GRANISETRON

N/A

Manufactured by Cumberland Pharmaceuticals Inc.

21,280 FDA adverse event reports analyzed

Last updated: 2026-04-14

About GRANISETRON

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

Top Adverse Reactions

NAUSEA1,305 reports
VOMITING753 reports
FEBRILE NEUTROPENIA720 reports
DIARRHOEA709 reports
PYREXIA641 reports
DEATH601 reports
DYSPNOEA592 reports
FATIGUE549 reports
NEUTROPENIA473 reports
ANAEMIA469 reports
OFF LABEL USE435 reports
PRODUCT ADHESION ISSUE399 reports
CONSTIPATION393 reports
DECREASED APPETITE368 reports
PNEUMONIA363 reports
GENERAL PHYSICAL HEALTH DETERIORATION343 reports
THROMBOCYTOPENIA318 reports
PLATELET COUNT DECREASED307 reports
ABDOMINAL PAIN286 reports
ASTHENIA281 reports
RASH280 reports
MALAISE275 reports
WHITE BLOOD CELL COUNT DECREASED268 reports
HEADACHE260 reports
SEPSIS254 reports
HYPOTENSION249 reports
DRUG INEFFECTIVE240 reports
LEUKOPENIA240 reports
DIZZINESS229 reports
NEUTROPHIL COUNT DECREASED221 reports
DEHYDRATION218 reports
COUGH210 reports
WEIGHT DECREASED194 reports
PAIN190 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS179 reports
BACK PAIN175 reports
MALIGNANT NEOPLASM PROGRESSION173 reports
ACUTE KIDNEY INJURY172 reports
ERYTHEMA167 reports
STOMATITIS167 reports
PANCYTOPENIA165 reports
TACHYCARDIA165 reports
PRURITUS164 reports
HYPOKALAEMIA160 reports
PRODUCT USE IN UNAPPROVED INDICATION160 reports
DISEASE PROGRESSION159 reports
NEUROPATHY PERIPHERAL153 reports
ALOPECIA149 reports
MUCOSAL INFLAMMATION148 reports
URINARY TRACT INFECTION138 reports
HAEMOGLOBIN DECREASED135 reports
HYPERSENSITIVITY134 reports
HYPERTENSION134 reports
INFUSION RELATED REACTION134 reports
CHEST PAIN132 reports
CHILLS128 reports
PARAESTHESIA126 reports
PAIN IN EXTREMITY125 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION122 reports
ABDOMINAL PAIN UPPER119 reports
FLUSHING115 reports
PULMONARY EMBOLISM115 reports
INFECTION114 reports
OEDEMA PERIPHERAL114 reports
DRUG INTERACTION113 reports
PLEURAL EFFUSION113 reports
RESPIRATORY FAILURE113 reports
NO ADVERSE EVENT112 reports
ALANINE AMINOTRANSFERASE INCREASED108 reports
INTERSTITIAL LUNG DISEASE108 reports
SOMNOLENCE108 reports
HYPERHIDROSIS107 reports
CHEST DISCOMFORT106 reports
INSOMNIA106 reports
SEPTIC SHOCK105 reports
CONDITION AGGRAVATED102 reports
RENAL FAILURE102 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION99 reports
ASPARTATE AMINOTRANSFERASE INCREASED97 reports
ANAPHYLACTIC REACTION95 reports
ATRIAL FIBRILLATION95 reports
SYNCOPE92 reports
PNEUMONITIS91 reports
HYPONATRAEMIA90 reports
ARTHRALGIA88 reports
BLOOD CREATININE INCREASED88 reports
CONFUSIONAL STATE83 reports
EPISTAXIS82 reports
FALL82 reports
CARDIAC FAILURE78 reports
BONE MARROW FAILURE77 reports
DYSPHAGIA77 reports
HYPOAESTHESIA77 reports
OEDEMA77 reports
DYSGEUSIA75 reports
PRODUCT USE ISSUE75 reports
MYALGIA73 reports
ABDOMINAL DISTENSION71 reports
GASTROINTESTINAL HAEMORRHAGE71 reports
C REACTIVE PROTEIN INCREASED70 reports

Report Outcomes

Out of 10,198 classified reports for GRANISETRON:

Serious 83.2%Non-Serious 16.8%

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

Female4,266 (53.7%)
Male3,659 (46.0%)
Unknown25 (0.3%)

Reports by Age

Age 68234 reports
Age 72216 reports
Age 69207 reports
Age 66206 reports
Age 57198 reports
Age 70198 reports
Age 63190 reports
Age 67186 reports
Age 71180 reports
Age 62176 reports
Age 73173 reports
Age 60168 reports
Age 64167 reports
Age 65164 reports
Age 76164 reports
Age 61154 reports
Age 74154 reports
Age 77154 reports
Age 58153 reports
Age 56145 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?

This profile reflects 21,280 FDA FAERS reports that mention GRANISETRON. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for GRANISETRON?

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

Who manufactures GRANISETRON?

Labeling and FAERS entries often list Cumberland Pharmaceuticals Inc. in connection with GRANISETRON. 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.