OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

N/A

Manufactured by Accord Healthcare Inc.

373 FDA adverse event reports analyzed

Last updated: 2026-04-15

About OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare Inc.. The most commonly reported adverse reactions for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE include DIARRHOEA, FATIGUE, ASTHENIA, DIZZINESS, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE.

Top Adverse Reactions

DIARRHOEA15 reports
FATIGUE13 reports
ASTHENIA10 reports
DIZZINESS10 reports
VOMITING9 reports
DRUG INEFFECTIVE8 reports
DYSPNOEA8 reports
HEADACHE8 reports
NAUSEA8 reports
HYPERTENSION7 reports
PRODUCT DOSE OMISSION ISSUE7 reports
DECREASED APPETITE6 reports
FEELING ABNORMAL6 reports
PERIPHERAL SWELLING6 reports
WEIGHT DECREASED6 reports
CHEST PAIN5 reports
CONFUSIONAL STATE5 reports
HOT FLUSH5 reports
MALAISE5 reports
OFF LABEL USE5 reports
PAIN5 reports
PSORIASIS5 reports
RASH5 reports
ABDOMINAL PAIN UPPER4 reports
BLOOD PRESSURE INCREASED4 reports
CONDITION AGGRAVATED4 reports
DEATH4 reports
DRUG ABUSE4 reports
GAIT DISTURBANCE4 reports
HYPOAESTHESIA4 reports
ILLNESS4 reports
MYALGIA4 reports
PAIN IN EXTREMITY4 reports
PRODUCT ODOUR ABNORMAL4 reports
ANAEMIA3 reports
ANXIETY3 reports
ARTHRALGIA3 reports
BACK PAIN3 reports
BASAL CELL CARCINOMA3 reports
BONE PAIN3 reports
BRONCHITIS3 reports
CARDIAC ARREST3 reports
COMPLETED SUICIDE3 reports
CONSTIPATION3 reports
DRUG INTERACTION3 reports
DRY SKIN3 reports
FALL3 reports
GASTROINTESTINAL DISORDER3 reports
GENERALISED OEDEMA3 reports
HYPOKALAEMIA3 reports
INJECTION SITE ERYTHEMA3 reports
INSOMNIA3 reports
MEMORY IMPAIRMENT3 reports
METABOLIC ACIDOSIS3 reports
PRODUCT SUBSTITUTION ISSUE3 reports
PRODUCT TASTE ABNORMAL3 reports
RHABDOMYOLYSIS3 reports
SPRUE LIKE ENTEROPATHY3 reports
SWELLING3 reports
SYNCOPE3 reports
TACHYCARDIA3 reports
TOXICITY TO VARIOUS AGENTS3 reports
URINARY TRACT INFECTION3 reports
WEIGHT INCREASED3 reports
ABDOMINAL DISCOMFORT2 reports
ABDOMINAL DISTENSION2 reports
ACUTE KIDNEY INJURY2 reports
AORTIC STENOSIS2 reports
BALANCE DISORDER2 reports
BLOOD CREATININE INCREASED2 reports
BLOOD GLUCOSE DECREASED2 reports
BLOOD PRESSURE INADEQUATELY CONTROLLED2 reports
BRAIN FOG2 reports
BREAST CANCER2 reports
CARDIAC DISORDER2 reports
DERMATITIS ATOPIC2 reports
DEVICE MALFUNCTION2 reports
DISCOMFORT2 reports
DYSGEUSIA2 reports
DYSPEPSIA2 reports
FLUID RETENTION2 reports
GINGIVAL BLEEDING2 reports
HAEMORRHAGE2 reports
HAEMORRHOIDS2 reports
HEPATIC ENZYME INCREASED2 reports
HYPOACUSIS2 reports
HYPOGLYCAEMIA2 reports
HYPOTENSION2 reports
INFECTION2 reports
INFUSION SITE PAIN2 reports
INJECTION SITE PAIN2 reports
INJECTION SITE REACTION2 reports
INJECTION SITE SWELLING2 reports
INTENTIONAL OVERDOSE2 reports
INTENTIONAL PRODUCT USE ISSUE2 reports
INTENTIONAL SELF INJURY2 reports
INTESTINAL INTRAEPITHELIAL LYMPHOCYTES INCREASED2 reports
LOWER RESPIRATORY TRACT INFECTION2 reports
MALABSORPTION2 reports
MOVEMENT DISORDER2 reports

Report Outcomes

Out of 160 classified reports for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE:

Serious 58.1%Non-Serious 41.9%

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

Male75 (52.4%)
Female68 (47.6%)

Reports by Age

Age 728 reports
Age 587 reports
Age 636 reports
Age 696 reports
Age 655 reports
Age 715 reports
Age 604 reports
Age 764 reports
Age 774 reports
Age 573 reports
Age 663 reports
Age 743 reports
Age 753 reports
Age 813 reports
Age 612 reports
Age 672 reports
Age 682 reports
Age 702 reports
Age 832 reports
Age 842 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 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE?

This profile reflects 373 FDA FAERS reports that mention OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE?

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

Who manufactures OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE?

Labeling and FAERS entries often list Accord Healthcare Inc. in connection with OLMESARTAN MEDOXOMIL 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.