Methylprednisolone Sodium Succinate side effects: what 46,150 FDA adverse event reports show

Methylprednisolone Sodium Succinate · 1,234 reaction terms · 380,491 drug–reaction co-reports · data 2026-09-14

Drug class

Corticosteroid

FDA label (Established Pharmacologic Class) · compare the class

Who reports

46,150 reports · 89% serious · 8,762 with death outcome · 60% 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

Labeled (related wording) 1Likely indication confounding 5Lab value / disease marker 11Not in label — unassessed 23

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). 1,194 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Vaginal flatulence	150	441.5 352.4–553.1ROR 442.9 · calibrated p 4e-13 ✓	216.6 EB05 189.0 · IC025 +6.7 3/3 methods agree vs other Corticosteroids: PRR 6.1 (5.2–7.2)	Not in label — unassessed	serious n=150 · ♀ 100% (drug 60%)	no trial arm names this drug
Hepatic enzyme	66	410.1 293.7–572.6ROR 410.7 · calibrated p 2e-12 ✓	202.0 EB05 164.3 · IC025 +6.0 3/3 methods agree vs other Corticosteroids: PRR 28.6 (21.6–38.0)	Not in label — unassessed	serious n=66 · ♀ 100% (drug 60%) · 100% clinician	no trial arm names this drug
Anti-cyclic citrullinated peptide antibody	262	295.2 252.7–345.0ROR 296.9 · calibrated p 1e-11 ✓	176.0 EB05 158.8 · IC025 +6.9 3/3 methods agree vs other Corticosteroids: PRR 4.6 (4.1–5.2)	Lab value / disease marker	serious n=262 · ♀ 100% (drug 60%) · 93% clinician	no trial arm names this drug
Subcutaneous drug absorption impaired	205	275.4 231.5–327.7ROR 276.6 · calibrated p 3e-11 ✓	168.2 EB05 149.7 · IC025 +6.7 3/3 methods agree vs other Corticosteroids: PRR 8.4 (7.3–9.7)	Not in label — unassessed	serious n=205 · ♀ 100% (drug 60%) · 100% clinician	no trial arm names this drug
Blood pressure diastolic abnormal	919	254.1 234.5–275.4ROR 259.2 · calibrated p 4e-11 ✓	161.9 EB05 153.3 · IC025 +7.1 3/3 methods agree vs other Corticosteroids: PRR 23.2 (21.5–24.9)	Lab value / disease marker	serious n=847 · 93% clinician	no trial arm names this drug
Blood pressure systolic abnormal	826	226.4 208.3–246.1ROR 230.5 · calibrated p 1e-10 ✓	150.2 EB05 141.8 · IC025 +7.0 3/3 methods agree vs other Corticosteroids: PRR 23.0 (21.3–24.8)	Lab value / disease marker	serious n=765 · 92% clinician	no trial arm names this drug
Hypocholesterolaemia	95	203.3 159.6–259.1ROR 203.8 · calibrated p 6e-10 ✓	136.3 EB05 114.8 · IC025 +6.0 3/3 methods agree vs other Corticosteroids: PRR 10.2 (8.2–12.6)	Not in label — unassessed	serious n=95 · ♀ 100% (drug 60%) · 100% clinician	no trial arm names this drug
Lupus vulgaris	356	194.5 171.8–220.1ROR 196.0 · calibrated p 5e-10 ✓	134.9 EB05 123.5 · IC025 +6.7 3/3 methods agree vs other Corticosteroids: PRR 3.6 (3.2–4.0)	Not in label — unassessed	serious n=356 · ♀ 100% (drug 60%) · 94% clinician	no trial arm names this drug
Swollen joint count	72	188.4 143.0–248.0ROR 188.7 · calibrated p 1e-9 ✓	128.4 EB05 105.4 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: PRR 5.9 (4.6–7.4)	Not in label — unassessed	serious n=72 · ♀ 100% (drug 60%) · 100% clinician	no trial arm names this drug
Neurologic neglect syndrome	158	178.9 148.8–215.2ROR 179.6 · calibrated p 1e-9 ✓	126.2 EB05 110.5 · IC025 +6.3 3/3 methods agree vs other Corticosteroids: PRR 36.5 (30.2–44.1)	Not in label — unassessed	serious n=158 · ♀ 100% (drug 60%) · 93% clinician	no trial arm names this drug
Human bocavirus infection	47	149.1 107.2–207.4ROR 149.3 · calibrated p 1e-8 ✓	107.3 EB05 83.9 · IC025 +5.2 3/3 methods agree vs other Corticosteroids: PRR 3.2 (2.4–4.2)	Not in label — unassessed	serious n=47 · 100% clinician	no trial arm names this drug
Retinitis	394	140.6 125.6–157.3ROR 141.8 · calibrated p 8e-9 ✓	106.7 EB05 98.1 · IC025 +6.4 3/3 methods agree vs other Corticosteroids: PRR 4.6 (4.2–5.1)	Likely indication confounding term in indications	serious n=394 · ♀ 100% (drug 60%) · 95% clinician	no trial arm names this drug
Rheumatic fever	984	132.3 123.3–141.9ROR 135.1 · calibrated p 1e-8 ✓	102.1 EB05 96.9 · IC025 +6.5 3/3 methods agree vs other Corticosteroids: PRR 2.8 (2.7–3.0)	Likely indication confounding shares a disease stem with the indications wording	serious n=984 · ♀ 100% (drug 60%) · 94% clinician	no trial arm names this drug
Seronegative arthritis	252	131.7 114.5–151.5ROR 132.4 · calibrated p 1e-8 ✓	101.2 EB05 91.1 · IC025 +6.2 3/3 methods agree vs other Corticosteroids: PRR 9.1 (8.0–10.4)	Likely indication confounding shares a disease stem with the indications wording	serious n=252 · ♀ 93% (drug 60%) · 96% clinician	no trial arm names this drug
Facet joint syndrome	703	130.5 120.1–141.9ROR 132.6 · calibrated p 1e-8 ✓	101.0 EB05 94.9 · IC025 +6.4 3/3 methods agree vs other Corticosteroids: PRR 3.0 (2.8–3.3)	Not in label — unassessed	serious n=703 · ♀ 100% (drug 60%) · 93% clinician	no trial arm names this drug
Dislocation of vertebra	496	130.5 118.1–144.2ROR 131.9 · calibrated p 1e-8 ✓	100.9 EB05 93.6 · IC025 +6.4 3/3 methods agree vs other Corticosteroids: PRR 3.8 (3.5–4.2)	Not in label — unassessed	serious n=496 · ♀ 100% (drug 60%) · 96% clinician	no trial arm names this drug
Adjustment disorder with depressed mood	443	128.1 115.3–142.3ROR 129.3 · calibrated p 2e-8 ✓	99.4 EB05 91.9 · IC025 +6.3 3/3 methods agree vs other Corticosteroids: PRR 3.4 (3.1–3.7)	Not in label — unassessed	serious n=443 · ♀ 100% (drug 60%) · 97% clinician	no trial arm names this drug
Deep vein thrombosis postoperative	408	119.5 107.1–133.2ROR 120.5 · calibrated p 3e-8 ✓	94.1 EB05 86.7 · IC025 +6.2 3/3 methods agree vs other Corticosteroids: PRR 2.4 (2.1–2.6)	Not in label — unassessed	serious n=408 · ♀ 100% (drug 60%) · 95% clinician	no trial arm names this drug
Swollen joint count increased	612	111.0 101.6–121.2ROR 112.5 · calibrated p 5e-8 ✓	88.9 EB05 83.1 · IC025 +6.2 3/3 methods agree vs other Corticosteroids: PRR 2.5 (2.3–2.7)	Lab value / disease marker	serious n=612 · ♀ 100% (drug 60%) · 95% clinician	no trial arm names this drug
Carotid artery thrombosis	157	102.4 86.1–121.7ROR 102.7 · calibrated p 1e-7 ✓	82.7 EB05 72.4 · IC025 +5.8 3/3 methods agree vs other Corticosteroids: PRR 35.9 (29.7–43.3)	Not in label — unassessed	serious n=157 · ♀ 100% (drug 60%) · 93% clinician	no trial arm names this drug
X-ray abnormal	324	100.8 89.4–113.7ROR 101.5 · calibrated p 1e-7 ✓	82.1 EB05 74.8 · IC025 +6.0 3/3 methods agree vs other Corticosteroids: PRR 3.0 (2.7–3.4)	Lab value / disease marker	serious n=324 · ♀ 100% (drug 60%) · 97% clinician	no trial arm names this drug
C-reactive protein	162	98.7 83.3–117.0ROR 99.1 · calibrated p 1e-7 ✓	80.3 EB05 70.5 · IC025 +5.8 3/3 methods agree vs other Corticosteroids: PRR 2.0 (1.8–2.4)	Lab value / disease marker	serious n=162 · ♀ 100% (drug 60%) · 94% clinician	no trial arm names this drug
Peripheral venous disease	643	87.2 80.2–94.8ROR 88.4 · calibrated p 3e-7 ✓	73.0 EB05 68.4 · IC025 +6.0 3/3 methods agree vs other Corticosteroids: PRR 3.6 (3.3–3.9)	Not in label — unassessed	serious n=643 · ♀ 100% (drug 60%) · 95% clinician	no trial arm names this drug
Anti-cyclic citrullinated peptide antibody positive	1,103	83.5 78.3–88.9ROR 85.5 · calibrated p 4e-7 ✓	70.4 EB05 67.0 · IC025 +6.0 3/3 methods agree vs other Corticosteroids: PRR 2.4 (2.3–2.5)	Lab value / disease marker	serious PRR 45.6 · ♀ 100% (drug 60%) · 94% clinician	no trial arm names this drug
Duodenal ulcer perforation	1,122	82.0 77.0–87.3ROR 84.0 · calibrated p 4e-7 ✓	69.3 EB05 66.0 · IC025 +6.0 3/3 methods agree vs other Corticosteroids: PRR 2.4 (2.3–2.6)	Labeled (related wording) related wording	serious PRR 44.7 · ♀ 100% (drug 60%) · 94% clinician	no trial arm names this drug
Overlap syndrome	104	80.6 65.5–99.3ROR 80.8 · calibrated p 7e-7 ✓	67.7 EB05 57.4 · IC025 +5.4 3/3 methods agree vs other Corticosteroids: PRR 7.6 (6.2–9.3)	Not in label — unassessed	serious n=104 · ♀ 100% (drug 60%) · 91% clinician	no trial arm names this drug
Rheumatoid factor positive	802	73.3 68.1–79.0ROR 74.6 · calibrated p 1e-6 ✓	63.0 EB05 59.5 · IC025 +5.8 3/3 methods agree vs other Corticosteroids: PRR 2.3 (2.2–2.5)	Lab value / disease marker	serious n=802 · ♀ 100% (drug 60%) · 95% clinician	no trial arm names this drug
Temperature regulation disorder	258	60.8 53.4–69.2ROR 61.1 · calibrated p 4e-6 ✓	53.4 EB05 48.2 · IC025 +5.4 3/3 methods agree vs other Corticosteroids: PRR 15.2 (13.3–17.4)	Not in label — unassessed	serious n=258 · ♀ 100% (drug 60%) · 93% clinician	no trial arm names this drug
Helicobacter infection	1,202	60.7 57.2–64.4ROR 62.3 · calibrated p 3e-6 ✓	53.5 EB05 51.0 · IC025 +5.6 3/3 methods agree vs other Corticosteroids: PRR 2.6 (2.5–2.7)	Not in label — unassessed	serious PRR 36.5 · ♀ 100% (drug 60%) · 95% clinician	no trial arm names this drug
Adjustment disorder	153	60.3 51.0–71.4ROR 60.5 · calibrated p 5e-6 ✓	52.9 EB05 46.3 · IC025 +5.2 3/3 methods agree vs other Corticosteroids: PRR 35.9 (29.6–43.5)	Not in label — unassessed	serious n=153 · ♀ 100% (drug 60%) · 92% clinician	no trial arm names this drug
Pemphigus	1,430	59.0 55.9–62.3ROR 60.9 · calibrated p 4e-6 ✓	52.2 EB05 50.0 · IC025 +5.6 3/3 methods agree vs other Corticosteroids: PRR 2.4 (2.3–2.5)	Likely indication confounding term in indications	serious PRR 33.8 · ♀ 98% (drug 60%) · 95% clinician	no trial arm names this drug
Muscle injury	941	58.8 55.0–62.9ROR 60.0 · calibrated p 4e-6 ✓	52.0 EB05 49.3 · IC025 +5.6 3/3 methods agree vs other Corticosteroids: PRR 2.8 (2.7–3.0)	Not in label — unassessed	serious PRR 36.4 · ♀ 100% (drug 60%) · 95% clinician	no trial arm names this drug
Hypercholesterolaemia	1,096	58.7 55.2–62.5ROR 60.1 · calibrated p 4e-6 ✓	52.0 EB05 49.5 · IC025 +5.6 3/3 methods agree vs other Corticosteroids: PRR 5.0 (4.7–5.3)	Likely indication confounding shares a disease stem with the indications wording	serious PRR 35.7 · ♀ 100% (drug 60%) · 94% clinician	no trial arm names this drug
Crystal urine present	63	57.5 44.3–74.8ROR 57.6 · calibrated p 8e-6 ✓	50.3 EB05 40.8 · IC025 +4.8 3/3 methods agree vs other Corticosteroids: PRR 33.8 (25.1–45.4)	Lab value / disease marker	serious n=62 · ♀ 100% (drug 60%) · 100% clinician	no trial arm names this drug
Urinary sediment present	72	57.4 44.9–73.4ROR 57.5 · calibrated p 7e-6 ✓	50.4 EB05 41.3 · IC025 +4.9 3/3 methods agree vs other Corticosteroids: PRR 32.7 (24.8–43.1)	Lab value / disease marker	serious n=72 · ♀ 100% (drug 60%) · 100% clinician	no trial arm names this drug
Urine leukocyte esterase positive	77	55.4 43.7–70.2ROR 55.5 · calibrated p 9e-6 ✓	48.8 EB05 40.3 · IC025 +4.9 3/3 methods agree vs other Corticosteroids: PRR 26.1 (20.1–33.7)	Lab value / disease marker	serious n=76 · ♀ 100% (drug 60%) · 100% clinician	no trial arm names this drug
Onychomadesis	434	52.9 48.0–58.5ROR 53.4 · calibrated p 9e-6 ✓	47.4 EB05 43.7 · IC025 +5.3 3/3 methods agree vs other Corticosteroids: PRR 4.5 (4.1–5.0)	Not in label — unassessed	serious n=434 · ♀ 100% (drug 60%) · 92% clinician	no trial arm names this drug
Folliculitis	1,060	51.9 48.7–55.3ROR 53.1 · calibrated p 9e-6 ✓	46.6 EB05 44.3 · IC025 +5.4 3/3 methods agree vs other Corticosteroids: PRR 2.7 (2.5–2.8)	Not in label — unassessed	serious PRR 35.3 · ♀ 96% (drug 60%) · 94% clinician	no trial arm names this drug
Death neonatal	141	51.7 43.5–61.6ROR 51.9 · calibrated p 1e-5 ✓	46.2 EB05 40.2 · IC025 +5.0 3/3 methods agree vs other Corticosteroids: PRR 8.5 (7.1–10.1)	Not in label — unassessed	serious n=141 · ♀ 100% (drug 60%)	no trial arm names this drug
Bone erosion	359	51.2 45.9–57.1ROR 51.6 · calibrated p 1e-5 ✓	45.9 EB05 42.1 · IC025 +5.3 3/3 methods agree vs other Corticosteroids: PRR 4.2 (3.7–4.6)	Not in label — unassessed	serious n=358 · ♀ 100% (drug 60%) · 97% 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
Interstitial lung disease	1,421	6.86.5–7.2	signal
Liver injury	3,706	5.65.5–5.8	signal
Opportunistic infection	1,328	4.54.2–4.7	signal
Anaphylaxis / angioedema	1,068	3.93.7–4.1	signal
Hyperglycaemia / diabetes	2,873	3.83.7–3.9	signal
Thrombocytopenia	1,727	3.63.4–3.8	signal
Serious infection	6,011	3.63.5–3.6	signal
Rhabdomyolysis / myopathy	598	3.43.1–3.6	signal
Osteonecrosis	360	2.82.6–3.2	signal
Anaemia	1,838	2.82.7–2.9	signal
Neutropenia / agranulocytosis	1,488	2.72.6–2.9	signal
Gi bleeding	1,074	2.72.5–2.8	signal
Depression	1,542	2.52.4–2.6	signal
Pancreatitis	430	2.42.2–2.7	signal
Severe cutaneous reaction	373	2.32.1–2.5	signal
Kidney injury	2,217	2.22.1–2.3	signal

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Methylprednisolone Sodium Succinate 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)	8,011	4.2 4.1–4.3ROR 4.9 · calibrated p 0.245	4.2 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other Corticosteroids: PRR 2.3 (2.3–2.4)	Reporting / coding artifact	age-adj. PRR 3.4 · serious PRR 4.8	no trial arm names this drug
Drug ineffective (drug did not work)	4,395	1.5 1.5–1.6ROR 1.6 · calibrated p 0.689	1.5 EB05 1.5 · IC025 +0.6 vs other Corticosteroids: PRR 1.4 (1.4–1.4)	Reporting / coding artifact	age-adj. PRR 1.8 · serious PRR 2.6	no trial arm names this drug
Fatigue (tiredness)	4,280	2.5 2.4–2.6ROR 2.7 · calibrated p 0.745	2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree vs other Corticosteroids: PRR 2.0 (2.0–2.1)	Not in label — unassessed	age-adj. PRR 2.2 · serious PRR 2.9 · ♀ 82% (drug 60%)	no trial arm names this drug
Headache	4,074	3.0 2.9–3.1ROR 3.2 · calibrated p 0.577	3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Corticosteroids: PRR 2.8 (2.7–2.9)	Labeled adverse reaction exact term	age-adj. PRR 2.4 · serious PRR 3.7 · ♀ 88% (drug 60%)	no trial arm names this drug
Pain	4,049	3.0 2.9–3.1ROR 3.2 · calibrated p 0.566	3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Corticosteroids: PRR 2.4 (2.4–2.5)	Not in label — unassessed	age-adj. PRR 2.8 · serious PRR 2.9 · ♀ 85% (drug 60%)	no trial arm names this drug
Infusion related reaction (reaction during infusion)	3,922	28.6 27.8–29.5ROR 31.2 · calibrated p 2e-4 ✓	27.0 EB05 26.3 · IC025 +4.7 3/3 methods agree vs other Corticosteroids: PRR 4.1 (4.0–4.3)	Not in label — unassessed	age-adj. PRR 21.1 · serious PRR 20.3 · ♀ 83% (drug 60%)	no trial arm names this drug
Nausea	3,821	2.2 2.1–2.3ROR 2.3 · calibrated p 0.896	2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Corticosteroids: PRR 2.3 (2.2–2.3)	Not in label — unassessed	age-adj. PRR 1.9 · serious PRR 2.5 · ♀ 84% (drug 60%)	no trial arm names this drug
Pyrexia (fever)	3,773	5.0 4.8–5.2ROR 5.4 · calibrated p 0.200	4.9 EB05 4.8 · IC025 +2.3 3/3 methods agree vs other Corticosteroids: PRR 2.5 (2.4–2.6)	Not in label — unassessed	age-adj. PRR 3.8 · serious PRR 3.9	no trial arm names this drug
Dyspnoea (shortness of breath)	3,642	2.9 2.8–3.0ROR 3.1 · calibrated p 0.593	2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other Corticosteroids: PRR 2.1 (2.0–2.2)	Not in label — unassessed	age-adj. PRR 2.5 · serious PRR 2.5	no trial arm names this drug
Rash	3,181	3.4 3.2–3.5ROR 3.5 · calibrated p 0.479	3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree vs other Corticosteroids: PRR 2.1 (2.0–2.2)	Not in label — unassessed	age-adj. PRR 2.9 · serious PRR 4.5 · ♀ 81% (drug 60%)	no trial arm names this drug
Arthralgia (joint pain)	3,025	3.3 3.2–3.5ROR 3.5 · calibrated p 0.485	3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree vs other Corticosteroids: PRR 2.0 (2.0–2.1)	Not in label — unassessed	age-adj. PRR 2.6 · serious PRR 3.8 · ♀ 83% (drug 60%)	no trial arm names this drug
Diarrhoea (diarrhea)	2,988	2.1 2.0–2.2ROR 2.2 · calibrated p 0.955	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Corticosteroids: PRR 1.8 (1.7–1.8)	Labeled adverse reaction exact term	age-adj. PRR 1.8 · serious PRR 2.3	no trial arm names this drug
Hypertension (high blood pressure)	2,912	6.3 6.1–6.5ROR 6.7 · calibrated p 0.113	6.2 EB05 6.0 · IC025 +2.6 3/3 methods agree vs other Corticosteroids: PRR 3.1 (3.0–3.2)	Labeled adverse reaction exact term	age-adj. PRR 5.0 · serious PRR 4.9 · ♀ 83% (drug 60%)	no trial arm names this drug
Pneumonia (lung infection)	2,895	4.1 4.0–4.2ROR 4.3 · calibrated p 0.326	4.1 EB05 3.9 · IC025 +2.0 3/3 methods agree vs other Corticosteroids: PRR 2.1 (2.0–2.2)	Labeled (related wording) related wording	age-adj. PRR 3.3 · serious PRR 2.7	no trial arm names this drug
Vomiting	2,831	2.8 2.7–2.9ROR 2.9 · calibrated p 0.670	2.7 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Corticosteroids: PRR 2.2 (2.1–2.3)	Not in label — unassessed	age-adj. PRR 2.2 · serious PRR 2.5 · ♀ 83% (drug 60%)	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=150, PRR 441.5
Hepatic enzyme — n=66, PRR 410.1
Subcutaneous drug absorption impaired — n=205, PRR 275.4
Hypocholesterolaemia — n=95, PRR 203.3
Lupus vulgaris — n=356, PRR 194.5
Swollen joint count — n=72, PRR 188.4
Neurologic neglect syndrome — n=158, PRR 178.9
Human bocavirus infection — n=47, PRR 149.1
Facet joint syndrome — n=703, PRR 130.5
Dislocation of vertebra — n=496, PRR 130.5

✓ A hand-written Bradford Hill causality assessment exists for this drug: Methotrexate Sodium ↔ Rheumatoid Arthritis.

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 Sodium Succinate?

In FDA FAERS, the most frequently co-reported reaction terms for Methylprednisolone Sodium Succinate are fatigue, headache, pain, infusion related reaction, nausea, pyrexia. 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 Sodium Succinate have an FDA boxed warning?

No. The FDA label retrieved for Methylprednisolone Sodium Succinate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Methylprednisolone Sodium Succinate 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")
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, field patient.drug.openfda.generic_name.exact, 1,234 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.