AMLODIPINE BESYLATE AND VALSARTAN

N/A

Manufactured by Novartis Pharmaceuticals Corporation

18,550 FDA adverse event reports analyzed

Last updated: 2026-04-14

About AMLODIPINE BESYLATE AND VALSARTAN

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

Top Adverse Reactions

BLOOD PRESSURE INCREASED652 reports
HYPERTENSION582 reports
DRUG INEFFECTIVE536 reports
DIZZINESS486 reports
MALAISE467 reports
DEATH466 reports
FATIGUE439 reports
FALL428 reports
HEADACHE390 reports
DYSPNOEA361 reports
OEDEMA PERIPHERAL353 reports
DIABETES MELLITUS351 reports
CEREBROVASCULAR ACCIDENT341 reports
DIARRHOEA337 reports
NAUSEA316 reports
ASTHENIA294 reports
PAIN292 reports
HYPOTENSION269 reports
OFF LABEL USE255 reports
PNEUMONIA255 reports
FEELING ABNORMAL253 reports
VOMITING240 reports
PAIN IN EXTREMITY238 reports
RENAL FAILURE224 reports
ACUTE KIDNEY INJURY219 reports
ARTHRALGIA215 reports
BLOOD PRESSURE DECREASED214 reports
COUGH211 reports
PRURITUS205 reports
GAIT DISTURBANCE204 reports
WEIGHT DECREASED203 reports
PYREXIA197 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS192 reports
BLOOD GLUCOSE INCREASED185 reports
PERIPHERAL SWELLING182 reports
ANAEMIA173 reports
BACK PAIN172 reports
ANXIETY165 reports
MYOCARDIAL INFARCTION164 reports
MEMORY IMPAIRMENT163 reports
DEPRESSION160 reports
CHEST PAIN158 reports
BLOOD PRESSURE INADEQUATELY CONTROLLED156 reports
CARDIAC FAILURE152 reports
DECREASED APPETITE152 reports
ABDOMINAL PAIN151 reports
RASH151 reports
INSOMNIA150 reports
ABDOMINAL PAIN UPPER149 reports
ERYTHEMA143 reports
ARRHYTHMIA139 reports
GENERAL PHYSICAL HEALTH DETERIORATION137 reports
JOINT SWELLING129 reports
URINARY TRACT INFECTION129 reports
VISUAL IMPAIRMENT129 reports
WEIGHT INCREASED127 reports
CONSTIPATION123 reports
FLUSHING123 reports
SYNCOPE123 reports
BLOOD CREATININE INCREASED121 reports
INFARCTION121 reports
MUSCLE SPASMS120 reports
MYALGIA118 reports
CARDIAC DISORDER117 reports
CHRONIC KIDNEY DISEASE117 reports
CONDITION AGGRAVATED117 reports
HYPOAESTHESIA117 reports
INCORRECT DOSE ADMINISTERED117 reports
DEAFNESS111 reports
TREMOR111 reports
LOSS OF CONSCIOUSNESS110 reports
SOMNOLENCE110 reports
BLOOD PRESSURE FLUCTUATION109 reports
DEHYDRATION107 reports
RENAL DISORDER103 reports
PARAESTHESIA100 reports
VISION BLURRED97 reports
SPEECH DISORDER96 reports
WRONG TECHNIQUE IN DRUG USAGE PROCESS96 reports
HYPERKALAEMIA95 reports
PALPITATIONS95 reports
BLOOD PRESSURE ABNORMAL94 reports
CATARACT93 reports
MUSCULAR WEAKNESS89 reports
RENAL IMPAIRMENT89 reports
ABDOMINAL DISCOMFORT88 reports
ATRIAL FIBRILLATION87 reports
NERVOUSNESS87 reports
DYSPEPSIA86 reports
FLUID RETENTION82 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE80 reports
HYPONATRAEMIA80 reports
INTERSTITIAL LUNG DISEASE80 reports
SWELLING80 reports
COVID 1978 reports
DRUG INTERACTION78 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION78 reports
CARDIAC ARREST76 reports
HYPERSENSITIVITY76 reports
HYPERHIDROSIS74 reports

Report Outcomes

Out of 10,868 classified reports for AMLODIPINE BESYLATE AND VALSARTAN:

Serious 86.1%Non-Serious 13.9%

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

Female5,674 (53.7%)
Male4,855 (46.0%)
Unknown28 (0.3%)

Reports by Age

Age 70219 reports
Age 75215 reports
Age 73204 reports
Age 63195 reports
Age 66195 reports
Age 67195 reports
Age 65194 reports
Age 64188 reports
Age 69186 reports
Age 71185 reports
Age 72184 reports
Age 68170 reports
Age 61161 reports
Age 76160 reports
Age 74157 reports
Age 62155 reports
Age 79153 reports
Age 78150 reports
Age 60144 reports
Age 77144 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 AMLODIPINE BESYLATE AND VALSARTAN?

This profile reflects 18,550 FDA FAERS reports that mention AMLODIPINE BESYLATE AND VALSARTAN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AMLODIPINE BESYLATE AND VALSARTAN?

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

Who manufactures AMLODIPINE BESYLATE AND VALSARTAN?

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