AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

N/A

Manufactured by Novartis Pharmaceuticals Corporation

18,930 FDA adverse event reports analyzed

Last updated: 2026-04-14

About AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE 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 BENAZEPRIL HYDROCHLORIDE include NAUSEA, FATIGUE, DRUG INEFFECTIVE, DIZZINESS, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE.

Top Adverse Reactions

NAUSEA620 reports
FATIGUE532 reports
DRUG INEFFECTIVE525 reports
DIZZINESS478 reports
DIARRHOEA452 reports
DYSPNOEA426 reports
HEADACHE414 reports
PAIN400 reports
ASTHENIA385 reports
MYOCARDIAL INFARCTION352 reports
RENAL FAILURE321 reports
HYPERTENSION319 reports
VOMITING308 reports
CARDIAC FAILURE CONGESTIVE305 reports
CEREBROVASCULAR ACCIDENT305 reports
ANXIETY291 reports
CHEST PAIN285 reports
ARTHRALGIA284 reports
PAIN IN EXTREMITY278 reports
OEDEMA PERIPHERAL277 reports
FALL276 reports
DEPRESSION274 reports
WEIGHT DECREASED272 reports
COUGH265 reports
CHRONIC KIDNEY DISEASE257 reports
PRURITUS252 reports
BACK PAIN234 reports
RASH231 reports
BLOOD PRESSURE INCREASED229 reports
INSOMNIA224 reports
MALAISE211 reports
HYPOTENSION200 reports
DEATH198 reports
ABDOMINAL PAIN197 reports
BLOOD GLUCOSE INCREASED196 reports
CONSTIPATION196 reports
ANAEMIA195 reports
ACUTE KIDNEY INJURY192 reports
PNEUMONIA190 reports
FLUSHING183 reports
PARAESTHESIA173 reports
CORONARY ARTERY DISEASE172 reports
FEELING ABNORMAL167 reports
MUSCLE SPASMS164 reports
HYPOAESTHESIA162 reports
ABDOMINAL PAIN UPPER161 reports
DEHYDRATION157 reports
WEIGHT INCREASED157 reports
DECREASED APPETITE152 reports
URINARY TRACT INFECTION150 reports
GAIT DISTURBANCE144 reports
INJECTION SITE PAIN144 reports
DIABETES MELLITUS141 reports
MYALGIA141 reports
TREMOR140 reports
PALPITATIONS136 reports
PYREXIA136 reports
SOMNOLENCE132 reports
ATRIAL FIBRILLATION131 reports
VISION BLURRED128 reports
INJURY125 reports
OFF LABEL USE125 reports
GASTROOESOPHAGEAL REFLUX DISEASE124 reports
DYSPEPSIA122 reports
HYPERHIDROSIS122 reports
RENAL FAILURE ACUTE122 reports
DRUG HYPERSENSITIVITY112 reports
ALOPECIA110 reports
EMOTIONAL DISTRESS107 reports
ERYTHEMA107 reports
HYPERSENSITIVITY107 reports
ANGIOEDEMA103 reports
CONDITION AGGRAVATED103 reports
END STAGE RENAL DISEASE103 reports
JOINT SWELLING101 reports
ABDOMINAL DISCOMFORT100 reports
LOSS OF CONSCIOUSNESS99 reports
MUSCULAR WEAKNESS98 reports
CONFUSIONAL STATE97 reports
SWOLLEN TONGUE95 reports
DYSGEUSIA94 reports
SYNCOPE92 reports
ABDOMINAL DISTENSION91 reports
SWELLING FACE91 reports
GASTROINTESTINAL HAEMORRHAGE90 reports
BLOOD CHOLESTEROL INCREASED89 reports
RENAL INJURY89 reports
BALANCE DISORDER88 reports
HAEMOGLOBIN DECREASED88 reports
SINUSITIS88 reports
BRONCHITIS87 reports
BLOOD CREATININE INCREASED85 reports
HEART RATE INCREASED85 reports
ARTHRITIS84 reports
INCORRECT DOSE ADMINISTERED83 reports
DRUG DOSE OMISSION82 reports
URTICARIA82 reports
CHILLS81 reports
DYSPHAGIA81 reports
OSTEOARTHRITIS81 reports

Report Outcomes

Out of 9,137 classified reports for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE:

Serious 60.0%Non-Serious 40.0%

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

Female4,992 (56.0%)
Male3,902 (43.8%)
Unknown13 (0.1%)

Reports by Age

Age 69176 reports
Age 59174 reports
Age 60170 reports
Age 65170 reports
Age 74169 reports
Age 61166 reports
Age 62165 reports
Age 64165 reports
Age 71164 reports
Age 72160 reports
Age 70159 reports
Age 63157 reports
Age 73157 reports
Age 66150 reports
Age 67147 reports
Age 68143 reports
Age 56139 reports
Age 55138 reports
Age 54134 reports
Age 57133 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 BENAZEPRIL HYDROCHLORIDE?

This profile reflects 18,930 FDA FAERS reports that mention AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE. 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 BENAZEPRIL HYDROCHLORIDE?

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

Who manufactures AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE?

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