VALSARTAN AND HYDROCHLOROTHIAZIDE

N/A

Manufactured by Novartis Pharmaceuticals Corporation

26,234 FDA adverse event reports analyzed

Last updated: 2026-04-14

About VALSARTAN AND HYDROCHLOROTHIAZIDE

VALSARTAN AND HYDROCHLOROTHIAZIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. The most commonly reported adverse reactions for VALSARTAN AND HYDROCHLOROTHIAZIDE include BLOOD PRESSURE INCREASED, DIZZINESS, HYPERTENSION, DRUG INEFFECTIVE, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VALSARTAN AND HYDROCHLOROTHIAZIDE.

Top Adverse Reactions

BLOOD PRESSURE INCREASED817 reports
DIZZINESS797 reports
HYPERTENSION767 reports
DRUG INEFFECTIVE738 reports
HEADACHE706 reports
FATIGUE681 reports
NAUSEA649 reports
DYSPNOEA606 reports
MALAISE565 reports
FALL554 reports
PAIN531 reports
DEATH492 reports
DIARRHOEA460 reports
CEREBROVASCULAR ACCIDENT444 reports
ASTHENIA427 reports
PAIN IN EXTREMITY390 reports
VOMITING388 reports
DIABETES MELLITUS385 reports
FEELING ABNORMAL369 reports
ARTHRALGIA354 reports
WEIGHT DECREASED352 reports
HYPOTENSION350 reports
COUGH336 reports
PRURITUS333 reports
PNEUMONIA319 reports
OEDEMA PERIPHERAL318 reports
CHEST PAIN310 reports
MYOCARDIAL INFARCTION303 reports
BLOOD GLUCOSE INCREASED298 reports
DEPRESSION288 reports
GAIT DISTURBANCE281 reports
WEIGHT INCREASED281 reports
ANXIETY280 reports
BACK PAIN278 reports
INSOMNIA268 reports
RENAL FAILURE258 reports
ABDOMINAL PAIN239 reports
BLOOD PRESSURE DECREASED231 reports
RASH228 reports
MUSCLE SPASMS227 reports
BLOOD PRESSURE INADEQUATELY CONTROLLED226 reports
PYREXIA223 reports
ANAEMIA220 reports
FLUSHING216 reports
ABDOMINAL PAIN UPPER213 reports
MYALGIA201 reports
BLOOD PRESSURE FLUCTUATION194 reports
DEHYDRATION193 reports
HYPOAESTHESIA192 reports
SYNCOPE191 reports
HYPERSENSITIVITY185 reports
URINARY TRACT INFECTION183 reports
ERYTHEMA182 reports
LOSS OF CONSCIOUSNESS182 reports
PARAESTHESIA174 reports
CONSTIPATION172 reports
SOMNOLENCE171 reports
CONDITION AGGRAVATED169 reports
CARDIAC DISORDER166 reports
DECREASED APPETITE165 reports
DRUG INTERACTION165 reports
MEMORY IMPAIRMENT164 reports
ABDOMINAL DISCOMFORT163 reports
PALPITATIONS163 reports
HYPONATRAEMIA162 reports
ARRHYTHMIA161 reports
RENAL FAILURE ACUTE155 reports
OFF LABEL USE154 reports
TREMOR154 reports
VISION BLURRED154 reports
CONFUSIONAL STATE152 reports
HYPERHIDROSIS152 reports
ALOPECIA151 reports
ARTHRITIS151 reports
MUSCULAR WEAKNESS150 reports
CATARACT149 reports
VISUAL IMPAIRMENT148 reports
ASTHMA145 reports
NERVOUSNESS144 reports
ACUTE KIDNEY INJURY142 reports
ATRIAL FIBRILLATION141 reports
JOINT SWELLING136 reports
PERIPHERAL SWELLING135 reports
HEART RATE INCREASED133 reports
BLOOD CHOLESTEROL INCREASED131 reports
BLOOD CREATININE INCREASED130 reports
BREAST CANCER130 reports
OSTEOARTHRITIS124 reports
CHRONIC KIDNEY DISEASE123 reports
GASTROOESOPHAGEAL REFLUX DISEASE120 reports
RENAL DISORDER120 reports
INFLUENZA118 reports
NASOPHARYNGITIS117 reports
SWELLING114 reports
SURGERY113 reports
BLOOD POTASSIUM DECREASED112 reports
FEELING HOT112 reports
INFECTION112 reports
CARDIAC FAILURE CONGESTIVE109 reports
DRUG HYPERSENSITIVITY109 reports

Report Outcomes

Out of 13,402 classified reports for VALSARTAN AND HYDROCHLOROTHIAZIDE:

Serious 77.1%Non-Serious 22.9%

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

Female8,494 (65.8%)
Male4,400 (34.1%)
Unknown11 (0.1%)

Reports by Age

Age 67230 reports
Age 70230 reports
Age 64217 reports
Age 65217 reports
Age 60215 reports
Age 59197 reports
Age 68196 reports
Age 74196 reports
Age 61195 reports
Age 69195 reports
Age 73189 reports
Age 66188 reports
Age 72187 reports
Age 63182 reports
Age 71180 reports
Age 56179 reports
Age 58167 reports
Age 77167 reports
Age 62164 reports
Age 76161 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 VALSARTAN AND HYDROCHLOROTHIAZIDE?

This profile reflects 26,234 FDA FAERS reports that mention VALSARTAN AND HYDROCHLOROTHIAZIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

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

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

Who manufactures VALSARTAN AND HYDROCHLOROTHIAZIDE?

Labeling and FAERS entries often list Novartis Pharmaceuticals Corporation in connection with VALSARTAN 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.