Medical Editor: John P. Cunha, DO, FACOEP
What Is Ketek?
What Are Side Effects of Ketek?
Common side effects of Ketek include:
- mild diarrhea,
- a strange taste in the mouth, or
- vaginal itching or discharge
Ketek may cause serious side effects including:
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- vision changes,
- blurred vision,
- double vision,
- difficulty focusing your eyes,
- irregular or fast heartbeat,
- worsening muscle weakness,
- extreme tiredness,
- loss of appetite,
- stomach pain,
- dark urine,
- yellowing of your eyes or skin (jaundice), and
- diarrhea (may occur weeks or months after treatment has stopped)
Get medical help right away, if you have any of the symptoms listed above.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Ketek
The dose of Ketek tablets is 800 mg (2 tablets of 400 mg) taken orally once every 24 hours, for 7–10 days.
What Drugs, Substances, or Supplements Interact with Ketek?
Ketek may interact with blood thinners, cholesterol-lowering medicines, ergot medicines, sedatives, itraconazole, ketoconazole, heart rhythm medications, rifampin, seizure medications, metoprolol, tacrolimus, sirolimus, cyclosporine, or digoxin. Tell your doctor all medications and supplements you use.
Ketek During Pregnancy or Breastfeeding
Our Ketek (telithromycin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
- Myasthenia gravis [see CONTRAINDICATIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- QTc prolongation [see WARNINGS AND PRECAUTIONS]
- Visual disturbances and loss of consciousness [see WARNINGS AND PRECAUTIONS]
- Clostridium difficile-associated diarrhea [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In Phase 3 clinical trials, 4,780 patients (n=2702 in controlled trials) received oral dosages of KETEK 800 mg once daily for 5 days or 7 to 10 days. Note that treatment with KETEK for 5 days duration is not a recommended dosage regimen. [see DOSAGE AND ADMINISTRATION]
In the combined Phase 3 studies, discontinuation due to adverse reactions occurred in 4.4% of KETEKtreated patients and 4.3% of combined comparator-treated patients. Most discontinuations in the KETEK group were due to adverse reactions in the gastrointestinal body system, primarily diarrhea (0.9% for KETEK vs. 0.7% for comparators), and nausea (0.7% for KETEK vs. 0.5% for comparators).
Adverse reactions (ARs) occurring in clinical studies in 2% or more of KETEK patients are included below.
Table 1: Adverse Reactions Reported in 2% or more of
Patients in Controlled Phase 3 Clinical Studies
|Adverse Reaction *||Percent Incidence|
|Dizziness (excl. vertigo)||2.8%||1.5%|
|*Based on a frequency of all and possibly related adverse
reactions of 2% or more in KETEK or comparator groups.
†Includes comparators from all controlled Phase 3 studies.
Less Common Adverse Reactions
Frequency Of 0.2% Or More And Less Than 2%
The following adverse reactions were observed at a frequency of 0.2% or more and less than 2% in KETEK-treated patients in clinical studies.
Liver and biliary system: abnormal liver function tests: increased transaminases (i.e., ALT, AST). Hepatitis, with or without jaundice, occurred in 0.07% of patients treated with KETEK. [see WARNINGS AND PRECAUTIONS]
Body as a whole: abdominal pain, fatigue
Special senses: Visual adverse reactions, some of them severe, most often included blurred vision, diplopia, or difficulty focusing. Some patients discontinued therapy due to these adverse reactions. Visual adverse reactions were reported as having occurred after any dose during treatment, but most (65%) occurred following the first or second dose. Visual adverse reactions lasted several hours and recurred upon subsequent dosing in some patients. For patients who continued treatment, some visual adverse reactions resolved on therapy while others persisted through the full course of treatment. [see WARNINGS AND PRECAUTIONS]
Females and patients under 40 years old experienced a higher incidence of KETEK-associated visual adverse reactions. Table 2 provides the incidence of all visual adverse reactions in controlled Phase 3 studies by age and gender. The group with the highest incidence was females under the age of 40, while males over the age of 40 had rates of visual adverse reactions similar to comparator-treated patients.
Table 2: Incidence of All Visual Adverse Reactions in
Controlled Phase 3 Studies
|Female 40 and under||2.1% (14/682)||0.0% (0/534)|
|Female greater than 40||1.0% (7/703)||0.35% (2/574)|
|Male 40 and under||1.2% (7/563)||0.48% (2/417)|
|Male greater than 40||0.27% (2/754)||0.33% (2/614)|
|Total||1.1% (30/2702)||0.28% (6/2139)|
|*Includes all comparators combined|
Hematologic: increased platelet count
Frequency of Less Than 0.2%
Other clinically-significant adverse reactions occurring in less than 0.2% of patients treated with KETEK from the controlled Phase 3 studies included: anxiety, bradycardia, eczema, elevated blood bilirubin, erythema multiforme, flushing, hypotension, increased blood alkaline phosphatase, increased eosinophil count, paresthesia, pruritus, urticaria.
The following adverse reactions have been identified during post-approval use of KETEK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular: atrial arrhythmias, ventricular arrhythmias (including ventricular tachycardia and torsades de pointes) with potential fatal outcome, palpitation, ischemic cardiac events in the context of hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
Nervous system: loss of consciousness, in some cases associated with vagal syndrome, tremor, convulsions
Psychiatric disorders: confusion, hallucinations (mostly visual)
Special senses: taste/smell perversion and/or loss, hearing loss
Respiratory, thoracic and mediastinal disorders: dyspnea
Read the entire FDA prescribing information for Ketek (Telithromycin)
© Ketek Patient Information is supplied by Cerner Multum, Inc. and Ketek Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
Health Solutions From Our Sponsors