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palonosetron

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Brand names: Aloxi

5-HT3 Receptor Antagonist (Antiemetic) Rx

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..

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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.

Feeling sick to your stomach
399
Feeling very tired
249
Fever with low white blood cell count
249
Loose, watery stools
246
Throwing up
246
Low white blood cell count
245
Hair loss
223
Difficulty breathing
194
Low red blood cell count
189
Using the medicine for something it's not approved for
179

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

Female 1,806 (59%)
Male 1,271 (41%)

Age Distribution

0–17 69
18–44 288
45–64 1,245
65–74 803
75+ 358

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

DEATH 174
FATIGUE 48
NAUSEA 43
DIARRHOEA 42
DISEASE PROGRESSION 40
PNEUMONIA 40
OFF LABEL USE 39
FEBRILE NEUTROPENIA 35
ANAEMIA 34
ASTHENIA 31

Reactions in Hospitalization Reports

FEBRILE NEUTROPENIA 221
NAUSEA 173
NEUTROPENIA 155
VOMITING 134
ANAEMIA 122
DIARRHOEA 122
PYREXIA 115
DYSPNOEA 98
DECREASED APPETITE 91
PNEUMONIA 91

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?
Palonosetron starts working before your chemotherapy or surgery begins to prevent nausea and vomiting.
Can I take palonosetron at home?
No, palonosetron is given as an injection by a healthcare provider.
What should I avoid while taking palonosetron?
Talk to your doctor about any other medicines you are taking, especially those that can affect serotonin levels.
Will palonosetron make me sleepy?
Drowsiness is not a common side effect, but some people may experience dizziness.
Can palonosetron be used for morning sickness?
Palonosetron is not typically used for morning sickness. Talk to your doctor about other options.
Is palonosetron a steroid?
No, palonosetron is not a steroid. It is a serotonin-3 receptor antagonist.
Can I drink alcohol while taking palonosetron?
Talk to your doctor about drinking alcohol while taking palonosetron.
What if I am allergic to similar medications?
Tell your doctor if you are allergic to any similar medications before receiving palonosetron.
How long does palonosetron stay in my system?
Palonosetron has a long half-life, meaning it stays in your system for a while. Ask your doctor for more specific information.
Can palonosetron cause heart problems?
Some people have experienced heart rhythm changes. Tell your doctor if you have any heart problems.
What are the common side effects of palonosetron?
The most commonly reported side effects of palonosetron include Headache, Constipation. Based on 2,419 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
What drug class is palonosetron?
palonosetron belongs to the 5-HT3 Receptor Antagonist (Antiemetic) drug class. It requires a prescription (Rx). Palonosetron is used to prevent nausea and vomiting caused by cancer chemotherapy.
Is palonosetron safe during pregnancy?
It is not known if palonosetron can harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Is palonosetron currently in shortage?
Yes, palonosetron is currently listed as to be discontinued by the FDA. Affected manufacturer: Teva Pharmaceuticals USA, Inc.. Visit the FDA Drug Shortages database for the latest updates.

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Related Health & Safety Data

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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

All federal data sources used on this page