Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS It is frequently difficult to distinguish between an adverse reaction to SULFAMYLON Cream and the effect of a severe burn.
A single case of bone marrow depression and a single case of acute attack of porphyria have been reported following therapy with SULFAMYLON Cream.
Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with SULFAMYLON Cream.
Dermatologic: The most frequently reported reaction was pain on application or a burning sensation.
Rare occurrences are excoriation of new skin and bleeding of skin.
Allergic: Rash itching, facial edema, swelling, hive, blisters, erythema, and eosinophilia.
Respiratory: Tachypnea or hyperventilation, decrease in arterial pCO 2 .
Metabolic: Acidosis, increase in serum chloride.
Accidental ingestion of SULFAMYLON Cream has been reported to cause diarrhea.
To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc.
WARNINGS Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with SULFAMYLON Cream.
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.
Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Like all medications, Sulfamylon can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: