Drug · FAERS side-effect profile with label screen
Methylprednisolone Acetate side effects: what 7,959 FDA adverse event reports show
Who reports
7,959 reports · 85% serious · 1,003 with death outcome · 71% 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
DESCRIPTION Methylprednisolone Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.
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
Likely indication confounding 12Reporting / coding artifact 1Lab value / disease marker 8Not in label — unassessed 19
What the badges mean
- 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. 1,051 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 |
|---|---|---|---|---|---|---|
| Synovial fluid analysis | 68 | 9,815.6 5,841.0–16,494.8ROR 9,900.2 · χ² 137,626 / p <1e-300 | 1,297.5 EB05 1,058.7 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=68 · ♀ 100% (drug 71%) · 93% clinician | no trial arm names this drug |
| Injection site joint infection | 26 | 2,937.2 1,676.7–5,145.2ROR 2,946.8 · χ² 34,456 / p <1e-300 | 682.0 EB05 489.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% consumer | no trial arm names this drug |
| Neurologic neglect syndrome | 151 | 976.0 810.5–1,175.2ROR 994.8 · χ² 106,206 / p <1e-300 | 650.8 EB05 568.2 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious n=151 · ♀ 100% (drug 71%) · 94% clinician | no trial arm names this drug |
| Temperature regulation disorder | 394 | 580.7 521.7–646.2ROR 610.8 · χ² 185,895 / p <1e-300 | 464.0 EB05 426.8 · IC025 +8.0 3/3 methods agree | Not in label — unassessed | serious n=394 · ♀ 100% (drug 71%) | no trial arm names this drug |
| Hepatic enzyme | 25 | 574.8 372.9–886.0ROR 576.6 · χ² 11,261 / p <1e-300 | 346.0 EB05 246.5 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 71%) · 100% clinician | no trial arm names this drug |
| Carotid artery thrombosis | 150 | 562.4 472.0–670.0ROR 573.2 · χ² 68,644 / p <1e-300 | 436.6 EB05 381.1 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=150 · ♀ 100% (drug 71%) · 94% clinician | no trial arm names this drug |
| Tenosynovitis stenosans | 79 | 434.0 342.3–550.1ROR 438.3 · χ² 28,872 / p <1e-300 | 341.2 EB05 282.6 · IC025 +6.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=79 · ♀ 100% (drug 71%) | no trial arm names this drug |
| Thyroid atrophy | 10 | 328.9 170.4–634.8ROR 329.3 · χ² 2,618 / p <1e-300 | 187.9 EB05 109.1 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=9 | no trial arm names this drug |
| Adjustment disorder | 144 | 327.1 275.4–388.4ROR 333.1 · χ² 41,288 / p <1e-300 | 279.8 EB05 243.5 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=144 · ♀ 100% (drug 71%) · 94% clinician | no trial arm names this drug |
| Meningitis fungal | 22 | 274.8 177.2–426.2ROR 275.6 · χ² 5,183 / p <1e-300 | 204.7 EB05 142.5 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=21 | no trial arm names this drug |
| Arachnoiditis | 63 | 264.0 203.9–341.8ROR 266.1 · χ² 14,747 / p <1e-300 | 223.5 EB05 180.9 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=62 · 78% consumer | no trial arm names this drug |
| Allergy to chemicals | 105 | 242.7 199.0–296.1ROR 246.0 · χ² 22,897 / p <1e-300 | 213.5 EB05 181.3 · IC025 +6.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=105 · ♀ 100% (drug 71%) | no trial arm names this drug |
| Post cholecystectomy syndrome | 22 | 223.3 144.5–344.9ROR 223.9 · χ² 4,281 / p <1e-300 | 174.7 EB05 121.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial arm names this drug |
| Synovial disorder | 31 | 192.2 133.6–276.7ROR 193.0 · χ² 5,315 / p <1e-300 | 161.4 EB05 119.1 · IC025 +4.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=31 · ♀ 100% (drug 71%) · 100% clinician | no trial arm names this drug |
| Food allergy | 480 | 178.8 163.4–195.6ROR 190.2 · χ² 79,256 / p <1e-300 | 166.2 EB05 154.1 · IC025 +7.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=479 · ♀ 100% (drug 71%) | no trial arm names this drug |
| Rheumatoid lung | 60 | 175.0 134.8–227.0ROR 176.3 · χ² 9,562 / p <1e-300 | 155.9 EB05 125.5 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=60 · ♀ 100% (drug 71%) | no trial arm names this drug |
| Red blood cell sedimentation rate decreased | 16 | 170.4 102.8–282.4ROR 170.7 · χ² 2,372 / p <1e-300 | 134.6 EB05 87.9 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=16 | no trial arm names this drug |
| Personality disorder | 152 | 161.2 137.0–189.6ROR 164.3 · χ² 22,638 / p <1e-300 | 149.0 EB05 130.2 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=152 · ♀ 100% (drug 71%) · 93% clinician | no trial arm names this drug |
| Tenosynovitis | 159 | 160.7 137.2–188.4ROR 164.0 · χ² 23,624 / p <1e-300 | 148.8 EB05 130.3 · IC025 +6.4 3/3 methods agree | Likely indication confounding term in indications | serious n=159 · ♀ 100% (drug 71%) | no trial arm names this drug |
| Facet joint syndrome | 175 | 154.8 133.1–180.0ROR 158.3 · χ² 25,099 / p <1e-300 | 143.9 EB05 126.9 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=175 · ♀ 99% (drug 71%) | no trial arm names this drug |
| Granulocyte count increased | 22 | 151.2 98.4–232.3ROR 151.6 · χ² 2,962 / p <1e-300 | 127.4 EB05 88.7 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=22 | no trial arm names this drug |
| Rheumatoid nodule | 139 | 138.4 116.8–163.9ROR 140.8 · χ² 17,871 / p <1e-300 | 129.1 EB05 112.1 · IC025 +6.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=139 · ♀ 100% (drug 71%) | no trial arm names this drug |
| Meningitis chemical | 11 | 138.1 75.3–253.1ROR 138.3 · χ² 1,294 / p 1e-283 | 107.3 EB05 63.9 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=11 | no trial arm names this drug |
| Scleritis | 78 | 135.3 107.9–169.7ROR 136.6 · χ² 9,756 / p <1e-300 | 124.8 EB05 103.2 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=78 · ♀ 100% (drug 71%) | no trial arm names this drug |
| Blood folate decreased | 35 | 133.7 95.3–187.7ROR 134.3 · χ² 4,260 / p <1e-300 | 119.1 EB05 89.5 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=35 · ♀ 100% (drug 71%) | no trial arm names this drug |
| Crepitations | 145 | 133.7 113.3–157.7ROR 136.2 · χ² 18,039 / p <1e-300 | 125.1 EB05 109.0 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=143 · ♀ 100% (drug 71%) | no trial arm names this drug |
| Bursitis | 555 | 127.0 117.0–137.9ROR 136.5 · χ² 66,073 / p <1e-300 | 120.7 EB05 112.5 · IC025 +6.6 3/3 methods agree | Likely indication confounding term in indications | serious PRR 96.2 · ♀ 99% (drug 71%) | no trial arm names this drug |
| C-reactive protein decreased | 28 | 118.3 81.1–172.7ROR 118.7 · χ² 3,004 / p <1e-300 | 105.2 EB05 76.4 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=28 · ♀ 0% (drug 71%) | no trial arm names this drug |
| Synovial cyst | 196 | 116.1 100.8–133.7ROR 119.0 · χ² 21,300 / p <1e-300 | 110.0 EB05 97.7 · IC025 +6.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=195 · ♀ 100% (drug 71%) | no trial arm names this drug |
| Coeliac disease | 410 | 114.8 104.3–126.4ROR 121.0 · χ² 44,213 / p <1e-300 | 109.5 EB05 100.8 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 92.7 · ♀ 100% (drug 71%) | no trial arm names this drug |
| Foetal death | 216 | 114.5 100.1–131.0ROR 117.7 · χ² 23,176 / p <1e-300 | 108.7 EB05 97.1 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=216 · ♀ 100% (drug 71%) · 92% clinician | no trial arm names this drug |
| Blood immunoglobulin a increased | 22 | 112.7 73.6–172.7ROR 113.1 · χ² 2,229 / p <1e-300 | 99.0 EB05 68.9 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=22 | no trial arm names this drug |
| Immunodeficiency | 503 | 93.1 85.4–101.5ROR 99.3 · χ² 44,197 / p <1e-300 | 89.6 EB05 83.3 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 66.1 · ♀ 100% (drug 71%) | no trial arm names this drug |
| Vitamin b12 increased | 24 | 82.4 54.9–123.6ROR 82.6 · χ² 1,792 / p <1e-300 | 75.3 EB05 53.2 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=24 | no trial arm names this drug |
| Pleuritic pain | 83 | 81.3 65.4–101.0ROR 82.1 · χ² 6,303 / p <1e-300 | 77.5 EB05 64.5 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=83 · ♀ 100% (drug 71%) | no trial arm names this drug |
| Gangrene | 180 | 80.5 69.5–93.2ROR 82.4 · χ² 13,639 / p <1e-300 | 77.5 EB05 68.5 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=180 · ♀ 100% (drug 71%) · 94% clinician | no trial arm names this drug |
| Onychomadesis | 123 | 80.3 67.2–96.0ROR 81.6 · χ² 9,273 / p <1e-300 | 77.1 EB05 66.3 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=123 · ♀ 100% (drug 71%) | no trial arm names this drug |
| Hepatic enzyme decreased | 13 | 78.9 45.5–137.0ROR 79.0 · χ² 896 / p 3e-197 | 69.2 EB05 43.0 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial arm names this drug |
| Glomerular filtration rate increased | 23 | 76.7 50.7–116.1ROR 76.9 · χ² 1,597 / p <1e-300 | 70.4 EB05 49.4 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=23 | no trial arm names this drug |
| Electric shock | 22 | 70.1 45.9–107.1ROR 70.3 · χ² 1,393 / p <1e-300 | 64.7 EB05 45.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial arm names this drug |
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 |
|---|---|---|---|---|---|---|
| Pain | 1,600 | 6.9 6.6–7.2ROR 8.3 · χ² 8,232 / p <1e-300 | 6.8 EB05 6.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 1,305 | 2.6 2.5–2.7ROR 2.9 · χ² 1,383 / p <1e-300 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial arm names this drug |
| Off label use (used outside approved label) | 1,303 | 4.0 3.8–4.2ROR 4.5 · χ² 2,999 / p <1e-300 | 3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 | no trial arm names this drug |
| Rheumatoid arthritis | 1,269 | 29.9 28.4–31.4ROR 35.4 · χ² 35,191 / p <1e-300 | 29.5 EB05 28.2 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 24.4 · ♀ 96% (drug 71%) | no trial arm names this drug |
| Fatigue (tiredness) | 1,188 | 4.0 3.8–4.3ROR 4.6 · χ² 2,806 / p <1e-300 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · ♀ 94% (drug 71%) | no trial arm names this drug |
| Headache | 1,115 | 4.7 4.4–5.0ROR 5.3 · χ² 3,335 / p <1e-300 | 4.7 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 · ♀ 93% (drug 71%) | no trial arm names this drug |
| Joint swelling | 948 | 20.9 19.7–22.2ROR 23.6 · χ² 17,889 / p <1e-300 | 20.7 EB05 19.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 23.7 | no trial arm names this drug |
| Nausea | 807 | 2.7 2.5–2.9ROR 2.9 · χ² 892 / p 3e-196 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial arm names this drug |
| Arthralgia (joint pain) | 770 | 4.9 4.6–5.2ROR 5.3 · χ² 2,431 / p <1e-300 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial arm names this drug |
| Drug hypersensitivity | 758 | 10.3 9.6–11.0ROR 11.3 · χ² 6,403 / p <1e-300 | 10.3 EB05 9.7 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 16.5 | no trial arm names this drug |
| Rash | 741 | 4.5 4.2–4.8ROR 4.9 · χ² 2,058 / p <1e-300 | 4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · ♀ 91% (drug 71%) | no trial arm names this drug |
| Pyrexia (fever) | 713 | 5.4 5.1–5.8ROR 5.9 · χ² 2,613 / p <1e-300 | 5.4 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial arm names this drug |
| Drug intolerance | 673 | 18.5 17.2–19.9ROR 20.2 · χ² 11,123 / p <1e-300 | 18.4 EB05 17.3 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 20.1 | no trial arm names this drug |
| Malaise (feeling unwell) | 668 | 4.0 3.7–4.3ROR 4.3 · χ² 1,535 / p <1e-300 | 4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 92% (drug 71%) | no trial arm names this drug |
| Back pain | 651 | 7.4 6.9–8.0ROR 8.0 · χ² 3,623 / p <1e-300 | 7.3 EB05 6.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | 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.
- Injection site joint infection — n=26, PRR 2,937.2
- Neurologic neglect syndrome — n=151, PRR 976.0
- Temperature regulation disorder — n=394, PRR 580.7
- Hepatic enzyme — n=25, PRR 574.8
- Carotid artery thrombosis — n=150, PRR 562.4
- Adjustment disorder — n=144, PRR 327.1
- Arachnoiditis — n=63, PRR 264.0
- Post cholecystectomy syndrome — n=22, PRR 223.3
- Personality disorder — n=152, PRR 161.2
- Facet joint syndrome — n=175, PRR 154.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.
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 pain, rheumatoid arthritis, fatigue, headache, joint swelling, nausea. 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") - 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, 1,091 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 2026-10-08. 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.