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Norvasc (Amlodipine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Norvasc (Amlodipine) 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 (1460)
Death (181)
Life Threatening Events (22)
Disability (61)

Reports by Reaction Type

Death (111)Hypertension (93)Malaise (77)Drug Ineffective (75)Dizziness (68)Headache (62)Oedema Peripheral (62)Blood Pressure Increased (58)Cerebrovascular Accident (49)Myocardial Infarction (41)Drug Hypersensitivity (41)Weight Decreased (38)

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

Possible Norvasc side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Abnormal Dreams, Arthralgia, Chronic Obstructive Pulmonary Disease

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

Norvasc
    Dosage: unk

Spiriva
    Dosage: unk

Zoloft
    Dosage: unk



Possible Norvasc side effects in 51 year old

Reported by a physician from United States on 2012-08-27

Patient: 51 year old

Reactions: Hepatitis C, Hypertension

Drug(s) suspected as cause:
Norvasc



Possible Norvasc side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Drug Ineffective, Rectal Haemorrhage, Headache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lopressor
    Dosage: unk ukn, unk
    Indication: Hypertension

Metoprolol Tartrate
    Dosage: unk ukn, unk

Norvasc
    Dosage: unk ukn, unk



Possible Norvasc side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Dental Caries, Loose Tooth, Memory Impairment

Drug(s) suspected as cause:
Detrol LA
    Dosage: unk

Lipitor
    Dosage: unk

Norvasc
    Dosage: unk



Possible Norvasc side effects in 48 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 48 year old male, weighing 102.0 kg (224.4 pounds)

Reactions: Haematology Test Abnormal, Thrombosis, Cerebrovascular Accident, Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neurontin
    Dosage: 500 mg in the morning, 300 mg in noon,400 mg at night ,3x/day
    Administration route: Oral
    Indication: Neuropathy Peripheral

Norvasc
    Dosage: half of 5 mg tablet in the morning and another half of 5 mg tablet at night
    Administration route: Oral
    Indication: Blood Pressure Abnormal

Other drugs received by patient: Coreg; Pantoprazole; Alprazolam; Aspirin; Dipyridamole; Humulin N; Amitiza; Crestor



Possible Norvasc side effects in 72 year old female

Reported by a physician from Japan on 2012-08-24

Patient: 72 year old female, weighing 63.0 kg (138.6 pounds)

Reactions: Pulmonary Congestion, Pleural Effusion, Generalised Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norvasc

Other drugs received by patient: Lopressor; Amlodipine; Zetia; Aspirin; Humalog; Micardis; Crestor; Lansoprazole; Pursennid; Metformin HCL; Plavix; Magmitt; Januvia



Possible Norvasc side effects in male

Reported by a physician from United States on 2012-08-24

Patient: male

Reactions: Drug Ineffective, Rectal Haemorrhage, Headache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lopressor
    Dosage: unk ukn, unk
    Indication: Hypertension

Metoprolol Tartrate
    Dosage: unk ukn, unk

Norvasc
    Dosage: unk ukn, unk



Possible Norvasc side effects in 58 year old female

Reported by a physician from United States on 2012-08-24

Patient: 58 year old female

Reactions: Diplopia, Myasthenia Gravis, General Physical Health Deterioration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norvasc



Possible Norvasc side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Intestinal Polyp, Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norvasc

PEG-Intron
    Dosage: unk, qw
    Indication: Hepatitis C
    Start date: 2012-02-16

Ribavirin
    Dosage: 600 mg, bid
    Administration route: Oral

Telaprevir
    Dosage: 750 mg, q8h
    Administration route: Oral

Other drugs received by patient: Centrum (Minerals (Unspecified) (+) Vitamins (Unspecified)); Xanthophyll



Possible Norvasc side effects in 53 year old

Reported by a physician from United States on 2012-08-24

Patient: 53 year old

Reactions: NO Adverse Event

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

Metformin HCL
    Dosage: unk

Metoprolol Tartrate
    Dosage: unk

Norvasc
    Dosage: unk

Pravastatin Sodium
    Dosage: unk

Vitamin D
    Dosage: unk



Possible Norvasc side effects in 76 year old female

Reported by a physician from Japan on 2012-08-24

Patient: 76 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Malaise, Dyspnoea, Atrioventricular Block Complete

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Norvasc

Other drugs received by patient: Valsartan and Hydrochlorothiazide; Januvia; Glimicron



Possible Norvasc side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Myalgia, Malaise, Asthenia, Panic Disorder

Drug(s) suspected as cause:
Norvasc



Possible Norvasc side effects in 84 year old female

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

Patient: 84 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Swelling, Erythema, Erysipelas

Drug(s) suspected as cause:
Norvasc

Other drugs received by patient: Levothyroxine Sodium; Lipitor; Metformin Hydrochloride; Clopidogrel; Olmesartan Medoxomil; Olmesartan Medoxomil and Hydrochlorothizide; Amiodarone Hydrochloride



Possible Norvasc side effects in 58 year old female

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

Patient: 58 year old female

Reactions: Diplopia, Myasthenia Gravis, General Physical Health Deterioration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norvasc



Possible Norvasc side effects in

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

Patient:

Reactions: Bedridden, Emphysema, Off Label Use, Lung Disorder, Amnesia, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Aspirin
    Dosage: 81 mg, prn
    Indication: Chest Pain

Atenolol
    Dosage: 25 mg, qd
    Administration route: Oral
    Indication: Hypertension

Ativan
    Dosage: 1 mg, tid
    Administration route: Oral
    Indication: Nervousness

Atropine Sulfate
    Dosage: 2.5 mg, qid
    Administration route: Oral
    Indication: Crohn's Disease

Depakote
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Convulsion

Dilantin
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: Convulsion

Furosemide
    Dosage: 40 mg, bid
    Administration route: Oral
    Indication: Diuretic Therapy

Generlac
    Dosage: 30 mg, prn
    Indication: Crohn's Disease

Humulin R
    Dosage: 24 units
    Indication: Diabetes Mellitus

Imdur
    Dosage: 30 mg, tid
    Indication: Cardiac Disorder

Lantus
    Dosage: 80 units in the moring and 90 units at night
    Indication: Diabetes Mellitus

Lantus
    Dosage: unk

Methocarbamol
    Indication: Neuropathy Peripheral

Methocarbamol
    Dosage: 750 mg, prn
    Administration route: Oral
    Indication: Muscle Spasms

Nitrostat
    Dosage: 0.4 mg, prn
    Indication: Chest Pain

Norvasc
    Administration route: Oral
    Indication: Palpitations

Potassium Chloride

Potassium Chloride (KV / 24)
    Dosage: 8 meq, qd
    Indication: Blood Potassium

Remeron
    Dosage: 30 mg, qd
    Administration route: Oral
    Indication: Insomnia

Tylenol
    Dosage: unk unk, qd
    Indication: Migraine

Zantac
    Dosage: 30 mg, tid
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Zocor
    Dosage: 40 mg, qd
    Administration route: Oral



Possible Norvasc side effects in 82 year old male

Reported by a physician from Japan on 2012-08-23

Patient: 82 year old male

Reactions: Renal Impairment, Hepatic Function Abnormal, Blood Creatine Phosphokinase Increased

Drug(s) suspected as cause:
Diovan
    Dosage: 40 mg daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-04-25
    End date: 2012-07-18

Norvasc
    Dosage: 5 mg, day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-11-12
    End date: 2012-07-05

Rabeprazole Sodium
    Dosage: 10 mg daily
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2011-12-22
    End date: 2012-07-18



Possible Norvasc side effects in

Reported by a physician from Japan on 2012-08-23

Patient:

Reactions: Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bufferin
    Dosage: 8 mg, qd
    Administration route: Oral
    Indication: Cerebral Infarction
    End date: 2012-05-24

Crestor
    Dosage: 2.5 mg, qd
    Administration route: Oral
    Indication: Lipids Abnormal
    End date: 2012-05-24

Famotidine
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Gastritis
    Start date: 2012-03-01
    End date: 2012-05-24

Norvasc
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-05-24

Olmesartan Medoxomil
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-05-24



Possible Norvasc side effects in female

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

Patient: female

Reactions: Myocardial Infarction

Drug(s) suspected as cause:
Norvasc



Possible Norvasc side effects in female

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

Patient: female

Reactions: Asthma, Hypersensitivity, Body Temperature Increased, Injury, Back Injury

Drug(s) suspected as cause:
Norvasc
    Dosage: unk
    Indication: Hypertension

Premarin
    Dosage: unk



Possible Norvasc side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient:

Reactions: Bedridden, Emphysema, Amnesia, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Aspirin

Atenolol
    Administration route: Oral

Ativan
    Administration route: Oral

Depakote
    Administration route: Oral

Dilantin
    Administration route: Oral

Furosemide
    Administration route: Oral

Generlac

Humulin R

Isosorbide Mononitrate

Lantus
    Dosage: 80 iu, qam

Lantus
    Dosage: 90 df, qpm

Lomotil
    Administration route: Oral

Methocarbamol
    Administration route: Oral

Nitrostat

Norvasc
    Administration route: Oral

Potassium Chloride

Remeron
    Administration route: Oral

Tylenol W / Codeine NO. 3

Zantac

Zocor
    Administration route: Oral



Possible Norvasc side effects in female

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

Patient: female

Reactions: Cerebral Disorder

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

Protonix
    Dosage: unk



Possible Norvasc side effects in female

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

Patient: female

Reactions: Vomiting, Dizziness

Drug(s) suspected as cause:
Norvasc



Possible Norvasc 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:
Cardura
    Dosage: unk

Cartia XT
    Dosage: unk

Celebrex
    Dosage: unk

Ciprofloxacin HCL
    Dosage: unk

Cymbalta
    Dosage: unk

Diltiazem
    Dosage: unk

Diovan
    Dosage: unk

Fentanyl
    Dosage: unk

Levaquin

Macrobid
    Dosage: unk

Micardis
    Dosage: unk

Mirtazapine
    Dosage: unk

Naproxen Sodium
    Dosage: unk

Norvasc
    Dosage: unk

Paxil
    Dosage: unk

Prozac
    Dosage: unk

Tekturna
    Dosage: unk

Tiazac
    Dosage: unk

Toprol-XL

Vasotec
    Dosage: unk

Wellbutrin XL
    Dosage: unk

Zoloft
    Dosage: unk

Other drugs received by patient: Effexor XR; Protonix



Possible Norvasc side effects in 56 year old female

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

Patient: 56 year old female

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Norvasc
    Dosage: 10 mg, daily

Zoloft
    Dosage: 100 mg, 2x/day



Possible Norvasc side effects in

Reported by a physician from United States on 2012-08-22

Patient:

Reactions: Asthenia

Adverse event resulted in: hospitalization

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

Lopid
    Dosage: unk

Neurontin
    Dosage: unk

Norvasc
    Dosage: unk



Possible Norvasc side effects in male

Reported by a physician from Japan on 2012-08-22

Patient: male

Reactions: Rheumatoid Arthritis, Nephrolithiasis

Drug(s) suspected as cause:
Emtricitabine / Tenofovir Disoproxil Fumarate
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-10-26
    End date: 2012-03-01

Norvasc
    Dosage: unk
    Start date: 2011-04-01

Other drugs received by patient: Viramune; Urinorm; Rimatil; Tenormin; Bezatol SR; Diovan



Possible Norvasc side effects in 73 year old female

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

Patient: 73 year old female, weighing 75.7 kg (166.6 pounds)

Reactions: Confusional State, Memory Impairment

Drug(s) suspected as cause:
Norvasc
    Dosage: unk
    Indication: Hypertension

Norvasc
    Dosage: 5 mg, daily

Other drugs received by patient: Valsartan



Possible Norvasc side effects in

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

Patient:

Reactions: Renal Failure, Angina Pectoris, Thyroid Disorder, Blood Potassium Increased, Blood Magnesium Decreased, Hypertension, Cardiac Disorder

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

Chantix

Lipitor
    Dosage: unk

Norvasc
    Dosage: unk

Viagra
    Dosage: unk



Possible Norvasc side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Arthritis

Drug(s) suspected as cause:
Arthrotec

Norvasc

Zoloft



Possible Norvasc side effects in 72 year old male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 72 year old male, weighing 84.4 kg (185.6 pounds)

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Lipitor
    Dosage: 40 mg, daily
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Norvasc
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Hypertension

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