CAPTOPRIL

N/A

Manufactured by AMICI PHARMACEUTICALS LLC

21,001 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CAPTOPRIL

CAPTOPRIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AMICI PHARMACEUTICALS LLC. The most commonly reported adverse reactions for CAPTOPRIL include DYSPNOEA, DRUG INEFFECTIVE, HYPERTENSION, NAUSEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CAPTOPRIL.

Top Adverse Reactions

DYSPNOEA606 reports
DRUG INEFFECTIVE591 reports
HYPERTENSION526 reports
NAUSEA496 reports
DIARRHOEA460 reports
PAIN454 reports
DIZZINESS440 reports
ASTHENIA415 reports
HEADACHE395 reports
VOMITING395 reports
FATIGUE387 reports
PNEUMONIA371 reports
MALAISE344 reports
HYPOTENSION341 reports
PYREXIA336 reports
FALL332 reports
RENAL FAILURE314 reports
BLOOD PRESSURE INCREASED301 reports
PAIN IN EXTREMITY300 reports
ARTHRALGIA297 reports
CHEST PAIN281 reports
DRUG INTERACTION281 reports
OFF LABEL USE274 reports
MYOCARDIAL INFARCTION268 reports
COUGH267 reports
ANAEMIA265 reports
DEATH265 reports
CEREBROVASCULAR ACCIDENT257 reports
OEDEMA PERIPHERAL253 reports
WEIGHT DECREASED252 reports
CARDIAC FAILURE CONGESTIVE251 reports
ANXIETY249 reports
CONDITION AGGRAVATED249 reports
ABDOMINAL PAIN231 reports
DEHYDRATION217 reports
CARDIAC FAILURE212 reports
CONFUSIONAL STATE207 reports
SOMNOLENCE205 reports
GAIT DISTURBANCE204 reports
PRURITUS200 reports
BLOOD GLUCOSE INCREASED194 reports
DEPRESSION193 reports
URINARY TRACT INFECTION192 reports
DECREASED APPETITE188 reports
BACK PAIN185 reports
ACUTE KIDNEY INJURY183 reports
INSOMNIA175 reports
WEIGHT INCREASED169 reports
FEELING ABNORMAL168 reports
ATRIAL FIBRILLATION167 reports
SYNCOPE165 reports
RASH161 reports
CARDIAC ARREST159 reports
HYPONATRAEMIA158 reports
ERYTHEMA156 reports
HYPOKALAEMIA154 reports
LOSS OF CONSCIOUSNESS152 reports
TREMOR152 reports
GENERAL PHYSICAL HEALTH DETERIORATION151 reports
RENAL IMPAIRMENT151 reports
CONSTIPATION149 reports
DIABETES MELLITUS149 reports
RENAL FAILURE ACUTE147 reports
BLOOD CREATININE INCREASED143 reports
ABDOMINAL PAIN UPPER140 reports
RESPIRATORY FAILURE139 reports
THROMBOCYTOPENIA139 reports
HYPERGLYCAEMIA131 reports
SEPSIS129 reports
TACHYCARDIA129 reports
INFLUENZA123 reports
ARRHYTHMIA122 reports
CARDIAC DISORDER120 reports
HYPERHIDROSIS120 reports
HYPERSENSITIVITY120 reports
MEMORY IMPAIRMENT120 reports
BLOOD PRESSURE DECREASED118 reports
BRADYCARDIA117 reports
PULMONARY OEDEMA116 reports
PERIPHERAL SWELLING113 reports
INJURY110 reports
PLEURAL EFFUSION110 reports
MYALGIA108 reports
HAEMOGLOBIN DECREASED107 reports
HYPERKALAEMIA107 reports
PARAESTHESIA107 reports
GASTROINTESTINAL HAEMORRHAGE106 reports
MUSCLE SPASMS104 reports
VISION BLURRED104 reports
HYPOGLYCAEMIA103 reports
PALPITATIONS103 reports
CORONARY ARTERY DISEASE101 reports
HEART RATE INCREASED101 reports
HYPOAESTHESIA101 reports
OXYGEN SATURATION DECREASED101 reports
TOXICITY TO VARIOUS AGENTS101 reports
MULTI ORGAN FAILURE98 reports
CARDIO RESPIRATORY ARREST96 reports
UNEVALUABLE EVENT95 reports
OVERDOSE92 reports

Report Outcomes

Out of 9,472 classified reports for CAPTOPRIL:

Serious 88.9%Non-Serious 11.1%

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

Female4,914 (54.6%)
Male4,063 (45.1%)
Unknown29 (0.3%)

Reports by Age

Age 73198 reports
Age 66197 reports
Age 67194 reports
Age 58172 reports
Age 65170 reports
Age 61169 reports
Age 63169 reports
Age 72168 reports
Age 64167 reports
Age 75167 reports
Age 70162 reports
Age 57161 reports
Age 69159 reports
Age 78158 reports
Age 74150 reports
Age 76149 reports
Age 59146 reports
Age 77142 reports
Age 68140 reports
Age 60139 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 CAPTOPRIL?

This profile reflects 21,001 FDA FAERS reports that mention CAPTOPRIL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CAPTOPRIL?

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

Who manufactures CAPTOPRIL?

Labeling and FAERS entries often list AMICI PHARMACEUTICALS LLC in connection with CAPTOPRIL. 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.