GRANISETRON HYDROCHLORIDE

N/A

Manufactured by Fresenius Kabi USA, LLC

22,079 FDA adverse event reports analyzed

Last updated: 2026-04-14

About GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. The most commonly reported adverse reactions for GRANISETRON HYDROCHLORIDE include NAUSEA, FEBRILE NEUTROPENIA, DIARRHOEA, VOMITING, PYREXIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GRANISETRON HYDROCHLORIDE.

Top Adverse Reactions

NAUSEA1,169 reports
FEBRILE NEUTROPENIA840 reports
DIARRHOEA771 reports
VOMITING744 reports
PYREXIA738 reports
DYSPNOEA642 reports
FATIGUE547 reports
NEUTROPENIA520 reports
ANAEMIA519 reports
OFF LABEL USE494 reports
DECREASED APPETITE416 reports
PNEUMONIA402 reports
DEATH394 reports
CONSTIPATION389 reports
GENERAL PHYSICAL HEALTH DETERIORATION375 reports
PLATELET COUNT DECREASED365 reports
THROMBOCYTOPENIA345 reports
WHITE BLOOD CELL COUNT DECREASED323 reports
ABDOMINAL PAIN316 reports
ASTHENIA315 reports
RASH298 reports
NEUTROPHIL COUNT DECREASED293 reports
SEPSIS282 reports
MALAISE276 reports
HYPOTENSION268 reports
LEUKOPENIA266 reports
HEADACHE240 reports
DEHYDRATION232 reports
DIZZINESS230 reports
COUGH216 reports
WEIGHT DECREASED199 reports
PANCYTOPENIA198 reports
MALIGNANT NEOPLASM PROGRESSION194 reports
STOMATITIS190 reports
PAIN189 reports
HYPOKALAEMIA187 reports
BACK PAIN186 reports
DISEASE PROGRESSION183 reports
ACUTE KIDNEY INJURY182 reports
ERYTHEMA177 reports
TACHYCARDIA176 reports
PRURITUS173 reports
NEUROPATHY PERIPHERAL171 reports
HYPERTENSION160 reports
MUCOSAL INFLAMMATION156 reports
INTERSTITIAL LUNG DISEASE154 reports
ALOPECIA150 reports
HAEMOGLOBIN DECREASED150 reports
INFUSION RELATED REACTION149 reports
PRODUCT ADHESION ISSUE148 reports
URINARY TRACT INFECTION146 reports
HYPERSENSITIVITY141 reports
INFECTION138 reports
CHEST PAIN136 reports
CHILLS136 reports
PAIN IN EXTREMITY132 reports
ABDOMINAL PAIN UPPER131 reports
DRUG INEFFECTIVE130 reports
PARAESTHESIA130 reports
ALANINE AMINOTRANSFERASE INCREASED129 reports
FLUSHING129 reports
PLEURAL EFFUSION127 reports
PULMONARY EMBOLISM126 reports
OEDEMA PERIPHERAL125 reports
RESPIRATORY FAILURE123 reports
DRUG INTERACTION122 reports
CHEST DISCOMFORT116 reports
ASPARTATE AMINOTRANSFERASE INCREASED115 reports
HEPATIC FUNCTION ABNORMAL114 reports
SEPTIC SHOCK114 reports
HYPERHIDROSIS113 reports
PRODUCT USE IN UNAPPROVED INDICATION112 reports
ATRIAL FIBRILLATION111 reports
ANAPHYLACTIC REACTION109 reports
CONDITION AGGRAVATED109 reports
INSOMNIA106 reports
BLOOD CREATININE INCREASED105 reports
RENAL FAILURE105 reports
SYNCOPE105 reports
SOMNOLENCE101 reports
HYPONATRAEMIA99 reports
ARTHRALGIA97 reports
PNEUMONITIS97 reports
CARDIAC FAILURE96 reports
OEDEMA94 reports
DYSPHAGIA92 reports
DISSEMINATED INTRAVASCULAR COAGULATION91 reports
BONE MARROW FAILURE90 reports
C REACTIVE PROTEIN INCREASED90 reports
FALL86 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION86 reports
CYTOKINE RELEASE SYNDROME84 reports
EPISTAXIS84 reports
CONFUSIONAL STATE83 reports
MYALGIA83 reports
GASTROINTESTINAL HAEMORRHAGE80 reports
HYPOAESTHESIA80 reports
OXYGEN SATURATION DECREASED79 reports
RENAL IMPAIRMENT78 reports
CARDIAC ARREST77 reports

Report Outcomes

Out of 10,127 classified reports for GRANISETRON HYDROCHLORIDE:

Serious 91.4%Non-Serious 8.6%

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

Female4,684 (52.8%)
Male4,174 (47.0%)
Unknown20 (0.2%)

Reports by Age

Age 68272 reports
Age 70245 reports
Age 72242 reports
Age 66239 reports
Age 69239 reports
Age 67216 reports
Age 63215 reports
Age 57211 reports
Age 71211 reports
Age 73209 reports
Age 62193 reports
Age 76193 reports
Age 65187 reports
Age 74172 reports
Age 60171 reports
Age 64171 reports
Age 61170 reports
Age 58167 reports
Age 75166 reports
Age 59160 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 GRANISETRON HYDROCHLORIDE?

This profile reflects 22,079 FDA FAERS reports that mention GRANISETRON HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for GRANISETRON HYDROCHLORIDE?

Frequently reported terms in FAERS include NAUSEA, FEBRILE NEUTROPENIA, DIARRHOEA, VOMITING, PYREXIA, DYSPNOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures GRANISETRON HYDROCHLORIDE?

Labeling and FAERS entries often list Fresenius Kabi USA, LLC in connection with GRANISETRON 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.