What the label lists and what reports show
Corticotropin side effects
Corticotropin's FDA label: “The most common adverse reactions (5% or greater in the recommended twice daily dosing group) for the treatment of infantile spasms are increased risk of infections, convulsions, hypertension, irritability, and pyrexia.” FAERS holds 2,727 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (249 reports).
- No generic listed
Check it at the source: the corticotropin FDA label on DailyMed (effective July 15, 2026, Mallinckrodt ARD LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Acthar Gel?Acthar Gel can cause serious side effects. See " What is the most important information I should know about Acthar Gel. " Acthar Gel may make certain other medical conditions worse, such as diabetes (may increase blood sugar). Eye problems. Your child can get cataracts, increased pressure in the eye (glaucoma), and possible damage to the optic nerve if treated with Acthar Gel for a long time. Allergic reactions to Acthar Gel. Your child may have an allergic reaction to Acthar Gel. Allergic reactions may not happen until your child has received several injections of Acthar Gel. Tell your doctor right away if your child has any of the following signs of an allergic reaction: skin rash swelling of the face, tongue, lips, or throat trouble breathing Changes in growth and physical development. Acthar Gel may affect your child's growth and physical development and may weaken his or her bones. […]
Source: FDA drug label, Mallinckrodt ARD LLC, effective July 15, 2026 (SPL set 7b48ddec-e815-45f4-9ca0-5c0daaf56f30), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (5% or greater in the recommended twice daily dosing group) for the treatment of infantile spasms are increased risk of infections, convulsions, hypertension, irritability, and pyrexia.
TABLE: Incidence (%) of Adverse Reactions Occurring in ≥2% of Infants and Children Under 2 Years of Age Treated with Acthar Gel
| Adverse Reactions | Recommended 75 U/m 2 twice daily n=122, (%) | 150 U/m 2 once daily n=37 (%) |
|---|---|---|
| Cardiac Hypertrophy | 3 | 0 |
| Cushingoid | 3 | 22 |
| Diarrhea | 3 | 14 |
| Vomiting | 3 | 5 |
| Constipation | 0 | 5 |
| Irritability | 7 | 19 |
| Pyrexia | 5 | 8 |
| Infection Specific infections that occurred at ≥2% were candidiasis, otitis media,… | 20 | 46 |
| Weight gain | 1 | 3 |
| Increased appetite | 0 | 5 |
| Decreased appetite | 3 | 3 |
| Convulsion In the treatment of infantile spasms, other types of seizures/convulsions may… | 12 | 3 |
| Nasal Congestion | 1 | 5 |
| Acne | 0 | 14 |
| Rash | 0 | 8 |
| Hypertension | 11 | 19 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Infections [see Warnings and Precautions (5.1) ] Cushing's Syndrome and Adrenal Insufficiency Upon Withdrawal [see Warnings and Precautions (5.2) ] Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia [see Warnings and Precautions (5.3) ] Masking Symptoms of Other Diseases [see Warnings and Precautions (5.5) ] Gastrointestinal Perforation and Bleeding [see Warnings and Precautions (5.6) ] Behavioral and Mood Disturbances [see Warnings and Precautions (5.7) ] Ophthalmic Effects [see Warnings and Precautions (5.9) ] Immunogenicity Potential [see Warnings and Precautions (5.10) ] Negative Effects on Growth and Physical Development [see Warnings and Precautions (5.12) ] Decrease in Bone Density [see Warnings and Precautions (5.13) ] Commonly reported postmarketing adverse reactions for Acthar Gel include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased. ( 6.2 ) The most common adverse reactions (5% or greater in the recommended twice daily dosing group) for the treatment of infantile spasms are increased risk of infections, convulsions, hypertension, irritability, and pyrexia.
Source: FDA drug label, Mallinckrodt ARD LLC, effective July 15, 2026 (SPL set 7b48ddec-e815-45f4-9ca0-5c0daaf56f30), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,727 reports list corticotropin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 46 are coded as a death and 373 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Corticotropin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions