Applies to lefamulin: oral tablet. Other dosage forms:

• intravenous solution

Serious side effects of Lefamulin

Along with its needed effects, lefamulin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lefamulin:

Less common

• Convulsions
• decreased urine
• dry mouth
• increased thirst
• irregular heartbeat
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• trouble breathing
• unusual tiredness or weakness

Incidence not known

• Abdominal or stomach tenderness
• chest pain or discomfort
• fainting
• fever
• irregular or slow heart rate
• severe abdominal or stomach cramps and pain
• watery and severe diarrhea, which may also be bloody

Other side effects of Lefamulin

Some side effects of lefamulin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Headache
• trouble sleeping

For Healthcare Professionals

Applies to lefamulin: intravenous solution, oral tablet.

Gastrointestinal

Very common (10% or more): Diarrhea (up to 12%)

Common (1% to 10%): Nausea, vomiting

Frequency not reported: Abdominal pain, constipation, dyspepsia, epigastric discomfort, erosive gastritis, Clostridium difficile-associated diarrhea, C difficile colitis, oropharyngeal candidiasis^[Ref]

Local

Common (1% to 10%): Administration site reactions (included infusion site pain, infusion site phlebitis, injection site reaction)^[Ref]

Hepatic

Common (1% to 10%): Hepatic enzyme elevation (included increased ALT, increased AST, increased liver function test)

Frequency not reported: Increased GGT^[Ref]

Metabolic

Common (1% to 10%): Hypokalemia^[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Frequency not reported: Anxiety^[Ref]

Nervous system

Common (1% to 10%): Headache

Frequency not reported: Somnolence^[Ref]

Other

Common (1% to 10%): Death within 28 days

Frequency not reported: Increased alkaline phosphatase^[Ref]

Death within 28 days occurred in 1.2% of patients treated with this drug and 1.1% of patients treated with moxifloxacin.^[Ref]

Cardiovascular

Frequency not reported: Atrial fibrillation, palpitations, prolonged QT on ECG^[Ref]

Genitourinary

Frequency not reported: Vulvovaginal candidiasis, urinary retention^[Ref]

Hematologic

Frequency not reported: Anemia, thrombocytopenia^[Ref]

Musculoskeletal

Frequency not reported: Increased creatine phosphokinase^[Ref]