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.
More about H.P. Acthar Gel (corticotropin)
- Check interactions
- Compare alternatives
- Reviews (4)
- Dosage information
- During pregnancy
- Drug class: corticotropin
- Breastfeeding
Patient resources
Professional resources
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Related treatment guides
References
1. Product Information. Acthar Gel, H.P. (corticotropin). Questcor Pharmaceuticals Inc. 2019.
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.