Silvadene Side Effects

Generic Name: silver sulfadiazine topical

Note: This document contains side effect information about silver sulfadiazine topical. Some of the dosage forms listed on this page may not apply to the brand name Silvadene.

Some side effects of Silvadene 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

Along with its needed effects, silver sulfadiazine topical (the active ingredient contained in Silvadene) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking silver sulfadiazine topical:

Incidence not known
  • Back, leg, or stomach pains
  • blistering, peeling, or loosening of the skin
  • blue-green to black skin discoloration
  • dark urine
  • fever with or without chills
  • general body swelling
  • increased sensitivity of the skin to sunlight, especially in patients with burns on large areas
  • intense itching of burn wounds
  • light-colored stools
  • lower back or side pain
  • nausea or vomiting
  • pinpoint red spots on the skin
  • red skin lesions, often with a purple center
  • red, swollen skin
  • skin rash
  • sores, ulcers, or white spots in the mouth or on the lips
  • swollen or painful glands
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • yellow eyes and skin

Some side effects of silver sulfadiazine topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Brownish-gray skin discoloration
  • burning feeling on treated areas

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 (the active ingredient contained in Silvadene) 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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