H.P. Acthar Gel Side Effects

Generic name: corticotropin

Medically reviewed by Drugs.com. Last updated on Mar 30, 2023.

Note: This document contains side effect information about corticotropin. Some dosage forms listed on this page may not apply to the brand name H.P. Acthar Gel.

Applies to corticotropin: parenteral solution for injection.

Side effects include:

Associated with long-term therapy: Bone loss, cataracts, indigestion, muscle weakness, back pain, bruising, acne, hyperpigmentation, menstrual irregularities, oral candidiasis. (See Warnings/Precautions under Cautions.)

For Healthcare Professionals

Applies to corticotropin: injectable powder for injection, injectable solution.

General

The more commonly reported adverse effects have included fluid retention, changes in glycemic control, increased appetite and weight gain; for children less than 2 years, increased risk of infections, hypertension, irritability, Cushingoid symptoms, cardiac hypertrophy, and weight gain have been reported.^[Ref]

Cardiovascular

The incidence of cardiac hypertrophy in patients less than 2 years treated for infantile spasm was 3% for patients receiving 75 units/m2 twice a day and 0% for those receiving 150 units/m2/day based on retrospective chart reviews and clinical trials. For hypertension, the incidence of was 11% for patients receiving 75 units/m2 twice a day and 19% for those receiving 150 units/m2/day.

Very Common (10% or more): Hypertension

Common (1% to 10%): Cardiac hypertrophy

Frequency not reported: Fluid retention

Postmarketing reports: Necrotizing angitis (adults only), congestive heart failure

Nervous system

In the treatment of infantile spasms, other types of seizures/convulsions may occur because some patients progress to other forms of seizures such as Lennox-Gastaut syndrome and because spasms may be masking other seizures. The incidence of seizure was 12% for patients receiving 75 units/m2 twice a day and 3% for those receiving 150 units/m2/day based on retrospective chart reviews and clinical trials.

Very Common (10% to more): Convulsions

Postmarketing reports: Headache (adults only), subdural hematoma, intracranial hemorrhage (adults only), reversible brain shrinkage (secondary to hypertension; infants only)

Psychiatric

Common (1% to 10%): Irritability

Frequency not reported: Behavioral and mood changes

Metabolic

Common (1% to 10%): Increased appetite, decreased appetite, weight gain

Frequency not reported: Alteration in glucose tolerance

Postmarketing reports: Hypokalemic alkalosis (infants only), decreased carbohydrate tolerance (infants only)

Dermatologic

The incidence of acne and rash in patients less than 2 years treated for infantile spasm was 0% for patients receiving 75 units/m2 twice a day and 12% and 8%, respectively for those receiving 150 units/m2/day based on retrospective chart reviews and clinical trials.

Very common (10% or more): Acne

Common (1% to 10%): Rash

Postmarketing reports: Skin thinning (adults only), facial erythema, increased sweating (adults only), hirsutism

Local

Postmarketing reports: Injection site reactions

Musculoskeletal

Postmarketing reports: Muscle weakness and vertebral compression fractures (infants only)

Endocrine

The incidence of Cushingoid in patients less than 2 years treated for infantile spasm was 3% for patients receiving 75 units/m2 twice a day and 22% for those receiving 150 units/m2/day based on retrospective chart reviews and clinical trials.

Common (1% to 10%): Cushingoid

Gastrointestinal

Very common (10% or more): Diarrhea

Common (1% to 10%): Constipation, diarrhea, vomiting

Postmarketing reports: Pancreatitis (adults only), abdominal distention, ulcerative esophagitis

Hypersensitivity

Postmarketing reports: Allergic responses presenting as dizziness, nausea, and shock (adults only)

Other

Very Common (10% or more): Infection

Common (1% or 10%): Pyrexia, candidiasis, otitis media, vertigo (adults only)

Respiratory

Common (1% or 10%): Nasal congestion, pneumonia, upper respiratory infections.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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