Drug · FAERS side-effect profile with label screen
Repository Corticotropin side effects: what 2,726 FDA adverse event reports show
Drug class
Adrenocorticotropic Hormone
FDA label (Established Pharmacologic Class)
Brand names
Acthar
openFDA label
Who reports
2,726 reports · 41% serious · 46 with death outcome · 71% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age. ( 1.1 ) Acthar Gel is indicated for the treatment of exacerbations of multiple sclerosis in adults. ( 1.2 ) Acthar Gel may be use.
FDA label, Indications and Usage
What it is
Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. The Acthar Gel manufacturing process converts the initial porcine pituita.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 8Labeled (related wording) 15Likely indication confounding 6Reporting / coding artifact 6Lab value / disease marker 2Not in label — unassessed 3
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 44 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Injection site discolouration | 49 | 30.5 23.1–40.3ROR 31.0 · χ² 1,364 / p 6e-299 | 30.1 EB05 23.6 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=14 · 100% consumer | no trial data cached |
| Injection site bruising | 208 | 20.3 17.8–23.2ROR 21.9 · χ² 3,809 / p <1e-300 | 20.3 EB05 18.0 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 41.8 · 98% consumer | no trial data cached |
| Brain fog | 27 | 14.3 9.8–20.8ROR 14.4 · χ² 319 / p 1e-71 | 13.8 EB05 9.7 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.3 · ♀ 100% (drug 71%) · 93% consumer | no trial data cached |
| Fluid retention | 83 | 12.6 10.2–15.5ROR 12.9 · χ² 873 / p 3e-192 | 12.4 EB05 10.3 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · 91% consumer | no trial data cached |
| Increased appetite | 25 | 10.2 6.9–15.1ROR 10.3 · χ² 199 / p 2e-45 | 9.4 EB05 6.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 100% consumer | no trial data cached |
| Increased tendency to bruise | 12 | 10.0 5.7–17.6ROR 10.1 · χ² 89 / p 2e-21 | 8.3 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Multiple sclerosis relapse | 88 | 9.8 8.0–12.0ROR 10.1 · χ² 688 / p 6e-152 | 9.6 EB05 8.0 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 15.3 · 70% consumer | no trial data cached |
| Injection site pruritus | 79 | 9.1 7.4–11.4ROR 9.4 · χ² 565 / p 3e-125 | 8.9 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.7 · 89% consumer | no trial data cached |
| Injection site mass | 39 | 8.1 6.0–11.1ROR 8.2 · χ² 237 / p 7e-54 | 7.6 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.6 · 92% consumer | no trial data cached |
| Systemic lupus erythematosus | 31 | 6.7 4.8–9.6ROR 6.8 · χ² 146 / p 6e-34 | 6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 9.8 · ♀ 97% (drug 71%) · 97% consumer | no trial data cached |
| Injection site haemorrhage | 67 | 6.5 5.1–8.2ROR 6.6 · χ² 307 / p 5e-69 | 6.2 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.4 · 99% consumer | no trial data cached |
| Swelling | 75 | 6.2 4.9–7.7ROR 6.3 · χ² 322 / p 3e-72 | 6.0 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 76% consumer | no trial data cached |
| Seasonal allergy | 10 | 5.4 2.9–10.1ROR 5.5 · χ² 32 / p 8e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=5 | no trial data cached |
| Injection site urticaria | 17 | 5.4 3.4–8.7ROR 5.4 · χ² 57 / p 3e-14 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious n=3 | no trial data cached |
| Feeling jittery | 13 | 5.2 3.0–9.0ROR 5.3 · χ² 40 / p 1e-10 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Peripheral swelling | 104 | 5.2 4.3–6.3ROR 5.4 · χ² 352 / p 6e-79 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 · 88% consumer | no trial data cached |
| Contraindicated product administered | 20 | 5.1 3.3–7.9ROR 5.1 · χ² 62 / p 2e-15 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 · ♀ 100% (drug 71%) · 95% consumer | no trial data cached |
| Injection site swelling | 50 | 5.1 3.9–6.7ROR 5.2 · χ² 160 / p 5e-37 | 4.9 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.4 · 96% consumer | no trial data cached |
| Blood pressure abnormal | 13 | 5.0 2.9–8.7ROR 5.1 · χ² 38 / p 3e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 4.0 | no trial data cached |
| Swelling face | 42 | 5.0 3.7–6.7ROR 5.0 · χ² 130 / p 3e-30 | 4.7 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 · 80% consumer | no trial data cached |
| Injection site rash | 19 | 4.8 3.1–7.5ROR 4.8 · χ² 54 / p 1e-13 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious n=3 | no trial data cached |
| Illness | 62 | 4.7 3.7–6.1ROR 4.8 · χ² 180 / p 2e-41 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 · 90% consumer | no trial data cached |
| Product dose omission in error | 16 | 4.6 2.8–7.5ROR 4.6 · χ² 41 / p 6e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 | no trial data cached |
| Limb discomfort | 18 | 4.5 2.8–7.1ROR 4.5 · χ² 45 / p 9e-12 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Insomnia (trouble sleeping) | 151 | 4.4 3.7–5.1ROR 4.6 · χ² 392 / p 2e-87 | 4.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 91% consumer | no trial data cached |
| Injection site pain (pain where injected) | 171 | 4.3 3.7–5.0ROR 4.6 · χ² 441 / p 3e-98 | 4.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.8 · 96% consumer | no trial data cached |
| Product dose omission issue | 160 | 4.3 3.7–5.0ROR 4.5 · χ² 411 / p 1e-91 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 · 96% consumer | no trial data cached |
| Blood glucose increased | 103 | 4.2 3.5–5.1ROR 4.3 · χ² 249 / p 2e-56 | 4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 · 82% consumer | no trial data cached |
| Blood glucose abnormal | 10 | 4.2 2.2–7.7ROR 4.2 · χ² 21 / p 2e-6 | 3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree | Lab value / disease marker | serious PRR 3.8 | no trial data cached |
| Weight increased (weight gain) | 120 | 4.1 3.5–4.9ROR 4.3 · χ² 286 / p 2e-64 | 4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 · 92% consumer | no trial data cached |
| Injection site warmth | 11 | 4.1 2.3–7.4ROR 4.1 · χ² 23 / p 9e-7 | 3.6 EB05 2.2 · IC025 +0.8 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Eye pain | 29 | 4.0 2.8–5.8ROR 4.1 · χ² 63 / p 8e-16 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 · 76% consumer | no trial data cached |
| Rheumatoid arthritis | 56 | 3.8 2.9–4.9ROR 3.9 · χ² 114 / p 7e-27 | 3.7 EB05 3.0 · IC025 +1.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 6.5 · 89% consumer | no trial data cached |
| Injection site erythema (redness where injected) | 61 | 3.8 3.0–4.9ROR 3.9 · χ² 124 / p 5e-29 | 3.7 EB05 3.0 · IC025 +1.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.7 · 89% consumer | no trial data cached |
| Irritability | 29 | 3.7 2.6–5.3ROR 3.7 · χ² 55 / p 7e-14 | 3.5 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · 79% consumer | no trial data cached |
| Laboratory test abnormal | 14 | 3.7 2.2–6.2ROR 3.7 · χ² 24 / p 4e-7 | 3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 | no trial data cached |
| Mood swings | 15 | 3.6 2.2–6.0ROR 3.6 · χ² 26 / p 2e-7 | 3.3 EB05 2.1 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Blood pressure increased | 72 | 3.6 2.9–4.5ROR 3.7 · χ² 134 / p 2e-31 | 3.5 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 · 83% consumer | no trial data cached |
| Inappropriate schedule of product administration | 79 | 3.4 2.8–4.3ROR 3.5 · χ² 135 / p 2e-31 | 3.4 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 97% consumer | no trial data cached |
| Multiple sclerosis | 21 | 3.4 2.2–5.1ROR 3.4 · χ² 33 / p 6e-9 | 3.2 EB05 2.2 · IC025 +0.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.8 · 71% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Injection site bruising | 208 | 20.3 17.8–23.2ROR 21.9 · χ² 3,809 / p <1e-300 | 20.3 EB05 18.0 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 41.8 · 98% consumer | no trial data cached |
| Injection site pain (pain where injected) | 171 | 4.3 3.7–5.0ROR 4.6 · χ² 441 / p 3e-98 | 4.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.8 · 96% consumer | no trial data cached |
| Product dose omission issue | 160 | 4.3 3.7–5.0ROR 4.5 · χ² 411 / p 1e-91 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 · 96% consumer | no trial data cached |
| Insomnia (trouble sleeping) | 151 | 4.4 3.7–5.1ROR 4.6 · χ² 392 / p 2e-87 | 4.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 91% consumer | no trial data cached |
| Weight increased (weight gain) | 120 | 4.1 3.5–4.9ROR 4.3 · χ² 286 / p 2e-64 | 4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 · 92% consumer | no trial data cached |
| Peripheral swelling | 104 | 5.2 4.3–6.3ROR 5.4 · χ² 352 / p 6e-79 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 · 88% consumer | no trial data cached |
| Blood glucose increased | 103 | 4.2 3.5–5.1ROR 4.3 · χ² 249 / p 2e-56 | 4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 · 82% consumer | no trial data cached |
| Multiple sclerosis relapse | 88 | 9.8 8.0–12.0ROR 10.1 · χ² 688 / p 6e-152 | 9.6 EB05 8.0 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 15.3 · 70% consumer | no trial data cached |
| Fluid retention | 83 | 12.6 10.2–15.5ROR 12.9 · χ² 873 / p 3e-192 | 12.4 EB05 10.3 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · 91% consumer | no trial data cached |
| Inappropriate schedule of product administration | 79 | 3.4 2.8–4.3ROR 3.5 · χ² 135 / p 2e-31 | 3.4 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 97% consumer | no trial data cached |
| Injection site pruritus | 79 | 9.1 7.4–11.4ROR 9.4 · χ² 565 / p 3e-125 | 8.9 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.7 · 89% consumer | no trial data cached |
| Swelling | 75 | 6.2 4.9–7.7ROR 6.3 · χ² 322 / p 3e-72 | 6.0 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 76% consumer | no trial data cached |
| Blood pressure increased | 72 | 3.6 2.9–4.5ROR 3.7 · χ² 134 / p 2e-31 | 3.5 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 · 83% consumer | no trial data cached |
| Injection site haemorrhage | 67 | 6.5 5.1–8.2ROR 6.6 · χ² 307 / p 5e-69 | 6.2 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.4 · 99% consumer | no trial data cached |
| Illness | 62 | 4.7 3.7–6.1ROR 4.8 · χ² 180 / p 2e-41 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 · 90% consumer | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Repository Corticotropin?
In FDA FAERS, the most frequently co-reported reaction terms for Repository Corticotropin are injection site bruising, injection site pain, insomnia, weight increased, peripheral swelling, blood glucose increased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Repository Corticotropin have an FDA boxed warning?
No. The FDA label retrieved for Repository Corticotropin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Repository Corticotropin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 7b48ddec-e815-45f4-9ca0-5c0daaf56f30, effective 20260715; matched on
openfda.generic_name.exact:"REPOSITORY CORTICOTROPIN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 84 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.