Last reviewed · How we verify
NALTREXONE
At a glance
| Generic name | NALTREXONE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1984 |
Approved indications
Common side effects
- Nausea
- Headache
- Dizziness
- Nervousness
- Fatigue
- Insomnia
- Vomiting
- Anxiety
- Somnolence
- Abdominal cramps
- Restlessness
- Bone or joint pain
Serious adverse events
- Hepatocellular injury
- Precipitated opioid withdrawal
- Depression
- Suicidal ideation
- Suicidal attempts
Key clinical trials
- Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1) (PHASE2, PHASE3)
- Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep (PHASE3)
- Preoperative Weight Loss for Open Abdominal Wall Reconstruction (NA)
- A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients (PHASE1, PHASE2)
- Low-dose Naltrexone for Post-COVID Fatigue Syndrome (PHASE2)
- Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients (PHASE1)
- Combination Gerotherapeutic Interventions for Healthspan Improvement (PHASE3)
- Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder (PHASE4)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- NALTREXONE CI brief — competitive landscape report
- NALTREXONE updates RSS · CI watch RSS