Prescription medicine
Oliceridine Brand names: Olinvyk
Oliceridine (Olinvyk) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the oliceridine FDA label on DailyMed (effective December 31, 2025, Trevena, Inc.); the NDA 210730 record on Drugs@FDA; every oliceridine label on DailyMed.
Highlights of the record
FDA label of December 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OLINVYK.
Addiction, Abuse, and Misuse Because the use of OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1 )]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of OLINVYK are essential [see Warnings and Precautions ( 5.2 )]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of OLINVYK and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )]. […]
Used for
From the label: indications and usageOLINVYK 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.
Forms and strengths
- 1 mg/ml
- 2 mg/2ml
Injection (solution).
On the market
- Earliest approval on file
- August 7, 2020 Olinvyk, Trevena; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 23, 2032 Olinvyk injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3 through July 30, 2026
What is oliceridine used for?
From the label: indications and usageOLINVYK 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 [see Warnings and Precautions ( 5.1 )], and persist over the course of therapy, reserve opioid analgesics, including OLINVYK, for use in patients for whom alternative treatment options are ineffective, not management of pain. […]
Conditions named in the indications of oliceridine's FDA labels, with every medicine labeled for each:
Source: FDA drug label (OLINVYK), Trevena, Inc., effective December 31, 2025 (SPL set ce167984-8b9d-40b7-84ce-d0f33fff1eaa), via openFDA; the full label on DailyMed
Is there a generic for oliceridine (Olinvyk)?
No generic oliceridine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Olinvyk injection: the compound patent runs to March 23, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the oliceridine label say about other medicines?
The oliceridine label names 25 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Buprenorphine | drug interactions | Clinical Impact: May reduce the analgesic effect of OLINVYK and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Bupropion | drug interactions | Moderate to Strong Inhibitors of CYP2D6 Clinical Impact: Concomitant administration of a moderate to strong CYP2D6 inhibitor can increase the plasma concentration of oliceridine, resulting in increased or prolonged opioid effects. … signs of opioid withdrawal. Examples: Paroxetine, fluoxetine, quinidine, bupropion |
| Butorphanol | drug interactions | Clinical Impact: May reduce the analgesic effect of OLINVYK and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Carbamazepine | drug interactions | Inducers of CYP3A4 Clinical Impact: The concomitant use of OLINVYK and CYP3A4 inducers can decrease the plasma concentration of oliceridine, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to oliceridine.. … reduction and monitor for signs of respiratory depression. Examples: Rifampin, carbamazepine, phenytoin |
| Cyclobenzaprine | drug interactions | Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as … |
| Erythromycin | drug interactions | Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir). |
| Fluoxetine | drug interactions | Moderate to Strong Inhibitors of CYP2D6 Clinical Impact: Concomitant administration of a moderate to strong CYP2D6 inhibitor can increase the plasma concentration of oliceridine, resulting in increased or prolonged opioid effects. … are achieved. Monitor for signs of opioid withdrawal. Examples: Paroxetine, fluoxetine, quinidine, bupropion |
| Gabapentin | drug interactions | Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of hypotension, respiratory depression, profound sedation, coma, and death. … anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol |
| Itraconazole | drug interactions | Strong and Moderate CYP3A4 Inhibitors and CYP2D6 Inhibitors Clinical Impact: OLINVYK is primarily metabolized by both CYP3A4 and CYP2D6. Compared to inhibition of either metabolic pathway, inhibition of both pathways can result in a greater increase of the plasma concentrations of oliceridine and prolong opioid … antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole, itraconazole), anti-retroviral agents, selective serotonin re-uptake inhibitors (SSRIs), protease inhibitors (e.g., ritonavir), NS3/4A … |
| Ketoconazole | drug interactions | Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir). |
| Linezolid | drug interactions | Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics |
| Metaxalone | drug interactions | Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and … |
| Methylene blue | drug interactions | Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics |
| Mirtazapine | drug interactions | Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those … |
Every other medicine the oliceridine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nalbuphine | drug interactions | Clinical Impact: May reduce the analgesic effect of OLINVYK and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Nalmefene | warnings and precautions | … and use of opioid opioid overdose reversal agents (e.g., naloxone, nalmefene), depending on the patient’s clinical status [see Overdosage ( 10.2 )]. |
| Naloxone | warnings and precautions | Management of respiratory depression may include close observation, supportive measures, and use of opioid opioid overdose reversal agents (e.g., naloxone, nalmefene), depending on the patient’s … |
| Paroxetine | drug interactions | Moderate to Strong Inhibitors of CYP2D6 Clinical Impact: Concomitant administration of a moderate to strong CYP2D6 inhibitor can increase the plasma concentration of oliceridine, resulting in increased or prolonged opioid effects. … drug effects are achieved. Monitor for signs of opioid withdrawal. Examples: Paroxetine, fluoxetine, quinidine, bupropion |
| Phenytoin | drug interactions | Inducers of CYP3A4 Clinical Impact: The concomitant use of OLINVYK and CYP3A4 inducers can decrease the plasma concentration of oliceridine, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to oliceridine.. … monitor for signs of respiratory depression. Examples: Rifampin, carbamazepine, phenytoin |
| Pregabalin | drug interactions | Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of hypotension, respiratory depression, profound sedation, coma, and death. … relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol |
| Quinidine | drug interactions | Moderate to Strong Inhibitors of CYP2D6 Clinical Impact: Concomitant administration of a moderate to strong CYP2D6 inhibitor can increase the plasma concentration of oliceridine, resulting in increased or prolonged opioid effects. … Monitor for signs of opioid withdrawal. Examples: Paroxetine, fluoxetine, quinidine, bupropion |
| Rifampin | drug interactions | Inducers of CYP3A4 Clinical Impact: The concomitant use of OLINVYK and CYP3A4 inducers can decrease the plasma concentration of oliceridine, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to oliceridine.. … dosage reduction and monitor for signs of respiratory depression. Examples: Rifampin, carbamazepine, phenytoin |
| Ritonavir | drug interactions | Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir). |
| Tramadol | drug interactions | Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat … |
| Trazodone | drug interactions | Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat … |
Source: FDA drug label (OLINVYK), Trevena, Inc., effective December 31, 2025 (SPL set ce167984-8b9d-40b7-84ce-d0f33fff1eaa), via openFDA; the full label on DailyMed
What do FAERS reports show for oliceridine?
The FDA Adverse Event Reporting System holds 3 reports that list oliceridine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 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.
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 oliceridine?
3 other medicines are given the same way (intravenous) and in the same FDA class as oliceridine or labeled mainly for the same use (pain), the same class first. Pain lists all 80 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 |
|---|---|---|---|---|
| Morphine | Pain | 3 labelers | $2.32 per mL 4 mg/mL vial | In shortage |
| Acetaminophen and ibuprofen | Pain | none listed | n/a | No current entry |
| Methadone | Pain | 1 labeler | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Oliceridine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other