The following adverse reactions associated with the use of H.P. Acthar Gel have been identified from postmarketing experience with H.P. Acthar Gel. Only adverse events that are not listed above as adverse events reported from retrospective chart reviews and non-sponsor conducted clinical trials and those not discussed elsewhere in labeling, are listed in this section. Because the adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to use with H.P. Acthar Gel. Events are categorized by system organ class. Unless otherwise noted these adverse events have been reported in infants, children and adults.

Allergic responses have presented as dizziness, nausea and shock (adults only).

Necrotizing angitis (adults only) and congestive heart failure.

Skin thinning (adults only), facial erythema and increased sweating (adults only).

Decreased carbohydrate tolerance (infants only) and hirsutism.

Pancreatitis (adults only), abdominal distention and ulcerative esophagitis.

Hypokalemic alkalosis (infants only).

Muscle weakness and vertebral compression fractures (infants only).

Headache (adults only), vertigo (adults only), subdural hematoma, intracranial hemorrhage (adults only), and reversible brain shrinkage (usually secondary to hypertension) (infants only).

Based on steroidogenic effects of H.P. Acthar Gel certain adverse events may be expected due to the pharmacological effects of corticosteroids. The adverse events that may occur but have not been reported for H.P. Acthar Gel are:

Impaired wound healing, abscess, petechiae and ecchymoses, and suppression of skin test reactions.

Menstrual irregularities.

Negative nitrogen balance due to protein catabolism.

Loss of muscle mass and aseptic necrosis of femoral and humeral heads.

Increased intracranial pressure with papilledema, (pseudo-tumor cerebri) usually after treatment, and subdural effusion.

Exophthalmos.

Formal drug-drug interaction studies have not been performed.

H.P. Acthar Gel may accentuate the electrolyte loss associated with diuretic therapy.

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Pregnancy Class C: H.P. Acthar Gel has been shown to have an embryocidal effect. There are no adequate and well-controlled studies in pregnant women. H.P. Acthar Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from H.P. Acthar Gel, when treating a nursing mother, a decision should be made whether to discontinue nursing or to discontinue the drug, considering the risk and benefit to the mother.

H.P. Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age. Both serious and other adverse reactions in this population are discussed in Warnings and Adverse Reactions in Infants and Children Under 2 Years of Age [see Sections 5 and 6.1.1 ].

The efficacy of