{"publisher":"Low Dose Naltrexone Rx","product":"Low-dose naltrexone","preparedAt":"2026-11-07","reviewStatus":"Research drafts; medical review has not been claimed","facts":[{"label":"Research finding 1","text":"A randomised, double-blind, placebo-controlled trial of 6 mg low-dose naltrexone in 99 women with fibromyalgia concluded that the study did not show treatment with low-dose naltrexone was superior to placebo in relieving pain.","href":"https://pubmed.ncbi.nlm.nih.gov/38258677/"},{"label":"Research finding 2","text":"A 12-month randomised, double-blind, placebo-controlled trial of LDN 4.5 mg/day in 98 women with fibromyalgia concluded that LDN was well tolerated but did not demonstrate a clinically meaningful benefit over placebo for pain-related outcomes.","href":"https://pubmed.ncbi.nlm.nih.gov/42385209/"},{"label":"Research finding 3","text":"A systematic review and meta-analysis of five randomized controlled trials reports that low-dose naltrexone was superior to placebo in alleviating fibromyalgia pain in its primary analysis (SMD -0.61; 95% CI -1.14, -0.08) but not in raising mechanical pain threshold.","href":"https://pubmed.ncbi.nlm.nih.gov/40337423/"},{"label":"Research finding 4","text":"A 12-week randomized, double-blind, placebo-controlled trial of 4.5-mg naltrexone in forty adults with active Crohn's disease reports that 88% of naltrexone-treated patients had at least a 70-point decline in CDAI scores compared to 40% of placebo-treated patients (p = 0.009). Its conflict-of-interest statement discloses that two of its authors have intellectual property rights and have a patent for the use of naltrexone in IBD.","href":"https://pubmed.ncbi.nlm.nih.gov/21380937/"},{"label":"Research finding 5","text":"A Cochrane review on low dose naltrexone for Crohn's disease concludes that currently there is insufficient evidence to allow any firm conclusions regarding the efficacy and safety of LDN used to treat patients with active Crohn's disease.","href":"https://pubmed.ncbi.nlm.nih.gov/29607497/"},{"label":"Research finding 6","text":"A narrative review of 105 low-dose naltrexone studies says early positive findings from uncontrolled studies were rarely replicated in placebo-controlled trials and most available evidence consists of case reports and small feasibility studies. It says LDN is generally safe, inexpensive and well tolerated, with most studies using a daily dose of 4.5 mg, but that current evidence does not support routine clinical use.","href":"https://pubmed.ncbi.nlm.nih.gov/42060160/"},{"label":"Research finding 7","text":"The FDA says compounded drugs are not FDA approved, which means the agency does not review their safety, effectiveness or quality before they are marketed.","href":"https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding"}],"sources":[{"title":"Naltrexone hydrochloride 50 mg tablets prescribing information","href":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=06ff2d5a-e62b-4fa4-bbdb-01938535bc65"},{"title":"Drugs@FDA: Revia (naltrexone hydrochloride) application overview","href":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018932"},{"title":"FDA: understanding unapproved use of approved drugs (off label)","href":"https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label"},{"title":"FDA: human drug compounding","href":"https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding"},{"title":"Cochrane review: low dose naltrexone for active Crohn's disease","href":"https://pubmed.ncbi.nlm.nih.gov/29607497/"}],"guides":[{"title":"Low-dose naltrexone in chronic pain and other conditions: reviews and studies","url":"https://lowdosenaltrexonerx.com/research-guides/ldn-and-chronic-pain-reviews-and-other-conditions","description":"What randomized trials, observational cohorts and reviews report about low-dose naltrexone in chronic pain and other conditions, with their limits.","date":"2026-11-10"},{"title":"Low-dose naltrexone and Crohn's disease: what the trials and the Cochrane review measured","url":"https://lowdosenaltrexonerx.com/research-guides/ldn-and-crohns-disease-what-trials-measured","description":"What the Cochrane review and three trials of low-dose naltrexone in Crohn's disease measured, with doses, sizes and disclosures.","date":"2026-11-10"},{"title":"Low-dose naltrexone and fibromyalgia: what the trials and reviews measured","url":"https://lowdosenaltrexonerx.com/research-guides/ldn-and-fibromyalgia-what-trials-measured","description":"What six fibromyalgia trials of low-dose naltrexone measured, what four reviews concluded, and the limits of both.","date":"2026-11-10"},{"title":"Low-dose naltrexone and multiple sclerosis: what the studies measured","url":"https://lowdosenaltrexonerx.com/research-guides/ldn-and-multiple-sclerosis-what-trials-measured","description":"What three published abstracts report about low-dose naltrexone in multiple sclerosis: doses, designs, sizes, dropouts and the authors' own limits.","date":"2026-11-10"},{"title":"Naltrexone, pregnancy and breastfeeding: what the 50 mg label says","url":"https://lowdosenaltrexonerx.com/research-guides/ldn-pregnancy-and-breastfeeding","description":"What the 50 mg naltrexone label says about pregnancy, animal data and breastfeeding; it does not cover low-dose naltrexone.","date":"2026-11-10"},{"title":"Liver, mood and other warnings: what the 50 mg naltrexone label says","url":"https://lowdosenaltrexonerx.com/research-guides/liver-mood-and-other-label-warnings","description":"What the 50 mg naltrexone label says about liver injury, depression and symptoms to report; low-dose use is not covered.","date":"2026-11-10"},{"title":"What the prescribing information for naltrexone hydrochloride 50 mg tablets says","url":"https://lowdosenaltrexonerx.com/research-guides/naltrexone-label-what-it-says","description":"What the label for the 50 mg naltrexone tablet says about its use, its dosing and the opioid-free period before starting, not about low-dose use.","date":"2026-11-10"},{"title":"Opioids and naltrexone: what the 50 mg label and two overdose pages say","url":"https://lowdosenaltrexonerx.com/research-guides/opioids-and-naltrexone-what-the-label-says","description":"What the 50 mg naltrexone label says about precipitated withdrawal, overdose and opioid-containing medicines, plus two general overdose pages.","date":"2026-11-10"},{"title":"Low-dose naltrexone side effects: what trials, reviews and the 50 mg label report","url":"https://lowdosenaltrexonerx.com/research-guides/side-effects-what-sources-report","description":"What low-dose naltrexone trials, reviews and observational studies report about side effects, with the 50 mg label's figures kept separate.","date":"2026-11-10"},{"title":"What compounded low-dose naltrexone means: what the FDA says and what was tested","url":"https://lowdosenaltrexonerx.com/research-guides/what-compounded-ldn-means","description":"What FDA pages say compounded drugs are and are not, how section 503A is described, and what two laboratory analyses of compounded capsules reported.","date":"2026-11-10"},{"title":"What low-dose naltrexone is and how it might work","url":"https://lowdosenaltrexonerx.com/research-guides/what-low-dose-naltrexone-is-and-how-it-might-work","description":"What low-dose naltrexone is, how review abstracts say it might work, and why it is an off-label use separate from the 50 mg tablet.","date":"2026-11-10"},{"title":"What off-label use means and when to see a clinician","url":"https://lowdosenaltrexonerx.com/research-guides/what-off-label-means-and-when-to-see-a-clinician","description":"What the FDA says about off-label use, what MedlinePlus and drug labels list for three conditions, and the emergency steps the sources give.","date":"2026-11-10"}]}