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.
Verify with FDA → · CMS NADAC pricing →
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.
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
- Nausea
Nausea
399 reports
- Fatigue
Fatigue
249 reports
- Febrile Neutropenia
Febrile Neutropenia
249 reports
- Diarrhoea
Diarrhoea
246 reports
- Vomiting
Vomiting
246 reports
- Neutropenia
Neutropenia
245 reports
- Alopecia
Alopecia
223 reports
- Dyspnoea
Dyspnoea
194 reports
- Anaemia
Anaemia
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) 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?
What pregnancy or breastfeeding source fields are listed for palonosetron?
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
Lotronex
Alosetron (Lotronex) is a medicine for women with severe diarrhea-predominant irritable bowel syndrome (IBS).
Compare with palonosetron →
aprepitant
Emend
Aprepitant (Emend) is a medicine that helps prevent nausea and vomiting.
Compare with palonosetron →
bisacodyl
Dulcolax
Bisacodyl is a medicine that helps you have a bowel movement.
Compare with palonosetron →
bismuth subsalicylate
Pepto-Bismol
Bismuth subsalicylate (Pepto-Bismol) is a medicine that can treat diarrhea and upset stomach.
Compare with palonosetron →
cimetidine
Tagamet
Cimetidine (Tagamet) reduces stomach acid.
Compare with palonosetron →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for palonosetron: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 3,330.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 15.59%.
- furosemide Δ 0.04 pts · 387,984 reports · Loop Diuretic 15.63%death share
- thiamine Δ 0.10 pts · 11,724 reports · Vitamin B1 Supplement 15.49%death share
- enoxaparin Δ 0.12 pts · 55,714 reports · Low-Molecular-Weight Heparin 15.70%death share
- mirtazapine Δ 0.16 pts · 87,759 reports · Noradrenergic and Specific Serotonergic Antidepressant (NaSSA) 15.43%death share
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: May 15, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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