Vamorolone side effects: what 1,610 FDA adverse event reports show
Drug class
Corticosteroid
Brand names
Agamree
Who reports
1,610 reports · 25% serious · 26 with death outcome · 1% female
Used for
AGAMREE is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. AGAMREE is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. ( 1 )
What it is
AGAMREE (vamorolone) oral suspension contains vamorolone, a corticosteroid. Vamorolone [17α,21-dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione] is a white to off-white powder with a molecular formula of C 22 H 28 O 4 and a molecular weight of 356.46 g/mol.
Boxed warning
None in the current label
Causality screen of the 26 strongest signals
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.
- 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. 5 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Increased appetite | 62 | 43.1 33.7–55.0ROR 44.8 · χ² 2,501 / p <1e-300 | 42.4 EB05 34.3 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.1 · 100% consumer | no trial data cached |
| Gastroenteritis viral | 50 | 36.1 27.4–47.4ROR 37.2 · χ² 1,666 / p <1e-300 | 35.5 EB05 28.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 35.3 · 100% consumer | no trial data cached |
| Pharyngitis streptococcal | 18 | 21.7 13.7–34.3ROR 21.9 · χ² 334 / p 5e-75 | 21.2 EB05 14.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Product use complaint | 20 | 16.8 10.9–26.0ROR 17.0 · χ² 282 / p 1e-63 | 16.3 EB05 10.9 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=3 · 95% consumer | no trial data cached |
| Emotional disorder | 39 | 16.4 12.0–22.4ROR 16.8 · χ² 549 / p 1e-121 | 16.2 EB05 12.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · 100% consumer | no trial data cached |
| Anger | 40 | 15.4 11.3–20.9ROR 15.7 · χ² 523 / p 5e-116 | 15.1 EB05 11.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 98% consumer | no trial data cached |
| Weight increased (weight gain) | 254 | 14.9 13.3–16.6ROR 17.5 · χ² 3,302 / p <1e-300 | 14.8 EB05 13.4 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.7 · 94% consumer | no trial data cached |
| Ear infection | 23 | 11.3 7.5–16.9ROR 11.4 · χ² 206 / p 6e-47 | 10.5 EB05 7.0 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | 100% consumer | no trial data cached |
| Abnormal behaviour | 34 | 11.1 8.0–15.5ROR 11.3 · χ² 303 / p 3e-68 | 10.6 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · 85% consumer | no trial data cached |
| Mood altered | 23 | 11.0 7.3–16.6ROR 11.2 · χ² 200 / p 1e-45 | 10.2 EB05 6.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 · 96% consumer | no trial data cached |
| Adrenal insufficiency | 10 | 10.9 5.9–20.2ROR 10.9 · χ² 80 / p 2e-19 | 8.8 EB05 4.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.8 | no trial data cached |
| Aggression | 38 | 9.9 7.2–13.5ROR 10.1 · χ² 295 / p 2e-66 | 9.3 EB05 7.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 · 100% consumer | no trial data cached |
| Seasonal allergy | 10 | 9.2 5.0–17.1ROR 9.3 · χ² 65 / p 3e-16 | 7.2 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Psychomotor hyperactivity | 11 | 8.6 4.8–15.5ROR 8.7 · χ² 66 / p 2e-16 | 6.9 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Mood swings | 20 | 8.2 5.3–12.6ROR 8.3 · χ² 119 / p 6e-28 | 7.2 EB05 4.8 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 · 100% consumer | no trial data cached |
| Blood triglycerides increased | 11 | 8.1 4.5–14.6ROR 8.1 · χ² 61 / p 2e-15 | 6.4 EB05 3.7 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 2.7 | no trial data cached |
| Influenza | 67 | 7.8 6.2–9.9ROR 8.1 · χ² 393 / p 1e-87 | 7.5 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · 100% consumer | no trial data cached |
| Irritability | 31 | 6.7 4.7–9.5ROR 6.8 · χ² 145 / p 1e-33 | 6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | 100% consumer | no trial data cached |
| Blood creatine phosphokinase increased | 15 | 6.7 4.0–11.1ROR 6.7 · χ² 67 / p 1e-16 | 5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 5.8 | no trial data cached |
| Viral infection | 17 | 6.7 4.2–10.7ROR 6.7 · χ² 76 / p 1e-18 | 5.8 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 | no trial data cached |
| Upper limb fracture | 10 | 6.5 3.5–12.1ROR 6.5 · χ² 41 / p 7e-11 | 5.2 EB05 3.0 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.5 | no trial data cached |
| Pollakiuria (frequent urination) | 20 | 6.3 4.0–9.7ROR 6.3 · χ² 83 / p 4e-20 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | 85% consumer | no trial data cached |
| Crying | 15 | 5.4 3.2–8.9ROR 5.4 · χ² 49 / p 1e-12 | 4.7 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 1.4 | no trial data cached |
| Product dose omission issue | 109 | 5.0 4.2–6.0ROR 5.3 · χ² 348 / p 5e-78 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 17.0 · 99% consumer | no trial data cached |
| Femur fracture | 11 | 4.6 2.6–8.3ROR 4.6 · χ² 28 / p 7e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.9 | no trial data cached |
| Disease progression | 41 | 4.5 3.3–6.1ROR 4.6 · χ² 110 / p 5e-26 | 4.3 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 12.0 · 100% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Weight increased (weight gain) | 254 | 14.9 13.3–16.6ROR 17.5 · χ² 3,302 / p <1e-300 | 14.8 EB05 13.4 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.7 · 94% consumer | no trial data cached |
| Product dose omission issue | 109 | 5.0 4.2–6.0ROR 5.3 · χ² 348 / p 5e-78 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 17.0 · 99% consumer | no trial data cached |
| Influenza | 67 | 7.8 6.2–9.9ROR 8.1 · χ² 393 / p 1e-87 | 7.5 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · 100% consumer | no trial data cached |
| Increased appetite | 62 | 43.1 33.7–55.0ROR 44.8 · χ² 2,501 / p <1e-300 | 42.4 EB05 34.3 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.1 · 100% consumer | no trial data cached |
| Gastroenteritis viral | 50 | 36.1 27.4–47.4ROR 37.2 · χ² 1,666 / p <1e-300 | 35.5 EB05 28.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 35.3 · 100% consumer | no trial data cached |
| Disease progression | 41 | 4.5 3.3–6.1ROR 4.6 · χ² 110 / p 5e-26 | 4.3 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 12.0 · 100% consumer | no trial data cached |
| Anger | 40 | 15.4 11.3–20.9ROR 15.7 · χ² 523 / p 5e-116 | 15.1 EB05 11.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 98% consumer | no trial data cached |
| Emotional disorder | 39 | 16.4 12.0–22.4ROR 16.8 · χ² 549 / p 1e-121 | 16.2 EB05 12.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · 100% consumer | no trial data cached |
| Aggression | 38 | 9.9 7.2–13.5ROR 10.1 · χ² 295 / p 2e-66 | 9.3 EB05 7.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 · 100% consumer | no trial data cached |
| Abnormal behaviour | 34 | 11.1 8.0–15.5ROR 11.3 · χ² 303 / p 3e-68 | 10.6 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · 85% consumer | no trial data cached |
| Irritability | 31 | 6.7 4.7–9.5ROR 6.8 · χ² 145 / p 1e-33 | 6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | 100% consumer | no trial data cached |
| Mood altered | 23 | 11.0 7.3–16.6ROR 11.2 · χ² 200 / p 1e-45 | 10.2 EB05 6.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 · 96% consumer | no trial data cached |
| Ear infection | 23 | 11.3 7.5–16.9ROR 11.4 · χ² 206 / p 6e-47 | 10.5 EB05 7.0 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | 100% consumer | no trial data cached |
| Pollakiuria (frequent urination) | 20 | 6.3 4.0–9.7ROR 6.3 · χ² 83 / p 4e-20 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | 85% consumer | no trial data cached |
| Mood swings | 20 | 8.2 5.3–12.6ROR 8.3 · χ² 119 / p 6e-28 | 7.2 EB05 4.8 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 · 100% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Gastroenteritis viral — n=50, PRR 36.1
- Emotional disorder — n=39, PRR 16.4
- Anger — n=40, PRR 15.4
- Abnormal behaviour — n=34, PRR 11.1
- Influenza — n=67, PRR 7.8
- Pollakiuria — n=20, PRR 6.3
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 Vamorolone?
In FDA FAERS, the most frequently co-reported reaction terms for Vamorolone are weight increased, influenza, increased appetite, gastroenteritis viral, anger, emotional disorder. 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 Vamorolone have an FDA boxed warning?
No. The FDA label retrieved for Vamorolone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Vamorolone 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 fb376f09-cf9c-42b5-b4dd-02d5bcd73211, effective 20260122; matched on
openfda.generic_name.exact:"VAMOROLONE") - 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, 31 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.