Note: This document contains side effect information about telithromycin. Some of the dosage forms listed on this page may not apply to the brand name Ketek.
Common side effects of Ketek include: diarrhea. Other side effects include: headache and nausea. See below for a comprehensive list of adverse effects.
Applies to telithromycin: oral tablet
Oral route (Tablet)
Fatal and life-threatening respiratory failure has been reported in patients with myasthenia gravis treated with telithromycin.
Along with its needed effects, telithromycin (the active ingredient contained in Ketek) 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 telithromycin:
Incidence not known
Some side effects of telithromycin 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:
Applies to telithromycin: oral tablet
Severe liver injury and acute liver failure (in some cases fatal) have been reported. Such hepatic reactions were observed during or immediately after therapy and included fulminant hepatitis and hepatic necrosis leading to liver transplant. In some cases, liver injury progressed rapidly and occurred after a few doses of this drug were administered. Less severe liver dysfunction (associated with reversible hepatitis, elevated liver enzymes, and sometimes jaundice) has been reported.
Drug-related hepatotoxicity was reported in a 46-year-old man receiving treatment for an ear and sinus infection. The patient presented with a 4-day history of malaise, dark urine, jaundice, mild pruritus, and anorexia. The patient denied toxin exposure, IV drug abuse, or hepatic injury. ALT 948 units/L, AST 200 units/L, total bilirubin 65 mmol/L, and alkaline phosphatase 291 units/L were observed. These values warranted withdrawal of this drug and within 2 weeks the ALT decreased to 450 units/L and his jaundice resolved. After 8 weeks, the patient's liver tests had normalized.
Common (1% to 10%): Increased liver enzymes (AST, ALT, alkaline phosphatase, GGT)
Uncommon (0.1% to 1%): Hepatitis (with or without jaundice)
Rare (0.01% to 0.1%): Cholestatic jaundice
Frequency not reported: Abnormal liver function tests, increased transaminases (ALT, AST), elevated blood bilirubin, increased ALT (at least 3 times the upper limit of normal), hepatocellular and/or cholestatic hepatitis (with or without jaundice), severe liver toxicity, hepatotoxicity (including acute liver failure, severe liver injury)
Postmarketing reports: Hepatic dysfunction, fulminant hepatitis, hepatic necrosis, hepatic failure, severe hepatitis
Very common (10% or more): Diarrhea (10.8%)
Common (1% to 10%): Nausea, vomiting, gastrointestinal pain, flatulence
Uncommon (0.1% to 1%): Constipation, oral candidiasis, stomatitis
Very rare (less than 0.01%): Pseudomembranous colitis
Frequency not reported: Abdominal distension, dry mouth, dyspepsia, gastrointestinal upset, gastroenteritis, gastritis, glossitis, Clostridium difficile-associated diarrhea, loose stools, watery stools
Postmarketing reports: Pancreatitis
Pseudomembranous colitis has also been reported during postmarketing experience.
Exacerbations of myasthenia gravis (including fatal and life-threatening acute respiratory failure) have been reported. Rapid onset was observed in some cases, occurring within a few hours after the first dose.
Common (1% to 10%): Headache, dizziness (excluding vertigo), taste disturbance/dysgeusia
Uncommon (0.1% to 1%): Somnolence, vertigo
Rare (0.01% to 0.1%): Paresthesia, transient loss of consciousness
Very rare (less than 0.01%): Parosmia
Postmarketing reports: Loss of consciousness (in some cases associated with vagal syndrome), exacerbation of myasthenia gravis, tremors, convulsions, taste/smell perversion, ageusia, anosmia, hearing loss
Fatal and life-threatening acute respiratory failure has been reported in patients with myasthenia gravis.
Frequency not reported: Acute respiratory failure, rhinitis, upper respiratory infection
Postmarketing reports: Dyspnea
Common (1% to 10%): Vaginal candidiasis
Frequency not reported: Vaginitis, fungal vaginosis
Postmarketing reports: Chromaturia
Uncommon (0.1% to 1%): Flush/flushing, palpitations
Rare (0.01% to 0.1%): Atrial arrhythmia, hypotension, bradycardia
Frequency not reported: Increased QTc interval
Postmarketing reports: QT/QTc interval prolongation, ventricular arrhythmias (including ventricular tachycardia, torsades de pointes) with potential fatal outcome, ischemic cardiac events (in the context of hypersensitivity reactions)
Ventricular arrhythmias (including ventricular tachycardia, torsades de pointes) have sometimes occurred within a few hours after the first dose.
Atrial arrhythmias and palpitation have also been reported during postmarketing experience.
Visual disturbances (some severe) most often included blurred vision, difficulty focusing, or diplopia; some patients stopped therapy due to these effects. Most visual side effects were reported after the first or second dose, lasted 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 up to 40 years of age had a higher rate of these side effects (females up to 40 years: 2.1%; females older than 40 years: 1%; males up to 40 years: 1.2%; males older than 40 years: 0.27%).
Uncommon (0.1% to 1%): Blurred vision
Rare (0.01% to 0.1%): Diplopia
Frequency not reported: Visual disturbances (including blurred vision, difficulty focusing, diplopia)
Uncommon (0.1% to 1%): Rash, pruritus, urticaria
Rare (0.01% to 0.1%): Eczema
Very rare (less than 0.01%): Erythema multiforme
Frequency not reported: Increased sweating
Postmarketing reports: Angioneurotic edema
Uncommon (0.1% to 1%): Eosinophilia
Frequency not reported: Increased platelet count, increased eosinophil count
Uncommon (0.1% to 1%): Anorexia
Frequency not reported: Increased blood alkaline phosphatase
Uncommon (0.1% to 1%): Insomnia, nervousness
Frequency not reported: Anxiety
Postmarketing reports: Confusion, hallucinations (mostly visual)
Muscle cramps have also been reported during postmarketing experience.
Very rare (less than 0.01%): Muscle cramps
Postmarketing reports: Arthralgia, myalgia
Postmarketing reports: Severe allergic reactions (including angioedema, anaphylaxis), anaphylactic reactions (including anaphylactic shock), hypersensitivity
Frequency not reported: Abdominal pain, fatigue, upper abdominal pain
Postmarketing reports: Face edema
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Ketek