Last reviewed · How we verify
NALBUPHINE
At a glance
| Generic name | NALBUPHINE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1979 |
Approved indications
Boxed warnings
- WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF NALBUPHINE HYDROCHLORIDE INJECTION Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Nalbuphine Hydrochloride Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Nalbuphine Hydrochloride Injection are essential [see WARNINGS ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use with benzodiazepines and/or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Nalbuphine Hydrochloride Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see WARNINGS ; Drug Interactions ].
Common side effects
- Sedation
- Sweaty/clammy
- Nausea/vomiting
- Dizziness/vertigo
- Dry mouth
- Headache
- Nervousness
- Depression
- Restlessness
- Crying
- Euphoria
- Floating
Serious adverse events
- Anaphylactic/anaphylactoid reactions
- Respiratory arrest
- Cardiac arrest
- Laryngeal edema
- Serotonin syndrome
- Adrenal insufficiency
- Seizures
- Pulmonary edema
- Death
- Fetal death
Key clinical trials
- A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants (PHASE1)
- Study of Nalbuphine ER in Participants With Hepatic Impairment (PHASE1)
- Erector Spinae Plane Block for Pain Control After Open Abdominal Surgery (NA)
- Comparison of Intrathecal Nalbuphine Versus Intrathecal Tramadol as Adjuvants in Subarachnoid Block for Lower Limb Orthopaedic Surgeries (NA)
- Effect of Nalbuphine Versus Fentanyl on Hemdoynamic Effects of Laryngoscopy (PHASE4)
- NAL ER IPF Respiratory Function and Safety Study (PHASE1)
- Comparison Of Clinical Outcomes of Intraperitoneal Bupivacaine Instillation Versus Placebo as Preemptive Analgesia in Patients Undergoing Open Appendectomy (PHASE1)
- Intravenous Nalbuphine Versus Lidocaine for Prevention of Propofol Injection Pain (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |