NICARDIPINE HYDROCHLORIDE

N/A

Manufactured by Baxter Healthcare Corporation

3,434 FDA adverse event reports analyzed

Last updated: 2026-04-15

About NICARDIPINE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Baxter Healthcare Corporation. The most commonly reported adverse reactions for NICARDIPINE HYDROCHLORIDE include ACUTE KIDNEY INJURY, PREMATURE BABY, HYPOTENSION, MATERNAL EXPOSURE DURING PREGNANCY, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NICARDIPINE HYDROCHLORIDE.

Top Adverse Reactions

ACUTE KIDNEY INJURY100 reports
PREMATURE BABY95 reports
HYPOTENSION91 reports
MATERNAL EXPOSURE DURING PREGNANCY83 reports
OFF LABEL USE79 reports
FOETAL EXPOSURE DURING PREGNANCY72 reports
PYREXIA70 reports
DRUG INTERACTION66 reports
DIARRHOEA63 reports
HEPATIC CYTOLYSIS57 reports
FALL55 reports
HYPONATRAEMIA53 reports
ANAEMIA52 reports
DRUG EXPOSURE DURING PREGNANCY52 reports
HYPERTENSION52 reports
PREMATURE DELIVERY49 reports
VOMITING49 reports
CONFUSIONAL STATE47 reports
RENAL FAILURE46 reports
LOW BIRTH WEIGHT BABY44 reports
PNEUMONIA43 reports
FOETAL DISORDER41 reports
PNEUMONIA ASPIRATION39 reports
CARDIAC ARREST38 reports
EOSINOPHILIA38 reports
SEPSIS38 reports
ASTHENIA37 reports
BRADYCARDIA37 reports
DYSPNOEA37 reports
HEPATIC FUNCTION ABNORMAL37 reports
NAUSEA37 reports
RASH MACULO PAPULAR37 reports
CEREBRAL INFARCTION36 reports
DECREASED APPETITE36 reports
RENAL IMPAIRMENT36 reports
BLOOD PRESSURE DECREASED34 reports
NEUTROPENIA34 reports
RHABDOMYOLYSIS34 reports
ABDOMINAL PAIN33 reports
CEREBRAL HAEMORRHAGE33 reports
CONDITION AGGRAVATED33 reports
DRUG INEFFECTIVE32 reports
SOMNOLENCE32 reports
CAESAREAN SECTION31 reports
EXPOSURE DURING PREGNANCY31 reports
MALAISE31 reports
RESPIRATORY FAILURE31 reports
THROMBOCYTOPENIA31 reports
ALANINE AMINOTRANSFERASE INCREASED30 reports
CARDIAC FAILURE30 reports
CONSTIPATION29 reports
HYPOKALAEMIA29 reports
ASPARTATE AMINOTRANSFERASE INCREASED28 reports
GENERAL PHYSICAL HEALTH DETERIORATION28 reports
HEADACHE28 reports
LUNG DISORDER28 reports
PAIN IN EXTREMITY28 reports
PLEURAL EFFUSION28 reports
HYPERKALAEMIA27 reports
RESPIRATORY DISTRESS27 reports
NEUTROPENIA NEONATAL26 reports
PLATELET COUNT DECREASED26 reports
RASH26 reports
DEPRESSED LEVEL OF CONSCIOUSNESS25 reports
DIZZINESS25 reports
FATIGUE24 reports
HAEMOGLOBIN DECREASED24 reports
MUSCULAR WEAKNESS24 reports
PANCYTOPENIA24 reports
ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS23 reports
ACUTE PULMONARY OEDEMA23 reports
ARTHRALGIA23 reports
BLOOD CREATININE INCREASED23 reports
CHOLESTASIS23 reports
BLOOD PRESSURE INCREASED22 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS22 reports
HYPOXIA22 reports
LOSS OF CONSCIOUSNESS22 reports
OEDEMA PERIPHERAL22 reports
PRURITUS22 reports
COMA20 reports
EPILEPSY20 reports
URINARY TRACT INFECTION20 reports
FOETAL GROWTH RESTRICTION19 reports
PAIN19 reports
PANCREATITIS ACUTE19 reports
SEPTIC SHOCK19 reports
THROMBOTIC MICROANGIOPATHY19 reports
GASTROINTESTINAL HAEMORRHAGE18 reports
NEONATAL RESPIRATORY DISTRESS SYNDROME18 reports
RENAL FAILURE ACUTE18 reports
TOXIC EPIDERMAL NECROLYSIS18 reports
CIRCULATORY COLLAPSE17 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED17 reports
METABOLIC ACIDOSIS17 reports
POISONING DELIBERATE17 reports
SYNCOPE17 reports
WHITE BLOOD CELL COUNT INCREASED17 reports
ALTERED STATE OF CONSCIOUSNESS16 reports
ANGIOEDEMA16 reports

Report Outcomes

Out of 2,094 classified reports for NICARDIPINE HYDROCHLORIDE:

Serious 97.4%Non-Serious 2.6%

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

Female1,015 (53.0%)
Male897 (46.9%)
Unknown2 (0.1%)

Reports by Age

Age 7650 reports
Age 7750 reports
Age 6948 reports
Age 5945 reports
Age 7245 reports
Age 6544 reports
Age 7842 reports
Age 6141 reports
Age 7041 reports
Age 8041 reports
Age 7437 reports
Age 7534 reports
Age 7934 reports
Age 6833 reports
Age 8333 reports
Age 8533 reports
Age 6232 reports
Age 8432 reports
Age 8131 reports
Age 129 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 NICARDIPINE HYDROCHLORIDE?

This profile reflects 3,434 FDA FAERS reports that mention NICARDIPINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NICARDIPINE HYDROCHLORIDE?

Frequently reported terms in FAERS include ACUTE KIDNEY INJURY, PREMATURE BABY, HYPOTENSION, MATERNAL EXPOSURE DURING PREGNANCY, OFF LABEL USE, FOETAL EXPOSURE DURING PREGNANCY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures NICARDIPINE HYDROCHLORIDE?

Labeling and FAERS entries often list Baxter Healthcare Corporation in connection with NICARDIPINE 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.