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Vasotec (Enalapril) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Vasotec (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 (19)
Life Threatening Events (2)
Disability (2)

Reports by Reaction Type

Nausea (6)Pruritus (4)Muscle Spasms (4)Drug Hypersensitivity (4)Tremor (4)Pharyngeal Oedema (3)Blood Pressure Increased (3)Nightmare (3)Angioedema (3)Agitation (2)Drug Eruption (2)Hypersensitivity (2)

Possible Vasotec side effects in 79 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 79 year old female

Reactions: Abdominal Pain, Agitation, Pruritus, Restless Legs Syndrome, Orthostatic Hypotension, Disorientation, Pharyngeal Oedema, Dyspepsia, Palpitations, Feeling of Body Temperature Change, Muscle Spasms, Blood Pressure Increased, Nightmare, Nausea, Hypotension, Blood Creatine Increased, Tremor, Anxiety, Heart Rate Decreased, Arthralgia, Diarrhoea

Drug(s) suspected as cause:
Zoloft
    Dosage: unk

Cardura
    Dosage: unk

Tekturna
    Dosage: unk

Prozac
    Dosage: unk

Tiazac
    Dosage: unk

Diltiazem
    Dosage: unk

Cymbalta
    Dosage: unk

Mirtazapine
    Dosage: unk

Fentanyl
    Dosage: unk

Levaquin

Ciprofloxacin HCL
    Dosage: unk

Vasotec
    Dosage: unk

Cartia XT
    Dosage: unk

Diovan
    Dosage: unk

Naproxen Sodium
    Dosage: unk

Norvasc
    Dosage: unk

Wellbutrin XL
    Dosage: unk

Toprol-XL

Paxil
    Dosage: unk

Micardis
    Dosage: unk

Celebrex
    Dosage: unk

Macrobid
    Dosage: unk

Other drugs received by patient: Effexor XR; Protonix



Possible Vasotec side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-07-02

Patient: 67 year old male

Reactions: Pneumonia, Pharyngeal Oedema, Angioedema

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Amlodipine

Zocor
    Administration route: Oral

Vasotec
    Administration route: Oral
    Indication: Hypertension



Possible Vasotec side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: female, weighing 78.0 kg (171.6 pounds)

Reactions: Product Quality Issue, Tablet Physical Issue, Chest Pain, Incorrect Product Storage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vasotec

Other drugs received by patient: Many Concomitant Drugs



Possible Vasotec side effects in 86 year old female

Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-06-15

Patient: 86 year old female

Reactions: Angioedema, Hypersensitivity, Drug Hypersensitivity

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vasotec
    Dosage: 20 mg qd, oral
    Administration route: Oral
    Indication: Essential Hypertension
    End date: 2012-04-16

Acetylcysteine (Acetadote)
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Hydroxocobalamin; Metoprolol Succinate; Plendil



Possible Vasotec side effects in

Reported by a physician from United States on 2012-06-04

Patient: , weighing 110.0 kg (242.0 pounds)

Reactions: Nausea, Dizziness, Gastroenteritis Viral

Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
    Dosage: 81 mg, 1x/day
    Administration route: Oral

Vitamin B1 TAB
    Dosage: unk
    Administration route: Oral

Zocor
    Dosage: 80 mg, every evening
    Administration route: Oral

Warfarin Sodium
    Dosage: as instructed
    Administration route: Oral

Omeprazole
    Dosage: 20 mg, daily
    Administration route: Oral

Vasotec
    Dosage: 5 mg, 2x/day
    Administration route: Oral

Toprol-XL
    Dosage: 50 mg, 2x/day
    Administration route: Oral

Colchicine
    Dosage: 0.6 mg, 2x/day
    Administration route: Oral

Tikosyn
    Dosage: 250 ug, 2x/day
    Administration route: Oral
    Indication: Arrhythmia

Vitamin B-12
    Dosage: unk
    Administration route: Oral



Possible Vasotec side effects in 50 year old female

Reported by a consumer/non-health professional from United States on 2012-05-04

Patient: 50 year old female, weighing 93.0 kg (204.6 pounds)

Reactions: Burning Sensation, Pruritus, Dyspnoea, Angioedema, Nausea, Abdominal Distension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vasotec



Possible Vasotec side effects in

Reported by a physician from United States on 2012-04-27

Patient:

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Potassium Penicillin G
    Dosage: unk

Codeine
    Dosage: unk

Procardia
    Dosage: unk

Crestor
    Dosage: unk

Klonopin
    Dosage: unk

Neurontin
    Dosage: unk

Vasotec
    Dosage: unk

Fosamax
    Dosage: unk

Pravastatin
    Dosage: unk

Amoxicillin
    Dosage: unk

Zocor
    Dosage: unk



Possible Vasotec side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-04-18

Patient: 62 year old female, weighing 75.0 kg (165.0 pounds)

Reactions: Hypersensitivity, Pruritus, Somnolence, Depression, Muscle Spasms, Blood Glucose Increased, Decreased Appetite, Blood Iron Decreased, Vomiting, Nausea, Drug Hypersensitivity, DRY Skin, Stress, Tremor, Blood Glucose Decreased, Hypertension, Frustration

Drug(s) suspected as cause:
Diovan
    Dosage: , oral
    Administration route: Oral
    Indication: Hypertension

Glipizide
    Dosage: 5 mg, unk, oral
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2009-01-01

Chantix
    Dosage: 0.5 mg, unk, oral 1 mg, unk, oral 0.5 mg, unk unk 1 mg, unk, oral
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2007-01-01

Chantix
    Dosage: 0.5 mg, unk, oral 1 mg, unk, oral 0.5 mg, unk unk 1 mg, unk, oral
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2008-01-01

Chantix
    Dosage: 0.5 mg, unk, oral 1 mg, unk, oral 0.5 mg, unk unk 1 mg, unk, oral
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2009-01-01

Chantix
    Dosage: 0.5 mg, unk, oral 1 mg, unk, oral 0.5 mg, unk unk 1 mg, unk, oral
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    End date: 2009-06-19

Chantix
    Dosage: 0.5 mg, unk, oral 1 mg, unk, oral 0.5 mg, unk unk 1 mg, unk, oral
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2008-01-01

Celebrex
    Dosage: , oral
    Administration route: Oral
    Indication: Osteoarthritis

Novolog
    Dosage: unk
    Indication: Diabetes Mellitus
    End date: 2009-01-01

Vasotec
    Dosage: , oral
    Administration route: Oral
    Indication: Hypertension

Other drugs received by patient: Xanax; Nitroglycerin; Lopressor; Vitamin D; Atarax; Calcium with Vitamin D (Calcium Phosphate, Calcium Sodium Lactate, ERG; Lasix; Neurontin; Ditropan; Vitamin B (NO Ingredients / Substances); Prilosec; Acetylsalicylic Acid (Acetylsalicylic Acid), 81 MG; Lantus; Ascorbic Acid; Celexa; Loperamide Hydrochloride; Vitamin B6



Possible Vasotec side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-04-18

Patient: 62 year old female, weighing 74.8 kg (164.6 pounds)

Reactions: Pruritus, Somnolence, Abdominal Discomfort, Depression, Blood Glucose Increased, Decreased Appetite, Blood Iron Decreased, Vomiting, Nausea, Drug Hypersensitivity, DRY Skin, Stress, Tremor, Dysstasia, Frustration, Hypertension

Drug(s) suspected as cause:
Novolog
    Indication: Diabetes Mellitus
    End date: 2009-01-01

Celebrex
    Dosage: oral
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Celebrex
    Dosage: oral
    Administration route: Oral
    Indication: Osteoarthritis

Diovan
    Dosage: oral
    Administration route: Oral
    Indication: Hypertension

Chantix
    Dosage: 0.5 mg, bid, oral, 0.5 mg, daily, oral, oral, 1 mg, bid, oral, 0.5 mg, daily, oral
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2008-01-01

Chantix
    Dosage: 0.5 mg, bid, oral, 0.5 mg, daily, oral, oral, 1 mg, bid, oral, 0.5 mg, daily, oral
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2009-09-01

Chantix
    Dosage: 0.5 mg, bid, oral, 0.5 mg, daily, oral, oral, 1 mg, bid, oral, 0.5 mg, daily, oral
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2009-06-01

Chantix
    Dosage: 0.5 mg, bid, oral, 0.5 mg, daily, oral, oral, 1 mg, bid, oral, 0.5 mg, daily, oral
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2007-01-01

Chantix
    Dosage: 0.5 mg, bid, oral, 0.5 mg, daily, oral, oral, 1 mg, bid, oral, 0.5 mg, daily, oral
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2010-04-01
    End date: 2010-06-19

Glucotrol
    Dosage: 5 mg, tid, oral
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2009-01-01

Vasotec
    Dosage: oral
    Administration route: Oral
    Indication: Hypertension

Other drugs received by patient: Vitamin B (NO Ingredients / Substances); Ditropan; Antidepressants (NO Ingredients / Substances); Xanax; Vitamin B6; Lantus; Aspirin; Celexa; Atarax; Imodium; Ascorbic Acid; Lasix; Neurontin; Lopressor; Prilosec; Nitroglycerin; Vitamins (NO Ingredients / Substances); Calcium D (Calcium, Colecalciferol); Vitamin D



Possible Vasotec side effects in female

Reported by a physician from United States on 2012-04-17

Patient: female

Reactions: Chest Discomfort, Dyspnoea Exertional, Coronary Artery Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vasotec

Other drugs received by patient: Hydrochlorothiazide; Zestoretic



Possible Vasotec side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-02

Patient: female

Reactions: Wrong Technique in Drug Usage Process, Musculoskeletal Discomfort, Hypoaesthesia, Muscle Spasms

Drug(s) suspected as cause:
Carvedilol

Norvasc

Vasotec

Exforge
    Dosage: 1 df, qd

Other drugs received by patient: Aspirin; Symbicort; Potassium Chloride; Coq10 (Ubidecarenone); Fish OIL (Fish Oil); Osteo-Biflex (Chondroitin Sulfate, Glucosamine Hydrochloride); Synthroid; B Complex (Nicotinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamin; Combivent



Possible Vasotec side effects in 72 year old male

Reported by a physician from Hong Kong on 2012-01-26

Patient: 72 year old male

Reactions: Cervical Cord Compression

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Pepcid
    Dosage: 20 mg;bid;po
    Administration route: Oral
    Start date: 2011-10-06
    End date: 2011-10-17

Metoprolol Tartrate
    Dosage: 150 mg;bid;po, 150 mg;bid;po
    Administration route: Oral
    Start date: 2011-10-06
    End date: 2011-10-17

Metoprolol Tartrate
    Dosage: 150 mg;bid;po, 150 mg;bid;po
    Administration route: Oral
    Start date: 2011-10-21
    End date: 2011-10-25

Nitroglycerin
    Dosage: 500 mcg;;sl
    Start date: 2011-10-06
    End date: 2011-10-17

Metformin (NO Pref. Name)
    Dosage: 250 mg;tid;po
    Administration route: Oral
    Start date: 2011-10-06
    End date: 2011-10-17

MK-0431 OR Placebo (NO Pref. Name)

Vasotec
    Dosage: 10 mg;bid;po
    Administration route: Oral
    Start date: 2011-10-06
    End date: 2011-10-17

Aspirin
    Dosage: 80 mg;qd;po, 80 mg;qw;po
    Administration route: Oral
    Start date: 2011-10-21
    End date: 2011-10-25

Aspirin
    Dosage: 80 mg;qd;po, 80 mg;qw;po
    Administration route: Oral
    Start date: 2011-10-06
    End date: 2011-10-17

Zocor
    Dosage: 10 mg;hs;po
    Administration route: Oral
    Start date: 2011-10-06
    End date: 2011-10-17

Isosorbide Mononitrate
    Dosage: 20 mg;bid;po
    Administration route: Oral
    Start date: 2011-10-06
    End date: 2011-10-17



Possible Vasotec side effects in 72 year old male

Reported by a individual with unspecified qualification from Hong Kong on 2012-01-24

Patient: 72 year old male

Reactions: Cervical Cord Compression

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Isosorbide Mononitrate
    Dosage: 20 mg/bid po
    Administration route: Oral
    Start date: 2011-10-03
    End date: 2011-10-17

Pepcid
    Dosage: 20 mg/bid po
    Administration route: Oral
    Start date: 2011-10-06
    End date: 2011-10-17

Metformin Hydrochloride
    Dosage: 250 mg/tid/po
    Administration route: Oral
    Start date: 2011-10-05
    End date: 2011-10-17

Metoprolol Tartrate
    Dosage: 150 mg/bid/po
    Administration route: Oral
    Start date: 2011-10-06
    End date: 2011-10-17

Vasotec
    Dosage: 10 mg/bid po
    Administration route: Oral
    Start date: 2011-10-06
    End date: 2011-10-17

Aspirin
    Dosage: 80 mg/daily po
    Administration route: Oral
    Start date: 2011-10-06
    End date: 2011-10-17

Nitroglycerin
    Dosage: 500 microgm sl
    Start date: 2011-10-03
    End date: 2011-10-17

Aspirin
    Dosage: 80 mg/wky po
    Administration route: Oral
    Start date: 2011-10-21
    End date: 2011-10-25

Zocor
    Dosage: 10mg/pm po,
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-06
    End date: 2011-10-17

Metoprolol Tartrate
    Dosage: 150 mg/bid/po
    Administration route: Oral
    Start date: 2011-10-21
    End date: 2011-10-25

Placebo
    Dosage: po
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus



Possible Vasotec side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-14

Patient: female, weighing 72.6 kg (159.6 pounds)

Reactions: Blood Pressure Increased, Confusional State, Nightmare

Drug(s) suspected as cause:
Vasotec
    Dosage: 10 mg, 2x/day
    Administration route: Oral
    Indication: Blood Pressure Increased
    Start date: 1981-01-01

Lipitor
    Dosage: 10 mg, unk
    Indication: Blood Pressure Increased

Other drugs received by patient: Multi-Vitamins; Acetylsalicylic Acid; Calcium



Possible Vasotec side effects in 65 year old female

Reported by a pharmacist from United States on 2011-12-08

Patient: 65 year old female

Reactions: Swollen Tongue, Erythema

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Vasotec



Possible Vasotec side effects in 67 year old female

Reported by a physician from Japan on 2011-11-23

Patient: 67 year old female

Reactions: Drug Eruption, Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pepcid RPD
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2010-12-03
    End date: 2011-01-05

Vasotec
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-12-09
    End date: 2011-01-04

Merislon
    Administration route: Oral
    Indication: Dizziness
    Start date: 2010-12-05
    End date: 2011-01-05

Phenobarbital TAB
    Administration route: Oral
    Indication: Brain Contusion
    Start date: 2010-12-05
    End date: 2011-01-04

Candesartan Cilexetil
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-12-05
    End date: 2011-01-04

Other drugs received by patient: LAC-B



Possible Vasotec side effects in 79 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-16

Patient: 79 year old female

Reactions: Agitation, Restless Legs Syndrome, Orthostatic Hypotension, Disorientation, Pharyngeal Oedema, Dyspepsia, Palpitations, Dizziness, Feeling of Body Temperature Change, Nervousness, Muscle Spasms, Blood Pressure Increased, Nightmare, Nausea, Hypotension, Tremor, Anxiety, Heart Rate Decreased, Diarrhoea, Arthralgia

Drug(s) suspected as cause:
Mirtazapine
    Indication: Product Used FOR Unknown Indication

Micardis
    Indication: Product Used FOR Unknown Indication

Cardura
    Indication: Product Used FOR Unknown Indication

Macrobid
    Indication: Product Used FOR Unknown Indication

Prozac
    Indication: Product Used FOR Unknown Indication

Cipro
    Indication: Product Used FOR Unknown Indication

Norvasc
    Indication: Product Used FOR Unknown Indication

Vasotec
    Indication: Product Used FOR Unknown Indication

Diovan
    Indication: Product Used FOR Unknown Indication

Diltiazem
    Indication: Product Used FOR Unknown Indication

Tiazac
    Indication: Product Used FOR Unknown Indication

Zoloft
    Indication: Product Used FOR Unknown Indication

Cymbalta
    Indication: Product Used FOR Unknown Indication

Celebrex
    Indication: Product Used FOR Unknown Indication

Fentanyl
    Indication: Product Used FOR Unknown Indication

Naproxen
    Indication: Product Used FOR Unknown Indication

Wellbutrin XL
    Indication: Product Used FOR Unknown Indication

Levaquin
    Indication: Product Used FOR Unknown Indication

Tekturna
    Indication: Product Used FOR Unknown Indication

Toprol-XL
    Indication: Product Used FOR Unknown Indication

Cartia XT
    Indication: Product Used FOR Unknown Indication

Paxil
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Effexor XR; Protonix



Possible Vasotec side effects in female

Reported by a consumer/non-health professional from United States on 2011-11-14

Patient: female

Reactions: Fatigue, Glucose Tolerance Impaired, Memory Impairment

Drug(s) suspected as cause:
Tenormin
    Dosage: unk, 1x/day

Norvasc
    Dosage: 2.5 mg, 1x/day

Vasotec
    Dosage: 5 mg, 2x/day



Possible Vasotec side effects in 67 year old female

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

Patient: 67 year old female

Reactions: Drug Eruption, Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Phenobarbital TAB
    Administration route: Oral
    Indication: Brain Contusion
    Start date: 2010-12-05
    End date: 2011-01-04

Merislon
    Administration route: Oral
    Indication: Dizziness
    Start date: 2010-12-05
    End date: 2011-01-05

Pepcid RPD
    Administration route: Oral
    Indication: Brain Contusion
    Start date: 2010-12-03
    End date: 2011-01-05

Candesartan Cilexetil
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-12-05
    End date: 2011-01-04

Vasotec
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-12-09
    End date: 2011-01-04

Other drugs received by patient: LAC-B

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