July 30, 2016


Sulfamylon Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/3/2016

Sulfamylon (mafenide acetate) is a topical (for the skin) antibiotic used to prevent infection in severe burn wounds. Common side effects of Sulfamylon include skin rash, redness, or itching, or pain, burning, or redness of the treated skin areas.

Clean the affected area, and apply a dose of Sulfamylon to the wound while wearing a clean pair of medical gloves (e.g., latex, vinyl), once or twice daily or as directed by your doctor. The layer of cream should be about one-sixteenth of an inch (1 to 2 millimeters) thick. Cover the wound with this medication at all times. If the cream rubs off the wound, re-apply it immediately. Length of treatment is based on the patient's medical condition and response to treatment. It is not likely that other drugs you take orally or inject will have an effect on topically applied Sulfamylon. But many drugs can interact with each other. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Sulfamylon should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Sulfamylon (mafenide acetate) 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.

Sulfamylon 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.

Tell your caregivers right away if you have a serious side effect such as:

  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • chest pain, fast or pounding heartbeats, headache, confusion;
  • nausea, vomiting, stomach pain, appetite changes, muscle weakness, bone pain, and weight loss;
  • rapid breathing, gasping, or feeling short of breath; or
  • severe skin rash, bruising, severe tingling, numbness, or pain.

Less serious side effects may include:

  • mild skin rash, redness, or itching; or
  • pain or burning of treated skin areas.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sulfamylon (Mafenide Acetate)

What is Patient Information Overview?

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

Sulfamylon Overview - Patient Information: Side Effects

SIDE EFFECTS: Pain, burning, or redness 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: blisters, fast breathing, nausea, vomiting, diarrhea, headache, change in alertness, shaking (tremors), seizures.

Tell your doctor immediately if any of these rare but very serious side effects occur: weakness, dark urine, stomach/abdominal pain, arm/leg/back pain, fast heartbeat.

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 Sulfamylon (Mafenide Acetate)

What is Prescribing information?

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

Sulfamylon FDA Prescribing Information: Side Effects
(Adverse Reactions)


In the clinical setting of severe bums, it is often difficult to distinguish between an adverse reaction to mafenide acetate and bum sequelae. In a clinical study of pediatric patients with acute bums requiring autografts who received SULFAMYLON® (mafenide acetate) 5% SOLUTION in addition to double antibiotic solution (DAB) wound therapy (neomycin sulfate 40 mg and polymyxin B 200,000 units/liter), the incidence of rash (4.6%) and itching (2.8%) in the group which received SULFAMYLON® (mafenide acetate) 5% Solution was not different from that experienced with (DAB) dressings alone (5.7% and 1.3%, respectively).

From other clinical settings, a single case of bone marrow depression and a single case of an acute attack of porphyria have been reported following therapy with mafenide acetate. Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with mafenide acetate. The following adverse reactions have been reported with topical mafenide acetate therapy:

Dermatologlc and Allergic: Pain or burning sensation, rash and pruritus (often localized to the area covered by the wound dressing), erythema, skin maceration from prolonged wet dressings, facial edema, swelling, hives, blisters, eosinophilia.

Respiratory or Metabolic: Tachypnea, hyperventilation, decrease in pCOa, metabolic acidosis, increase in serum chloride.

Read the entire FDA prescribing information for Sulfamylon (Mafenide Acetate)

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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