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    HomeMedication GuideNaltrexone safety
    Opioid antagonistFDA-Approved

    Naltrexone: What to Know Before You Take It

    Also known as Vivitrol, Revia

    Other names: vivitrol, revia, low-dose-naltrexone, ldn

    Naltrexone is an FDA-approved opioid receptor antagonist used for opioid use disorder and alcohol use disorder. At standard doses it blocks opioid receptors. At sub-therapeutic "low doses" (LDN, 1.5–4.5 mg) it is used off-label for chronic pain, fibromyalgia, Crohn's disease, and immune modulation — an area of active research.

    FDA-approved at standard doses (50 mg oral, 380 mg injectable) for opioid use disorder and alcohol use disorder. Low-dose naltrexone (LDN) is an off-label, compounded use not FDA-approved for pain, fibromyalgia, or inflammatory conditions.
    Reviewed by the OmniRx Health clinical teamLast reviewed Jul 4, 2026

    In plain language

    What Naltrexone is used for

    • FDA-approved: opioid use disorder, alcohol use disorder
    • Off-label/compounded: fibromyalgia, Crohn's disease, inflammatory conditions (active research)

    Taking this medicine

    How it is administered

    • Oral tablet
    • Oral capsule (compounded, low-dose)

    Read before you decide

    Risks and precautions

    Risks and warnings

    • Nausea, vomiting
    • Loss of appetite
    • Joint pain, muscle cramps
    • Headache, dizziness, drowsiness
    • Insomnia

    Who should not take it

    • Current opioid agonist use (precipitates acute withdrawal — serious risk)
    • Acute hepatitis or liver failure
    • Hypersensitivity to naltrexone

    Medication review

    Naltrexone drug interactions

    Check this against your full medication list in the Interaction Checker

    FDA safety data

    Most-reported side effects

    Based on 39,971 FAERS reports. Reports do not prove the drug caused the effect.

    injection site reaction 4,416nausea 4,174injection site pain 3,156headache 2,661fatigue 2,455dizziness 2,094drug ineffective 2,029feeling abnormal 2,019alcoholism 1,955injection site mass 1,914pain 1,841vomiting 1,721
    Explore full FDA safety data

    Regulatory record

    FDA recalls (7)

    Class IITerminated · Apr 13, 2022

    cGMP deviations: Temperature abuse

    Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office

    Class IITerminated · Sep 26, 2019

    Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.

    Recalling firm: Alkermes, Inc.

    Class IITerminated · Aug 8, 2019

    Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.

    Recalling firm: Alkermes Inc

    Class IIITerminated · Oct 5, 2018

    Container packaging defect.

    Recalling firm: Orexigen Therapeutics, Inc.

    Class IIITerminated · Aug 9, 2018

    Defective Container: Customer complaints of punctures in the bottle.

    Recalling firm: Orexigen Therapeutics, Inc.

    Class IITerminated · Mar 4, 2014

    Customer complaints for failure to deliver the dose.

    Recalling firm: Alkermes, Inc.

    Class IITerminated · Nov 6, 2012

    Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.

    Recalling firm: Alkermes, Inc.

    Common questions

    Patient questions

    What is low-dose naltrexone (LDN) used for?

    LDN (1.5–4.5 mg) is used off-label for chronic pain, fibromyalgia, Crohn's disease, and other inflammatory conditions. It is not FDA-approved for these uses. Evidence is emerging but not yet sufficient for FDA approval. It requires a prescription from a licensed provider and is typically dispensed as a compounded preparation.

    Can I take naltrexone if I use opioids?

    No. Naltrexone can precipitate severe opioid withdrawal in individuals physically dependent on opioids. You must be completely free of opioids (typically 7–10 days for short-acting opioids) before starting naltrexone. Your provider will confirm this before prescribing.

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    This information is educational — not medical advice.

    This page is provided for general educational purposes and summarizes publicly available data from sources such as the U.S. Food & Drug Administration. It is not a substitute for the judgment of a licensed clinician and should not be used to start, stop, or change any medication. It may be incomplete or out of date, and individual circumstances vary. Always talk with your prescriber or pharmacist about your specific medications and health conditions. If you think you may have a medical emergency, call 911.

    Have medication questions?

    A licensed OmniRx provider can review your health history and medication list. Availability and treatment options are determined individually.