Ketek Pak Side Effects

Generic name: telithromycin

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 Pak.

Some side effects of Ketek Pak may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to telithromycin: oral tablet

Telithromycin may cause sudden and serious liver damage. In rare cases, liver failure can develop and may cause death. Stop using the medication and call your doctor right away if you have nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Get emergency medical help if you have any of these signs of an allergic reaction while taking telithromycin (the active ingredient contained in Ketek Pak) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using telithromycin and call your doctor at once if you have a serious side effect such as:

• diarrhea that is watery or bloody;

• severe dizziness, fainting, fast or pounding heartbeats;

• confusion, hallucinations; or

• problems with vision (difficulty focusing, double vision).

Less serious side effects of telithromycin may include:

• mild diarrhea;

• mild nausea, vomiting;

• vaginal itching or discharge; or

• changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to telithromycin: oral tablet

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 hepatotoxicity due to telithromycin (the active ingredient contained in Ketek Pak) therapy, for an 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. Hepatic dysfunction and severe (and in some cases fatal) hepatotoxicity, including fulminant hepatitis, hepatic necrosis, and hepatic failure, have been reported during postmarketing experience. Such hepatic reactions were observed during or immediately following therapy, and 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. Pancreatitis has been reported during postmarketing experience.

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. Loss of consciousness/syncope (in some cases associated with vagal syndrome) and taste/smell perversion and/or loss have been reported during postmarketing experience.

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. Atrial arrhythmia, palpitations, and torsades de pointes have been reported during postmarketing experience.

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, arthralgia, myalgia, and rare reports of exacerbation of myasthenia gravis during postmarketing experience.

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 rare reports of severe allergic (hypersensitivity) reactions, including angioedema and anaphylaxis during postmarketing experience.

Psychiatric

Psychiatric side effects have included confusion and hallucinations (mostly visual) during postmarketing experience.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.