Prescription medicine
Palonosetron Brand names: Posfrea; first approved as Aloxi
Palonosetron (Aloxi) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 13 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the palonosetron FDA label on DailyMed (effective April 29, 2025, Avyxa Pharma, LLC); the NDA 21372 record on Drugs@FDA; every palonosetron label on DailyMed.
Highlights of the record
FDA label of April 29, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePOSFREA 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).
Forms and strengths
- 0.05 mg/ml
- 0.075 mg/1.5ml
- 0.25 mg/5ml
Injection (solution); injection.
On the market
- Earliest approval on file
- July 25, 2003 Aloxi, Helsinn Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 18 first October 13, 2015; 14 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 13 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5,254 through July 30, 2026
What is palonosetron used for?
From the label: indications and usagePOSFREA 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. Efficacy beyond 24 hours has not been demonstrated. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. […]
Conditions named in the indications of palonosetron's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Serotonin-3 Receptor Antagonist.
Source: FDA drug label (posfrea), Avyxa Pharma, LLC, effective April 29, 2025 (SPL set 13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7), via openFDA; the full label on DailyMed
Is there a generic for palonosetron (Aloxi)?
The FDA approved the first generic palonosetron on October 13, 2015. 18 generic applications are approved; 14 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists palonosetron from 13 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2003 earliest approval on file
- 2015 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is palonosetron in shortage?
No palonosetron presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated November 14, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Palonosetron Hydrochloride, Injection, .25 mg/5 mL (NDC 0703-4094-01) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | November 14, 2025 |
Every palonosetron presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the palonosetron label say about other medicines?
The palonosetron label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name palonosetron. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aprepitant | drug interactions | In an interaction study in healthy subjects where palonosetron 0.25 mg (I.V. bolus) was administered on day 1 and oral aprepitant for 3 days (125 mg/80 mg/80 mg), the pharmacokinetics of palonosetron were not significantly altered (AUC: no change, C max: |
| Cisplatin | drug interactions | Palonosetron did not inhibit the antitumor activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C) in murine tumor models. |
| Cyclophosphamide | drug interactions | Palonosetron did not inhibit the antitumor activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C) in murine tumor models. |
| Cytarabine | drug interactions | Palonosetron did not inhibit the antitumor activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C) in murine tumor models. |
| Dexamethasone | drug interactions | Coadministration of 0.25 mg I.V. palonosetron and 20 mg I.V. dexamethasone in healthy subjects revealed no pharmacokinetic drug-interactions between palonosetron and dexamethasone. |
| Doxorubicin | drug interactions | Palonosetron did not inhibit the antitumor activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C) in murine tumor models. |
| Fentanyl | warnings and precautions | Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). |
| Lithium | warnings and precautions | Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). |
| Methylene blue | warnings and precautions | Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). |
| Metoclopramide | drug interactions | A study in healthy volunteers involving single-dose I.V. palonosetron (0.75 mg) and steady state oral metoclopramide (10 mg four times daily) demonstrated no significant pharmacokinetic interaction. |
| Mirtazapine | warnings and precautions | Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). |
| Mitomycin | drug interactions | Palonosetron did not inhibit the antitumor activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C) in murine tumor models. |
| Tramadol | warnings and precautions | Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). |
Other labels that name palonosetron
Source: FDA drug label (posfrea), Avyxa Pharma, LLC, effective April 29, 2025 (SPL set 13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7), via openFDA; the full label on DailyMed
What do FAERS reports show for palonosetron?
The FDA Adverse Event Reporting System holds 5,254 reports that list palonosetron among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 897 are coded as a death and 2,710 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as palonosetron?
3 other medicines are given the same way (intravenous) and in the same FDA class as palonosetron or labeled mainly for the same use (nausea and vomiting), the same class first. Nausea and vomiting lists all 16 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Granisetron | Nausea and vomiting | 4 labelers | n/a | No current entry |
| Aprepitant | Nausea and vomiting | none listed | n/a | A presentation being discontinued |
| Amisulpride | Nausea and vomiting | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as palonosetron
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does palonosetron compare with medicines for the same use?
1 side-by-side page set palonosetron beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to palonosetron
- 3 medicines for the same use
- Other serotonin-3 receptor antagonists
- the pharmacologic class, with prices and generics
- Palonosetron side effects
- the label's list beside FAERS reports
- Palonosetron shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other