Prescription medication · 5-HT3 Receptor Antagonist (Antiemetic)
palonosetron
Also sold as Aloxi. Palonosetron is used to prevent nausea and vomiting caused by cancer chemotherapy.
Data updated 2026-05-15
- 3,330
- FDA reportsLightly reported
- In shortage
- FDA status
What the data shows
palonosetron (Aloxi) is a prescription 5-HT3 Receptor Antagonist (Antiemetic), among the least-reported drugs the FDA tracks (3,330 FDA reports).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
palonosetron (Aloxi) is a prescription 5-HT3 Receptor Antagonist (Antiemetic). Palonosetron is used to prevent nausea and vomiting caused by cancer chemotherapy.
Palonosetron is a medicine that helps prevent nausea and vomiting. It is often used before, during, and after chemotherapy or surgery.
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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.
The sections below are summarized in plain English from palonosetron's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of palonosetron's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of palonosetron's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of palonosetron's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature, away from freezing, and protect from light.
Side Effects (from patient reports)
Based on 3,330 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for palonosetron, by number of reports
- Feeling sick to your stomach
Feeling sick to your stomach
399 reports
- Feeling very tired
Feeling very tired
249 reports
- Fever with low white blood cell count
Fever with low white blood cell count
249 reports
- Loose, watery stools
Loose, watery stools
246 reports
- Throwing up
Throwing up
246 reports
- Low white blood cell count
Low white blood cell count
245 reports
- Hair loss
Hair loss
223 reports
- Difficulty breathing
Difficulty breathing
194 reports
- Low red blood cell count
Low red blood cell count
189 reports
- Death
Death
174 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for palonosetron each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where palonosetron sits
palonosetron has more FDA adverse-event reports than 20% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is palonosetron; the line is the median (50th percentile).
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
Reports Mentioning Death
519
15.6% of reports — not proof of cause
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 |
| 11 | DEATH | 174 |
| 12 | DECREASED APPETITE | 166 |
| 13 | PYREXIA | 164 |
| 14 | ASTHENIA | 151 |
| 15 | THROMBOCYTOPENIA | 142 |
| 16 | CONSTIPATION | 135 |
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?
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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 3,330 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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