PALONOSETRON HYDROCHLORIDE

N/A

Manufactured by Apotex Corp.

11,239 FDA adverse event reports analyzed

Last updated: 2026-04-15

About PALONOSETRON HYDROCHLORIDE

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

Top Adverse Reactions

NAUSEA558 reports
DIARRHOEA342 reports
VOMITING342 reports
FEBRILE NEUTROPENIA331 reports
FATIGUE330 reports
OFF LABEL USE319 reports
NEUTROPENIA312 reports
ANAEMIA297 reports
ALOPECIA275 reports
PYREXIA273 reports
DEATH258 reports
DECREASED APPETITE257 reports
DYSPNOEA239 reports
NEUTROPHIL COUNT DECREASED218 reports
CONSTIPATION204 reports
ASTHENIA195 reports
PNEUMONIA185 reports
THROMBOCYTOPENIA179 reports
PLATELET COUNT DECREASED177 reports
WHITE BLOOD CELL COUNT DECREASED149 reports
NEUROPATHY PERIPHERAL147 reports
ABDOMINAL PAIN142 reports
MYELOSUPPRESSION141 reports
INFUSION RELATED REACTION129 reports
MALIGNANT NEOPLASM PROGRESSION125 reports
HYPOTENSION123 reports
HYPOKALAEMIA117 reports
RASH117 reports
ACUTE KIDNEY INJURY116 reports
DIZZINESS116 reports
LEUKOPENIA113 reports
DEHYDRATION112 reports
BACK PAIN103 reports
DISEASE PROGRESSION102 reports
MALAISE100 reports
PAIN98 reports
HEADACHE97 reports
PRURITUS96 reports
ASPARTATE AMINOTRANSFERASE INCREASED93 reports
STOMATITIS92 reports
ERYTHEMA91 reports
DRUG INTERACTION89 reports
HYPERTENSION89 reports
FLUSHING87 reports
SEPSIS86 reports
WEIGHT DECREASED86 reports
PAIN IN EXTREMITY85 reports
ALANINE AMINOTRANSFERASE INCREASED84 reports
OEDEMA PERIPHERAL77 reports
CHEST PAIN73 reports
PARAESTHESIA71 reports
TACHYCARDIA70 reports
CHEST DISCOMFORT69 reports
INTERSTITIAL LUNG DISEASE69 reports
PANCYTOPENIA67 reports
ANXIETY66 reports
CHILLS65 reports
COUGH65 reports
HYPONATRAEMIA65 reports
HAIR COLOUR CHANGES64 reports
HAIR TEXTURE ABNORMAL64 reports
MUCOSAL INFLAMMATION64 reports
ARTHRALGIA63 reports
URINARY TRACT INFECTION63 reports
OXYGEN SATURATION DECREASED61 reports
PRODUCT USE IN UNAPPROVED INDICATION60 reports
ABDOMINAL PAIN UPPER59 reports
HYPERSENSITIVITY59 reports
DRUG INEFFECTIVE58 reports
LYMPHOCYTE COUNT DECREASED58 reports
SYNCOPE58 reports
CYTOKINE RELEASE SYNDROME57 reports
HAIR DISORDER54 reports
HYPOAESTHESIA53 reports
MADAROSIS53 reports
PSYCHOLOGICAL TRAUMA52 reports
EPISTAXIS51 reports
HYPERHIDROSIS51 reports
CONFUSIONAL STATE50 reports
RESPIRATORY FAILURE50 reports
INSOMNIA49 reports
BLOOD PRESSURE INCREASED48 reports
OROPHARYNGEAL PAIN48 reports
PNEUMONITIS48 reports
CARDIAC ARREST46 reports
HAEMOGLOBIN DECREASED44 reports
HYPOXIA44 reports
ABDOMINAL DISCOMFORT43 reports
GENERAL PHYSICAL HEALTH DETERIORATION43 reports
HYPOMAGNESAEMIA43 reports
MYALGIA43 reports
ATRIAL FIBRILLATION42 reports
CONDITION AGGRAVATED42 reports
DEEP VEIN THROMBOSIS42 reports
HICCUPS41 reports
PULMONARY EMBOLISM41 reports
URTICARIA40 reports
DYSPHAGIA39 reports
EMOTIONAL DISTRESS39 reports
SEIZURE39 reports

Report Outcomes

Out of 5,017 classified reports for PALONOSETRON HYDROCHLORIDE:

Serious 93.5%Non-Serious 6.5%

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

Female2,590 (55.8%)
Male2,049 (44.1%)
Unknown6 (0.1%)

Reports by Age

Age 71147 reports
Age 62146 reports
Age 69144 reports
Age 66143 reports
Age 72143 reports
Age 59135 reports
Age 70123 reports
Age 64122 reports
Age 68122 reports
Age 58121 reports
Age 60119 reports
Age 61116 reports
Age 67116 reports
Age 73114 reports
Age 57113 reports
Age 54106 reports
Age 63106 reports
Age 5399 reports
Age 6598 reports
Age 5094 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 PALONOSETRON HYDROCHLORIDE?

This profile reflects 11,239 FDA FAERS reports that mention PALONOSETRON HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PALONOSETRON HYDROCHLORIDE?

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

Who manufactures PALONOSETRON HYDROCHLORIDE?

Labeling and FAERS entries often list Apotex Corp. in connection with PALONOSETRON 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.