CANDESARTAN CILEXETIL

N/A

Manufactured by ANI Pharmaceuticals, Inc.

59,566 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CANDESARTAN CILEXETIL

CANDESARTAN CILEXETIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. The most commonly reported adverse reactions for CANDESARTAN CILEXETIL include DYSPNOEA, FATIGUE, NAUSEA, DRUG INEFFECTIVE, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CANDESARTAN CILEXETIL.

Top Adverse Reactions

DYSPNOEA1,665 reports
FATIGUE1,624 reports
NAUSEA1,572 reports
DRUG INEFFECTIVE1,507 reports
HEADACHE1,494 reports
DIZZINESS1,427 reports
DIARRHOEA1,293 reports
MALAISE1,279 reports
FALL1,208 reports
OFF LABEL USE1,181 reports
BLOOD PRESSURE INCREASED1,111 reports
PAIN1,107 reports
HYPERTENSION1,093 reports
VOMITING1,066 reports
ASTHENIA1,002 reports
ARTHRALGIA955 reports
PYREXIA944 reports
HYPOTENSION918 reports
COUGH911 reports
PNEUMONIA893 reports
ACUTE KIDNEY INJURY851 reports
ANXIETY769 reports
DRUG INTERACTION769 reports
PAIN IN EXTREMITY720 reports
CONDITION AGGRAVATED660 reports
INSOMNIA660 reports
PRURITUS660 reports
WEIGHT DECREASED653 reports
ANAEMIA637 reports
RASH634 reports
OEDEMA PERIPHERAL615 reports
CONFUSIONAL STATE613 reports
CHEST PAIN603 reports
PALPITATIONS600 reports
MUSCULAR WEAKNESS582 reports
ABDOMINAL PAIN UPPER581 reports
BACK PAIN567 reports
MYOCARDIAL INFARCTION523 reports
MYALGIA505 reports
CEREBROVASCULAR ACCIDENT493 reports
RENAL FAILURE492 reports
DEHYDRATION484 reports
HYPERKALAEMIA480 reports
WEIGHT INCREASED478 reports
DEATH475 reports
NASOPHARYNGITIS466 reports
ASTHMA463 reports
DECREASED APPETITE463 reports
RENAL FAILURE ACUTE461 reports
FEELING ABNORMAL455 reports
MIGRAINE451 reports
ATRIAL FIBRILLATION440 reports
HYPONATRAEMIA437 reports
ABDOMINAL PAIN432 reports
MEMORY IMPAIRMENT427 reports
BRADYCARDIA424 reports
GAIT DISTURBANCE420 reports
GASTROOESOPHAGEAL REFLUX DISEASE414 reports
PARAESTHESIA411 reports
ABDOMINAL DISCOMFORT393 reports
DEPRESSION393 reports
BLOOD CREATININE INCREASED392 reports
CHEST DISCOMFORT389 reports
SOMNOLENCE387 reports
HYPERHIDROSIS385 reports
RHEUMATOID ARTHRITIS384 reports
SYNCOPE378 reports
HYPOAESTHESIA377 reports
PRODUCT USE IN UNAPPROVED INDICATION374 reports
BLOOD GLUCOSE INCREASED372 reports
CARDIAC FAILURE372 reports
PERIPHERAL SWELLING372 reports
ARTHRITIS370 reports
ANGINA PECTORIS369 reports
GENERAL PHYSICAL HEALTH DETERIORATION367 reports
CONSTIPATION364 reports
MUSCLE SPASMS364 reports
SINUSITIS355 reports
RENAL IMPAIRMENT348 reports
WHEEZING347 reports
HEART RATE INCREASED343 reports
ALOPECIA342 reports
CATARACT341 reports
HAEMOGLOBIN DECREASED340 reports
URINARY TRACT INFECTION337 reports
TACHYCARDIA328 reports
JOINT SWELLING327 reports
LOSS OF CONSCIOUSNESS321 reports
DRUG INTOLERANCE313 reports
VASCULITIS306 reports
PRODUCTIVE COUGH303 reports
PULMONARY EMBOLISM297 reports
DYSPEPSIA292 reports
GASTROINTESTINAL DISORDER291 reports
DRUG HYPERSENSITIVITY289 reports
INFLUENZA289 reports
TREMOR288 reports
DYSPHAGIA285 reports
VISUAL IMPAIRMENT284 reports
INTENTIONAL PRODUCT USE ISSUE280 reports

Report Outcomes

Out of 25,375 classified reports for CANDESARTAN CILEXETIL:

Serious 87.7%Non-Serious 12.3%

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

Female13,883 (57.3%)
Male10,270 (42.4%)
Unknown59 (0.2%)

Reports by Age

Age 65712 reports
Age 72650 reports
Age 70569 reports
Age 71553 reports
Age 73551 reports
Age 74549 reports
Age 75540 reports
Age 67535 reports
Age 69514 reports
Age 68513 reports
Age 76507 reports
Age 78498 reports
Age 66494 reports
Age 77483 reports
Age 63478 reports
Age 61476 reports
Age 62475 reports
Age 60462 reports
Age 79456 reports
Age 64449 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 CANDESARTAN CILEXETIL?

This profile reflects 59,566 FDA FAERS reports that mention CANDESARTAN CILEXETIL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CANDESARTAN CILEXETIL?

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

Who manufactures CANDESARTAN CILEXETIL?

Labeling and FAERS entries often list ANI Pharmaceuticals, Inc. in connection with CANDESARTAN CILEXETIL. 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.