This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Trandate (Labetalol) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (16)
Death (1)
Reports by Reaction Type
Foetal Growth Restriction (7),
Leukocytoclastic Vasculitis (5),
Maternal Exposure Timing Unspecified (3),
Foetal Exposure During Pregnancy (2),
Vascular Purpura (2),
Premature Baby (2),
Renal Impairment (2),
Renal Injury (1),
Creatinine Renal Clearance Decreased (1),
Hypoglycaemia (1),
Coma (1),
HIV Infection (1)
Possible Trandate side effects in 64 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-05-07
Patient: 64 year old male
Reactions: Leukocytoclastic Vasculitis, Renal Impairment
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldactazine (Aldaztazine - Althiazide / Spironolactone) 1 DF (Not Spec
Dosage: 1 df qd oral
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Digoxin
Dosage: df oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2008-10-01
Omeprazole
Dosage: 1 df qd oral
Administration route: Oral
Indication: Gastritis
Start date: 2008-10-01
Levothyroxine Sodium
Dosage: 1 df qd oral
Administration route: Oral
Indication: Hypothyroidism
Start date: 2008-10-01
Trandate
Dosage: 10 mg qd oral
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Allopurinol
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Gout
Start date: 2008-10-01
End date: 2012-03-23
Diamicron (Diamicron - Gliclazide) 30 MG (Not Specified)
Dosage: 30 mg tablet, 4 tablets in the morning oral
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2008-10-01
Influenza Virus (Influenza Immunization) 1 DF (Not Specified)
Dosage: 1 df 1x
Indication: Influenza Immunisation
Start date: 2011-11-01
End date: 2011-11-01
Enalapril Maleate
Dosage: 20 mg qd oral
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Sintrom
Dosage: 4 mg, frequency unknown oral
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2008-10-01
Glucophage
Dosage: df oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2008-10-01
Lercan (Lercan - Lercanidipine / Spironolactone) 10 MG (Not Specified
Dosage: 10 mg qd, oral
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Lasilix (Lasilix Furosemide) 40 MG (Not Specified)
Dosage: 40 mg, taken 1 to 4 tablets per day oral
Administration route: Oral
Indication: Cardiac Failure
Start date: 2008-10-01
Possible Trandate side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-05-03
Patient: male
Reactions: Leukocytoclastic Vasculitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diamicron
Dosage: 4 tablets in the morning
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2008-10-01
Allopurinol
Administration route: Oral
Indication: Gout
Start date: 2008-10-01
End date: 2012-03-23
Aldactazine
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Lasix
Dosage: 1-several tabs/day
Administration route: Oral
Indication: Cardiac Failure
Start date: 2010-10-01
Enalapril Maleate
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Glucophage
Administration route: Oral
Indication: Diabetes Mellitus
Start date: 2008-10-01
Sintrom
Dosage: 1 + 1/4 df or 1 df every other day
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2008-10-01
Levothyroxine Sodium
Indication: Hypothyroidism
Start date: 2008-10-01
Digoxin
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Lercanidipine
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Trandate
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Influvac
Indication: Antiviral Prophylaxis
Start date: 2011-11-01
End date: 2011-11-01
Omeprazole
Administration route: Oral
Indication: Gastritis
Start date: 2008-10-01
Possible Trandate side effects in 64 year old male
Reported by a individual with unspecified qualification from France on 2012-04-30
Patient: 64 year old male
Reactions: Renal Impairment, Vascular Purpura
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Influvac (Influenza Virus Vaccine Polyvalet) (Influenza Virus Surface
Dosage: 0.0027 df (1 df, 1 in 1 in 1 y), intramuscular
Indication: Influenza Immunisation
Start date: 2011-11-01
Renitec (Enalapril) (20 MG, Oral Lyophilisate) (Enalapril)
Dosage: 1 df (1 df, 1 in 1 d), oral
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Diamicron (Gliclazide) (30 MG, Modified-Release Tablet) (Gliclazide)
Dosage: 4 df (4 df, morning), oral
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2008-10-01
Sinrom (Acenociymarol) (4 MG, Tablet) (Acenocoumarol)
Dosage: 1.25 df and 1df alternately, oral
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2008-10-01
Glucophage
Dosage: oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2008-10-01
Allopurinol
Dosage: 1 df (1 df, 1 in 1 d), oral
Administration route: Oral
Indication: Gout
Start date: 2008-10-01
End date: 2012-03-23
Lercan (Lercanidioube Hydrochloride) (10 MG, Film-Coated Talbet) (Lerc
Dosage: 1 df (1 df, 1 in 1 d), oral
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Aldactazide
Dosage: 1 df (1 df, 1 in 1 d),oral
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Omeprazole
Dosage: 1 df (1 df, 1 in 1d), oral
Administration route: Oral
Indication: Gastritis
Start date: 2008-10-01
Trandate
Dosage: 3 df (1 df, 3 in 1 d), oral
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Levothyroxine Sodium
Dosage: 1 df (1 df, 1 in 1d),oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2008-10-01
Furosemide
Dosage: from 1 df to several df depending on respiratory conditions, oral
Administration route: Oral
Indication: Cardiac Failure
Start date: 2010-10-01
Digoxin
Dosage: oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2008-10-01
Possible Trandate side effects in 64 year old male
Reported by a consumer/non-health professional from Germany on 2012-04-27
Patient: 64 year old male
Reactions: Leukocytoclastic Vasculitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levothyroxine Sodium
Dosage: 200 mcg tabs
Administration route: Oral
Start date: 2008-10-01
Allopurinol
Dosage: 200mg tabs
Administration route: Oral
Start date: 2008-10-01
End date: 2012-03-23
Enalapril Maleate
Dosage: 20mg oral lyophilisate
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Influvac
Dosage: 0.0027 df
Indication: Influenza Immunisation
Start date: 2011-11-01
Omeprazole
Administration route: Oral
Indication: Gastritis
Start date: 2008-10-01
Glucophage
Administration route: Oral
Start date: 2008-10-01
Lasix
Dosage: 40mg tabs 1df to several df depending on respiratory conditions
Administration route: Oral
Indication: Cardiac Failure
Start date: 2010-10-01
Diamicron
Dosage: 1df:4 dosage form 30mg modified release tablet
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2008-10-01
Spironolactone
Dosage: film coated tabs
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Trandate
Dosage: 200mg film coated tabs
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Lercanidipine
Dosage: 10mg film coated tabs
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Digoxin
Administration route: Oral
Start date: 2008-10-01
Sintrom
Dosage: 1df:1.25 df and 1df alternately 4mg tabs
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Possible Trandate side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-25
Patient: male
Reactions: Leukocytoclastic Vasculitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Enalapril Maleate
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Levothyroxine Sodium
Administration route: Oral
Indication: Hypothyroidism
Start date: 2008-10-01
Sintrom
Dosage: 1 + 1/4 df or 1 df every other day
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2008-10-01
Digoxin
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Allopurinol
Administration route: Oral
Indication: Gout
Start date: 2008-10-01
End date: 2012-03-23
Influvac
Indication: Antiviral Prophylaxis
Start date: 2011-09-01
End date: 2011-09-01
Omeprazole
Administration route: Oral
Indication: Gastritis
Start date: 2008-10-01
Diamicron
Administration route: Oral
Indication: Diabetes Mellitus
Start date: 2008-10-01
Lasix
Administration route: Oral
Indication: Cardiac Failure
Start date: 2010-10-01
Lercanidipine
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Trandate
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Glucophage
Administration route: Oral
Indication: Diabetes Mellitus
Start date: 2008-10-01
Spironolactone
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Possible Trandate side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-24
Patient: male
Reactions: Renal Injury, Leukocytoclastic Vasculitis, Creatinine Renal Clearance Decreased, Vascular Purpura
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Allopurinol
Dosage: 1 df, qd
Administration route: Oral
Indication: Gout
Start date: 2008-10-01
End date: 2012-03-23
Trandate
Dosage: 1 df, tid
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Enalapril Maleate
Dosage: 1 df, daily
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Lercanidipine
Dosage: 1 df, daily
Indication: Hypertension
Start date: 2008-10-01
Lasix
Dosage: 1 df, prn
Administration route: Oral
Indication: Cardiac Failure
Start date: 2008-10-01
End date: 2010-10-01
Aldactazide
Dosage: 1 df, daily
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-01
Sintrom
Dosage: 1.25df and 1df taken alternatively per day
Administration route: Oral
Start date: 2008-10-01
Omeprazole
Dosage: 1 df, daily
Administration route: Oral
Indication: Gastritis
Start date: 2008-10-01
Influvac
Dosage: 1 df, per year
Start date: 2011-11-01
Levothyroxine Sodium
Dosage: 1 df, daily
Administration route: Oral
Start date: 2008-10-01
Diamicron
Dosage: 4 df, daily in the morning
Indication: Type 2 Diabetes Mellitus
Start date: 2008-10-01
Digoxin
Administration route: Oral
Start date: 2008-10-01
Glucophage
Administration route: Oral
Start date: 2008-10-01
Possible Trandate side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-16
Patient: female
Reactions: Foetal Growth Restriction, Premature Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Insulatard NPH Human
Dosage: (8 iu in morning, 4 iu in evening)
Indication: Diabetes Mellitus
End date: 2011-06-30
Aspirin
Dosage: 75 mg, qd
End date: 2011-06-30
Tacrolimus
Dosage: unk
End date: 2011-06-30
Amaryl
Dosage: 5 mg, qd
End date: 2011-06-30
Pravastatin
Dosage: 10 mg, qd
End date: 2011-06-30
Azathioprine
Dosage: 50 mg
End date: 2011-06-30
Prednisone TAB
Dosage: 6 mg, qd
End date: 2011-06-30
Colistin Sulfate
Dosage: unk
End date: 2011-06-30
Trandate
Dosage: unk
End date: 2011-06-30
Mucomyst
Dosage: 600 mg, qd
End date: 2011-06-30
Other drugs received by patient: Sterogyl / 00107901 /; Caltrate / 00751519 /; Ursolvan; Toco; Creon
Possible Trandate side effects in 8 month old female
Reported by a consumer/non-health professional from France on 2012-04-15
Patient: 8 month old female, weighing 1.0 kg (2.2 pounds)
Reactions: Foetal Growth Restriction
Drug(s) suspected as cause:
Imuran
Dosage: film coated tablet
End date: 2011-06-30
Aspirin
Dosage: form: powder for oral solution sachet
End date: 2011-06-30
Amlodipine Besylate
Dosage: capsule
End date: 2011-06-30
Pravastatin
Dosage: form: scored tabs
End date: 2011-06-30
Mucomyst
Dosage: 3 sachets 3 times a day
End date: 2011-06-30
Colimycine
Dosage: 1 df= 1 miu. form: powder and solvent for nebulizer solution
End date: 2011-06-30
Insulatard NPH Human
Dosage: 8iu morning + 4iu evening
End date: 2011-06-30
Tacrolimus
Dosage: increased to 12mg/day on 20may11
End date: 2011-06-30
Trandate
End date: 2011-06-30
Prednisone TAB
End date: 2011-06-30
Other drugs received by patient: Ergocalciferol; Creon; Toco; Calcium Carbonate; Ursolvan
Possible Trandate side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-13
Patient: female
Reactions: Foetal Growth Restriction, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Prednisone TAB
Dosage: 6 mg daily
Tacrolimus
Dosage: unk
Tacrolimus
Dosage: 12 mg daily
Start date: 2011-05-20
Pravastatin
Dosage: 10 mg, 1x/day
Indication: Dyslipidaemia
Mucomyst
Dosage: 600 mg, 3x/day
Imuran
Dosage: 50 mg, 1x/day
Aspirin
Dosage: 75 mg, 1x/day
Insulatard NPH Human
Dosage: 8 iu in the morning and 4 iu in the evening
Indication: Diabetes Mellitus
Trandate
Dosage: 100 mg daily
Indication: Hypertension
Amlodipine Besylate
Dosage: 5 mg, 1x/day
Indication: Hypertension
Colimycine
Dosage: unk
Other drugs received by patient: Toco; Calcium Carbonate; Ergocalciferol; Ursolvan-200; Creon; Aspegic 1000
Possible Trandate side effects in 30 year old female
Reported by a consumer/non-health professional from France on 2012-04-03
Patient: 30 year old female
Reactions: Premature Delivery, Pregnancy, PRE-Eclampsia
Drug(s) suspected as cause:
Colistimethate Sodium
Dosage: 1 df= 1 miu. form: powder and solvent for nebulizer solution
Amlodipine Besylate
Dosage: capsule
Administration route: Oral
Indication: Hypertension
Insulatard NPH Human
Dosage: 8iu morning + 4iu evening
Indication: Diabetes Mellitus
Pravastatin
Dosage: form: scored tabs
Administration route: Oral
Indication: Dyslipidaemia
Mucomyst
Dosage: 3 sachets 3 times a day
Administration route: Oral
Indication: Diabetes Mellitus
Prednisone TAB
Administration route: Oral
End date: 2011-01-27
Tacrolimus
Dosage: increased to 12mg/day on 20may11
Administration route: Oral
End date: 2011-01-27
Imuran
Dosage: film coated tablet
Administration route: Oral
End date: 2011-01-27
Trandate
Administration route: Oral
Indication: Hypertension
Aspirin
Dosage: form: powder for oral solution sachet
Administration route: Oral
Indication: Diabetes Mellitus
Other drugs received by patient: Ergocalciferol; Calcium Carbonate; Creon; Ursolvan; Toco
Possible Trandate side effects in 8 month old female
Reported by a physician from France on 2012-04-03
Patient: 8 month old female, weighing 1.0 kg (2.2 pounds)
Reactions: Foetal Growth Restriction
Drug(s) suspected as cause:
Mucomyst
Dosage: 3 sachets 3 times a day
Insulatard NPH Human
Dosage: 8iu morning + 4iu evening
Pravastatin
Dosage: form: scored tabs
Imuran
Dosage: film coated tablet
End date: 2011-01-27
Trandate
Tacrolimus
Dosage: increased to 12mg/day on 20may11
End date: 2011-01-27
Amlodipine Besylate
Dosage: capsule
Prednisone TAB
End date: 2011-01-27
Colimycine
Dosage: 1 df= 1 miu. form: powder and solvent for nebulizer solution
Aspirin
Dosage: form: powder for oral solution sachet
Other drugs received by patient: Ursolvan; Creon; Toco; Ergocalciferol; Calcium Carbonate
Possible Trandate side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-30
Patient: female
Reactions: Foetal Growth Restriction, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Colimycine
Dosage: unk
Pravastatin
Dosage: 10 mg, 1x/day
Indication: Dyslipidaemia
Imuran
Dosage: 50 mg, 1x/day
Mucomyst
Dosage: 600 mg, 3x/day
Tacrolimus
Dosage: unk
Aspirin
Dosage: 75 mg, 1x/day
Insulatard NPH Human
Dosage: 8 iu in the morning and 4 iu in the evening
Indication: Diabetes Mellitus
Prednisone TAB
Dosage: 6 mg daily
Tacrolimus
Dosage: 12 mg daily
Start date: 2011-05-20
Trandate
Dosage: 100 mg daily
Indication: Hypertension
Amlodipine Besylate
Dosage: 5 mg, 1x/day
Indication: Hypertension
Other drugs received by patient: Sterogyl; Calcium Carbonate; Toco; Aspegic 1000; Ursolvan-200; Creon
Possible Trandate side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-29
Patient: female
Reactions: Foetal Growth Restriction, Premature Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Azathioprine
Dosage: 50 mg
End date: 2011-01-27
Tacrolimus
Dosage: unk
End date: 2011-01-27
Mucomyst
Dosage: 600 mg, qd
Colimycine / 00013203 /
Dosage: unk
Amaryl
Dosage: 5 mg
Pravastatin
Dosage: 10 mg, qd
Aspirin
Dosage: 75 mg, qd
Insulatard NPH Human
Dosage: 12 iu, qd
Indication: Diabetes Mellitus
Prednisone TAB
Dosage: 6 mg, qd
End date: 2011-01-27
Trandate
Dosage: unk
Other drugs received by patient: Caltrate / 00751519 /; Ursolvan; Creon; Sterogyl / 00107901 /; Toco
Possible Trandate side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-26
Patient: female
Reactions: Foetal Growth Restriction, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Insulatard NPH Human
Dosage: 8 iu in the morning and 4 iu in the evening
Indication: Diabetes Mellitus
Tacrolimus
Dosage: 12 mg daily
Start date: 2011-05-20
Amlodipine Besylate
Dosage: 5 mg, 1x/day
Indication: Hypertension
Prednisone TAB
Dosage: 6 mg daily
End date: 2011-01-27
Imuran
Dosage: 50 mg, 1x/day
End date: 2011-01-27
Colimycine
Mucomyst
Dosage: 600 mg, 3x/day
Trandate
Dosage: 100 mg daily
Indication: Hypertension
Pravastatin
Dosage: 10 mg, 1x/day
Indication: Dyslipidaemia
Tacrolimus
Dosage: unk
End date: 2011-01-27
Aspirin
Dosage: 75 mg, 1x/day
Other drugs received by patient: Toco; Ursolvan-200; Calcium Carbonate; Aspegic 1000; Sterogyl; Creon
Possible Trandate side effects in male
Reported by a consumer/non-health professional from United States on 2012-02-23
Patient: male, weighing 68.0 kg (149.7 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Blood Pressure Increased, HIV Infection, Coma, Cardiac Arrest
Adverse event resulted in: death
Drug(s) suspected as cause:
Trandate
Possible Trandate side effects in 67 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-02-03
Patient: 67 year old female
Reactions: Hypoglycaemia, Convulsion
Drug(s) suspected as cause:
Repaglinide
Dosage: 1 mg, qd
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2011-09-01
Enoxor
Dosage: unk
Start date: 2011-09-01
Enoxor
Dosage: 400 mg, qd
Administration route: Oral
Start date: 2011-12-12
End date: 2011-12-13
Diamicron
Dosage: 60 mg, qd
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Trandate
Dosage: unk
Indication: Product Used FOR Unknown Indication
Enoxor
Dosage: unk
Indication: Urinary Tract Infection
Start date: 2011-05-01
Other drugs received by patient: Eurelix; Candesartan Cilexetil and Hydrochlorothiazide
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