Quick answers
- What is Palonosetron hydrochloride used for?
- The FDA-approved label (Posfrea, Avyxa Pharma, LLC, April 29, 2025) says: “POSFREA is indicated in adults for prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC). postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Palonosetron hydrochloride?
- The “Adverse Reactions” section of the FDA label (Posfrea, Avyxa Pharma, LLC, April 29, 2025) begins: “Serious or otherwise clinically significant adverse reactions reported in other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Serotonin Syndrome [see Warnings and Precautions (5.2)] Most common adverse reactions in chemotherapy-induced nausea and vomiting in adults (≥5%) are: headache and constipation (6.1) postoperative nausea and vomiting (≥ 2%) are: QT prolongation, bradycardia, headache, and constipation (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Avyxa Pharma, LLC at 1-888-520-0954 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatc h. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Palonosetron hydrochloride?
- The “Drug Interactions” section of the FDA label (Posfrea, Avyxa Pharma, LLC, April 29, 2025) begins: “Serotonergic Drugs: Monitor for serotonin syndrome; if symptoms occur, discontinue POSFREA and initiate supportive treatment (7.1) 7.1 Serotonergic Drugs Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs).” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Palonosetron hydrochloride have a boxed warning?
- No. None of the 18 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Palonosetron hydrochloride?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated November 14, 2025). Ask your pharmacist about alternatives.
- Has Palonosetron hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Palonosetron hydrochloride?
- 15 companies list prescription products of Palonosetron hydrochloride in the FDA NDC Directory, including Apotex Corp., Fresenius Kabi USA, LLC and Qilu Pharmaceutical Co., Ltd.
What Palonosetron hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
POSFREA is indicated in adults for prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC). postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. …
— FDA label: Posfrea, Avyxa Pharma, LLC, effective April 29, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (injection, solution, intravenous), Posfrea, Avyxa Pharma, LLC; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 18 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 18 FDA labels for this medicine have a boxed warning.
Palonosetron hydrochloride side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Serious or otherwise clinically significant adverse reactions reported in other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Serotonin Syndrome [see Warnings and Precautions (5.2)] Most common adverse reactions in chemotherapy-induced nausea and vomiting in adults (≥5%) are: headache and constipation (6.1) postoperative nausea and vomiting (≥ 2%) are: QT prolongation, bradycardia, headache, and constipation (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Avyxa Pharma, LLC at 1-888-520-0954 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatc h. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
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The safety of POSFREA has been established from adequate and well-controlled studies of another intravenous formulation of palonosetron [see Clinical Studies (14)]. Below is a display of the adverse reactions of palonosetron in these adequate and well-controlled studies. Chemotherapy-Induced Nausea and Vomiting (CINV) Adults In double-blind randomized clinical trials for the prevention of nausea and vomiting induced by MEC or HEC, 1374 adult patients received a single dose of palonosetron, ondansetron (Studies 1 and 3) or dolasetron (Study 2) administered intravenously 30 minutes prior to chemotherapy [see Clinical Studies (14.1)]. Adverse reactions were similar in frequency and severity in all three treatment groups. Common adverse reactions reported in at least 2% of patients in these trials are shown in Table 2. Table 2: Common Adverse Reactions* in Adults with Receiving MEC (Studies 1 and 2) or HEC (Study 3) *Reported in at least 2% of patients in any treatment group Adverse Reaction Palonosetron 0.25 mg intravenously (N=633) Ondansetron 32 mg intravenously (N=410) Dolasetron 100 mg intravenously (N=194) Headache 9% 8% 16% Constipation 5% 2% 6% Diarrhea 1% 2% 2% Dizziness 1% 2% 2% Fatigue < 1% 1% 2% Abdominal Pain < 1% < 1% 2% Insomnia < 1% 1% 2% Less common adverse reactions, reported in 1% or less of patients in any treatment group, in Studies 1, 2 and 3 were: Cardiac disorders: non-sustained tachycardia, bradycardia, myocardial ischemia, extrasystoles, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles. Skin & subcutaneous tissue disorders: allergic dermatitis, rash. Ear &labyrinth disorders: motion sickness, tinnitus. Gastrointestinal disorders: diarrhea, dyspepsia, abdominal pain, dry mouth, hiccups and flatulence. General disorders and administration site conditions: weakness, fatigue, fever, hot flash, flu-like syndrome. Investigations: QT prolongation, transient, asymptomatic increases in AST and/or ALT and bilirubin and these changes occurred predominantly in patients receiving HEC. Metabolism and nutrition disorders: hyperkalemia, electrolyte fluctuations, hyperglycemia, metabolic acidosis, appetite decrease, anorexia. Musculoskeletal and connective tissue disorders: arthralgia. Nervous System disorders: dizziness, somnolence, insomnia, hypersomnia, paresthesia. Psychiatric disorders: anxiety, euphoric mood. Renal and urinary disorders: urinary retention, glycosuria. Vascular disorders: vein discoloration, vein distention, hypotension, hypertension. In other studies, two subjects experienced severe constipation following a single dose of approximately 0.75 mg (three times the recommended dose).
— FDA label: Posfrea, Avyxa Pharma, LLC, effective April 29, 2025. This is part of the section. Read the full label on DailyMed →
Palonosetron hydrochloride drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Serotonergic Drugs: Monitor for serotonin syndrome; if symptoms occur, discontinue POSFREA and initiate supportive treatment (7.1) 7.1 Serotonergic Drugs Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs).
Read more of this section
Monitor for the emergence of serotonin syndrome. If symptoms occur, discontinue POSFREA and initiate supportive treatment [see Warnings and Precautions (5.2)].
— FDA label: Posfrea, Avyxa Pharma, LLC, effective April 29, 2025. Read the full label on DailyMed →
Palonosetron hydrochloride dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Chemotherapy-Induced Nausea and Vomiting (CINV) (2.1) *Note different dosing units in pediatrics Age Dose* Infusion Time Adults 0.25 mg as a single dose Infuse over 30 seconds beginning approximately 30 minutes before the start of chemotherapy Pediatrics (1 month to less than 17 years) 20 micrograms per kilogram (maximum 1.5 mg) as a single dose Infuse over 15 minutes beginning approximately 30 minutes before the start of chemotherapy Postoperative Nausea and Vomiting (2.1) …
— FDA label: Posfrea, Avyxa Pharma, LLC, effective April 29, 2025. This is part of the section. Read the full label on DailyMed →
Palonosetron hydrochloride in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary There are no available data on palonosetron use in pregnant women to inform a drug-associated risk. In animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron during the period of organogenesis at doses up to 1,894 and 3,789 times the recommended human intravenous dose in rats and rabbits, respectively (see Data).
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The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In animal reproduction studies, no effects on embryo-fetal development were observed in pregnant rats given oral palonosetron at doses up to 60 mg/kg/day (1,894 times the recommended human intravenous dose based on body surface area) or pregnant rabbits given oral doses up to 60 mg/kg/day (3,789 times the recommended human intravenous dose based on body surface area) during the period of organogenesis.
— FDA label: Posfrea, Avyxa Pharma, LLC, effective April 29, 2025. Read the full label on DailyMed →
When Palonosetron hydrochloride should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
POSFREA is contraindicated in patients known to have hypersensitivity to palonosetron [see Warnings and Precautions (5.1)]. Hypersensitivity to palonosetron or any of its components. (4)
— FDA label: Posfrea, Avyxa Pharma, LLC, effective April 29, 2025. Read the full label on DailyMed →
Palonosetron hydrochloride overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
There is no known antidote to palonosetron. Overdose should be managed with supportive care. Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for palonosetron overdose. A single intravenous dose of palonosetron at 30 mg/kg (947 and 474 times the human dose for rats and mice, respectively, based on body surface area) was lethal to rats and mice.
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The major signs of toxicity were convulsions, gasping, pallor, cyanosis and collapse.
— FDA label: Posfrea, Avyxa Pharma, LLC, effective April 29, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 18 in the FDA NDC Directory |
| Brand names | Posfrea |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Apotex Corp.2 products
- Fresenius Kabi USA, LLC2 products
- Qilu Pharmaceutical Co., Ltd.2 products
- BluePoint Laboratories2 products
- Sandoz Inc1 product
- Dr. Reddy's Laboratories Limited1 product
- Meitheal Pharmaceuticals Inc.1 product
- Teva Parenteral Medicines, Inc.1 product
- Avyxa Pharma, LLC1 product
- Sagent Pharmaceuticals1 product
- NorthStar Rx LLC1 product
- Baxter Healthcare Corporation1 product
- Eugia US LLC1 product
- Cipla USA Inc.1 product
- Mylan Institutional LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021372 ALOXI | Helsinn Hlthcare | July 25, 2003 | 10, latest April 1, 2020 2020: Labeling · 2014: Labeling · 2014: Efficacy |
| NDA203050 POSFREA | Avyxa Holdings | March 1, 2016 | 2, latest April 16, 2025 2025: Efficacy · 2024: Labeling |
Generic approvals (11)
- ANDA202521Sandoz · October 13, 2015
- ANDA201533DR Reddys · April 21, 2016
- ANDA090713Teva Pharms USA · March 23, 2018
- ANDA204289Sagent Pharms Inc · September 19, 2018
- ANDA205648Qilu Pharm Hainan · September 19, 2018
- ANDA206416Mylan Institutional · September 19, 2018
- ANDA206801Fresenius Kabi USA · September 19, 2018
- ANDA206802Fresenius Kabi USA · September 19, 2018
- ANDA204702Eugia Pharma · November 6, 2018
- ANDA206916Baxter Hlthcare Corp · November 12, 2021
- ANDA215861Meitheal · August 14, 2023
Shortage status
To be discontinued · updated November 14, 2025 · first posted November 14, 2025
| Product | Palonosetron Hydrochloride, Injection, .25 mg/5 mL (NDC 0703-4094-01) |
|---|---|
| Company | Teva Pharmaceuticals USA, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- PosfreaBrand page: products, maker and price
- Apotex Corp.Maker or distributor
- Fresenius Kabi USA, LLCMaker or distributor
- Qilu Pharmaceutical Co., Ltd.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Posfrea, Avyxa Pharma, LLC, effective April 29, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →