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Nifedipine (Nifedipine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Nifedipine 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 (371)
Death (19)
Life Threatening Events (25)
Disability (5)

Reports by Reaction Type

Drug Ineffective (56)Blood Pressure Increased (31)Dizziness (30)Malaise (28)Hypertension (21)Hypotension (20)Headache (19)Oedema Peripheral (18)Asthenia (17)Shock (16)Dyspnoea (15)Palpitations (14)

Below are a few examples of reports where side effects / adverse reactions may be related to Nifedipine. For a complete list or a specific selection of reports, please use the links above.

Possible Nifedipine side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nifedipine
    Dosage: unk, prn
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-01-01

Pepcid
    Dosage: 30 mg, prn
    Administration route: Oral
    Indication: Gastric Disorder
    Start date: 2011-01-01

Pepcid
    Dosage: 30 mg, prn
    Administration route: Oral
    Indication: Abdominal Pain Upper
    Start date: 2011-01-01
    End date: 2012-01-01



Possible Nifedipine side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Premature Baby, Foetal Exposure During Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amphetamines
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Barbiturates
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Benzodiazepines
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Cocaine
    Indication: Product Used FOR Unknown Indication

Hydroxyzine
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Lorazepam
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Methylphenidate
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Nifedipine
    Dosage: dosing details unknown
    Indication: Premature Labour

Seroquel
    Dosage: unknown dosing details
    Indication: Product Used FOR Unknown Indication

Suboxone
    Dosage: dosing details unknown
    Indication: Drug Dependence

Subutex
    Dosage: dosing details unknown
    Indication: Drug Dependence

Terbutaline
    Indication: Premature Labour



Possible Nifedipine side effects in 70 year old female

Reported by a physician from Canada on 2012-08-21

Patient: 70 year old female

Reactions: Bezoar, Intestinal Stenosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nifedipine



Possible Nifedipine side effects in 55 year old

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 55 year old

Reactions: Drug Hypersensitivity, Skin Burning Sensation, Dizziness, Erythema

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

Nifedipine
    Dosage: unk



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

Amlodipine
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Captopril
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

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

Diazepam
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Enalapril
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Enoxaparin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

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

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

Simvastatin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Spironolactone
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Warfarin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

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



Possible Nifedipine side effects in 2 year old female

Reported by a physician from United States on 2012-08-14

Patient: 2 year old female

Reactions: Circulatory Collapse, Toxicity To Various Agents, Accidental Overdose, Accidental Drug Intake by Child

Adverse event resulted in: death

Drug(s) suspected as cause:
Nifedipine



Possible Nifedipine side effects in 14 month old female

Reported by a physician from United States on 2012-08-13

Patient: 14 month old female

Reactions: Circulatory Collapse, Toxicity To Various Agents, Accidental Drug Intake by Child

Adverse event resulted in: death

Drug(s) suspected as cause:
Nifedipine



Possible Nifedipine side effects in 49 year old male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 49 year old male, weighing 89.8 kg (197.6 pounds)

Reactions: Drug Ineffective, Bipolar Disorder

Drug(s) suspected as cause:
Nifedipine
    Dosage: unk
    Indication: Hypertension
    Start date: 2011-01-01

Norvasc
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-05-15



Possible Nifedipine side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: 52 year old female

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Nifedipine



Possible Nifedipine side effects in female

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

Patient: female

Reactions: Abdominal Pain, Pancreatic Pseudocyst, Chest Pain, Heart Rate Irregular, Feeling Abnormal, Muscle Spasms

Drug(s) suspected as cause:
Nifedipine



Possible Nifedipine side effects in 72 year old female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: 72 year old female, weighing 79.8 kg (175.6 pounds)

Reactions: Capsule Physical Issue, Drug Ineffective, Hypertension

Drug(s) suspected as cause:
Nifedipine



Possible Nifedipine side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: female

Reactions: Nausea, Headache, Faeces Discoloured, Abdominal Pain Upper, Abdominal Discomfort, Dizziness, Myocardial Infarction, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nifedipine

Other drugs received by patient: Atenolol



Possible Nifedipine side effects in 26 year old male

Reported by a physician from Japan on 2012-08-06

Patient: 26 year old male, weighing 54.0 kg (118.8 pounds)

Reactions: Drug Level Increased, Encephalopathy

Drug(s) suspected as cause:
Nifedipine

Other drugs received by patient: Tacrolimus; Tacrolimus; Thymoglobulin



Possible Nifedipine side effects in male

Reported by a physician from Japan on 2012-08-05

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Pemphigus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ain457
    Dosage: 300 mg, qd
    Indication: Psoriasis
    Start date: 2012-01-24
    End date: 2012-01-31

Diovan
    Dosage: 40 mg, qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-10-26

Nifedipine
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-10-26
    End date: 2012-04-06

Other drugs received by patient: Propeto; Allegra



Possible Nifedipine side effects in 76 year old female

Reported by a physician from Japan on 2012-08-02

Patient: 76 year old female

Reactions: Stress Cardiomyopathy

Drug(s) suspected as cause:
Nifedipine



Possible Nifedipine side effects in male

Reported by a physician from Japan on 2012-08-01

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Pemphigus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ain457
    Dosage: 300 mg, qd
    Indication: Psoriasis
    Start date: 2012-01-24
    End date: 2012-01-31

Diovan
    Dosage: 40 mg, qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-10-26

Nifedipine
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-10-26
    End date: 2012-04-06

Other drugs received by patient: Propeto; Allegra



Possible Nifedipine side effects in 76 year old female

Reported by a physician from Greece on 2012-07-31

Patient: 76 year old female

Reactions: Interstitial Lung Disease, Oesophageal Disorder, Condition Aggravated, Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

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

Nifedipine
    Dosage: 40 mg, daily
    Administration route: Oral
    Indication: Raynaud's Phenomenon



Possible Nifedipine side effects in 79 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

Patient: 79 year old female, weighing 158.0 kg (347.6 pounds)

Reactions: Intra-Abdominal Haemorrhage, Impaired Work Ability, Blood Count Abnormal, Adhesion, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nifedipine
    Dosage: daily dose 90 mg
    Administration route: Oral
    Indication: Myocardial Infarction
    Start date: 1995-01-01

Procardia XL
    Dosage: 90 mg, unk
    Administration route: Oral
    Indication: Myocardial Infarction
    End date: 1995-01-01

Other drugs received by patient: Clopidogrel; Levothyroxine Sodium; Ezetimibe / Samvastatin; Lisinopril; Metoprolol; Hydrochlorothiazide; Clonidine; Ezetimibe / Samvastatin



Possible Nifedipine side effects in 42 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

Patient: 42 year old male

Reactions: Confusional State, Dyspnoea, Metabolic Acidosis, Hypotension, Bundle Branch Block Left, Hyperhidrosis, Overdose, Hypoxia, Pulmonary Oedema, Bradycardia, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diltiazem Hydrochloride
    Indication: Dizziness

Diltiazem Hydrochloride
    Dosage: unk
    Administration route: Oral
    Indication: Palpitations

Nifedipine
    Dosage: unk
    Administration route: Oral
    Indication: Palpitations

Nifedipine
    Indication: Dizziness

Verapamil HCL
    Dosage: unk
    Administration route: Oral
    Indication: Supraventricular Tachycardia



Possible Nifedipine side effects in female

Reported by a physician from United States on 2012-07-25

Patient: female, weighing 52.7 kg (115.9 pounds)

Reactions: Vein Disorder, Oedema Peripheral, Aortic Aneurysm, Left Ventricular Failure, Dermatitis Exfoliative, Cardiac Failure Congestive

Drug(s) suspected as cause:
Atenolol
    Indication: Cardiomyopathy
    End date: 2012-03-01

Humira
    Indication: Pustular Psoriasis
    Start date: 2012-06-01
    End date: 2012-06-01

Humira
    Start date: 2012-06-01
    End date: 2012-06-01

Nifedipine
    Indication: Hypertension

Other drugs received by patient: Aspirin; Lisinopril; Omeprazole; Hydrochlorothiazide



Possible Nifedipine side effects in 55 year old female

Reported by a health professional (non-physician/pharmacist) from Singapore on 2012-07-24

Patient: 55 year old female

Reactions: Abdominal Distension, Dizziness

Drug(s) suspected as cause:
Nifedipine



Possible Nifedipine side effects in 55 year old male

Reported by a individual with unspecified qualification from Japan on 2012-07-24

Patient: 55 year old male

Reactions: Overdose, Suicide Attempt, Circulatory Collapse, Gait Disturbance, Sinus Bradycardia, Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Atenolol
    Dosage: 1175 mg, per oral
    Administration route: Oral
    Indication: Suicide Attempt

Doxazosin Mesylate
    Dosage: 78 mg, per oral
    Administration route: Oral
    Indication: Suicide Attempt

Nifedipine
    Dosage: 1680 mg, per oral
    Administration route: Oral
    Indication: Suicide Attempt

Olmesartan Medoxomil
    Dosage: 940 mg, per oral
    Administration route: Oral
    Indication: Suicide Attempt



Possible Nifedipine side effects in 76 year old female

Reported by a physician from Greece on 2012-07-18

Patient: 76 year old female

Reactions: Organising Pneumonia, Interstitial Lung Disease, Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nifedipine



Possible Nifedipine side effects in female

Reported by a pharmacist from Japan on 2012-07-18

Patient: female

Reactions: Pruritus, Erythema, Generalised Oedema

Drug(s) suspected as cause:
Mepivacaine HCL
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-15
    End date: 2012-05-19

Nifedipine
    Dosage: 20 mg, daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-15
    End date: 2012-05-19

Rebamipide
    Dosage: 300 mg, daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-15
    End date: 2012-05-19

Theophylline
    Dosage: 200 mg, bid
    Administration route: Oral
    Indication: Asthma
    Start date: 2012-03-15
    End date: 2012-05-19

Other drugs received by patient: Famotidine; Levothyroxine Sodium; Olmesartan Medoxomil; Bisolvon



Possible Nifedipine side effects in 76 year old female

Reported by a physician from Greece on 2012-07-18

Patient: 76 year old female

Reactions: Organising Pneumonia, Interstitial Lung Disease, Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nifedipine



Possible Nifedipine side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient: female

Reactions: Pain, Insomnia, Cognitive Disorder, Depression, Asthenia

Drug(s) suspected as cause:
Nifedipine



Possible Nifedipine side effects in 63 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-13

Patient: 63 year old male, weighing 92.5 kg (203.5 pounds)

Reactions: Angioedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nifedipine



Possible Nifedipine side effects in 87 year old male

Reported by a pharmacist from United States on 2012-07-13

Patient: 87 year old male, weighing 74.8 kg (164.6 pounds)

Reactions: Bradycardia, Sinus Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atenolol
    Dosage: 50 mg every day po
    Administration route: Oral
    Start date: 2011-07-29
    End date: 2011-01-01

Nifedipine
    Dosage: 30 mg every day po
    Administration route: Oral
    Start date: 2011-12-17
    End date: 2012-01-05



Possible Nifedipine side effects in female

Reported by a pharmacist from United States on 2012-07-10

Patient: female, weighing 85.1 kg (187.2 pounds)

Reactions: Angioedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nifedipine



Possible Nifedipine side effects in male

Reported by a physician from Japan on 2012-07-09

Patient: male, weighing 60.8 kg (133.8 pounds)

Reactions: Agranulocytosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra
    Start date: 2012-02-23
    End date: 2012-02-23

Actemra
    Start date: 2010-09-17

Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2011-03-04

Efonidipine
    Administration route: Oral
    Indication: Hypertension
    Start date: 2004-01-01

Imidapril Hydrochloride
    Administration route: Oral
    Indication: Hypertension
    Start date: 2004-01-01

Ketoprofen
    Administration route: Topical
    Indication: Rheumatoid Arthritis
    Start date: 2003-07-04

Misoprostol
    Administration route: Oral
    Indication: Gastritis Prophylaxis
    Start date: 2012-03-22
    End date: 2012-05-25

Nifedipine
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-10-01

Olmesartan Medoxomil
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-03-06

Placebo
    Indication: Rheumatoid Arthritis
    Start date: 2010-09-17

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