GRISEOFULVIN (griseofulvin, microsize)

There are 3 contraindications. Absolute contraindication.

Contraindication List
Hepatic failure
Porphyria
Pregnancy

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Disease of liver

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Alcohol use disorder
Granulocytopenic disorder
Lupus-like syndrome
Systemic lupus erythematosus

There are 16 severe adverse reactions.

More Frequent	Less Frequent
None.	Acute cognitive impairment Granulocytopenic disorder Hepatitis Leukopenia Oral candidiasis Peripheral neuropathy Skin photosensitivity Skin rash Urticaria

Rare/Very Rare
Abnormal hepatic function tests Angioedema Erythema multiforme Hyperbilirubinemia Lupus-like syndrome Stevens-johnson syndrome Toxic epidermal necrolysis

There are 9 less severe adverse reactions.

More Frequent	Less Frequent
Headache disorder	Diarrhea Dizziness Fatigue Gastrointestinal irritation Insomnia Nausea Proteinuria Vomiting

Rare/Very Rare
None.

Griseofulvin may cause fetal toxicity when administered to pregnant women. Griseofulvin is embryotoxic and/or teratogenic in animals. Fetal abnormalities have included multiple defects in rats; cleft palate in dogs; cleft palate and cardiac, CNS, and ocular defects in cats; and skeletal defects in mice.

Although the potential risk to the fetus of maternal use of griseofulvin remains to be clearly established in humans, at least two women who received griseofulvin therapy during the first trimester of pregnancy delivered conjoined twins, and some women who received the drug during pregnancy reportedly have had spontaneous abortions or delivered infants with other congenital malformations. In an analysis of spontaneous or threatened abortion diagnoses in one large group of women, the estimated relative risk of spontaneous abortion in women who received griseofulvin within the 3 months prior to such diagnoses was estimated to be increased 2.5 times.

Some experts state that while limited data indicate that the outcome for most pregnancies is likely to be normal after fetal exposure to the drug, evidence from the US Food and Drug Administration's teratogen information system indicates that an association between conjoined twins and griseofulvin use exists and data are insufficient to exclude a moderate association between use of the drug and other defects. However, other experts have questioned whether an association between use of the drug and conjoined twinning has been established. The manufacturers state that griseofulvin is contraindicated in women who are or may become pregnant.

One manufacturer states that additional contraceptive precautions should be taken during and for 1 month after griseofulvin therapy and that griseofulvin should not be used in any woman who intends to become pregnant within 1 month after therapy with the drug would be discontinued. If griseofulvin is inadvertently administered during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be informed of the potential hazard to the fetus.

No enhanced Lactation information available for this drug.

No enhanced Geriatric Use information available for this drug.