Altabax Side Effects

Please note - some side effects for Altabax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Altabax - for the Consumer

Altabax Ointment

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 Altabax Ointment:

Mild redness or irritation at the application site.

Seek medical attention right away if any of these SEVERE side effects occur when using Altabax Ointment:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering, burning, itching, oozing, swelling, or severe irritation or redness at the application site.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Altabax Side Effects - for the Professional

Altabax

Clinical Studies Experience

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

Adverse events rated by investigators as drug-related occurred in 5.5% (116/2,115) of patients treated with retapamulin ointment, 6.6% (54/819) of patients receiving cephalexin, and 2.8% (2/71) of patients receiving placebo. The most common drug-related adverse events (≥1% of patients) 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.

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

Adults

The adverse events, regardless of attribution, reported in at least 1% of adults (18 years of age and older) who received Altabax are listed in Table 1.

Table 1. Adverse Events Reported by ≥1% of Adult Patients Treated With Altabax in Phase 3 Clinical Studies

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 patients aged 9 months to 17 years who received Altabax are listed in Table 2.

Table 2. Adverse Events Reported by ≥1% in Pediatric Patients Aged 9 Months to 17 Years Treated With Altabax in Phase 3 Clinical Studies

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 patients in clinical studies.

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Side Effects by Body System - for Healthcare Professionals

Dermatologic

Dermatologic side effects have included application site irritation (1.6%), pruritus (1.9%), and eczema (1%). Dermatologic side effects that have been reported in less than 1% of patients include application site pain, erythema, and contact dermatitis.

Other

Other side effects have included headache (1% to 2%) and pyrexia (1.2%).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (1.7%) and nausea (1.2%).

Respiratory

Respiratory side effects have included nasopharyngitis (1.5%).

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