AMLODIPINE AND ATORVASTATIN

N/A

Manufactured by Pfizer Laboratories Div Pfizer Inc

6,537 FDA adverse event reports analyzed

Last updated: 2026-04-15

About AMLODIPINE AND ATORVASTATIN

AMLODIPINE AND ATORVASTATIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. The most commonly reported adverse reactions for AMLODIPINE AND ATORVASTATIN include DIZZINESS, NAUSEA, DRUG INEFFECTIVE, FATIGUE, MALAISE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMLODIPINE AND ATORVASTATIN.

Top Adverse Reactions

DIZZINESS181 reports
NAUSEA175 reports
DRUG INEFFECTIVE174 reports
FATIGUE167 reports
MALAISE161 reports
PAIN143 reports
DYSPNOEA141 reports
DEATH137 reports
HYPERTENSION129 reports
HEADACHE127 reports
ASTHENIA123 reports
OEDEMA PERIPHERAL117 reports
DIARRHOEA116 reports
FALL113 reports
PRURITUS102 reports
RENAL FAILURE102 reports
PAIN IN EXTREMITY100 reports
BLOOD PRESSURE INCREASED96 reports
WEIGHT DECREASED95 reports
MYALGIA92 reports
ARTHRALGIA90 reports
COUGH89 reports
BLOOD GLUCOSE INCREASED84 reports
CHEST PAIN82 reports
RASH82 reports
VOMITING82 reports
PNEUMONIA77 reports
GAIT DISTURBANCE76 reports
MYOCARDIAL INFARCTION76 reports
CARDIAC FAILURE CONGESTIVE75 reports
CEREBROVASCULAR ACCIDENT75 reports
FEELING ABNORMAL74 reports
ANXIETY72 reports
DECREASED APPETITE72 reports
INSOMNIA71 reports
DIABETES MELLITUS69 reports
BACK PAIN67 reports
CONSTIPATION66 reports
FLUSHING65 reports
MUSCLE SPASMS65 reports
CHRONIC KIDNEY DISEASE64 reports
TYPE 2 DIABETES MELLITUS64 reports
BLOOD CHOLESTEROL INCREASED62 reports
WEIGHT INCREASED62 reports
DEPRESSION59 reports
SOMNOLENCE58 reports
HYPOTENSION57 reports
OFF LABEL USE57 reports
JOINT SWELLING56 reports
MEMORY IMPAIRMENT53 reports
MUSCULAR WEAKNESS53 reports
ACUTE KIDNEY INJURY52 reports
ANAEMIA51 reports
CARDIAC DISORDER50 reports
HYPOAESTHESIA50 reports
VISION BLURRED49 reports
HYPOGLYCAEMIA48 reports
ABDOMINAL PAIN UPPER47 reports
DRUG HYPERSENSITIVITY45 reports
CONFUSIONAL STATE44 reports
DEHYDRATION44 reports
HYPERSENSITIVITY44 reports
NASOPHARYNGITIS44 reports
ERYTHEMA42 reports
OEDEMA42 reports
PARAESTHESIA42 reports
PALPITATIONS41 reports
SYNCOPE40 reports
ARTHRITIS39 reports
ATRIAL FIBRILLATION38 reports
TREMOR38 reports
PYREXIA37 reports
BLOOD CREATININE INCREASED35 reports
LOSS OF CONSCIOUSNESS35 reports
RENAL FAILURE ACUTE35 reports
URINARY TRACT INFECTION35 reports
ABDOMINAL PAIN34 reports
HEART RATE INCREASED33 reports
ALOPECIA32 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED32 reports
BLOOD PRESSURE INADEQUATELY CONTROLLED32 reports
DYSPEPSIA32 reports
HYPOACUSIS32 reports
PERIPHERAL SWELLING32 reports
CATARACT31 reports
BRONCHITIS30 reports
DRY MOUTH30 reports
HYPERHIDROSIS30 reports
METABOLIC ACIDOSIS30 reports
SEPSIS30 reports
ABDOMINAL DISCOMFORT29 reports
DRUG INTERACTION29 reports
NEUROPATHY PERIPHERAL29 reports
OROPHARYNGEAL PAIN29 reports
SINUSITIS29 reports
SWELLING29 reports
EPISTAXIS28 reports
NERVOUSNESS28 reports
THROMBOSIS28 reports
ASTHMA27 reports

Report Outcomes

Out of 4,023 classified reports for AMLODIPINE AND ATORVASTATIN:

Serious 65.0%Non-Serious 35.0%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female2,025 (54.1%)
Male1,709 (45.7%)
Unknown6 (0.2%)

Reports by Age

Age 6872 reports
Age 7169 reports
Age 7668 reports
Age 6067 reports
Age 6967 reports
Age 7467 reports
Age 6366 reports
Age 7366 reports
Age 6165 reports
Age 6565 reports
Age 5363 reports
Age 6462 reports
Age 7562 reports
Age 7961 reports
Age 7260 reports
Age 6759 reports
Age 6658 reports
Age 7758 reports
Age 8058 reports
Age 7056 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with AMLODIPINE AND ATORVASTATIN?

This profile reflects 6,537 FDA FAERS reports that mention AMLODIPINE AND ATORVASTATIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AMLODIPINE AND ATORVASTATIN?

Frequently reported terms in FAERS include DIZZINESS, NAUSEA, DRUG INEFFECTIVE, FATIGUE, MALAISE, PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures AMLODIPINE AND ATORVASTATIN?

Labeling and FAERS entries often list Pfizer Laboratories Div Pfizer Inc in connection with AMLODIPINE AND ATORVASTATIN. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.