Lofexidine
Lofexidine is a once-prescribed oral medicine that eases opioid withdrawal symptoms so adults can stop opioids abruptly.
⚡ Quick answers about Lofexidine
What is lofexidine for?
It helps ease opioid withdrawal symptoms in adults who are stopping opioids abruptly. It is not a treatment for opioid use disorder by itself, so it should be part of a larger treatment program.
See it in the FAQ →How do I take it?
You swallow the tablets several times a day, spacing doses 5 to 6 hours apart. You can take them with or without food.
Read the full answer →What side effects should I expect?
The common ones are trouble sleeping, dizziness, sleepiness, dry mouth, low blood pressure, and a slow pulse. Stand up slowly and stay hydrated.
Read the full answer →Can I drink alcohol or take other medicines with it?
Alcohol, benzodiazepines, and other sedating drugs can make you much sleepier. Tell me about everything you take. Methadone, paroxetine, and oral naltrexone are the ones that need special attention.
See it in the FAQ →🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 8 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →📖 Lofexidine: Patient Information Guide
A plain-language walkthrough of Lofexidine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Lofexidine is used for
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Lofexidine is used for one main purpose across all supplied products.
- Lofexidine tablets (including lofexidine hydrochloride) ease opioid withdrawal symptoms to help adults stop opioids abruptly.
- Lucemyra, an oral tablet brand, is used for the same purpose in adults.
How Lofexidine works
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Lofexidine is a central alpha-2 adrenergic agonist. It attaches to alpha-2 receptors on adrenergic nerve cells and reduces the release of norepinephrine. That lowers sympathetic tone, the body's stress-response activity, which helps calm withdrawal symptoms.
How Lofexidine is taken (dosage)
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Lofexidine tablets are taken by mouth, usually several times a day, with 5 to 6 hours between doses. They can be taken with or without food.
- Dosing is guided by your symptoms and side effects, with the heaviest dosing during the peak of withdrawal, generally the first 5 to 7 days after last opioid use.
- Treatment can continue for up to 14 days.
- Your prescriber may lower, hold, or stop doses if you are sensitive to side effects, and may adjust for liver or kidney problems.
- When stopping, the dose is lowered gradually over 2 to 4 days.
Follow your prescriber and the label for exact amounts.
Dosing details from the FDA-approved label
Excerpt from the Lofexidine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
2 DOSAGE AND ADMINISTRATION • The usual lofexidine tablets dosage are three 0.18 mg tablets taken orally 4 times daily at 5-to 6-hour intervals lofexidine tablets treatment may be continued for up to14 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 tablets 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 tablets 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 tablets withdrawal symptoms (e.g., reducing by 1 tablet per dose every 1 to 2 days). [see Warnings & Precautions (5.5) ]. The lofexidine tablets dose should be reduced, held, or discontinued for individuals who demonstrate a greater sensitivity to lofexidine tablets side effects [see Adverse Reactions (6.1), Warnings and Precautions (5.1) ]. Lower doses may be appropriate as opioid withdrawal symptoms wane. Lofexidine tablets can be administered in the presence or absence of food. 2.2 Dosage Recommendations for Patients with Hepatic Impairment Recommended dosage adjustments based on the degree of hepatic impairment are shown in Table 1. [see Use in Specific Populations (8.5), Clinical Pharmacology (12.3) ]. Table 1: Dosage Recommendations in Patients with Hepatic Impairment Mild Impairment Moderate Impairment Severe Impairment Child-Pugh score 5-6 7-9 > 9 Recommended dose 3 tablets 4 times daily (2.16 mg per day) 2 tablets 4 times daily (1.44 mg per day) 1 tablet 4 times daily (0.72 mg per day) 2.3 Dosage Recommendations for Patients with Renal Impairment Recommended dosage adjustments based on the degree of renal impairment are shown in Table 2.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Lofexidine side effects in detail
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Common side effects
- Low blood pressure, including dizziness when standing up
- Slow heart rate
- Dizziness
- Sleepiness or sedation
- Dry mouth
- Trouble sleeping (insomnia)
When to get medical help
- Fainting, severe dizziness, or symptoms of very low blood pressure or a very slow pulse. Hold your next dose and call your prescriber.
- Fast, pounding, or irregular heartbeat, or feeling like you might pass out, which can signal a heart rhythm problem (QT prolongation).
- Extreme drowsiness or trouble staying awake, especially if you also use alcohol, benzodiazepines, or other sedating drugs.
- A sharp rise in blood pressure, diarrhea, anxiety, chills, sweating, or limb pain after stopping the medicine too quickly.
- Signs of opioid overdose if you return to opioid use after stopping. Get emergency help right away.
The most common side effects in studies were:
- Trouble sleeping (insomnia)
- Low blood pressure, including when standing up
- Slow heart rate
- Dizziness
- Sleepiness and sedation
- Dry mouth
Call your prescriber if you faint, feel very dizzy, or have a very slow pulse. Seek help for irregular heartbeat or extreme drowsiness.
Lofexidine warnings and precautions
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- Low blood pressure, slow pulse, and fainting: Vital signs are checked before doses. Avoid use with severe coronary insufficiency, recent heart attack, cerebrovascular disease, chronic renal failure, or marked bradycardia (very slow heart rate).
- QT prolongation: Avoid in congenital long QT syndrome. ECG monitoring is advised with heart failure, slow rhythm problems, liver or kidney impairment, or other QT-prolonging drugs.
- Added sedation: Risk rises with benzodiazepines, alcohol, barbiturates, and other sedating drugs.
- Overdose risk after stopping opioids: Lofexidine does not treat opioid use disorder. Tolerance falls, so resuming opioids can be fatal.
- Stopping suddenly: Can cause a marked rise in blood pressure, diarrhea, insomnia, anxiety, chills, sweating, and limb pain.
Lofexidine interactions: what it interacts with
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Several medicines can change how lofexidine works or add to its effects.
- Methadone: both prolong the QT interval, so ECG monitoring is recommended.
- Oral naltrexone: may work less well if taken within 2 hours of lofexidine.
- Benzodiazepines, alcohol, barbiturates, other sedating drugs: added drowsiness.
- Paroxetine and other CYP2D6 inhibitors: raise lofexidine levels, so watch for dizziness on standing and slow pulse.
- Medicines that lower pulse or blood pressure: avoid combining due to excessive slow pulse and low blood pressure.
Interactions listed in the FDA-approved label
Excerpt from the Lofexidine prescribing information (“Drug Interactions”). This is what the manufacturer studied or reported to the FDA.
7 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 tablets. 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 potentiates 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 tablets. Monitor for orthostatic hypotension and bradycardia when an inhibitor of CYP2D6 is used concomitantly with Lofexidine tablets [see Clinical Pharmacology (12.3) ] .
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Lofexidine
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- No absolute contraindications are listed, but several heart conditions call for avoiding it.
- Pregnancy: safety has not been established, and animal studies showed fetal harm.
- Breastfeeding: it is unknown whether it passes into milk, so caution is advised.
- Children: safety and effectiveness have not been established.
- Adults over 65: use caution. Dose adjustments like those for kidney impairment may be considered.
- Liver or kidney impairment: dose adjustments are recommended and QT prolongation may occur.
- CYP2D6 poor metabolizers: levels may be higher, so monitor for dizziness on standing and slow pulse.
Lofexidine overdose: if you take too much
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Too much lofexidine may cause low blood pressure, a slow heart rate, and sedation. Seek emergency care. Treatment is supportive, and dialysis does not remove much of the drug.
Pharmacodynamics: what Lofexidine does in the body
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Lofexidine lowers sympathetic activity by acting on alpha-2A and alpha-2C receptors. It can lengthen the QT interval, with greater effects in people with liver or kidney impairment. Used with methadone it raised QTcF measurably, while the increase with buprenorphine was small.
Pharmacokinetics: how your body processes Lofexidine
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Lofexidine is well absorbed, with peak levels 3 to 5 hours after a dose, and food does not change this. It is mainly broken down by the liver enzyme CYP2D6, and most of the dose leaves through the kidneys. Half-life is about 11 to 13 hours after the first dose and 17 to 22 hours at steady state. Liver or kidney impairment slows its elimination.
How to store Lofexidine
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Store in original container at controlled room temperature, 25°C (77°F); with excursions permitted between 15°C to 30°C (59°F to 86°F) .
📄 Written from Lofexidine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Lofexidine
139 supplements and herbal products have documented interactions with Lofexidine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 95
- Minor · 41
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Lofexidine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Lofexidine — the kind of thing our pharmacy team would talk through with you at the counter.
What is lofexidine for?
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How do I take it?
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What side effects should I expect?
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Can I drink alcohol or take other medicines with it?
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Why is overdose a concern after I finish?
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Is it safe in pregnancy?
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Is Lofexidine available over the counter?
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When was Lofexidine first available?
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Who makes Lofexidine?
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💬 Answers drafted from Lofexidine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Lofexidine on HelloPharmacist
💊 Lofexidine forms and strengths (how it comes)
Lofexidine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Lofexidine tablets and Lucemyra are used in adults to ease opioid withdrawal symptoms and help with abrupt opioid discontinuation.
- Lofexidine tablets and Lucemyra are taken by mouth several times a day, with 5 to 6 hours between doses.
- Lofexidine tablets and Lucemyra can be taken with or without food.
- Lofexidine tablets and Lucemyra treatment may continue for up to 14 days, guided by symptoms.
- Lofexidine tablets and Lucemyra should be stopped with a gradual dose reduction over 2 to 4 days.
📊 Lofexidine on the U.S. market: products, makers and brands
How Lofexidine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
13 companies list 18 Lofexidine product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2018. Brand names on the directory include Lucemyra; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Lofexidine is used (Medicaid data)
A general measure of how commonly Lofexidine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Lofexidine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Lofexidine prescribed? Of the 1,599 medications we measure, Lofexidine ranks #1,076 by Medicaid prescriptions — more than 33% of them.
Utilization by Lofexidine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
lofexidine 0.18 MG Oral Tablet
Summed across the 8 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2046591
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Lofexidine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 8 of 16 listed Lofexidine NDCs with Medicaid activity.
🔍 Compare Lofexidine products
A representative set of FDA-listed product records for Lofexidine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 0.18 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 0.2 mg | Oral | BioCorRx Pharmaceuticals Inc × 2 listings | NDA | View NDC → |
| 0.18 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 0.18 mg | Oral | Florida Pharmaceutical Products, LLC | ANDA | View NDC → |
| 0.18 mg | Oral | Indoco Remedies Limited | ANDA | View NDC → |
| 0.2 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 0.2 mg | Oral | Prasco Laboratories × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 0.2 mg | Oral | Uswm, Llc × 4 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | HAS Healthcare Advanced Synthesis SA | BULK INGREDIENT | View NDC → |
| 75 kg/75 kg | — | Medichem Manufacturing (Malta) Ltd. | BULK INGREDIENT | View NDC → |
| 75 kg/75 kg | — | Medichem S.A. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Laboratories Private Limited | BULK INGREDIENT | View NDC → |
| 50 kg/50 kg | — | Procos SpA | BULK INGREDIENT | View NDC → |
Showing 18 of 18 products — FDA National Drug Code Directory. See every product, package size and price: browse all 18 Lofexidine NDCs →
📈 Lofexidine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Lofexidine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Lofexidine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Lofexidine FDA approval history
How Lofexidine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Lofexidine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 28863 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 372627In current FDA listingsClinical drug / strength (SCD) 0.18 MGRxCUI 2046591
Look up RxCUI 28863 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Lofexidine supply and shortage status
Whether Lofexidine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Lofexidine brand names
Lofexidine is sold under one brand name in the FDA directory — Lucemyra. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
🏭 Who makes Lofexidine: manufacturers and labelers
13 companies list Lofexidine products with the FDA. By number of product records, the largest are Uswm, Llc, BioCorRx Pharmaceuticals Inc, Prasco Laboratories. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Lofexidine drug class (RxNorm)
Lofexidine belongs to the Drugs used in opioid dependence class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Lofexidine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 8 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Indoco Remedies Limited is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.