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Lofexidine Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Sep 27, 2021.

For the Consumer

Applies to lofexidine: oral tablets

Side effects include:

Insomnia, orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, dry mouth.

For Healthcare Professionals

Applies to lofexidine: oral tablet

General

The more commonly reported adverse effects have included orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, and dry mouth.[Ref]

Cardiovascular

Adverse reactions are reported at mean average daily doses up to 2.88 mg/day. With a mean dose of 2.16 mg/day, insomnia, orthostatic hypotension, bradycardia, and hypotension, were reported at 51%, 29%, 24%, and 30%, respectively. Syncope was reported in 0.9% of patients receiving 2.16 mg/day (1.4% for patients receiving 2.88 mg/day and 0% for placebo).

Blood pressure (BP) elevations of 140 mmHg (systolic) or higher, and above the subject's pretreatment BP, occurred in 39.7% (n= 23/58) of patients following discontinuation of a 5-day course of 2.88 mg/day. BP peaked on the second day after discontinuation.

Since market introduction (1992 in UK), there has been 1 case of QT prolongation, bradycardia, torsades de pointes, and cardiac arrest with successful resuscitation; there have been 3 reports of clinically significant QT prolongation in patients concomitantly receiving methadone.

Cardiac electrophysiology studies with single doses of 1.44 to 1.8 mg produced maximum mean change from baseline QTcF of 14.4 and 13.6 milliseconds, respectively in healthy normal volunteers. In a phase 3 study in opioid-dependent subjects, a maximal mean prolongation of the QTcF interval of 7.3 and 9.3 milliseconds occurred at doses of 2.16 and 2.88 mg/day respectively. In patients with renal or hepatic impairment, QT prolongation was reported; it was more pronounced in subjects with severe renal or hepatic impairment.

Very common (10% or more): Orthostatic hypotension (up to 42%); bradycardia (up to 32%); hypotension (30%), hypertension with abrupt discontinuation

Uncommon (0.1% to 1%): Syncope

Postmarketing reports: QT prolongation

Nervous system

Very common (10% or more): Dizziness (up to 23%), somnolence (up to 13%), sedation (up to 13%)

Gastrointestinal

Very common (10% or more): Dry mouth (up to 11%)

Other

Uncommon (0.1% to 1%): Tinnitus

Psychiatric

Insomnia was reported in 51% of patients receiving a mean average daily dose of 2.16 mg/day and 55% of those receiving 2.88 mg/day; however, it was also reported by 48% of those receiving placebo.

For patients stopping this drug, a higher incidence of diarrhea, insomnia, anxiety, chills, hyperhidrosis, and extremity pain occurred in drug-treated patients compared to those taking placebo.

Very common (10% or more): Insomnia (up to 55%)

Frequency not reported: Withdrawal symptoms

Frequently asked questions

References

1. "Product Information. Lucemyra (lofexidine)." US WorldMeds LLC (2018):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.