Pharmacist from JAPAN on Mar 07, 2008. Male patient, 71 years of age, was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: parkinson's disease. TOFRANIL dosage: 25 MG/DAY. During the same period patient was treated with ANTIHYPERTENSIVES, EURODIN, BETAMAC, ESIDRI. Patient recovered.

Tofranil Side Effects Report #5676108-X
Consumer or non-health professional from reported TOFRANIL problem on Mar 13, 2008. Male patient, 31 years of age, weighting 180.8 lb, was diagnosed with depression and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: burning sensation, depression, muscle rigidity, pain in extremity, vein disorder. TOFRANIL dosage: unknown. Patient recovered.

Tofranil Side Effects Report #5641802-3
TOFRANIL problem was reported by a Physician from JAPAN on Feb 19, 2008. Female patient was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: electrocardiogram abnormal, intentional overdose, suicide attempt. TOFRANIL dosage: unknown. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5571476-1
Consumer or non-health professional from JAPAN reported TOFRANIL problem on Dec 13, 2007. Female patient, 54 years of age, was diagnosed with major depression and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: cerebrovascular disorder, condition aggravated, decreased appetite, hallucination, auditory, nystagmus, vertigo positional. TOFRANIL dosage: 75 MG/D. During the same period patient was treated with MILNACIPRAN HYDROCHLORIDE, MILNACIPRAN HYDROCHLORIDE, MILNACIPRAN HYDROCHLORIDE, AMOXAPINE. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5572884-5
TOFRANIL problem was reported by a Consumer or non-health professional from JAPAN on Dec 20, 2007. Female patient, 32 years of age, weighting 99.21 lb, was diagnosed with depression and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: arrhythmia, blood pressure decreased, cardio-respiratory arrest, depressed level of consciousness, glossoptosis, intubation, life support, overdose, shock. TOFRANIL dosage: unknown. During the same period patient was treated with TRIAZOLAM, CLOXAZOLAM, BROMAZEPAM, FLUNITRAZEPAM. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5577612-5
Physician from UNITED STATES reported TOFRANIL problem on Dec 21, 2007. Female patient, weighting 7.80 lb, was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: aspartate aminotransferase increased, blood lactate dehydrogenase increased, decreased activity, foetal distress syndrome, hypertonia neonatal, irritability, leukocytosis. TOFRANIL dosage: MATERNAL DOSE 25 MG TID. During the same period patient was treated with RESLIN, AMOXAPINE, SOLANAX. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5578606-6
TOFRANIL problem was reported by a Consumer or non-health professional from JAPAN on Dec 28, 2007. Female patient, 32 years of age, weighting 99.21 lb, was diagnosed with depression and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: arrhythmia, blood pressure decreased, cardio-respiratory arrest, depressed level of consciousness, glossoptosis, intubation, life support, overdose, shock. TOFRANIL dosage: unknown. During the same period patient was treated with TRIAZOLAM, CLOXAZOLAM, BROMAZEPAM, FLUNITRAZEPAM. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5521688-8
Pharmacist from JAPAN reported TOFRANIL problem on Nov 15, 2007. Female patient, 58 years of age, weighting 108.0 lb, was diagnosed with depression, anxiety and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: anxiety, brain natriuretic peptide increased, depressed level of consciousness, dyspnoea, hyperglycaemia, insomnia, loss of consciousness, malaise, mental disorder. TOFRANIL dosage: 20 MG/D. During the same period patient was treated with AMOXAPINE, SEPAZON. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5476873-0
TOFRANIL problem was reported by a Consumer or non-health professional from SPAIN on Oct 01, 2007. Female patient, 50 years of age, was diagnosed with major depression and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, haemodialysis, rhabdomyolysis, serotonin syndrome. TOFRANIL dosage: 150 MG/DAY. During the same period patient was treated with VENLAFAXINE, TRANKIMAZIN, CINITAPRIDE, ZYPREXA, RABEPRAZOLE, ANAFRANIL. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5479166-0
Consumer or non-health professional from JAPAN reported TOFRANIL problem on Sept 28, 2007. Female patient, 54 years of age, was diagnosed with major depression and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: cerebrovascular disorder, condition aggravated, decreased appetite, hallucination, auditory, nystagmus, vertigo positional. TOFRANIL dosage: 50 MG/D. During the same period patient was treated with MILNACIPRAN HYDROCHLORIDE, MILNACIPRAN HYDROCHLORIDE, MILNACIPRAN HYDROCHLORIDE, AMOXAPINE. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5480117-3
TOFRANIL problem was reported by a Physician from JAPAN on Oct 01, 2007. Female patient, 48 years of age, was diagnosed with irritable bowel syndrome and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, anorexia, aspartate aminotransferase increased, blood lactate dehydrogenase increased, human herpes virus 6 serology positive, liver disorder, pyrexia. TOFRANIL dosage: unknown. During the same period patient was treated with POLYCARBOPHIL CALCIUM, THIATON, LANSOPRAZOLE, SEDIEL, TRANCOLON. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5490401-5
Consumer or non-health professional from BRAZIL reported TOFRANIL problem on Oct 15, 2007. Female patient, 30 years of age, weighting 174.2 lb, was diagnosed with panic disorder, nervousness, hypertension and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: abdominal pain, agitation, alopecia, arrhythmia, constipation, dry mouth, ear operation, euphoric mood, feeling hot. TOFRANIL dosage: 25 MG, 5QD. During the same period patient was treated with LORAX, ATENOLOL W. Patient recovered.

Tofranil Side Effects Report #5441313-4
TOFRANIL problem was reported by a Consumer or non-health professional from JAPAN on Aug 30, 2007. Female patient, 32 years of age, weighting 99.21 lb, was diagnosed with depression and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: arrhythmia, blood pressure decreased, cardio-respiratory arrest, depressed level of consciousness, electrocardiogram qt prolonged, glossoptosis, intubation, life support, overdose. TOFRANIL dosage: unknown. During the same period patient was treated with TRIAZOLAM, CLOXAZOLAM, BROMAZEPAM, FLUNITRAZEPAM. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5441322-5
Physician from JAPAN reported TOFRANIL problem on Aug 27, 2007. Female patient, 48 years of age, was diagnosed with irritable bowel syndrome and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, anorexia, aspartate aminotransferase increased, blood lactate dehydrogenase increased, human herpes virus 6 serology positive, liver disorder, pyrexia. TOFRANIL dosage: unknown. During the same period patient was treated with POLYCARBOPHIL CALCIUM, THIATON, LANSOPRAZOLE, SEDIEL, TRANCOLON. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5443066-2
TOFRANIL problem was reported by a Pharmacist from JAPAN on Aug 29, 2007. Female patient, 58 years of age, was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, hyperglycaemia, loss of consciousness, tachycardia. TOFRANIL dosage: 20 MG/D. During the same period patient was treated with AMOXAN, SEPAZON. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5409270-4
Consumer or non-health professional from BRAZIL reported TOFRANIL problem on Aug 03, 2007. Female patient, 45 years of age, weighting 105.8 lb, was diagnosed with epilepsy, procedural pain and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: aphthous stomatitis, dyskinesia, insomnia, somnolence. TOFRANIL dosage: 25 MG, BID. During the same period patient was treated with GARDAN, TENOXICAM, CYCLOBENZAPRINE, RANITIDINE. Patient recovered.

Tofranil Side Effects Report #5411937-9
TOFRANIL problem was reported by a Health Professional from UNITED STATES on Aug 09, 2007. Female patient was diagnosed with depression, migraine and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: agitation, depression, dizziness, migraine. TOFRANIL dosage: 10MG 35-45 MG HS PO 20MG 35-45 MG HS PO ON/OFF. Patient recovered.

Tofranil Side Effects Report #5451006-5
Consumer or non-health professional from UNITED STATES reported TOFRANIL problem on July 20, 2006. Female patient, 47 years of age, weighting 278.0 lb, was diagnosed with sleep disorder and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: delusion, depression, insomnia, poor quality sleep, restlessness, somnolence. TOFRANIL dosage: 25 MG, 3-4 TABLETS AT NIGHT, QD, ORAL. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5381629-3
TOFRANIL problem was reported by a Consumer or non-health professional from JAPAN on June 27, 2007. Female patient, 32 years of age, was diagnosed with depression and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, glossoptosis, overdose, shock, ventricular tachycardia. TOFRANIL dosage: unknown. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5388943-6
Consumer or non-health professional from BRAZIL reported TOFRANIL problem on July 09, 2007. Female patient, 33 years of age, weighting 141.1 lb, was diagnosed with depression, alcoholism, anxiety and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: cataract, erythema, headache, mass, mydriasis, poisoning. TOFRANIL dosage: 75 MG/D. During the same period patient was treated with DISULFIRAM, RIVOTRIL, NEOZINE, CHLORDIAZEPOXIDE, BIOTONICO. Patient recovered.

Tofranil Side Effects Report #5388955-2
TOFRANIL problem was reported by a Consumer or non-health professional from JAPAN on July 09, 2007. Female patient, 32 years of age, was diagnosed with depression and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, electrocardiogram qt prolonged, glossoptosis, overdose, shock, ventricular tachycardia. TOFRANIL dosage: unknown. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5391147-4
Consumer or non-health professional from FRANCE reported TOFRANIL problem on July 10, 2007. Female patient, 17 years of age, weighting 119.0 lb, was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: blepharospasm, conversion disorder, myoclonus. TOFRANIL dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PRIMPERAN. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5396218-4
TOFRANIL problem was reported by a Physician from JAPAN on July 18, 2007. Female patient, 48 years of age, was diagnosed with irritable bowel syndrome and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, liver disorder, pyrexia. TOFRANIL dosage: unknown. During the same period patient was treated with POLYCARBOPHIL CALCIUM, THIATON, LANSOPRAZOLE. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5381629-3
Consumer or non-health professional from JAPAN reported TOFRANIL problem on June 27, 2007. Female patient, 32 years of age, was diagnosed with depression and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, glossoptosis, overdose, shock, ventricular tachycardia. TOFRANIL dosage: unknown. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5388943-6
TOFRANIL problem was reported by a Consumer or non-health professional from BRAZIL on July 09, 2007. Female patient, 33 years of age, weighting 141.1 lb, was diagnosed with depression, alcoholism, anxiety and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: cataract, erythema, headache, mass, mydriasis, poisoning. TOFRANIL dosage: 75 MG/D. During the same period patient was treated with DISULFIRAM, RIVOTRIL, NEOZINE, CHLORDIAZEPOXIDE, BIOTONICO. Patient recovered.

Tofranil Side Effects Report #5388955-2
Consumer or non-health professional from JAPAN reported TOFRANIL problem on July 09, 2007. Female patient, 32 years of age, was diagnosed with depression and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, electrocardiogram qt prolonged, glossoptosis, overdose, shock, ventricular tachycardia. TOFRANIL dosage: unknown. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5391147-4
TOFRANIL problem was reported by a Consumer or non-health professional from FRANCE on July 10, 2007. Female patient, 17 years of age, weighting 119.0 lb, was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: blepharospasm, conversion disorder, myoclonus. TOFRANIL dosage: 20 MG, ONCE/SINGLE. During the same period patient was treated with PRIMPERAN. Patient was hospitalized. Patient recovered.

Tofranil Side Effects Report #5396218-4
Physician from JAPAN reported TOFRANIL problem on July 18, 2007. Female patient, 48 years of age, was diagnosed with irritable bowel syndrome and was treated with TOFRANIL. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, liver disorder, pyrexia. TOFRANIL dosage: unknown. During the same period patient was treated with POLYCARBOPHIL CALCIUM, THIATON, LANSOPRAZOLE. Patient was hospitalized. Patient recovered.


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