DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Trandate (Labetalol) - Side Effect Reports to FDA

 
 



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

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012