Lofexidine: uses, dosing, side effects & brands
Lofexidine is a medicine sold in the U.S. under one brand, for substance withdrawal syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Substance Withdrawal Syndrome
- Available as
- Tablet
- Sold as
- Lucemyra
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- What the pharmacy pays
- about $291 for a 30-count supply — not your price
How lofexidine is dosed
From the FDA label for Lucemyra (application NDA209229). Other lofexidine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The usual Lofexidine tablet dosage is three 0.18 mg tablets taken orally 4 times daily at 5- to 6-hour intervals. Lofexidine tablet treatment may be continued for up to 14 days with dosing guided by symptoms. ( 2.1 ) Discontinue Lofexidine tablets with a gradual dose reduction over 2 to 4 days. ( 2.1 ) Hepatic or Renal Impairment: Dosage adjustments are recommended based on degree of impairment. ( 2.2 , 2.3 ) 2.1 Dosing Information The usual Lofexidine tablet starting dosage is three 0.18 mg tablets taken orally 4 times daily during the period of peak withdrawal symptoms (generally the first 5 to 7 days following last use of opioid) with dosing guided by symptoms and side effects. There should be 5 to 6 hours between each dose. The total daily dosage of Lofexidine tablets should not exceed 2.88 mg (16 tablets) and no single dose should exceed 0.72 mg (4 tablets). Lofexidine tablet treatment may be continued for up to 14 days with dosing guided by symptoms. Discontinue Lofexidine tablets with a gradual dose reduction over a 2- to 4-day period to mitigate Lofexidine tablet withdrawal symptoms (e.g., reducing by 1 tablet per dose every 1 to 2 days) [see Warnings & Precautions (5.5) ] . The Lofexidine tablet dose should be reduced, held, or discontinued for individuals who demonstrate a greater sensitivity to Lofexidine tablets side effects [see Warnings and Precautions (5.1) ,…
Lofexidine side effects
The following serious adverse reactions are described elsewhere in labeling: Hypotension, Bradycardia, and Syncope [see Warnings and Precautions (5.1) ] QT Prolongation [see Warnings and Precautions (5.2) ] Central Nervous System Depression [see Warnings and Precautions (5.3) ] Opioid Overdose [see Warnings and Precautions (5.4) ] Discontinuation Symptoms [see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence ≥ 10% and notably more frequent than placebo) are orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, and dry mouth. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact US WorldMeds at 1-888-900-8796 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to adverse reaction rates observed for another drug and may not reflect the rates observed in practice. The safety of Lofexidine tablets was supported by three randomized, double-blind, placebo-controlled clinical trials, an open-label study, and clinical pharmacology studies with concomitant administration of either methadone, buprenorphine, or naltrexone. The three randomized, double-blind, placebo-controlled clinical trials enrolled 935 subjects dependent on short-acting…
Who shouldn’t take lofexidine
None. None. ( 4 )
Lofexidine drug interactions
Methadone : Methadone and Lofexidine tablets both prolong the QT interval. ECG monitoring is recommended when used concomitantly. ( 7.1 ) Oral Naltrexone : Concomitant use may reduce efficacy of oral naltrexone. ( 7.2 ) CYP2D6 Inhibitors : Concomitant use of paroxetine resulted in increased plasma levels of Lofexidine. Monitor for symptoms of orthostasis and bradycardia with concomitant use of a CYP2D6 inhibitor. ( 7.4 ) 7.1 Methadone Lofexidine tablets and methadone both prolong the QT interval. ECG monitoring is recommended in patients receiving methadone and Lofexidine tablets concomitantly [see Warnings and Precautions (5.2) , Clinical Pharmacology (12.3) ] . 7.2 Oral Naltrexone Coadministration of Lofexidine tablets and oral naltrexone resulted in statistically significant differences in the steady-state pharmacokinetics of naltrexone. It is possible that oral naltrexone efficacy may be reduced if used concomitantly within 2 hours of Lofexidine tablets. This interaction is not expected if naltrexone is administered by non-oral routes [see Clinical Pharmacology (12.3) ] . 7.3 CNS Depressant Drugs Lofexidine tablets potentiate the CNS depressant effects of benzodiazepines and may potentiate the CNS depressant effects of alcohol, barbiturates, and other sedating drugs. Advise patients to inform their healthcare provider of other medications they are taking, including alcohol [see Warnings and Precautions (5.3) ] . 7.4 CYP2D6 Inhibitor - Paroxetine Coadministration of Lofexidine tablets and paroxetine resulted in a 28% increase in the extent of absorption of Lofexidine. Monitor for orthostatic hypotension and bradycardia when an inhibitor of CYP2D6 is used concomitantly with Lofexidine tablets [see Clinical Pharmacology (12.3) ] .
Every lofexidine product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Lucemyra.
What lofexidine pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
How long lofexidine keeps
No lofexidine label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does lofexidine expire? The in-use limits and storage rules from its labelsLofexidine and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for lofexidine: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo data are available in nursing mothers on the excretion into milk or safety of lofexidine in nursing mothers. A computer model predicted a maximum relative infant dose of about 3%, which should be acceptable. Although it is not contraindicated during breastfeeding, lofexidine should be used with caution until more data are available. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.
National Institute of Child Health and Human Development, record revised April 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about lofexidine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 6 reports naming lofexidine, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- electrocardiogram qt prolonged2 reports
- abortion induced1 reports
- atrioventricular block first degree1 reports
- diarrhoea1 reports
- ductus arteriosus premature closure1 reports
- exposure during pregnancy1 reports
- fatigue1 reports
- head injury1 reports
Read these as a signal, not a rate. A report does not mean lofexidine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
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Frequently asked questions
What is lofexidine?
Lucemyra (Lofexidine Hydrochloride) is a medication used to treat Substance Withdrawal Syndrome.
Can you take lofexidine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run lofexidine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does lofexidine come in?
Across the brands we track, lofexidine is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic lofexidine?
We do not currently list a generic-labelled lofexidine product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Lofexidine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/lofexidine
- MLA
- “Lofexidine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/lofexidine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for lofexidine on DailyMed (NIH) ↗.