IRBESARTAN AND HYDROCHLOROTHIAZIDE

N/A

Manufactured by Sanofi-Aventis U.S. LLC

10,188 FDA adverse event reports analyzed

Last updated: 2026-04-15

About IRBESARTAN AND HYDROCHLOROTHIAZIDE

IRBESARTAN AND HYDROCHLOROTHIAZIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sanofi-Aventis U.S. LLC. The most commonly reported adverse reactions for IRBESARTAN AND HYDROCHLOROTHIAZIDE include NAUSEA, DIZZINESS, FATIGUE, DRUG INEFFECTIVE, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IRBESARTAN AND HYDROCHLOROTHIAZIDE.

Top Adverse Reactions

NAUSEA349 reports
DIZZINESS336 reports
FATIGUE306 reports
DRUG INEFFECTIVE292 reports
DYSPNOEA245 reports
HEADACHE240 reports
BLOOD PRESSURE INCREASED217 reports
DIARRHOEA212 reports
HYPERTENSION199 reports
VOMITING191 reports
PAIN190 reports
ASTHENIA186 reports
FALL172 reports
PAIN IN EXTREMITY170 reports
ARTHRALGIA160 reports
OEDEMA PERIPHERAL155 reports
MALAISE154 reports
WEIGHT DECREASED143 reports
CHEST PAIN141 reports
INSOMNIA138 reports
ANXIETY128 reports
PRURITUS128 reports
RENAL FAILURE127 reports
BLOOD GLUCOSE INCREASED123 reports
COUGH122 reports
MYOCARDIAL INFARCTION121 reports
BACK PAIN118 reports
RASH118 reports
DEPRESSION115 reports
FEELING ABNORMAL114 reports
ANAEMIA110 reports
OFF LABEL USE104 reports
DEHYDRATION103 reports
HYPOTENSION102 reports
WEIGHT INCREASED102 reports
CEREBROVASCULAR ACCIDENT100 reports
MYALGIA100 reports
MUSCLE SPASMS98 reports
FLUSHING97 reports
PNEUMONIA97 reports
DECREASED APPETITE93 reports
ABDOMINAL PAIN92 reports
CHRONIC KIDNEY DISEASE87 reports
ABDOMINAL PAIN UPPER86 reports
PALPITATIONS86 reports
DEATH84 reports
PYREXIA84 reports
SOMNOLENCE84 reports
DYSGEUSIA82 reports
PARAESTHESIA82 reports
CONFUSIONAL STATE80 reports
CONSTIPATION77 reports
HYPERHIDROSIS74 reports
HYPONATRAEMIA74 reports
GAIT DISTURBANCE73 reports
RENAL FAILURE ACUTE73 reports
ALOPECIA72 reports
URINARY TRACT INFECTION72 reports
VISION BLURRED72 reports
ACUTE KIDNEY INJURY71 reports
MUSCULAR WEAKNESS71 reports
HYPOAESTHESIA70 reports
CARDIAC FAILURE CONGESTIVE67 reports
DYSPEPSIA67 reports
SYNCOPE66 reports
ABDOMINAL DISCOMFORT65 reports
CONDITION AGGRAVATED65 reports
TREMOR63 reports
HEART RATE INCREASED62 reports
ATRIAL FIBRILLATION61 reports
CHEST DISCOMFORT61 reports
CORONARY ARTERY DISEASE61 reports
DIABETES MELLITUS61 reports
DRUG INTERACTION56 reports
HYPOGLYCAEMIA55 reports
SINUSITIS55 reports
URTICARIA55 reports
LOSS OF CONSCIOUSNESS54 reports
BLOOD CREATININE INCREASED53 reports
JOINT SWELLING53 reports
DRY MOUTH52 reports
ERYTHEMA52 reports
BRONCHITIS51 reports
ABDOMINAL DISTENSION49 reports
ARTHRITIS49 reports
OSTEOARTHRITIS49 reports
CHILLS48 reports
SWELLING48 reports
DRUG HYPERSENSITIVITY47 reports
DYSPHAGIA47 reports
GASTROOESOPHAGEAL REFLUX DISEASE47 reports
MUSCULOSKELETAL PAIN47 reports
BLOOD CHOLESTEROL INCREASED46 reports
RENAL IMPAIRMENT46 reports
BLOOD PRESSURE DECREASED45 reports
HAEMOGLOBIN DECREASED45 reports
HYPOKALAEMIA45 reports
MEDICATION ERROR45 reports
HYPERSENSITIVITY44 reports
INJECTION SITE PAIN44 reports

Report Outcomes

Out of 5,273 classified reports for IRBESARTAN AND HYDROCHLOROTHIAZIDE:

Serious 56.7%Non-Serious 43.3%

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

Female3,149 (63.4%)
Male1,815 (36.5%)
Unknown4 (0.1%)

Reports by Age

Age 66131 reports
Age 64118 reports
Age 63101 reports
Age 70101 reports
Age 7498 reports
Age 6796 reports
Age 6996 reports
Age 7396 reports
Age 5994 reports
Age 6290 reports
Age 5388 reports
Age 6887 reports
Age 7285 reports
Age 6583 reports
Age 7883 reports
Age 7982 reports
Age 7579 reports
Age 6078 reports
Age 5676 reports
Age 5874 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 IRBESARTAN AND HYDROCHLOROTHIAZIDE?

This profile reflects 10,188 FDA FAERS reports that mention IRBESARTAN AND HYDROCHLOROTHIAZIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for IRBESARTAN AND HYDROCHLOROTHIAZIDE?

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

Who manufactures IRBESARTAN AND HYDROCHLOROTHIAZIDE?

Labeling and FAERS entries often list Sanofi-Aventis U.S. LLC in connection with IRBESARTAN AND HYDROCHLOROTHIAZIDE. 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.