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Review Sotalol Safety Reports submitted to FDA

Total Sotalol reports: 147.
Sotalol FDA safety alerts: No.
Reported deaths: 27    Reported hospitalizations: 76.
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FDA Reported Sotalol Side Effects: atrial fibrillation, hypotension, electrocardiogram qt prolonged, bradycardia foetal, cardiomegaly, bradycardia, abdominal tenderness, torsade de pointes, depressed level of consciousness, condition aggravated, cardiac failure congestive.
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Showing 1-100 of 147 Next >

Sotalol Side Effects Report #5401093-5
Consumer or non-health professional from UNITED STATES reported SOTALOL problem on July 25, 2007. Male patient, 46 years of age, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: amyotrophic lateral sclerosis, thrombosis, walking aid user. SOTALOL dosage: unknown. During the same period patient was treated with WARFARIN, ATORVASTATIN CALCIUM. Patient recovered.

Sotalol Side Effects Report #5401895-5
SOTALOL problem was reported by a Physician from GERMANY on July 17, 2007. Female patient, weighting 26.46 lb, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: accidental exposure. SOTALOL dosage: 160 MG, 1 DOSE. During the same period patient was treated with ENAHEXAL COMP. Patient recovered.

Sotalol Side Effects Report #5765069-0
Pharmacist from UNITED STATES reported SOTALOL problem on June 06, 2008. Male patient was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: burning sensation, erythema, flushing, formication, paraesthesia, pruritus. SOTALOL dosage: 120 MG TWICE DAILY ORAL. Patient recovered.

Sotalol Side Effects Report #5777440-1
SOTALOL problem was reported by a Consumer or non-health professional from UNITED STATES on June 03, 2008. Male patient, 79 years of age, was diagnosed with cardiac disorder and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, heart rate increased. SOTALOL dosage: 80 MG;BID;PO. During the same period patient was treated with ISOSORBIDE MONONITRATE, OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE, SIMVASTATIN, EZETIMIBE, WARFARIN, ASPIRIN. Patient recovered.


Sotalol Side Effects Report #5788219-9
Consumer or non-health professional from UNITED STATES reported SOTALOL problem on June 13, 2008. Male patient, 83 years of age, was diagnosed with ventricular tachycardia and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: asthenia, dyspnoea, electrocardiogram qt prolonged, gait disturbance, syncope. SOTALOL dosage: 40 MG;TID;PO, 80 MG;BID;PO. During the same period patient was treated with TOPROL, SORINE, ACETYLSALICYLIC ACID SRT, ATORVASTATIN, FINASTERIDE, MAGNESIUM, VITAMINS. Patient recovered.

Sotalol Side Effects Report #5737599-9
SOTALOL problem was reported by a Physician from UNITED STATES on May 12, 2008. Male patient, 78 years of age, weighting 132.3 lb, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: skin ulcer. SOTALOL dosage: unknown. During the same period patient was treated with ACETYLSALICYLIC ACID SRT, FENTANYL CITRATE, GLYCERYL TRINITRATE, FAMOTIDINE, ACETAMINOPHEN AND HYDROCODONE BITARTRATE, SERTRALINE, SIMVASTATIN. Patient recovered.

Sotalol Side Effects Report #5739092-6
Health Professional from TURKEY reported SOTALOL problem on Mar 26, 2008. Male patient, 53 years of age, weighting 187.4 lb, was diagnosed with arrhythmia prophylaxis, palpitations and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: bradycardia, cardiogenic shock, dizziness, hypotension. SOTALOL dosage: unknown. During the same period patient was treated with DILTIAZEM. Patient recovered.

Sotalol Side Effects Report #5751397-1
SOTALOL problem was reported by a Consumer or non-health professional from UNITED STATES on May 16, 2008. Male patient, 83 years of age, was diagnosed with ventricular tachycardia and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: asthenia, dyspnoea, electrocardiogram qt prolonged, gait disturbance, malaise, syncope. SOTALOL dosage: 40 MG;TID;PO : 80 MG;BID;PO. During the same period patient was treated with TOPROL, SORINE, ASPIRIN, ATORVASTATIN, FINASTERIDE, MAGNESIUM, VITAMINS. Patient recovered.

Sotalol Side Effects Report #5692683-3
Consumer or non-health professional from UNITED KINGDOM reported SOTALOL problem on Mar 27, 2008. Female patient, 64 years of age, was diagnosed with atrial fibrillation and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, abdominal pain, abdominal tenderness, atrial fibrillation, blood lactic acid increased, blood potassium increased, bradycardia, cardiac failure. SOTALOL dosage: unknown. During the same period patient was treated with VERAPAMIL, DIGOXIN, PERINDOPRIL ERBUMINE, WARFARIN, FRUMIL. Patient was hospitalized. Patient recovered.


Sotalol Side Effects Report #5692765-6
SOTALOL problem was reported by a Health Professional from BELGIUM on Mar 17, 2008. Female patient, 72 years of age, was diagnosed with atrial fibrillation and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: cerebral ischaemia, hypokalaemia, loss of consciousness, torsade de pointes, ventricular fibrillation. SOTALOL dosage: 320 MG; DAILY. During the same period patient was treated with DILTIAZEM, ACENOCOUMAROL. Patient was hospitalized. Patient died.

Sotalol Side Effects Report #5711381-0
Consumer or non-health professional from UNITED KINGDOM reported SOTALOL problem on Apr 02, 2008. Female patient, 64 years of age, was diagnosed with atrial fibrillation and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, abdominal pain, abdominal tenderness, atrial fibrillation, bradycardia, cardiac failure, cardiomegaly. SOTALOL dosage: unknown. During the same period patient was treated with VERAPAMIL, DIGOXIN, VERAPAMIL HYDROCHLORIDE, PERINDOPRIL ERBUMINE, WARFARIN, FRUMIL. Patient was hospitalized. Patient recovered.

Sotalol Side Effects Report #5714245-1
SOTALOL problem was reported by a Health Professional from TURKEY on Mar 26, 2008. Male patient, 53 years of age, weighting 187.4 lb, was diagnosed with arrhythmia prophylaxis, palpitations and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: bradycardia, cardiogenic shock, dizziness, hypotension. SOTALOL dosage: unknown. During the same period patient was treated with DILTIAZEM. Patient recovered.

Sotalol Side Effects Report #5719667-0
Pharmacist from UNITED STATES reported SOTALOL problem on Apr 25, 2008. Male patient, 84 years of age, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, bradycardia, hyperhidrosis. SOTALOL dosage: 80 MG BID PO. Patient recovered.

Sotalol Side Effects Report #5342491-8
SOTALOL problem was reported by a Physician from FRANCE on May 18, 2007. Male patient, 71 years of age, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: eosinophilia, haemolytic anaemia, hepatitis cholestatic, rash. SOTALOL dosage: unknown. During the same period patient was treated with INDAPAMIDE, ROVAMYCINE, KARDEGIC, ALLOPURINOL, TETRAZEPAM. Patient was hospitalized. Patient recovered.


Sotalol Side Effects Report #5344331-X
Physician from JAPAN reported SOTALOL problem on May 22, 2007. Male patient, 58 years of age, was diagnosed with ventricular tachycardia and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease. SOTALOL dosage: 40 MG, 1X/DAY. During the same period patient was treated with SOTALOL HYDROCHLORIDE, AMIODARONE, PREDNISOLONE, ASPIRIN, ITOROL, HERBESSOR R, TICLOPIDINE, LIPITOR. Patient was hospitalized. Patient recovered.

Sotalol Side Effects Report #5347983-3
SOTALOL problem was reported by a Physician from JAPAN on May 16, 2007. Male patient, 71 years of age, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure. SOTALOL dosage: 120 MG, 2X/DAY. During the same period patient was treated with ACECOL, ZYLORIC, SELBEX, GASTER D. Patient was hospitalized. Patient recovered.

Sotalol Side Effects Report #5367096-4
Pharmacist from UNITED STATES reported SOTALOL problem on June 20, 2007. Male patient, 62 years of age, was diagnosed with atrial flutter, hypertension, supraventricular tachycardia and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: hypotension, renal failure acute. SOTALOL dosage: 120MG BID PO. During the same period patient was treated with SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE. Patient was hospitalized. Patient recovered.

Sotalol Side Effects Report #5370838-5
SOTALOL problem was reported by a Consumer or non-health professional from UNITED STATES on June 25, 2007. Female patient, 54 years of age, weighting 143.3 lb, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: hypotension, overdose, suicide attempt. SOTALOL dosage: unknown. During the same period patient was treated with CAPTOPRIL AND HYDROCHLOROTHIAZIDE, INSIDON. Patient recovered.

Sotalol Side Effects Report #5370913-5
Consumer or non-health professional from AUSTRALIA reported SOTALOL problem on June 14, 2007. Male patient, 54 years of age, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: atelectasis, cardiac disorder, pulmonary oedema. SOTALOL dosage: 80 MG, 2X/DAY. During the same period patient was treated with ALLOPURINOL. Patient recovered.


Sotalol Side Effects Report #5375485-7
SOTALOL problem was reported by a Physician from JAPAN on June 19, 2007. Male patient, 68 years of age, was diagnosed with ventricular tachycardia and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage, cerebral infarction. SOTALOL dosage: 80 MG, 1X/DAY. During the same period patient was treated with ARTIST, BLOPRESS, DIART, NITROL, NORVASC, TICLOPIDINE. Patient died.

Sotalol Side Effects Report #5318358-8
Physician from JAPAN reported SOTALOL problem on Apr 24, 2007. Male patient, 75 years of age, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: renal failure chronic, sinus arrest. SOTALOL dosage: 40 MG, 2X/DAY. During the same period patient was treated with LASIX, KALIMATE, KREMEZIN. Patient recovered.

Sotalol Side Effects Report #5318362-X
SOTALOL problem was reported by a Physician from JAPAN on Apr 24, 2007. Male patient, 71 years of age, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure. SOTALOL dosage: 120 MG, 2X/DAY. During the same period patient was treated with ACECOL, ZYLORIC, SELBEX, GASTER D. Patient was hospitalized. Patient recovered.

Sotalol Side Effects Report #5326697-X
Consumer or non-health professional from GERMANY reported SOTALOL problem on May 04, 2007. Female patient, 70 years of age, was diagnosed with thyroid disorder and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: breast discomfort, breast enlargement. SOTALOL dosage: 80 MG, 1X/DAY. During the same period patient was treated with EUTHYROX, METOHEXAL. Patient recovered.

Sotalol Side Effects Report #5330369-5
SOTALOL problem was reported by a Physician from JAPAN on May 07, 2007. Male patient, 82 years of age, was diagnosed with ventricular tachycardia and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: cerebral infarction. SOTALOL dosage: 40 MG, 1X/DAY. During the same period patient was treated with ARTIST, DIOVAN. Patient died on 08/20/2006.

Sotalol Side Effects Report #5330759-0
Physician from UNITED KINGDOM reported SOTALOL problem on May 09, 2007. Female patient, 86 years of age, was diagnosed with cardioversion, atrial fibrillation and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: electrocardiogram qt prolonged, electrocardiogram t wave inversion, torsade de pointes. SOTALOL dosage: 40 MG, 1X/DAY. During the same period patient was treated with DIGOXIN, METOPROLOL SUCCINATE. Patient was hospitalized. Patient recovered.

Sotalol Side Effects Report #5333871-5
SOTALOL problem was reported by a Physician from GERMANY on May 12, 2007. Female patient, 54 years of age, weighting 143.3 lb, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: hypotension, intentional overdose, suicide attempt. SOTALOL dosage: 2400 MG, 1 DOSE. During the same period patient was treated with INSIDON, CAPTOPRIL, HYDROCHLOROTHIAZIDE. Patient recovered.

Sotalol Side Effects Report #5337331-7
Physician from JAPAN reported SOTALOL problem on May 16, 2007. Male patient, 71 years of age, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure. SOTALOL dosage: 120 MG, 2X/DAY. During the same period patient was treated with ACECOL, ZYLORIC, SELBEX, GASTER D. Patient was hospitalized. Patient recovered.

Sotalol Side Effects Report #5337333-0
SOTALOL problem was reported by a Physician from JAPAN on May 17, 2007. Male patient, 58 years of age, was diagnosed with ventricular tachycardia and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease. SOTALOL dosage: 40 MG, 2X/DAY. During the same period patient was treated with AMIODARONE. Patient was hospitalized. Patient recovered.

Sotalol Side Effects Report #5337367-6
Physician from JAPAN reported SOTALOL problem on May 16, 2007. Male patient, 68 years of age, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure, hepatic function abnormal, platelet count decreased. SOTALOL dosage: 120 MG, 2X/DAY. During the same period patient was treated with ACECOL, SELBEX, ZYLORIC, GASTER D. Patient was hospitalized. Patient recovered.

Sotalol Side Effects Report #5341391-7
SOTALOL problem was reported by a Physician from POLAND on May 15, 2007. Female patient, 72 years of age, was diagnosed with palpitations and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: abdominal pain, bezoar, bile output, blood potassium increased, duodenogastric reflux, gastritis erosive, helicobacter pylori identification test positive, hypotension, malaise. SOTALOL dosage: 160 MG, ORAL. During the same period patient was treated with KALDYUM, RELANIUM. Patient recovered.

Sotalol Side Effects Report #5343688-3
Pharmacist from UNITED STATES reported SOTALOL problem on May 31, 2007. Male patient, weighting 179.0 lb, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation. SOTALOL dosage: 160MG TWICE/DAY ORAL. Patient recovered.

Sotalol Side Effects Report #5285366-5
SOTALOL problem was reported by a Consumer or non-health professional from GERMANY on Mar 23, 2007. Male patient, 52 years of age, weighting 176.4 lb, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: intentional overdose, neurological symptom, suicide attempt. SOTALOL dosage: unknown. During the same period patient was treated with SOTALOL HYDROCHLORIDE, STILNOX. Patient recovered.

Sotalol Side Effects Report #5291204-7
Physician from GERMANY reported SOTALOL problem on Mar 29, 2007. Female patient, weighting 156.5 lb, was diagnosed with arrhythmia, influenza and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: cardiac discomfort, dyspnoea, influenza, pyrexia. SOTALOL dosage: unknown. During the same period patient was treated with TAMIFLU. Patient recovered.

Sotalol Side Effects Report #5292666-1
SOTALOL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 22, 2007. Female patient, 73 years of age, was diagnosed with cardiac disorder, diabetes mellitus non-insulin-dependent and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, hypoglycaemia, nausea. SOTALOL dosage: 80 MG; TWICE A DAY; ORAL. During the same period patient was treated with INSULIN GLARGINE, TRIAMTERENE AND HYDROCHLOROTHIAZIDE, LOSARTAN POSTASSIUM, AMITRIPTYLINE HYDROCHLORIDE, WARFARIN, OPTICLIK, ALPRAZOLAM. Patient recovered.

Sotalol Side Effects Report #5293667-X
Physician from FRANCE reported SOTALOL problem on Apr 04, 2007. Male patient, 19 years of age, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: renal aplasia, testicular disorder. SOTALOL dosage: 80 MG, 2X/DAY. Patient recovered.

Sotalol Side Effects Report #5300523-7
SOTALOL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 13, 2007. Female patient, weighting 250.0 lb, was diagnosed with palpitations and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: back pain, dizziness, dyspnoea exertional, fatigue, oedema peripheral, stress. SOTALOL dosage: unknown. Patient recovered.

Sotalol Side Effects Report #5254422-X
Physician from ITALY reported SOTALOL problem on Feb 26, 2007. Male patient, 82 years of age, was diagnosed with atrial fibrillation and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: retrograde amnesia, supraventricular extrasystoles, supraventricular tachycardia, syncope. SOTALOL dosage: 80 MG, UNK. Patient recovered.

Sotalol Side Effects Report #5255520-7
SOTALOL problem was reported by a Consumer or non-health professional from DENMARK on Feb 21, 2007. Female patient, 74 years of age, was diagnosed with hypertension and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: gangrene, skin discolouration. SOTALOL dosage: 80 MG, 2X/DAY. During the same period patient was treated with CAPOTEN, CENTYL. Patient recovered.

Sotalol Side Effects Report #5259286-6
Physician from FRANCE reported SOTALOL problem on Feb 26, 2007. Female patient, 81 years of age, was diagnosed with cardiac disorder and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: arrhythmia, bundle branch block left, candidiasis, diabetic hyperosmolar coma, multi-organ disorder, pancreatitis. SOTALOL dosage: unknown. During the same period patient was treated with KARDEGIC, EXELON, MEMANTINE. Patient was hospitalized. Patient recovered.

Sotalol Side Effects Report #5259668-2
SOTALOL problem was reported by a Pharmacist from UNITED STATES on Mar 07, 2007. Male patient, 70 years of age, weighting 194.0 lb, was diagnosed with atrial fibrillation, atrial flutter, coronary artery disease, hypertension and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, atrial flutter, bradycardia, myocardial infarction. SOTALOL dosage: 80MG BID PO. During the same period patient was treated with METOPROLOL TARTRATE, METOPROLOL TARTRATE. Patient was hospitalized. Patient recovered.

Sotalol Side Effects Report #5260945-X
Physician from FRANCE reported SOTALOL problem on Feb 28, 2007. Male patient was diagnosed with tachyarrhythmia and was treated with SOTALOL. SOTALOL dosage: 80 MG, 1X/DAY. Patient died.

Sotalol Side Effects Report #5262302-9
SOTALOL problem was reported by a Consumer or non-health professional from FRANCE on Mar 07, 2007. Female patient, 81 years of age, weighting 132.3 lb, was diagnosed with heart rate abnormal, dementia alzheimer's type and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood amylase increased, blood creatine phosphokinase increased, blood creatinine increased, blood sodium increased, blood urea increased, bundle branch block left, candiduria. SOTALOL dosage: unknown. During the same period patient was treated with KARDEGIC, MEMANTINE, EXELON. Patient was hospitalized. Patient recovered.

Sotalol Side Effects Report #5265315-6
Consumer or non-health professional from SWITZERLAND reported SOTALOL problem on Mar 01, 2007. Male patient, 81 years of age, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: blood pressure systolic increased, dehydration, hyponatraemia, hypotension, presyncope. SOTALOL dosage: unknown. During the same period patient was treated with CIBADREX, DANCOR, NITRODERM, ASPERGIC, PLAVIX. Patient was hospitalized. Patient recovered.

Sotalol Side Effects Report #5277595-1
SOTALOL problem was reported by a Consumer or non-health professional from GERMANY on Mar 15, 2007. Male patient, 52 years of age, weighting 176.4 lb, was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: intentional overdose, suicide attempt, unevaluable event. SOTALOL dosage: unknown. During the same period patient was treated with SOTALOL HYDROCHLORIDE, STILNOX. Patient recovered.

Sotalol Side Effects Report #5277597-5
Physician from UNITED KINGDOM reported SOTALOL problem on Mar 16, 2007. Female patient, 64 years of age, was diagnosed with atrial fibrillation and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: abdominal tenderness, atrial fibrillation, bowel sounds abnormal, bradycardia, cardiac failure, cardiomegaly, cough, depressed level of consciousness. SOTALOL dosage: unknown. During the same period patient was treated with DIGOXIN, WARFARIN, VERAPAMIL, PERINDOPRIL ERBUMINE, SECURON, FRUMIL. Patient was hospitalized. Patient recovered.

Sotalol Side Effects Report #5282642-7
SOTALOL problem was reported by a Physician from UNITED KINGDOM on Mar 22, 2007. Female patient, 86 years of age, was diagnosed with cardioversion and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, electrocardiogram qt prolonged, electrocardiogram t wave inversion, fall, torsade de pointes. SOTALOL dosage: 40 MG, 1X/DAY. Patient was hospitalized. Patient recovered.

Sotalol Side Effects Report #5286748-8
Consumer or non-health professional from UNITED KINGDOM reported SOTALOL problem on Mar 16, 2007. Female patient, 64 years of age, was diagnosed with atrial fibrillation and was treated with SOTALOL. After drug was administered, patient experienced the following problems/side effects: abdominal pain, abdominal tenderness, aortic dissection, atrial fibrillation, bowel sounds abnormal, bradycardia, cardiomegaly, cough. SOTALOL dosage: unknown. During the same period patient was treated with DIGOXIN, VERAPAMIL HYDROCHLORIDE, WARFARIN, FRUMIL, PERINDOPRIL ERBUMINE. Patient was hospitalized. Patient recovered.

Showing 1-100 of 147 Next >


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