What the label lists and what reports show
Lofexidine side effects
Lofexidine's FDA label: “Most common adverse reactions (incidence ≥ 10% and notably more frequent than placebo) are orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, and dry mouth.” FAERS holds 161 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dizziness (24 reports).
- Generic listed
Check it at the source: the lofexidine FDA label on DailyMed (effective July 22, 2026, BioCorRx Pharmaceuticals Inc); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of LUCEMYRA?The most common side effects of LUCEMYRA include: low blood pressure or symptoms of low blood pressure slow heart rate dizziness such as lightheadednes sleepiness dry mouth These are not all the possible side effects of LUCEMYRA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to BioCorRx Pharmaceuticals Inc at 1-833-LUCEMYRA.
Source: FDA drug label, BioCorRx Pharmaceuticals Inc, effective July 22, 2026 (SPL set 0a848cc2-4dda-40d9-8b01-d789fe8981ed), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 10% and notably more frequent than placebo) are orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, and dry mouth.
Table 3: Adverse Reactions Reported by ≥10% of LUCEMYRA-Treated Patients and More Frequently than Placebo
| Adverse Reaction | LUCEMYRA 2.16 mg 1 (%) N=229 | LUCEMYRA 2.88 mg 1 (%) N=222 | Placebo (%) N=151 |
|---|---|---|---|
| Insomnia | 51 | 55 | 48 |
| Orthostatic Hypotension | 29 | 42 | 5 |
| Bradycardia | 24 | 32 | 5 |
| Hypotension | 30 | 30 | 1 |
| Dizziness | 19 | 23 | 3 |
| Somnolence | 11 | 13 | 5 |
| Sedation | 13 | 12 | 5 |
| Dry Mouth | 10 | 11 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 BioCorRx Pharmaceuticals Inc at 1-833-LUCEMYRA 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 LUCEMYRA 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. …
Source: FDA drug label, BioCorRx Pharmaceuticals Inc, effective July 22, 2026 (SPL set 0a848cc2-4dda-40d9-8b01-d789fe8981ed), via openFDA; the full label on DailyMed
What do FAERS reports show?
161 reports list lofexidine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 24 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 24 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lofexidine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions