Altabax

Altabax

Altabax Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Altabax (retapamulin) is 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. It is a topical (for the skin) antibiotic. Common side effects include mild burning, stinging, or itching.

A thin layer of Altabax should be applied to the affected area (a dose of up to 100 cmē 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Altabax in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Altabax Overview - Patient Information: Side Effects

SIDE EFFECTS: Mild burning, stinging, or itching may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering/swelling/oozing skin.

Use of this medication for prolonged or repeated periods may result in a new infection (e.g., fungal infection). Contact your doctor if you notice signs of a new infection (e.g., new/worsening sores, fever).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Altabax (Retapamulin)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Altabax FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

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.

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.

Adults

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

Table 1: Adverse Events Reported by ≥ 1% of Adult Patients Treated With ALTABAX or Comparator 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 presented 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.

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) »

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Altabax - User Reviews

Altabax User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Altabax sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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