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Lefamulin Side Effects

The most commonly reported side effects of lefamulin include diarrhoea, vomiting, and product use in unapproved indication, based on 19 FDA adverse event reports from 2020 to 2025. 5.3% of reports found the drug to be ineffective.

Lefamulin side effects

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

1
Diarrhoea36.8%7
2
Vomiting21.1%4
3
Product Use In Unapproved Indication15.8%3
4
Nausea15.8%3
5
Palpitations10.5%2
6
Pneumonia10.5%2
7
Abdominal Discomfort10.5%2
8
Therapeutic Product Effective For Unapproved Indication10.5%2
9
Off Label Use10.5%2
10
Cold Sweat5.3%1
11
Headache5.3%1
12
Feeling Abnormal5.3%1
13
Periorbital Swelling5.3%1
14
Pruritus5.3%1
15
Hypersensitivity5.3%1

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

Report severity

21.1%Serious4 reports
5.3%Hospitalizations1 reports
5.3%Fatal1 reports

Seriousness is determined by the reporter, not by OpenClaim.

Lefamulin drug interactions

Other drugs that appear in adverse event reports alongside lefamulin. 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
Doxycycline5.3%1
2
Minocycline-hydrochloride5.3%1
3
Moxifloxacin-hydrochloride5.3%1

Taken alongside

1
Minocycline-hydrochloride10.5%2
2
Atorvastatin-calcium10.5%2
3
Metformin10.5%2
4
Albuterol10.5%2
5
Trazodone-hydrochloride5.3%1
6
Warfarin5.3%1
7
Sotalol-hydrochloride5.3%1
8
Quinapril-hydrochloride5.3%1
9
Benzonatate5.3%1
10
Eplerenone5.3%1
11
Azithromycin5.3%1
12
Rivaroxaban5.3%1
13
Diltiazem5.3%1
14
Doxycycline5.3%1
15
Folic-acid5.3%1

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 lefamulin side effects

26.3% of lefamulin adverse event reports involve female patients and 36.8% involve male patients. The largest age group is adult at 67%. These figures reflect who reports side effects, not underlying risk.

Sex

Female26.3%
Male36.8%
Unknown36.8%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6466.7%
65+33.3%

What is lefamulin used for

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

Arthritis BacterialCellulitisChronic Obstructive Pulmonary DiseaseEssential HypertensionHeart Valve ReplacementMycoplasma Genitalium InfectionMycoplasma InfectionMycoplasma Genitalium InfectionPneumoniaPneumonia BacterialPneumonia PneumococcalProduct Used For Unknown IndicationProduct Used For Unknown Indication

Lefamulin brand names and reporting trend

Lefamulin is sold under the brand name Xenleta.

Brand names

Xenleta2

Quarterly reports (20202025)

202020222025

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

Taking lefamulin with another medication?

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