palonosetron
Brand names: Aloxi
Palonosetron is a medicine that helps prevent nausea and vomiting. It is often used before, during, and after chemotherapy or surgery.
Drug Shortage Alert
palonosetron is currently listed as to be discontinued by the FDA. Affected manufacturer: Teva Pharmaceuticals USA, Inc..
View all drug shortages →What it does
Palonosetron is used to prevent nausea and vomiting caused by cancer chemotherapy.
Common side effects
Headache, Constipation
Key warnings
Palonosetron can cause serious allergic reactions, including anaphylaxis.
How It Works
Palonosetron blocks a natural substance in your body called serotonin. Serotonin can trigger nausea and vomiting. By blocking serotonin, palonosetron helps prevent these symptoms.
How to Take It
Palonosetron is given to you through a needle in your vein (IV). For chemotherapy, it is usually given about 30 minutes before your treatment starts. The IV infusion for adults takes about 30 seconds. For children, the IV infusion takes about 15 minutes.
Pregnancy & Breastfeeding
It is not known if palonosetron can harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is also not known if palonosetron passes into breast milk. Talk to your doctor about the best way to feed your baby if you are taking palonosetron.
Missed Dose
Since palonosetron is given by a healthcare provider, you are not likely to miss a dose. If you are concerned, talk to your doctor.
Storage
Store at room temperature, away from freezing, and protect from light.
Side Effects (from patient reports)
Based on 2,419 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 3,330 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
3,330
Death-Related Reports
519
Hospitalization Reports
1,660
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | NAUSEA | 399 |
| 2 | FATIGUE | 249 |
| 3 | FEBRILE NEUTROPENIA | 249 |
| 4 | DIARRHOEA | 246 |
| 5 | VOMITING | 246 |
| 6 | NEUTROPENIA | 245 |
| 7 | ALOPECIA | 223 |
| 8 | DYSPNOEA | 194 |
| 9 | ANAEMIA | 189 |
| 10 | OFF LABEL USE | 179 |
| 11 | DEATH | 174 |
| 12 | DECREASED APPETITE | 166 |
| 13 | PYREXIA | 164 |
| 14 | ASTHENIA | 151 |
| 15 | THROMBOCYTOPENIA | 142 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Palonosetron can cause serious allergic reactions, including anaphylaxis. Tell your doctor right away if you have any signs of an allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat. Palonosetron can also cause serotonin syndrome, especially if you are taking other medicines that affect serotonin. Symptoms may include agitation, hallucinations, fast heart rate, fever, and muscle stiffness.
Common Questions
How quickly does palonosetron work?
Can I take palonosetron at home?
What should I avoid while taking palonosetron?
Will palonosetron make me sleepy?
Can palonosetron be used for morning sickness?
Is palonosetron a steroid?
Can I drink alcohol while taking palonosetron?
What if I am allergic to similar medications?
How long does palonosetron stay in my system?
Can palonosetron cause heart problems?
What are the common side effects of palonosetron?
What drug class is palonosetron?
Is palonosetron safe during pregnancy?
Is palonosetron currently in shortage?
Related Medications in 5-HT3 Receptor Antagonist (Antiemetic)
Other drugs grouped near palonosetron — same-class peers and common alternatives.
alosetron
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aprepitant
Emend
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bisacodyl
Dulcolax
Bisacodyl is a medicine that helps you have a bowel movement.
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bismuth subsalicylate
Pepto-Bismol
Bismuth subsalicylate (Pepto-Bismol) is a medicine that can treat diarrhea and upset stomach.
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cimetidine
Tagamet
Cimetidine (Tagamet) reduces stomach acid.
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What the FDA Data Shows for palonosetron
The FDA label for palonosetron (sold under brand names such as Aloxi) classifies it as a prescription-only medication in the 5-HT3 Receptor Antagonist (Antiemetic) class. Palonosetron is used to prevent nausea and vomiting caused by cancer chemotherapy. Official labeling lists 2 commonly reported side effects, including Headache, Constipation.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 2,419 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: May 15, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages