H.P. Acthar Gel Side Effects

Generic name: corticotropin

Medically reviewed by Drugs.com. Last updated on Jun 3, 2024.

Note: This document provides detailed information about H.P. Acthar Gel.

Applies to corticotropin: parenteral solution for injection Side Effects associated with corticotropin. Some dosage forms listed on this page may not apply specifically 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, subcutaneous solution.

General adverse events

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

• 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

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.

Nervous system

• 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)

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.

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

• Very common (10% or more): Acne
• Common (1% to 10%): Rash
• Postmarketing reports: Skin thinning (adults only), facial erythema, increased sweating (adults only), hirsutism

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.

Local

• Postmarketing reports: Injection site reactions

Musculoskeletal

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

Endocrine

• Common (1% to 10%): Cushingoid

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.

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

H.P. Acthar Gel side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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