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Altabax

Last reviewed on RxList: 12/5/2016
Altabax Side Effects Center

Last reviewed on RxList 2/15/2016

Altabax (retapamulin) is a topical (for the skin) antibiotic used to treat an infection called impetigo. Impetigo usually affects the nose, lips, or other areas of the face, but it may also affect other areas of the body. Common side effects of Altabax include mild burning, stinging, or itching, skin irritation, nausea, diarrhea, headache, stuffy nose, and sore throat.

A thin layer of Altabax should be applied to the affected area (a dose of up to 100 cm² in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) twice daily for 5 days. The treated area may be covered with a sterile bandage or gauze dressing if desired. Altabax may interact with an antifungal called ketoconazole. Other drugs may affect Altabax topical. Tell your doctor all prescription and over-the-counter medications you use. During pregnancy, Altabax should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Altabax (retapamulin) 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.

Altabax Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using retapamulin and call your doctor at once if you have severe burning, itching, redness, swelling, blistering, oozing, or other skin irritation where the medicine was applied.

Less serious side effects may include:

  • mild skin irritation;
  • nausea, diarrhea;
  • headache; or
  • stuffy nose, sore throat.

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.

Read the entire detailed patient monograph for Altabax (Retapamulin)

Altabax Professional Information

SIDE EFFECTS

Clinical Studies Experience

Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from the clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The safety profile of ALTABAX was assessed in 2,115 adult and pediatric subjects 9 months and older who used at least one dose from a 5-day, twice-a-day regimen of retapamulin ointment. Control groups included 819 adult and pediatric subjects who used at least one dose of the active control (oral cephalexin), 172 subjects who used an active topical comparator (not available in the US), and 71 subjects who used placebo.

Adverse events rated by investigators as drug-related occurred in 5.5% (116/2,115) of subjects treated with retapamulin ointment, 6.6% (54/819) of subjects receiving cephalexin, and 2.8% (2/71) of subjects receiving placebo. The most common drug-related adverse events (greater than or equal to 1% of subjects) were application site irritation (1.4%) in the retapamulin group, diarrhea (1.7%) in the cephalexin group, and application site pruritus (1.4%) and application site paresthesia (1.4%) in the placebo group.

Adults

The adverse events, regardless of attribution, reported in at least 1% of adults (aged 18 years and older) who received ALTABAX or comparator are presented in Table 1.

Table 1: Adverse Events Reported by ≥ 1% of Adult Subjects Treated with ALTABAX or Comparator in Phase 3 Clinical Trials

Adverse Event ALTABAX
N = 1,527
%
Cephalexin
N = 698
%
Headache 2.0 2.0
Application site irritation 1.6 < 1.0
Diarrhea 1.4 2.3
Nausea 1.2 1.9
Nasopharyngitis 1.2 < 1.0
Creatinine phosphokinase increased < 1.0 1.0

Pediatrics

The adverse events, regardless of attribution, reported in at least 1% of pediatric subjects aged 9 months to 17 years who received ALTABAX are presented in Table 2.

Table 2: Adverse Events Reported by ≥ 1% in Pediatric Subjects Aged 9 Months to 17 Years Treated with ALTABAX in Phase 3 Clinical Trials

Adverse Event ALTABAX
N = 588
%
Cephalexin
N = 121
%
Placebo
N = 64
%
Application site pruritus 1.9 0 0
Diarrhea 1.7 5.0 0
Nasopharyngitis 1.5 1.7 0
Pruritus 1.5 1.0 1.6
Eczema 1.0 0 0
Headache 1.2 1.7 0
Pyrexia 1.2 < 1.0 1.6

Other Adverse Events

Application site pain, erythema, and contact dermatitis were reported in less than 1% of subjects in clinical trials.

Postmarketing Experience

In addition to reports in clinical trials, the following events have been identified during postmarketing use of ALTABAX. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General Disorders And Administration Site Conditions

Application site burning.

Immune System Disorders

Hypersensitivity including angioedema.

Read the entire FDA prescribing information for Altabax (Retapamulin)

Related Resources for Altabax

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Read the Altabax User Reviews »

© Altabax Patient Information is supplied by Cerner Multum, Inc. and Altabax Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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