Telithromycin Side Effects

Brand Names: Ketek

Please note - some side effects for Telithromycin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Telithromycin - for the Consumer

Telithromycin

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Telithromycin:

Diarrhea; dizziness; headache; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; blurred vision, double vision, difficulty focusing, or other vision problems; dark urine; fainting; fast, slow, or irregular heartbeat; hoarseness; loss of appetite; muscle cramps or weakness; pale stools; severe or persistent diarrhea; severe stomach pain, cramps, or tenderness; severe vomiting; unusual fatigue or tiredness; yellowing of eyes or skin.

Side Effects by Body System

Hepatic

Cases of severe liver toxicity have been reported: Four were fatal and one patient required a liver transplant.

A case report of a 46-year-old man with hepatoxicity due to telithromycin therapy, for an his ear and sinus infection was reported. The patient presented with a 4-day history of malaise, dark urine, jaundice, mild pruritus, and anorexia. The patient denied toxin exposure, intravenous drug abuse, or hepatic injury. ALT was 948 U/L, AST 200 U/L, total bilirubin 65 mmol/L, and alkaline phosphatase 291 U/L. These values warranted withdrawal of telithromycin and within two weeks the ALT decreased to 450 U/L and his jaundice resolved. After eight weeks the patient's liver tests were normalized.

Hepatic side effects have included severe liver toxicity, abnormal liver function tests such as increased transaminases and increased liver enzymes alanine transaminase (ALT) and aspartate transaminase (AST), increased ALT greater than or equal to 3 times the upper limit of normal or ULN (1.6%), reversible hepatitis with or without jaundice (0.07%), and hepatocellular and/or cholestatic hepatitis with or without jaundice. In postmarketing reports, cases of severe liver injury and acute liver failure, in some cases fatal, have been reported. Hepatic reactions observed during or immediately following telithromycin therapy have included fulminant hepatitis and hepatic necrosis leading to liver transplant. Some cases of liver injury progressed rapidly and occurred after administration of only a few doses of telithromycin. Clinical trial and postmarketing reports of hepatic dysfunction were usually mild to moderate.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (10.8%), nausea (7.9%), vomiting (2.9%), loose stools (2.3%), and dysgeusia (1.6%). Abdominal distension, dyspepsia, gastrointestinal upset, flatulence, constipation, gastroenteritis, gastritis, anorexia, glossitis, oral candidiasis, stomatitis, and watery stools have been reported in less than 2% of patients. Pseudomembranous colitis has also been reported. Postmarketing reports have included pancreatitis.

Ocular

Ocular side effects have included blurred vision, diplopia, or difficulty focusing in less than 2% of patients. Most visual side effects were reported after the first or second dose, lasted for several hours, and recurred with subsequent doses in some patients. Symptoms continued throughout the entire course of therapy in some patients and resolved spontaneously during therapy in others. Females and patients younger than 40 years had a higher rate of these side effects.

Nervous system

Nervous system side effects have included headache (5.5%) and dizziness (3.7%). Somnolence, insomnia, dry mouth, vertigo, and increased sweating have been reported in less than 2% of patients. Paresthesia and anxiety have rarely been reported. Postmarketing reports have included loss of consciousness/syncope (in some cases associated with vagal syndrome).

Respiratory

Respiratory side effects have included rhinitis (0.05%) and upper respiratory infection (0.05%). Life-threatening acute respiratory failure has been reported in patients with myasthenia gravis.

Hematologic

Hematologic side effects have included increased platelet count (less than 2%) and increased eosinophil count (less than 0.2%).

Other

Other side effects have included abdominal pain, upper abdominal pain, and fatigue in less than 2% of patients.

Dermatologic

Dermatologic side effects have included rash (less than 2%) and eczema, erythema multiforme, pruritus, and urticaria in less than 0.2% of patients.

Cardiovascular

Cardiovascular side effects have rarely included flushing, hypotension, bradycardia, and increased QTc interval. Postmarketing reports have included atrial arrhythmia, palpitations, and torsades de pointes.

Genitourinary

Genitourinary side effects have included vaginal candidiasis, vaginitis, and fungal vaginosis in less than 2% of patients.

Musculoskeletal

Musculoskeletal side effects have included muscle cramps and exacerbation of myasthenia gravis in postmarketing reports.

Metabolic

Metabolic side effects have included increased blood alkaline phosphatase and elevated blood bilirubin in less than 0.2% of patients.

Hypersensitivity

Hypersensitivity side effects have included facial edema and severe allergic reactions (rare) including angioedema and anaphylaxis in postmarketing reports.

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