ENALAPRIL MALEATE

N/A

Manufactured by Bausch Health US LLC

48,429 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ENALAPRIL MALEATE

ENALAPRIL MALEATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bausch Health US LLC. The most commonly reported adverse reactions for ENALAPRIL MALEATE include NAUSEA, DYSPNOEA, DIARRHOEA, FATIGUE, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ENALAPRIL MALEATE.

Top Adverse Reactions

NAUSEA1,363 reports
DYSPNOEA1,271 reports
DIARRHOEA1,245 reports
FATIGUE1,117 reports
DIZZINESS1,097 reports
DRUG INEFFECTIVE983 reports
PAIN938 reports
VOMITING924 reports
ASTHENIA894 reports
HYPERTENSION878 reports
HEADACHE860 reports
DRUG INTERACTION835 reports
FALL817 reports
HYPOTENSION785 reports
MYOCARDIAL INFARCTION779 reports
RENAL FAILURE768 reports
RENAL FAILURE ACUTE727 reports
CARDIAC FAILURE CONGESTIVE722 reports
PNEUMONIA719 reports
MALAISE686 reports
PYREXIA651 reports
ANAEMIA644 reports
COUGH619 reports
ARTHRALGIA616 reports
ANXIETY591 reports
CHEST PAIN590 reports
OEDEMA PERIPHERAL589 reports
BLOOD GLUCOSE INCREASED572 reports
CEREBROVASCULAR ACCIDENT568 reports
WEIGHT DECREASED568 reports
PAIN IN EXTREMITY566 reports
DEHYDRATION553 reports
BLOOD PRESSURE INCREASED549 reports
HYPERKALAEMIA542 reports
DEPRESSION532 reports
RASH529 reports
DEATH525 reports
CONDITION AGGRAVATED498 reports
PRURITUS491 reports
CARDIAC FAILURE483 reports
OFF LABEL USE476 reports
ATRIAL FIBRILLATION474 reports
BACK PAIN459 reports
DECREASED APPETITE456 reports
INSOMNIA450 reports
CONFUSIONAL STATE448 reports
ACUTE KIDNEY INJURY435 reports
ABDOMINAL PAIN434 reports
BLOOD CREATININE INCREASED424 reports
CONSTIPATION422 reports
SYNCOPE399 reports
URINARY TRACT INFECTION393 reports
GAIT DISTURBANCE375 reports
DIABETES MELLITUS373 reports
ABDOMINAL PAIN UPPER372 reports
RENAL IMPAIRMENT372 reports
WEIGHT INCREASED369 reports
SOMNOLENCE360 reports
HAEMOGLOBIN DECREASED358 reports
HYPONATRAEMIA339 reports
CORONARY ARTERY DISEASE318 reports
LOSS OF CONSCIOUSNESS317 reports
HYPOGLYCAEMIA314 reports
FEELING ABNORMAL312 reports
MYALGIA308 reports
GASTROINTESTINAL HAEMORRHAGE305 reports
ANGIOEDEMA300 reports
DRUG HYPERSENSITIVITY300 reports
BRADYCARDIA295 reports
INJURY295 reports
HYPERHIDROSIS294 reports
ERYTHEMA291 reports
PARAESTHESIA283 reports
BLOOD PRESSURE DECREASED282 reports
MUSCLE SPASMS282 reports
RESPIRATORY FAILURE280 reports
TREMOR279 reports
HYPOAESTHESIA277 reports
SEPSIS275 reports
MUSCULAR WEAKNESS271 reports
CARDIAC ARREST270 reports
HYPERSENSITIVITY270 reports
VISION BLURRED259 reports
CARDIAC DISORDER253 reports
THROMBOCYTOPENIA251 reports
PLEURAL EFFUSION249 reports
ABDOMINAL DISCOMFORT244 reports
PLATELET COUNT DECREASED232 reports
GENERAL PHYSICAL HEALTH DETERIORATION231 reports
DYSPHAGIA230 reports
EMOTIONAL DISTRESS228 reports
HEART RATE INCREASED228 reports
BLOOD UREA INCREASED223 reports
ACUTE MYOCARDIAL INFARCTION222 reports
CONVULSION221 reports
TACHYCARDIA217 reports
UNEVALUABLE EVENT216 reports
PALPITATIONS214 reports
GASTROOESOPHAGEAL REFLUX DISEASE211 reports
FLUSHING210 reports

Report Outcomes

Out of 24,422 classified reports for ENALAPRIL MALEATE:

Serious 81.0%Non-Serious 19.0%

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

Female12,147 (51.5%)
Male11,386 (48.3%)
Unknown36 (0.2%)

Reports by Age

Age 67501 reports
Age 74491 reports
Age 75478 reports
Age 70471 reports
Age 72464 reports
Age 71462 reports
Age 73448 reports
Age 65445 reports
Age 77441 reports
Age 69436 reports
Age 64434 reports
Age 66433 reports
Age 68433 reports
Age 63420 reports
Age 60413 reports
Age 78408 reports
Age 59389 reports
Age 76388 reports
Age 62382 reports
Age 79375 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 ENALAPRIL MALEATE?

This profile reflects 48,429 FDA FAERS reports that mention ENALAPRIL MALEATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ENALAPRIL MALEATE?

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

Who manufactures ENALAPRIL MALEATE?

Labeling and FAERS entries often list Bausch Health US LLC in connection with ENALAPRIL MALEATE. 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.