Ketek Side Effects

Generic Name: telithromycin

Please note - some side effects for Ketek 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 Ketek - for the Consumer

Ketek

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 Ketek:

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.

Ketek Side Effects - for the Professional

Ketek

In Phase III clinical trials, 4,780 patients (n=2702 in controlled trials) received daily oral doses of Ketek 800 mg once daily for 5 days or 7 to 10 days. Most adverse events were mild to moderate in severity. In the combined Phase III studies, discontinuation due to treatment-emergent adverse events occurred in 4.4% of Ketek-treated patients and 4.3% of combined comparator-treated patients. Most discontinuations in the Ketek group were due to treatment-emergent adverse events in the gastrointestinal body system, primarily diarrhea (0.9% for Ketek vs. 0.7% for comparators), nausea (0.7% for Ketek vs. 0.5% for comparators).

All and possibly related treatment-emergent adverse events (TEAEs) occurring in controlled clinical studies in ≥ 2.0% of all patients are included below:

The following events judged by investigators to be at least possibly drug related were observed infrequently (≥ 0.2% and < 2%), in Ketek-treated patients in the controlled Phase III studies.

Gastrointestinal system: abdominal distension, dyspepsia, gastrointestinal upset, flatulence, constipation, gastroenteritis, gastritis, anorexia, oral candidiasis, glossitis, stomatitis, watery stools.

Liver and biliary system: abnormal liver function tests: increased transaminases, increased liver enzymes (e.g., ALT, AST) were usually asymptomatic and reversible. ALT elevations above 3 times the upper limit of normal were observed in 1.6%, and 1.7% of patients treated with Ketek and comparators, respectively. Hepatitis, with or without jaundice, occurred in 0.07% of patients treated with Ketek, and was reversible.

Nervous system: dry mouth, somnolence, insomnia, vertigo, increased sweating

Body as a whole: abdominal pain, upper abdominal pain, fatigue

Special senses: Visual adverse events most often included blurred vision, diplopia, or difficulty focusing. Most events were mild to moderate; however, severe cases have been reported. Some patients discontinued therapy due to these adverse events.  Visual adverse events were reported as having occurred after any dose during treatment, but most visual adverse events (65%) occurred following the first or second dose. Visual events lasted several hours and recurred upon subsequent dosing in some patients. For patients who continued treatment, some resolved on therapy while others continued to have symptoms until they completed the full course of treatment.

Females and patients under 40 years old experienced a higher incidence of telithromycin-associated visual adverse events.

Urogenital system: vaginal candidiasis, vaginitis, vaginosis fungal

Skin: rash

Hematologic: increased platelet count

Other possibly related clinically-relevant events occurring in <0.2% of patients treated with Ketek from the controlled Phase III studies included: anxiety, bradycardia, eczema, elevated blood bilirubin, erythema multiforme, flushing, hypotension, increased blood alkaline phosphatase, increased eosinophil count, paresthesia, pruritus, urticaria.

Post-Marketing Adverse Event Reports

In addition to adverse events reported from clinical trials, the following events have been reported from worldwide post-marketing experience with Ketek. 

Allergic: face edema, rare reports of severe allergic reactions, including angioedema and anaphylaxis.

Cardiovascular: atrial arrhythmias, palpitations

Gastrointestinal system: pancreatitis

Liver and biliary system: Hepatic dysfunction has been reported.

Severe and in some cases fatal hepatotoxicity, including fulminant hepatitis, hepatic necrosis and hepatic failure have been reported in patients treated with Ketek. These hepatic reactions were observed during or immediately after treatment. In some of these cases, liver injury progressed rapidly and occurred after administration of only a few doses of Ketek. Severe reactions, in some but not all cases, have been associated with serious underlying diseases or concomitant medications.

Data from post-marketing reports and clinical trials show that most cases of hepatic dysfunction were mild to moderate.

Musculoskeletal: muscle cramps, rare reports of exacerbation of myasthenia gravis.

Nervous system: loss of consciousness, in some cases associated with vagal syndrome.

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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