Silver Sulfadiazine Side Effects

Brand Names: Silvadene, Thermazene

Please note - some side effects for Silver Sulfadiazine 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 Silver Sulfadiazine - for the Consumer

Silver Sulfadiazine

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 Silver Sulfadiazine:

Burning; hives; itching; rash; redness; skin discoloration.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating.

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.

Side Effects by Body System - for Healthcare Professionals

Hematologic

Hematologic side effects have included several cases of transient leukopenia (<5000 WBC/mm^3). The incidence of leukopenia in various reports averages 20%. Hemolytic anemia has been reported in patients with glucose-6-phosphate deficiency.

The leukopenia associated with the use of silver sulfadiazine topical therapy is primarily characterized by decreased neutrophil count. Maximal white blood cell depression occurs within two to four days of initiation of therapy.

Renal

In patients with extensive burns, it is recommended that serum sulfonamide concentrations and renal function be monitored and that the urine be examined for sulfonamide crystals.

Renal side effects have rarely included interstitial nephritis. Sulfonamide crystals have been reported following the use of silver sulfadiazine topical on extensive areas of the body.

Dermatologic

Dermatologic side effects have rarely included skin necrosis, skin discoloration, rashes, erythema multiforme, and burning sensation.

General

High serum sulfadiazine levels, up to 12 mcg/mL, that approximate adult therapeutic levels have been observed when the drug has been applied to extensive areas of the body. Side effects associated with sulfonamides may occur, such as blood dyscrasias, including agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, and hemolytic anemia. Other side effects reported have included Stevens-Johnson syndrome, exfoliative dermatitis, gastrointestinal reactions, hepatitis, hepatocellular necrosis, CNS reactions, and toxic nephrosis.

Hypersensitivity

Hypersensitivity side effects have included kernicterus with the use of sulfonamides. The possibility of cross-hypersensitivity should be kept in mind.

Other

Other side effects have included changes in serum osmolality which can interfere with some laboratory test results. This is attributed to the amount of propylene glycol, an ingredient in the topical product, that may absorbed by the body following the use on extensive areas of the body.

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