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Enalapril (Enalapril) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Enalapril 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 (26)
Death (3)
Life Threatening Events (2)

Reports by Reaction Type

Dementia (4)Drug Interaction (3)Completed Suicide (3)Renal Failure Acute (3)Intraocular Pressure Increased (2)Hypertension (2)Rhabdomyolysis (1)Intentional Overdose (1)Blood Triglycerides Increased (1)Headache (1)Hemiparesis (1)Somnolence (1)

Possible Enalapril side effects in 62 year old male

Reported by a physician from Portugal on 2012-08-15

Patient: 62 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Product Quality Issue, Product Substitution Issue, Ischaemic Stroke, Drug Interaction, Hemiparesis, Hemianopia, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simvastatin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Carvedilol
    Dosage: 25 mg/day
    Administration route: Oral
    Indication: Hypertension

Captopril
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Potassium Chloride
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Spironolactone
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Acetylsalicylic Acid SRT
    Dosage: 300 mg, unk
    Administration route: Oral
    Indication: Transient Ischaemic Attack

Diazepam
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Warfarin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Nifedipine
    Dosage: 30 mg, 2x/day
    Indication: Product Used FOR Unknown Indication

Enalapril
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Amlodipine
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Enoxaparin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Lisinopril Dihydrate; Irbesartan and Hydrochlorothiazide; Rilmenidine



Possible Enalapril side effects in 78 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-03

Patient: 78 year old female

Reactions: Dementia

Drug(s) suspected as cause:
Dipyrone TAB
    Dosage: 20 gtt as needed
    Administration route: Oral
    Indication: Pain
    Start date: 2005-06-01
    End date: 2007-05-01

Enalapril
    Dosage: 5 mg/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2003-01-01
    End date: 2008-07-01

Duragesic-100
    Dosage: 50 ug/day
    Indication: Pain
    Start date: 2004-09-01
    End date: 2005-10-01



Possible Enalapril side effects in 70 year old male

Reported by a physician from Spain on 2012-04-03

Patient: 70 year old male

Reactions: Hyperkalaemia, Diarrhoea, Nephroangiosclerosis, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eplerenone
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-12-01
    End date: 2012-01-18

Enalapril
    Dosage: unk
    Administration route: Oral
    Indication: Hypertension
    Start date: 2006-01-01
    End date: 2012-01-18



Possible Enalapril side effects in 78 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-03

Patient: 78 year old female

Reactions: Dementia

Drug(s) suspected as cause:
Enalapril
    Dosage: daily dose: 5 mg millgram(s) every days
    Administration route: Oral
    Indication: Hypertension
    Start date: 2003-01-01
    End date: 2008-07-01

Duragesic-100
    Indication: Bone Pain
    Start date: 2004-09-01
    End date: 2005-10-01

Dipyrone TAB
    Administration route: Oral
    Indication: Bone Pain
    Start date: 2005-06-01
    End date: 2007-05-01



Possible Enalapril side effects in 78 year old female

Reported by a physician from Germany on 2012-03-30

Patient: 78 year old female

Reactions: Dementia

Drug(s) suspected as cause:
Enalapril
    Dosage: 5 milligram;
    Administration route: Oral
    Indication: Hypertension
    Start date: 2003-01-01
    End date: 2008-07-01

Dipyrone TAB
    Indication: Intervertebral Disc Degeneration

Dipyrone TAB
    Indication: Pain
    Start date: 2005-06-01
    End date: 2007-05-01

Duragesic-100
    Indication: Bone Pain
    Start date: 2004-09-01
    End date: 2005-10-01

Duragesic-100
    Indication: Pain



Possible Enalapril side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-03-30

Patient: male

Reactions: Renal Tubular Necrosis, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enalapril



Possible Enalapril side effects in 78 year old female

Reported by a physician from Germany on 2012-03-30

Patient: 78 year old female

Reactions: Dementia

Drug(s) suspected as cause:
Duragesic-100
    Indication: Pain
    Start date: 2004-09-01
    End date: 2005-10-01

Enalapril
    Administration route: Oral
    Indication: Hypertension
    Start date: 2003-01-01
    End date: 2008-07-01

Duragesic-100
    Indication: Spinal Osteoarthritis
    Start date: 2004-09-01
    End date: 2005-10-01

Dipyrone TAB
    Administration route: Oral
    Indication: Pain
    Start date: 2005-06-01
    End date: 2007-05-01



Possible Enalapril side effects in female

Reported by a physician from United States on 2012-03-28

Patient: female, weighing 84.4 kg (185.6 pounds)

Reactions: Swollen Tongue

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enalapril
    Dosage: unk
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-01-01

Cyclosporine
    Dosage: 125 mg, 2x/day
    Administration route: Oral
    Indication: Immunosuppression
    Start date: 2008-05-21

Vancomycin HCL
    Dosage: unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-10-04
    End date: 2011-10-04

Other drugs received by patient: Hydrochlorothiazide; Metoprolol; Mycophenolate Mofetil (Cellcept); Omeprazole; Prednisone; Prevacid; Tramadol



Possible Enalapril side effects in 59 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-21

Patient: 59 year old male

Reactions: Pneumonia, Intentional Overdose, Respiratory Distress, Somnolence, Pallor, Hyperhidrosis, Mental Impairment, Electrocardiogram QRS Complex Prolonged, Suicide Attempt

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Sildenafil
    Dosage: 600 mg
    Administration route: Oral

Propafenone HCL
    Administration route: Oral

Enalapril
    Administration route: Oral

Dabigatran Etexilate
    Dosage: 4500 mg
    Administration route: Oral

Other drugs received by patient: Pravastatin



Possible Enalapril side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-20

Patient: male

Reactions: Ear Discomfort, Dizziness, Headache, Loss of Consciousness

Drug(s) suspected as cause:
Enalapril



Possible Enalapril side effects in 90 year old female

Reported by a physician from Germany on 2012-03-15

Patient: 90 year old female

Reactions: Anaemia

Drug(s) suspected as cause:
Enalapril
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Hypertension
    Start date: 2003-02-01
    End date: 2004-10-01

Quinapril HCL
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Hypertension
    Start date: 2005-02-01

Metamizole
    Dosage: 1000 mg, unk
    Administration route: Oral
    Indication: Pain
    Start date: 2010-07-01



Possible Enalapril side effects in female

Reported by a physician from Sweden on 2012-03-15

Patient: female, weighing 97.7 kg (214.9 pounds)

Reactions: Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amlodipine
    Dosage: active run in phase
    Indication: Cardiovascular Disorder

Blinded Aliskiren
    Dosage: active run in phase
    Indication: Cardiovascular Disorder

Blinded NO Treatment Received
    Dosage: active run in phase
    Indication: Cardiovascular Disorder

Esidrix
    Dosage: active run in phase
    Indication: Cardiovascular Disorder

Aliskiren
    Dosage: 300 mg, unk
    Start date: 2011-12-19
    End date: 2012-01-09

Blinded Placebo
    Dosage: active run in phase
    Indication: Cardiovascular Disorder

Enalapril
    Dosage: 20 mg, unk
    Start date: 2009-02-25

Other drugs received by patient: Lithium Citrate; Hydrochlorothiazide; Metoprolol Succinate; Atarax; Fenuril; Levothyroxine Sodium; Biguanides; Glipizide



Possible Enalapril side effects in 65 year old male

Reported by a consumer/non-health professional from Brazil on 2012-03-12

Patient: 65 year old male, weighing 85.0 kg (187.0 pounds)

Reactions: Intraocular Pressure Increased

Drug(s) suspected as cause:
Xalatan
    Dosage: 3 ug (one drop in each eye), 1x/day
    Indication: Glaucoma
    Start date: 2002-01-01

Enalapril
    Dosage: unk
    Indication: Hypertension
    Start date: 2010-01-01

Enalapril
    Indication: Blood Pressure

Simvastatin
    Dosage: unk
    Indication: Blood Cholesterol
    Start date: 2007-01-01



Possible Enalapril side effects in male

Reported by a physician from Japan on 2012-02-14

Patient: male

Reactions: Asthma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Warfarin Sodium
    Dosage: 3.5 mg, unk
    Administration route: Oral
    Start date: 2011-04-28
    End date: 2011-08-03

Warfarin Sodium
    Dosage: 3.5 mg, unk
    Administration route: Oral
    Start date: 2011-08-10
    End date: 2011-08-21

Enalapril
    Dosage: unk
    Administration route: Oral
    Start date: 2010-03-04

Aspirin
    Dosage: 200 mg, unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2008-07-22

Aspirin
    Dosage: 100 mg, unk
    Administration route: Oral
    Start date: 2011-10-21

Warfarin Sodium
    Dosage: 3.25 mg, unk
    Administration route: Oral
    Start date: 2011-09-16

Rabeprazole Sodium
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2008-07-22

Enalapril
    Dosage: unk
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2010-01-07
    End date: 2010-03-03

Sigmart
    Dosage: 15 mg, unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2008-07-22

Allopurinol
    Dosage: 200 mg, unk
    Administration route: Oral
    Start date: 2008-09-18

Aliskiren
    Dosage: unk
    Administration route: Oral
    Start date: 2010-03-04

Warfarin Sodium
    Dosage: 3.5 mg, unk
    Administration route: Oral
    Start date: 2011-08-27
    End date: 2011-09-05

Slow-K
    Dosage: 600 mg, unk
    Administration route: Oral
    Indication: Hypokalaemia
    Start date: 2010-09-16

Aliskiren
    Dosage: unk
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2010-02-18
    End date: 2010-03-03

Carvedilol
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2008-12-11

Aspirin
    Dosage: 200 mg, unk
    Administration route: Oral
    Start date: 2011-07-28

Aspirin
    Dosage: 200 mg, unk
    Administration route: Oral
    Start date: 2011-08-10
    End date: 2011-08-18

Lipitor
    Dosage: 10 mg, unk
    Administration route: Oral
    Start date: 2008-07-22

Lasix
    Dosage: 40 mg, unk
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2008-07-22

Pulmicort-100
    Dosage: unk
    Start date: 2011-09-15



Possible Enalapril side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-02-14

Patient: 76 year old female

Reactions: Rhinitis, Anosmia

Drug(s) suspected as cause:
Enalapril
    Dosage: unk
    End date: 2010-10-29

CO-Vals
    Dosage: unk
    Indication: Hypertension
    Start date: 2008-01-01
    End date: 2010-07-01

Other drugs received by patient: Aspirin; Bisoprolol Fumarate; Acrel; Calcium Carbonate; Omeprazole; Pravastatin



Possible Enalapril side effects in male

Reported by a physician from Germany on 2012-01-31

Patient: male, weighing 184.0 kg (404.8 pounds)

Reactions: Appendicitis Perforated, Appendicitis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Enalapril
    Dosage: unk
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2009-11-20
    End date: 2010-10-25

Aliskiren
    Dosage: unk
    Administration route: Oral
    Start date: 2010-10-27
    End date: 2011-09-26

Enalapril
    Dosage: unk
    Administration route: Oral
    Start date: 2010-10-27
    End date: 2011-09-26

Aliskiren
    Dosage: unk
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2009-11-20
    End date: 2010-10-25

Enalapril
    Dosage: unk
    Administration route: Oral
    Start date: 2011-10-08

Aliskiren
    Dosage: unk
    Administration route: Oral
    Start date: 2011-10-08

Other drugs received by patient: Digitoxin TAB; Xipamide; Paricalcitol; Metoprolol Tartrate and Hydrochlorothiazide; Torsemide; Allopurinol



Possible Enalapril side effects in male

Reported by a physician from Germany on 2012-01-27

Patient: male, weighing 103.0 kg (226.6 pounds)

Reactions: Ventricular Extrasystoles, Coronary Artery Disease, Concomitant Disease Progression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enalapril
    Indication: Cardiac Failure

Aliskiren
    Dosage: code not broken
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2012-01-17
    End date: 2012-01-17

Other drugs received by patient: Torsemide; Aspirin; Metformin HCL



Possible Enalapril side effects in 40 year old male

Reported by a physician from United States on 2012-01-27

Patient: 40 year old male

Reactions: Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Furosemide
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Clopidogrel
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Nisoldipine
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Glyburide
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Amlodipine
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Enalapril
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Levoxyl
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Hydralazine HCL
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Simvastatin
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Hydrocodone Bitartrate and Acetaminophen
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Tamsulosin HCL
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide



Possible Enalapril side effects in 40 year old male

Reported by a physician from United States on 2012-01-26

Patient: 40 year old male

Reactions: Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Nisoldipine
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Glyburide
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Clopidogrel
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Levoxyl
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Enalapril
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Amlodipine
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Tamsulosin HCL
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Furosemide
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Hydrocodone Bitartrate and Acetaminophen
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Hydralazine HCL
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide

Simvastatin
    Dosage: unk
    Administration route: Oral
    Indication: Completed Suicide



Possible Enalapril side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-01-26

Patient: 61 year old female, weighing 91.0 kg (200.2 pounds)

Reactions: Drug Interaction, Renal Failure Acute

Drug(s) suspected as cause:
Enalapril

Other drugs received by patient possibly interacting with the suspect drug:
Rasilez
    Dosage: 300 mg pro tag
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-03-01
    End date: 2011-12-15

Aspirin
    Administration route: Oral
    Indication: Influenza Like Illness



Possible Enalapril side effects in 65 year old male

Reported by a consumer/non-health professional from Brazil on 2012-01-25

Patient: 65 year old male, weighing 85.0 kg (187.0 pounds)

Reactions: Intraocular Pressure Increased

Drug(s) suspected as cause:
Enalapril
    Indication: Hypertension

Simvastatin

Xalatan
    Indication: Glaucoma



Possible Enalapril side effects in 59 year old female

Reported by a physician from United States on 2011-12-29

Patient: 59 year old female

Reactions: Completed Suicide, Toxicity To Various Agents, Intentional Drug Misuse

Adverse event resulted in: death

Drug(s) suspected as cause:
Enalapril
    Dosage: unk
    Administration route: Oral

Alprazolam
    Dosage: unk
    Administration route: Oral

Carbamazepine
    Dosage: unk
    Administration route: Oral

Omeprazole
    Dosage: unk
    Administration route: Oral

Acetaminophen and Hydrocodone Bitartrate
    Dosage: unk
    Administration route: Oral

Atenolol
    Dosage: unk
    Administration route: Oral

Prednisone
    Dosage: unk
    Administration route: Oral

Buspirone
    Dosage: unk
    Administration route: Oral

Hydroxychloroquine
    Dosage: unk
    Administration route: Oral



Possible Enalapril side effects in 76 year old male

Reported by a physician from Japan on 2011-12-19

Patient: 76 year old male

Reactions: Dehydration, Blood Pressure Decreased, Acute Prerenal Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Furosemide
    Dosage: 40 mg, 1 tablet daily
    Administration route: Oral
    Indication: Hypertension

Spironolactone
    Dosage: 25 mg, 1 tablet daily
    Administration route: Oral
    Indication: Hypertension

Nifedipine
    Dosage: 20 mg, 1 tablet daily
    Administration route: Oral
    Indication: Hypertension

Enalapril
    Dosage: 5 mg, 1 tablet daily
    Administration route: Oral
    Indication: Hypertension

Carvedilol
    Dosage: 2.5 mg, 1 tablet daily
    Administration route: Oral
    Indication: Hypertension

Losartan Potassium and Hydrochlorothiazide
    Dosage: 1 df, daily
    Indication: Hypertension

Other drugs received by patient: Lansoprazole; Lyrica; Zolpidem; Aspirin; Valproate Sodium; Cilostazol; Clonazepam



Possible Enalapril side effects in male

Reported by a physician from Japan on 2011-11-02

Patient: male, weighing 61.0 kg (134.2 pounds)

Reactions: Rhabdomyolysis, Pyrexia, Gastric Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aliskiren
    Dosage: 300 mg, unk
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2010-04-01
    End date: 2011-10-04

Enalapril
    Dosage: 10 mg, bid
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2010-04-01

Enalapril Maleate
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2010-01-28
    End date: 2011-10-04

Enalapril Maleate
    Dosage: 20 mg, unk
    Administration route: Oral
    Start date: 2010-02-10
    End date: 2010-03-31

Aliskiren
    Dosage: 150 mg, unk
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2010-03-11
    End date: 2011-10-04

Crestor
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2009-12-16
    End date: 2011-08-22

Other drugs received by patient: Flivas; Pletal; Bisoprolol Fumarate; Rabeprazole Sodium; Ketoprofen; Eplerenone; Aspirin; Zoladex; Rabeprazole Sodium; Nespo; Casodex; Nerisona; Plavix; Flivas; Cernilton; Cernilton; Lasix; Lasix; Eplerenone; Aspirin; Casodex



Possible Enalapril side effects in 21 year old male

Reported by a physician from Brazil on 2011-10-28

Patient: 21 year old male

Reactions: Proteinuria, Blood Potassium Increased, Blood Creatinine Increased

Drug(s) suspected as cause:
Spironolactone
    Dosage: 80 mg, 2x/day
    Start date: 2010-12-01
    End date: 2011-06-01

Enalapril
    Dosage: 60 mg, 3x/day

Spironolactone
    Dosage: 25 mg, unk
    End date: 2010-12-01



Possible Enalapril side effects in 77 year old male

Reported by a physician from Brazil on 2011-10-28

Patient: 77 year old male, weighing 81.0 kg (178.2 pounds)

Reactions: Overweight, Blood Triglycerides Increased, Hypertension, Diabetes Mellitus Inadequate Control

Drug(s) suspected as cause:
Enalapril
    Dosage: 10 mg, 1x/day

Metformin HCL

Insulin
    Dosage: 6 iu, 2x/day

Enalapril
    Dosage: unk

NPH Insulin
    Dosage: 30 iu in the morning and 10 iu at bedtime

Insulin
    Dosage: 8 iu, before breakfast and before dinner

Atorvastatin Calcium
    Dosage: 20 mg, unk

Other drugs received by patient: Acetylsalicylic Acid; Cilostazol

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