Silver sulfadiazine topical Side Effects

Some side effects of silver sulfadiazine topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to silver sulfadiazine topical: topical cream

Get emergency medical help if you have any of these signs of an allergic reaction while taking silver sulfadiazine topical: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• fever, chills, body aches, flu symptoms;

• easy bruising or bleeding, unusual weakness;

• pale or yellowed skin, dark colored urine;

• ulcers on treated skin areas;

• blood in your urine;

• urinating less than usual or not at all;

• drowsiness, confusion, mood changes, nausea and vomiting;

• swelling, weight gain; or

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects of silver sulfadiazine topical may include:

• brown or gray discoloration of treated skin;

• mild itching or burning; or

• upset stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to silver sulfadiazine topical: compounding powder, topical cream

General

The serum sulfa levels have approached adult therapeutic levels (8 mg% to 12 mg%) when the drug was used on extensive areas of the body. Although rare, side effects associated with sulfonamides may occur, such as blood dyscrasias (including agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, and hemolytic anemia), dermatologic and allergic reactions (including life-threatening cutaneous reactions [Stevens-Johnson syndrome, toxic epidermal necrolysis, and exfoliative dermatitis]), gastrointestinal reactions, hepatitis, hepatocellular necrosis, CNS reactions, and toxic nephrosis.

Hematologic

Leukopenia associated with silver sulfadiazine topical was primarily characterized by decreased neutrophil count. Maximal white blood cell depression occurred within 2 to 4 days of starting therapy. Rebound to normal leukocyte levels followed onset within 2 to 3 days. Recovery was not affected by continuation of silver sulfadiazine topical.

Hemolytic anemia has been reported in patients with glucose-6-phosphate deficiency.

Rare (less than 0.1%): Blood dyscrasias (including agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia)
Frequency not reported: Transient leukopenia (several cases)

Dermatologic

Rare (less than 0.1%): Skin necrosis, erythema multiforme, skin discoloration, rashes, dermatologic reactions (including life-threatening cutaneous reactions [Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis])

Renal

Rare (less than 0.1%): Interstitial nephritis, toxic nephrosis

Genitourinary

Rare (less than 0.1%): Sulfa crystals in urine

Sulfa crystals have been reported following the use of silver sulfadiazine topical on extensive areas of the body.

Hypersensitivity

Rare (less than 0.1%): Allergic reactions
Frequency not reported: Possibility of cross-hypersensitivity

Hepatic

Rare (less than 0.1%): Hepatitis, hepatocellular necrosis

Other

Changes in serum osmolality (which can interfere with some laboratory test results) have been reported. This was attributed to the amount of propylene glycol vehicle absorbed following use on extensive areas of the body.

Reduction in bacterial growth after use of topical antibacterial agents has been reported to permit spontaneous healing of deep partial-thickness burns by preventing conversion of the partial thickness to full thickness by sepsis. However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.

Frequency not reported: Changes in serum osmolality that may affect laboratory test interpretation, increased possibility of kernicterus, delayed separation

Nervous system

Rare (less than 0.1%): Burning sensation, CNS reactions

Gastrointestinal

Rare (less than 0.1%): Gastrointestinal reactions

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