Drug · FAERS side-effect profile with label screen
Methylprednisolone side effects: what 137,404 FDA adverse event reports show
Who reports
137,404 reports · 90% serious · 23,035 with death outcome · 57% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Methylprednisolone Tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).
FDA label, Indications and Usage
What it is
6alpha-methylprednisolone is the 6alpha-stereoisomer of 6-methylprednisolone. It has a role as an anti-inflammatory drug, a xenobiotic, an adrenergic agent, an antiemetic, a neuroprotective agent and an environmental contaminant.
PubChem CID 6741 (ChEBI)
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 (related wording) 3Likely indication confounding 4Lab value / disease marker 9Not in label — unassessed 24
What the badges mean
- 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.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,228 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 |
|---|---|---|---|---|---|---|
| Blood pressure diastolic abnormal | 1,504 | 217.8 201.2–235.7ROR 220.2 · calibrated p 2e-10 ✓ | 89.2 EB05 85.5 · IC025 +6.4 3/3 methods agree vs other Corticosteroids: PRR 46.8 (44.0–49.9) | Lab value / disease marker | serious n=1,474 · 92% clinician | no trial arm names this drug |
| Blood pressure systolic abnormal | 1,387 | 193.7 178.9–209.8ROR 195.7 · calibrated p 5e-10 ✓ | 84.9 EB05 81.2 · IC025 +6.3 3/3 methods agree vs other Corticosteroids: PRR 48.3 (45.2–51.6) | Lab value / disease marker | serious n=1,354 · 91% clinician | no trial arm names this drug |
| Vaginal flatulence | 134 | 119.3 95.1–149.7ROR 119.4 · calibrated p 4e-8 ✓ | 66.2 EB05 57.3 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 5.4 (4.6–6.5) | Not in label — unassessed | serious n=134 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Neurologic neglect syndrome | 183 | 74.0 62.0–88.3ROR 74.1 · calibrated p 1e-6 ✓ | 49.6 EB05 43.8 · IC025 +5.2 3/3 methods agree vs other Corticosteroids: PRR 45.7 (38.1–54.9) | Not in label — unassessed | serious n=183 · ♀ 100% (drug 57%) · 100% clinician | no trial arm names this drug |
| Urine leukocyte esterase positive | 214 | 66.0 56.2–77.5ROR 66.1 · calibrated p 2e-6 ✓ | 45.9 EB05 41.0 · IC025 +5.2 3/3 methods agree vs other Corticosteroids: PRR 181.5 (142.1–231.9) | Lab value / disease marker | serious n=207 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody | 197 | 63.8 54.0–75.4ROR 63.9 · calibrated p 3e-6 ✓ | 44.8 EB05 39.8 · IC025 +5.1 3/3 methods agree vs other Corticosteroids: PRR 3.4 (2.9–3.9) | Lab value / disease marker | serious n=197 · ♀ 100% (drug 57%) · 100% clinician | no trial arm names this drug |
| Mycobacterium chelonae infection | 215 | 62.8 53.6–73.7ROR 62.9 · calibrated p 3e-6 ✓ | 44.4 EB05 39.6 · IC025 +5.1 3/3 methods agree vs other Corticosteroids: PRR 7.3 (6.4–8.4) | Not in label — unassessed | serious n=215 | no trial arm names this drug |
| Delayed graft function | 198 | 59.2 50.3–69.8ROR 59.3 · calibrated p 5e-6 ✓ | 42.6 EB05 37.8 · IC025 +5.0 3/3 methods agree vs other Corticosteroids: PRR 38.0 (32.1–45.1) | Not in label — unassessed | serious n=198 · 100% clinician | no trial arm names this drug |
| Lupus vulgaris | 331 | 58.7 51.7–66.6ROR 58.8 · calibrated p 5e-6 ✓ | 42.3 EB05 38.6 · IC025 +5.1 3/3 methods agree vs other Corticosteroids: PRR 3.3 (3.0–3.7) | Not in label — unassessed | serious n=331 · ♀ 100% (drug 57%) · 100% clinician | no trial arm names this drug |
| Urinary sediment present | 170 | 54.9 46.1–65.5ROR 55.0 · calibrated p 9e-6 ✓ | 40.3 EB05 35.4 · IC025 +4.9 3/3 methods agree vs other Corticosteroids: PRR 182.3 (138.4–240.0) | Lab value / disease marker | serious n=163 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Pulmonary mucormycosis | 133 | 52.9 43.4–64.5ROR 53.0 · calibrated p 1e-5 ✓ | 39.1 EB05 33.9 · IC025 +4.8 3/3 methods agree vs other Corticosteroids: only this drug | Not in label — unassessed | serious n=133 · ♀ 0% (drug 57%) · 100% clinician | no trial arm names this drug |
| Crystal urine present | 144 | 52.7 43.6–63.7ROR 52.7 · calibrated p 1e-5 ✓ | 39.0 EB05 34.0 · IC025 +4.8 3/3 methods agree vs other Corticosteroids: PRR 176.4 (131.3–237.2) | Lab value / disease marker | serious n=139 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Subcutaneous drug absorption impaired | 140 | 52.6 43.4–63.8ROR 52.7 · calibrated p 1e-5 ✓ | 39.0 EB05 33.9 · IC025 +4.8 3/3 methods agree vs other Corticosteroids: PRR 5.5 (4.7–6.6) | Not in label — unassessed | serious n=140 · ♀ 100% (drug 57%) · 100% clinician | no trial arm names this drug |
| Facet joint syndrome | 793 | 51.2 47.2–55.4ROR 51.4 · calibrated p 1e-5 ✓ | 38.3 EB05 36.2 · IC025 +5.1 3/3 methods agree vs other Corticosteroids: PRR 3.4 (3.2–3.7) | Not in label — unassessed | serious n=793 · ♀ 100% (drug 57%) · 93% clinician | no trial arm names this drug |
| Red blood cells urine positive | 241 | 50.3 43.5–58.3ROR 50.4 · calibrated p 1e-5 ✓ | 37.8 EB05 34.0 · IC025 +4.9 3/3 methods agree vs other Corticosteroids: PRR 238.5 (184.8–307.8) | Lab value / disease marker | serious n=232 | no trial arm names this drug |
| Secondary immunodeficiency | 274 | 45.3 39.6–51.8ROR 45.4 · calibrated p 3e-5 ✓ | 34.9 EB05 31.6 · IC025 +4.8 3/3 methods agree vs other Corticosteroids: PRR 6.1 (5.4–6.9) | Labeled (related wording) related wording | serious n=274 | no trial arm names this drug |
| Retinitis | 375 | 44.1 39.3–49.4ROR 44.2 · calibrated p 3e-5 ✓ | 34.2 EB05 31.4 · IC025 +4.9 3/3 methods agree vs other Corticosteroids: PRR 4.4 (4.0–4.9) | Likely indication confounding term in indications | serious n=375 · ♀ 100% (drug 57%) · 100% clinician | no trial arm names this drug |
| Acute graft versus host disease in liver | 161 | 43.7 36.7–52.1ROR 43.8 · calibrated p 3e-5 ✓ | 33.9 EB05 29.8 · IC025 +4.7 3/3 methods agree vs other Corticosteroids: PRR 1,553.4 (763.8–3,159.2) | Not in label — unassessed | serious n=161 · ♀ 0% (drug 57%) · 100% clinician | no trial arm names this drug |
| Rheumatic fever | 965 | 43.1 40.2–46.3ROR 43.4 · calibrated p 3e-5 ✓ | 33.7 EB05 31.9 · IC025 +4.9 3/3 methods agree vs other Corticosteroids: PRR 2.8 (2.6–3.0) | Likely indication confounding shares a disease stem with the indications wording | serious n=965 · ♀ 100% (drug 57%) · 95% clinician | no trial arm names this drug |
| Carotid artery thrombosis | 188 | 42.9 36.5–50.5ROR 43.0 · calibrated p 4e-5 ✓ | 33.5 EB05 29.7 · IC025 +4.7 3/3 methods agree vs other Corticosteroids: PRR 47.3 (39.4–56.7) | Not in label — unassessed | serious n=188 · ♀ 100% (drug 57%) · 100% clinician | no trial arm names this drug |
| Steroid diabetes | 320 | 42.7 37.7–48.4ROR 42.8 · calibrated p 4e-5 ✓ | 33.4 EB05 30.4 · IC025 +4.8 3/3 methods agree vs other Corticosteroids: PRR 12.5 (11.1–14.0) | Labeled (related wording) related wording | serious n=319 · 91% clinician | no trial arm names this drug |
| Pulmonary nocardiosis | 179 | 42.6 36.1–50.3ROR 42.7 · calibrated p 4e-5 ✓ | 33.3 EB05 29.4 · IC025 +4.7 3/3 methods agree vs other Corticosteroids: PRR 20.6 (17.4–24.2) | Not in label — unassessed | serious n=179 · ♀ 0% (drug 57%) · 100% clinician | no trial arm names this drug |
| Seronegative arthritis | 245 | 42.5 36.9–48.9ROR 42.5 · calibrated p 4e-5 ✓ | 33.2 EB05 29.9 · IC025 +4.8 3/3 methods agree vs other Corticosteroids: PRR 8.8 (7.8–10.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=244 · ♀ 100% (drug 57%) · 100% clinician | no trial arm names this drug |
| Polyomavirus-associated nephropathy | 490 | 40.6 36.8–44.9ROR 40.7 · calibrated p 5e-5 ✓ | 32.1 EB05 29.8 · IC025 +4.8 3/3 methods agree vs other Corticosteroids: PRR 15.5 (14.0–17.0) | Likely indication confounding shares a disease stem with the indications wording | serious n=490 · ♀ 37% (drug 57%) · 95% clinician | no trial arm names this drug |
| Dislocation of vertebra | 440 | 37.5 33.8–41.6ROR 37.6 · calibrated p 8e-5 ✓ | 30.1 EB05 27.8 · IC025 +4.7 3/3 methods agree vs other Corticosteroids: PRR 3.4 (3.1–3.7) | Not in label — unassessed | serious n=440 · ♀ 100% (drug 57%) · 95% clinician | no trial arm names this drug |
| Graft versus host disease in gastrointestinal tract | 419 | 37.3 33.5–41.5ROR 37.4 · calibrated p 8e-5 ✓ | 30.0 EB05 27.7 · IC025 +4.7 3/3 methods agree vs other Corticosteroids: PRR 41.2 (36.6–46.4) | Labeled (related wording) related wording | serious n=419 · 93% clinician | no trial arm names this drug |
| Acute graft versus host disease in intestine | 270 | 36.2 31.7–41.4ROR 36.3 · calibrated p 1e-4 ✓ | 29.3 EB05 26.5 · IC025 +4.6 3/3 methods agree vs other Corticosteroids: PRR 443.4 (325.4–604.3) | Not in label — unassessed | serious n=270 · ♀ 35% (drug 57%) · 100% clinician | no trial arm names this drug |
| Granulomatosis with polyangiitis | 223 | 35.0 30.3–40.5ROR 35.1 · calibrated p 1e-4 ✓ | 28.5 EB05 25.5 · IC025 +4.5 3/3 methods agree vs other Corticosteroids: PRR 256.9 (195.6–337.5) | Not in label — unassessed | serious n=221 | no trial arm names this drug |
| Adjustment disorder with depressed mood | 368 | 33.9 30.3–38.0ROR 34.0 · calibrated p 1e-4 ✓ | 27.8 EB05 25.5 · IC025 +4.6 3/3 methods agree vs other Corticosteroids: PRR 2.8 (2.5–3.1) | Not in label — unassessed | serious n=368 · ♀ 100% (drug 57%) · 100% clinician | no trial arm names this drug |
| Peripheral venous disease | 726 | 33.8 31.2–36.6ROR 33.9 · calibrated p 1e-4 ✓ | 27.7 EB05 26.1 · IC025 +4.6 3/3 methods agree vs other Corticosteroids: PRR 4.1 (3.8–4.4) | Not in label — unassessed | serious n=724 · ♀ 100% (drug 57%) · 94% clinician | no trial arm names this drug |
| White blood cells urine positive | 335 | 33.2 29.5–37.4ROR 33.3 · calibrated p 2e-4 ✓ | 27.3 EB05 25.0 · IC025 +4.5 3/3 methods agree vs other Corticosteroids: PRR 194.4 (159.1–237.6) | Lab value / disease marker | serious n=323 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Cytomegalovirus viraemia | 774 | 32.7 30.2–35.3ROR 32.8 · calibrated p 2e-4 ✓ | 27.0 EB05 25.4 · IC025 +4.6 3/3 methods agree vs other Corticosteroids: PRR 12.2 (11.4–13.2) | Not in label — unassessed | serious n=767 · 93% clinician | no trial arm names this drug |
| Strongyloidiasis | 285 | 32.4 28.5–36.8ROR 32.5 · calibrated p 2e-4 ✓ | 26.8 EB05 24.3 · IC025 +4.5 3/3 methods agree vs other Corticosteroids: PRR 8.6 (7.6–9.7) | Not in label — unassessed | serious n=282 · ♀ 0% (drug 57%) · 100% clinician | no trial arm names this drug |
| Polyomavirus viraemia | 174 | 32.0 27.2–37.7ROR 32.1 · calibrated p 2e-4 ✓ | 26.5 EB05 23.3 · IC025 +4.4 3/3 methods agree vs other Corticosteroids: PRR 17.4 (14.8–20.5) | Not in label — unassessed | serious n=172 · ♀ 0% (drug 57%) · 100% clinician | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody positive | 1,230 | 31.8 29.9–33.8ROR 32.1 · calibrated p 2e-4 ✓ | 26.4 EB05 25.2 · IC025 +4.6 3/3 methods agree vs other Corticosteroids: PRR 2.7 (2.5–2.8) | Lab value / disease marker | serious PRR 16.9 · ♀ 100% (drug 57%) · 94% clinician | no trial arm names this drug |
| Human herpesvirus 6 infection | 326 | 31.4 27.8–35.3ROR 31.4 · calibrated p 2e-4 ✓ | 26.1 EB05 23.8 · IC025 +4.5 3/3 methods agree vs other Corticosteroids: PRR 10.5 (9.4–11.8) | Not in label — unassessed | serious n=325 | no trial arm names this drug |
| Mucormycosis | 435 | 30.9 27.9–34.3ROR 31.0 · calibrated p 2e-4 ✓ | 25.8 EB05 23.8 · IC025 +4.5 3/3 methods agree vs other Corticosteroids: PRR 16.8 (15.1–18.6) | Not in label — unassessed | serious n=435 · ♀ 30% (drug 57%) · 100% clinician | no trial arm names this drug |
| Onychomadesis | 683 | 29.9 27.5–32.4ROR 30.0 · calibrated p 3e-4 ✓ | 25.1 EB05 23.5 · IC025 +4.5 3/3 methods agree vs other Corticosteroids: PRR 7.4 (6.8–8.0) | Not in label — unassessed | serious n=681 · ♀ 100% (drug 57%) · 93% clinician | no trial arm names this drug |
| Temperature regulation disorder | 359 | 29.9 26.7–33.4ROR 29.9 · calibrated p 3e-4 ✓ | 25.0 EB05 22.9 · IC025 +4.4 3/3 methods agree vs other Corticosteroids: PRR 23.0 (20.4–25.8) | Not in label — unassessed | serious n=357 · ♀ 100% (drug 57%) · 91% clinician | no trial arm names this drug |
| Acute graft versus host disease in skin | 450 | 29.6 26.8–32.7ROR 29.7 · calibrated p 3e-4 ✓ | 24.9 EB05 23.0 · IC025 +4.4 3/3 methods agree vs other Corticosteroids: PRR 31.8 (28.5–35.4) | Not in label — unassessed | serious n=450 · 100% clinician | no trial arm names this drug |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Opportunistic infection | 6,066 | 7.16.9–7.2 | signal |
| Interstitial lung disease | 2,879 | 4.74.5–4.9 | signal |
| Liver injury | 7,253 | 3.73.7–3.8 | signal |
| Serious infection | 15,980 | 3.23.2–3.3 | signal |
| Thrombocytopenia | 4,289 | 3.02.9–3.1 | signal |
| Severe cutaneous reaction | 1,313 | 2.72.6–2.9 | signal |
| Neutropenia / agranulocytosis | 4,328 | 2.72.6–2.8 | signal |
| Kidney injury | 7,962 | 2.72.6–2.7 | signal |
| Anaemia | 4,965 | 2.62.5–2.6 | signal |
| Rhabdomyolysis / myopathy | 1,287 | 2.42.3–2.6 | signal |
| Osteonecrosis | 847 | 2.32.1–2.4 | signal |
| Hyperglycaemia / diabetes | 4,856 | 2.22.1–2.2 | signal |
| Anaphylaxis / angioedema | 1,719 | 2.12.0–2.2 | signal |
| Tendon disorder | 505 | 2.01.9–2.2 | raised |
| Gi bleeding | 2,281 | 1.91.8–2.0 | raised |
| Hyponatraemia | 988 | 1.91.8–2.0 | raised |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Methylprednisolone only as a background or rescue medication (NCT01471340, NCT01950819); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 22,327 | 4.0 4.0–4.1ROR 4.6 · calibrated p 0.284 | 3.9 EB05 3.9 · IC025 +2.0 3/3 methods agree vs other Corticosteroids: PRR 6.8 (6.8–6.9) | Reporting / coding artifact | age-adj. PRR 3.4 · serious PRR 4.3 · 91% clinician | no trial arm names this drug |
| Drug ineffective (drug did not work) | 16,306 | 1.9 1.9–1.9ROR 2.0 · calibrated p 0.956 | 1.9 EB05 1.9 · IC025 +0.9 vs other Corticosteroids: PRR 5.5 (5.4–5.5) | Reporting / coding artifact | age-adj. PRR 2.4 · serious PRR 3.1 | no trial arm names this drug |
| Fatigue (tiredness) | 8,102 | 1.6 1.6–1.6ROR 1.6 · calibrated p 0.729 | 1.6 EB05 1.6 · IC025 +0.6 vs other Corticosteroids: PRR 3.9 (3.8–4.0) | Not in label — unassessed | age-adj. PRR 1.4 · serious PRR 1.7 · ♀ 79% (drug 57%) | no trial arm names this drug |
| Pain | 7,566 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.910 | 1.9 EB05 1.8 · IC025 +0.9 vs other Corticosteroids: PRR 4.7 (4.6–4.7) | Not in label — unassessed | age-adj. PRR 1.8 · serious PRR 1.7 · ♀ 81% (drug 57%) | no trial arm names this drug |
| Nausea | 7,537 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.634 | 1.5 EB05 1.4 · IC025 +0.5 vs other Corticosteroids: PRR 4.6 (4.5–4.7) | Not in label — unassessed | age-adj. PRR 1.3 · serious PRR 1.6 · ♀ 82% (drug 57%) | no trial arm names this drug |
| Headache | 7,361 | 1.8 1.8–1.8ROR 1.8 · calibrated p 0.859 | 1.8 EB05 1.8 · IC025 +0.8 vs other Corticosteroids: PRR 5.2 (5.1–5.3) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 2.2 · ♀ 84% (drug 57%) | no trial arm names this drug |
| Pyrexia (fever) | 7,138 | 3.2 3.1–3.3ROR 3.3 · calibrated p 0.533 | 3.1 EB05 3.1 · IC025 +1.6 3/3 methods agree vs other Corticosteroids: PRR 4.8 (4.7–4.9) | Not in label — unassessed | age-adj. PRR 2.5 · serious PRR 2.5 | no trial arm names this drug |
| Pneumonia (lung infection) | 6,924 | 3.3 3.2–3.4ROR 3.4 · calibrated p 0.499 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree vs other Corticosteroids: PRR 5.2 (5.1–5.4) | Labeled (related wording) related wording | age-adj. PRR 2.8 · serious PRR 2.2 | no trial arm names this drug |
| Arthralgia (joint pain) | 6,595 | 2.5 2.4–2.5ROR 2.5 · calibrated p 0.802 | 2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Corticosteroids: PRR 4.5 (4.4–4.6) | Not in label — unassessed | age-adj. PRR 2.0 · serious PRR 2.7 · ♀ 81% (drug 57%) | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 6,590 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.846 | 1.8 EB05 1.7 · IC025 +0.8 vs other Corticosteroids: PRR 3.9 (3.8–4.0) | Not in label — unassessed | age-adj. PRR 1.6 · serious PRR 1.5 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 6,435 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.679 | 1.5 EB05 1.5 · IC025 +0.6 vs other Corticosteroids: PRR 3.9 (3.8–4.0) | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.6 | no trial arm names this drug |
| Condition aggravated | 6,098 | 3.1 3.0–3.2ROR 3.2 · calibrated p 0.558 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Corticosteroids: PRR 3.8 (3.8–3.9) | Reporting / coding artifact | age-adj. PRR 2.8 · serious PRR 2.9 | no trial arm names this drug |
| Infusion related reaction (reaction during infusion) | 5,820 | 14.7 14.3–15.1ROR 15.3 · calibrated p 0.006 ✓ | 13.4 EB05 13.2 · IC025 +3.7 3/3 methods agree vs other Corticosteroids: PRR 6.3 (6.2–6.5) | Not in label — unassessed | age-adj. PRR 10.8 · serious PRR 10.5 · ♀ 83% (drug 57%) | no trial arm names this drug |
| Product use in unapproved indication | 5,670 | 3.6 3.5–3.7ROR 3.7 · calibrated p 0.435 | 3.5 EB05 3.5 · IC025 +1.8 3/3 methods agree vs other Corticosteroids: PRR 6.4 (6.2–6.5) | Reporting / coding artifact | age-adj. PRR 3.3 · serious PRR 4.8 · 91% clinician | no trial arm names this drug |
| Rash | 5,595 | 2.0 1.9–2.0ROR 2.0 · calibrated p 0.957 | 2.0 EB05 1.9 · IC025 +0.9 vs other Corticosteroids: PRR 3.8 (3.7–3.9) | Not in label — unassessed | age-adj. PRR 1.8 · serious PRR 2.5 | no trial arm names this drug |
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.
- Vaginal flatulence — n=134, PRR 119.3
- Neurologic neglect syndrome — n=183, PRR 74.0
- Mycobacterium chelonae infection — n=215, PRR 62.8
- Delayed graft function — n=198, PRR 59.2
- Lupus vulgaris — n=331, PRR 58.7
- Pulmonary mucormycosis — n=133, PRR 52.9
- Subcutaneous drug absorption impaired — n=140, PRR 52.6
- Facet joint syndrome — n=793, PRR 51.2
- Acute graft versus host disease in liver — n=161, PRR 43.7
- Carotid artery thrombosis — n=188, PRR 42.9
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 Methylprednisolone?
In FDA FAERS, the most frequently co-reported reaction terms for Methylprednisolone are fatigue, pain, nausea, headache, pyrexia, pneumonia. 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 Methylprednisolone have an FDA boxed warning?
No. The FDA label retrieved for Methylprednisolone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Methylprednisolone 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 235ca8cf-1576-0dfd-e063-6394a90a8b25, effective 20260604; matched on
openfda.generic_name.exact:"METHYLPREDNISOLONE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 6741 description (ChEBI)
- 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, 1,268 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 - ClinicalTrials.gov API v2 (query
METHYLPREDNISOLONE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.