Silvadene Side Effects
Generic Name: silver sulfadiazine topical
Note: This page contains side effects data for the generic drug silver sulfadiazine topical. It is possible that some of the dosage forms included below may not apply to the brand name Silvadene.
For the Consumer
Applies to silver sulfadiazine topical: topical cream
As well as its needed effects, silver sulfadiazine topical (the active ingredient contained in Silvadene) may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking silver sulfadiazine topical, check with your doctor or nurse as soon as possible: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
Minor Side Effects
Some silver sulfadiazine topical side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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
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.[Ref]
Rare (less than 0.1%): Blood dyscrasias (including agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia)
Frequency not reported: Transient leukopenia (several cases)[Ref]
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.[Ref]
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])[Ref]
Rare (less than 0.1%): Interstitial nephritis, toxic nephrosis[Ref]
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.
Rare (less than 0.1%): Allergic reactions
Frequency not reported: Possibility of cross-hypersensitivity[Ref]
Rare (less than 0.1%): Hepatitis, hepatocellular necrosis[Ref]
Frequency not reported: Changes in serum osmolality that may affect laboratory test interpretation, increased possibility of kernicterus, delayed separation[Ref]
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.[Ref]
Rare (less than 0.1%): Burning sensation, CNS reactions
Rare (less than 0.1%): Gastrointestinal reactions
1. "Product Information. SSD (silver sulfADIAZINE topical)." Par Pharmaceutical Inc, Spring Valley, NY.
2. "Product Information. SSD AF (silver sulfADIAZINE topical)." Par Pharmaceutical Inc, Spring Valley, NY.
It is possible that some side effects of Silvadene may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
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