Quick answers
- What is Oliceridine used for?
- The FDA-approved label (Olinvyk, Trevena, Inc., December 31, 2025) says: “OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration […], and persist over the course of therapy, reserve opioid analgesics, including OLINVYK, for use in patients for …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Oliceridine have a boxed warning?
- Yes. The FDA label for Olinvyk has a boxed warning (“WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OLINVYK”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Oliceridine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Oliceridine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Oliceridine?
- 1 company lists prescription products of Oliceridine in the FDA NDC Directory, including Trevena, Inc..
What Oliceridine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration […], and persist over the course of therapy, reserve opioid analgesics, including OLINVYK, for use in patients for …
— FDA label: Olinvyk, Trevena, Inc., effective December 31, 2025. Read the full label on DailyMed →
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.
This label has a boxed warning. Its heading: WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OLINVYK
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Olinvyk |
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.
- Trevena, Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA210730 OLINVYK | Trevena | August 7, 2020 | 3, latest December 22, 2025 2025: Labeling · 2023: Labeling · 2021: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Olinvyk, Trevena, Inc., effective December 31, 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 →