OpenClaim

Lofexidine Side Effects

The most commonly reported side effects of lofexidine include dizziness, hypotension, and somnolence, based on 161 FDA adverse event reports from 2004 to 2025. 4.3% of reports found the drug to be ineffective.

Lofexidine side effects

Percentages show how often each reaction appears relative to total reports for lofexidine.

1
Dizziness14.9%24
2
Hypotension10.6%17
3
Somnolence9.3%15
4
Dyspnoea8.7%14
5
Diarrhoea7.5%12
6
Dry Mouth6.8%11
7
Fatigue6.2%10
8
Malaise6.2%10
9
Insomnia6.2%10
10
Withdrawal Syndrome6.2%10
11
Vomiting6.2%10
12
Nausea5.6%9
13
Loss Of Consciousness5.6%9
14
Syncope5.0%8
15
Fall5.0%8

These are voluntary reports and do not establish that lofexidine caused these reactions.

Report severity

28.6%Serious46 reports
14.9%Hospitalizations24 reports
1.2%Fatal2 reports

Seriousness is determined by the reporter, not by OpenClaim.

Lofexidine drug interactions

Other drugs that appear in adverse event reports alongside lofexidine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Ibuprofen3.7%6
2
Alprazolam3.7%6
3
Naltrexone3.7%6
4
Fentanyl2.5%4
5
Naproxen1.9%3
6
Methadone-hydrochloride1.9%3
7
Acetaminophen1.9%3
8
Vortioxetine1.9%3
9
Pregabalin1.9%3
10
Buprenorphine1.2%2
11
Oxycodone1.2%2
12
Ethinyl-estradiol0.6%1
13
Etonogestrel0.6%1
14
Hydroxyzine0.6%1
15
Midazolam0.6%1

Taken alongside

1
Acetaminophen9.9%16
2
Buprenorphine7.5%12
3
Diazepam5.6%9
4
Metoclopramide-hydrochloride4.3%7
5
Naproxen4.3%7
6
Albuterol4.3%7
7
Naloxone-hydrochloride4.3%7
8
Rosuvastatin4.3%7
9
Ondansetron3.7%6
10
Promethazine-hydrochloride3.7%6
11
Ibuprofen3.1%5
12
Oxycodone3.1%5
13
Pantoprazole-sodium3.1%5
14
Eszopiclone3.1%5
15
Promazine-hydrochloride2.5%4

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports lofexidine side effects

41.0% of lofexidine adverse event reports involve female patients and 49.1% involve male patients. The largest age group is adult at 87%. These figures reflect who reports side effects, not underlying risk.

Sex

Female41.0%
Male49.1%
Unknown9.9%

Age group

< 20.0%
2–111.2%
12–170.0%
18–6487.2%
65+11.6%

What is lofexidine used for

Conditions and purposes for which patients were taking lofexidine when the adverse event was reported.

Alcohol Withdrawal SyndromeDependenceDrug AbuseDrug DependenceDrug Withdrawal SyndromeDrug TherapyDrug Withdrawal SyndromeProduct Used For Unknown IndicationPruritusProduct Used For Unknown IndicationStressWithdrawal SyndromeWithdrawal Syndrome

Lofexidine brand names and reporting trend

Lofexidine is sold under the brand name Lofexidine Hydrochloride.

Brand names

Lofexidine Hydrochloride1

Quarterly reports (20042025)

200520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking lofexidine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.