Drug · FAERS side-effect profile with label screen
Methocarbamol side effects: what 22,550 FDA adverse event reports show
Who reports
22,550 reports · 62% serious · 1,735 with death outcome · 70% female
openFDA FAERS counts, all years, deduplication not applied
Used for
The injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
FDA label, Indications and Usage
What it is
DESCRIPTION Methocarbamol Injection, USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration.
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
Reporting / coding artifact 5Not in label — unassessed 35
What the badges mean
- 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.
- 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). 1,125 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 |
|---|---|---|---|---|---|---|
| Amyloid arthropathy | 28 | 712.3 434.8–1,167.0ROR 713.2 · calibrated p 4e-14 ✓ | 314.8 EB05 228.6 · IC025 +5.0 3/3 methods agree vs other Muscle Relaxants: PRR 4.0 (2.4–6.8) | Not in label — unassessed | serious n=28 · ♀ 100% (drug 70%) · 100% clinician | no trial data cached |
| Child abuse | 42 | 187.6 134.7–261.4ROR 188.0 · calibrated p 2e-9 ✓ | 145.7 EB05 112.3 · IC025 +5.3 3/3 methods agree vs other Muscle Relaxants: PRR 4.1 (2.7–6.3) | Reporting / coding artifact | serious n=42 · ♀ 0% (drug 70%) · 100% clinician | no trial data cached |
| Epidural lipomatosis | 43 | 130.8 95.1–180.0ROR 131.1 · calibrated p 3e-8 ✓ | 109.2 EB05 84.4 · IC025 +5.1 3/3 methods agree vs other Muscle Relaxants: PRR 4.1 (2.7–6.3) | Not in label — unassessed | serious n=43 · ♀ 0% (drug 70%) · 100% clinician | no trial data cached |
| Victim of child abuse | 28 | 118.7 80.1–176.0ROR 118.9 · calibrated p 9e-8 ✓ | 98.3 EB05 71.4 · IC025 +4.6 3/3 methods agree vs other Muscle Relaxants: PRR 4.1 (2.4–7.0) | Reporting / coding artifact | serious n=28 · ♀ 0% (drug 70%) · 100% clinician | no trial data cached |
| Jaw clicking | 18 | 92.1 56.7–149.5ROR 92.2 · calibrated p 9e-7 ✓ | 77.2 EB05 51.6 · IC025 +3.9 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=18 | no trial data cached |
| Multiple drug therapy | 43 | 61.0 44.8–83.0ROR 61.1 · calibrated p 6e-6 ✓ | 55.9 EB05 43.2 · IC025 +4.6 3/3 methods agree vs other Muscle Relaxants: PRR 4.4 (2.9–6.8) | Reporting / coding artifact | serious n=42 · ♀ 100% (drug 70%) · 100% clinician | no trial data cached |
| Necrosis ischaemic | 26 | 55.2 37.2–82.1ROR 55.3 · calibrated p 1e-5 ✓ | 50.4 EB05 36.1 · IC025 +4.1 3/3 methods agree vs other Muscle Relaxants: PRR 4.0 (2.3–6.9) | Not in label — unassessed | serious n=26 · ♀ 100% (drug 70%) · 100% clinician | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 42 | 37.7 27.7–51.3ROR 37.8 · calibrated p 1e-4 ✓ | 35.7 EB05 27.5 · IC025 +4.2 3/3 methods agree vs other Muscle Relaxants: PRR 2.3 (1.6–3.3) | Not in label — unassessed | serious n=42 | no trial data cached |
| Gallbladder polyp | 24 | 29.4 19.6–44.2ROR 29.5 · calibrated p 5e-4 ✓ | 28.0 EB05 19.8 · IC025 +3.5 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=24 · ♀ 100% (drug 70%) · 100% clinician | no trial data cached |
| Myofascial pain syndrome | 18 | 24.0 15.0–38.3ROR 24.0 · calibrated p 0.001 ✓ | 22.9 EB05 15.2 · IC025 +3.1 3/3 methods agree vs other Muscle Relaxants: PRR 3.4 (1.8–6.4) | Not in label — unassessed | serious n=18 | no trial data cached |
| Hepatitis viral | 20 | 23.8 15.2–37.0ROR 23.8 · calibrated p 0.001 ✓ | 22.7 EB05 15.5 · IC025 +3.2 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=20 | no trial data cached |
| Hyperparathyroidism secondary | 63 | 23.7 18.5–30.4ROR 23.7 · calibrated p 0.001 ✓ | 23.0 EB05 18.6 · IC025 +3.9 3/3 methods agree vs other Muscle Relaxants: PRR 2.7 (2.0–3.8) | Not in label — unassessed | serious n=63 · ♀ 46% (drug 70%) | no trial data cached |
| Rebound acid hypersecretion | 76 | 23.6 18.8–29.6ROR 23.7 · calibrated p 0.001 ✓ | 22.9 EB05 18.9 · IC025 +4.0 3/3 methods agree vs other Muscle Relaxants: PRR 2.6 (1.9–3.4) | Not in label — unassessed | serious n=76 | no trial data cached |
| Nephrogenic anaemia | 115 | 23.4 19.5–28.2ROR 23.5 · calibrated p 0.001 ✓ | 22.8 EB05 19.5 · IC025 +4.1 3/3 methods agree vs other Muscle Relaxants: PRR 2.6 (2.0–3.2) | Not in label — unassessed | serious n=115 | no trial data cached |
| Pneumonia streptococcal | 27 | 23.4 16.0–34.3ROR 23.4 · calibrated p 0.001 ✓ | 22.5 EB05 16.2 · IC025 +3.4 3/3 methods agree vs other Muscle Relaxants: PRR 4.0 (2.3–6.8) | Not in label — unassessed | serious n=27 · ♀ 100% (drug 70%) · 100% clinician | no trial data cached |
| Acquired haemophilia | 21 | 20.2 13.1–31.1ROR 20.2 · calibrated p 0.003 ✓ | 19.4 EB05 13.2 · IC025 +3.0 3/3 methods agree vs other Muscle Relaxants: PRR 4.0 (2.2–7.3) | Not in label — unassessed | serious n=21 | no trial data cached |
| Beta haemolytic streptococcal infection | 26 | 19.6 13.3–28.9ROR 19.7 · calibrated p 0.003 ✓ | 19.0 EB05 13.5 · IC025 +3.2 3/3 methods agree vs other Muscle Relaxants: PRR 4.0 (2.3–6.9) | Not in label — unassessed | serious n=26 · ♀ 100% (drug 70%) · 100% clinician | no trial data cached |
| Bone demineralisation | 21 | 18.7 12.2–28.8ROR 18.7 · calibrated p 0.004 ✓ | 18.0 EB05 12.2 · IC025 +3.0 3/3 methods agree vs other Muscle Relaxants: PRR 4.0 (2.2–7.3) | Not in label — unassessed | serious n=18 | no trial data cached |
| Distributive shock | 43 | 18.4 13.6–24.9ROR 18.5 · calibrated p 0.004 ✓ | 17.9 EB05 13.8 · IC025 +3.4 3/3 methods agree vs other Muscle Relaxants: PRR 2.9 (2.0–4.3) | Not in label — unassessed | serious n=43 · ♀ 100% (drug 70%) · 100% clinician | no trial data cached |
| Lumbar radiculopathy | 21 | 17.0 11.0–26.2ROR 17.0 · calibrated p 0.006 ✓ | 16.3 EB05 10.9 · IC025 +2.9 3/3 methods agree vs other Muscle Relaxants: PRR 2.6 (1.5–4.6) | Not in label — unassessed | serious n=19 | no trial data cached |
| Juvenile idiopathic arthritis | 44 | 17.0 12.6–22.9ROR 17.0 · calibrated p 0.005 ✓ | 16.5 EB05 12.8 · IC025 +3.3 3/3 methods agree vs other Muscle Relaxants: PRR 4.2 (2.7–6.4) | Not in label — unassessed | serious n=44 · ♀ 0% (drug 70%) · 100% clinician | no trial data cached |
| Cervical spinal stenosis | 27 | 14.7 10.1–21.5ROR 14.7 · calibrated p 0.010 ✓ | 14.1 EB05 9.9 · IC025 +2.9 3/3 methods agree vs other Muscle Relaxants: PRR 3.4 (2.0–5.6) | Not in label — unassessed | serious n=26 · ♀ 100% (drug 70%) | no trial data cached |
| Product administration interrupted | 106 | 13.0 10.7–15.7ROR 13.1 · calibrated p 0.013 ✓ | 12.7 EB05 10.8 · IC025 +3.3 3/3 methods agree vs other Muscle Relaxants: PRR 4.0 (3.1–5.2) | Reporting / coding artifact | serious n=95 | no trial data cached |
| Narcolepsy | 26 | 13.0 8.8–19.1ROR 13.0 · calibrated p 0.016 ✓ | 12.3 EB05 8.5 · IC025 +2.7 3/3 methods agree vs other Muscle Relaxants: PRR 2.7 (1.7–4.5) | Not in label — unassessed | serious n=24 | no trial data cached |
| Pre-existing condition improved | 86 | 12.8 10.4–15.9ROR 12.9 · calibrated p 0.014 ✓ | 12.5 EB05 10.4 · IC025 +3.2 3/3 methods agree vs other Muscle Relaxants: PRR 2.5 (1.9–3.3) | Not in label — unassessed | serious n=51 | no trial data cached |
| Essential hypertension | 33 | 12.0 8.5–16.9ROR 12.0 · calibrated p 0.020 ✓ | 11.4 EB05 8.2 · IC025 +2.8 3/3 methods agree vs other Muscle Relaxants: PRR 2.5 (1.6–3.8) | Not in label — unassessed | serious n=31 | no trial data cached |
| Neck injury | 37 | 11.8 8.5–16.3ROR 11.8 · calibrated p 0.021 ✓ | 11.2 EB05 8.3 · IC025 +2.8 3/3 methods agree vs other Muscle Relaxants: PRR 2.7 (1.8–4.1) | Not in label — unassessed | serious n=33 · 72% consumer | no trial data cached |
| Spinal fusion surgery | 49 | 11.5 8.6–15.2ROR 11.5 · calibrated p 0.022 ✓ | 11.0 EB05 8.5 · IC025 +2.9 3/3 methods agree vs other Muscle Relaxants: PRR 3.2 (2.2–4.6) | Not in label — unassessed | serious n=48 | no trial data cached |
| Obstructive sleep apnoea syndrome | 17 | 11.4 7.1–18.5ROR 11.4 · calibrated p 0.027 ✓ | 10.2 EB05 6.3 · IC025 +2.3 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=14 | no trial data cached |
| Intervertebral disc degeneration | 112 | 11.3 9.4–13.6ROR 11.4 · calibrated p 0.022 ✓ | 11.0 EB05 9.4 · IC025 +3.1 3/3 methods agree vs other Muscle Relaxants: PRR 2.1 (1.7–2.7) | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Spinal cord injury | 21 | 11.3 7.3–17.4ROR 11.3 · calibrated p 0.027 ✓ | 10.3 EB05 6.7 · IC025 +2.4 3/3 methods agree vs other Muscle Relaxants: PRR 4.4 (2.4–8.2) | Not in label — unassessed | serious n=21 | no trial data cached |
| Suspected suicide | 57 | 11.2 8.7–14.6ROR 11.3 · calibrated p 0.023 ✓ | 10.8 EB05 8.5 · IC025 +2.9 3/3 methods agree vs other Muscle Relaxants: PRR 2.6 (1.9–3.7) | Not in label — unassessed | serious n=57 · 100% clinician | no trial data cached |
| Kyphosis | 21 | 11.1 7.2–17.1ROR 11.1 · calibrated p 0.028 ✓ | 10.1 EB05 6.6 · IC025 +2.4 3/3 methods agree vs other Muscle Relaxants: PRR 4.7 (2.5–8.8) | Not in label — unassessed | serious n=21 | no trial data cached |
| Spinal osteoarthritis | 104 | 11.1 9.1–13.4ROR 11.1 · calibrated p 0.023 ✓ | 10.8 EB05 9.1 · IC025 +3.1 3/3 methods agree vs other Muscle Relaxants: PRR 2.5 (2.0–3.2) | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Infusion site discharge | 20 | 11.0 7.1–17.1ROR 11.0 · calibrated p 0.030 ✓ | 9.9 EB05 6.4 · IC025 +2.4 3/3 methods agree vs other Muscle Relaxants: PRR 4.2 (2.2–7.9) | Not in label — unassessed | serious n=14 | no trial data cached |
| Radiculopathy | 30 | 10.7 7.5–15.3ROR 10.7 · calibrated p 0.030 ✓ | 9.9 EB05 7.1 · IC025 +2.6 3/3 methods agree vs other Muscle Relaxants: PRR 2.4 (1.5–3.7) | Not in label — unassessed | serious n=30 | no trial data cached |
| Synovial cyst | 52 | 10.5 8.0–13.8ROR 10.5 · calibrated p 0.030 ✓ | 10.0 EB05 7.8 · IC025 +2.8 3/3 methods agree vs other Muscle Relaxants: PRR 5.6 (3.7–8.6) | Not in label — unassessed | serious n=49 · ♀ 100% (drug 70%) | no trial data cached |
| Intervertebral disc disorder | 48 | 10.5 7.9–13.9ROR 10.5 · calibrated p 0.030 ✓ | 10.0 EB05 7.7 · IC025 +2.8 3/3 methods agree vs other Muscle Relaxants: PRR 2.5 (1.7–3.6) | Not in label — unassessed | serious n=45 | no trial data cached |
| Lumbar spinal stenosis | 32 | 10.2 7.2–14.5ROR 10.3 · calibrated p 0.034 ✓ | 9.5 EB05 6.9 · IC025 +2.6 3/3 methods agree vs other Muscle Relaxants: PRR 2.7 (1.7–4.3) | Not in label — unassessed | serious n=30 | no trial data cached |
| Spinal operation | 131 | 10.2 8.6–12.1ROR 10.2 · calibrated p 0.031 ✓ | 9.9 EB05 8.5 · IC025 +3.0 3/3 methods agree vs other Muscle Relaxants: PRR 3.0 (2.4–3.7) | Reporting / coding artifact | serious PRR 9.7 | 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 |
|---|---|---|---|---|---|---|
| Pain | 1,731 | 2.6 2.5–2.7ROR 2.8 · calibrated p 0.712 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Muscle Relaxants: PRR 2.4 (2.3–2.6) | Likely indication confounding term in indications; also in warnings | serious PRR 2.7 | no trial data cached |
| Nausea | 1,680 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.976 | 2.0 EB05 1.9 · IC025 +0.9 vs other Muscle Relaxants: PRR 2.7 (2.6–2.9) | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Fatigue (tiredness) | 1,651 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.973 | 2.0 EB05 1.9 · IC025 +0.9 vs other Muscle Relaxants: PRR 3.0 (2.8–3.2) | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Drug ineffective (drug did not work) | 1,498 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.347 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Muscle Relaxants: PRR 2.5 (2.3–2.6) | Reporting / coding artifact | serious PRR 1.4 | no trial data cached |
| Headache | 1,297 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.935 | 1.9 EB05 1.8 · IC025 +0.9 vs other Muscle Relaxants: PRR 2.6 (2.4–2.7) | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Diarrhoea (diarrhea) | 1,184 | 1.7 1.6–1.8ROR 1.8 · calibrated p 0.800 | 1.7 EB05 1.6 · IC025 +0.7 vs other Muscle Relaxants: PRR 3.1 (2.8–3.3) | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Fall | 1,096 | 3.1 2.9–3.3ROR 3.2 · calibrated p 0.572 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Muscle Relaxants: PRR 2.5 (2.3–2.7) | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Dyspnoea (shortness of breath) | 1,056 | 1.7 1.6–1.8ROR 1.8 · calibrated p 0.813 | 1.7 EB05 1.6 · IC025 +0.7 vs other Muscle Relaxants: PRR 2.8 (2.6–3.0) | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Arthralgia (joint pain) | 1,036 | 2.3 2.2–2.5ROR 2.4 · calibrated p 0.861 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Muscle Relaxants: PRR 3.0 (2.8–3.2) | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Off label use (used outside approved label) | 980 | 1.0 1.0–1.1ROR 1.1 · calibrated p 0.341 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Muscle Relaxants: PRR 3.2 (2.9–3.4) | Reporting / coding artifact | serious PRR 1.2 | no trial data cached |
| Dizziness | 970 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.858 | 1.8 EB05 1.7 · IC025 +0.7 vs other Muscle Relaxants: PRR 2.8 (2.6–3.0) | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Back pain | 929 | 3.7 3.5–4.0ROR 3.8 · calibrated p 0.409 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree vs other Muscle Relaxants: PRR 2.8 (2.5–3.0) | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Anxiety | 909 | 3.0 2.8–3.2ROR 3.0 · calibrated p 0.611 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other Muscle Relaxants: PRR 2.2 (2.1–2.4) | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Vomiting | 857 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.786 | 1.7 EB05 1.6 · IC025 +0.7 vs other Muscle Relaxants: PRR 2.4 (2.2–2.6) | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Depression | 825 | 3.4 3.1–3.6ROR 3.5 · calibrated p 0.497 | 3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree vs other Muscle Relaxants: PRR 2.1 (1.9–2.3) | Labeled (related wording) related wording | serious PRR 3.5 | 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.
- Amyloid arthropathy — n=28, PRR 712.3
- Epidural lipomatosis — n=43, PRR 130.8
- Necrosis ischaemic — n=26, PRR 55.2
- Chronic kidney disease-mineral and bone disorder — n=42, PRR 37.7
- Gallbladder polyp — n=24, PRR 29.4
- Hepatitis viral — n=20, PRR 23.8
- Hyperparathyroidism secondary — n=63, PRR 23.7
- Rebound acid hypersecretion — n=76, PRR 23.6
- Nephrogenic anaemia — n=115, PRR 23.4
- Pneumonia streptococcal — n=27, PRR 23.4
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 Methocarbamol?
In FDA FAERS, the most frequently co-reported reaction terms for Methocarbamol are pain, nausea, fatigue, headache, diarrhoea, fall. 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 Methocarbamol have an FDA boxed warning?
No. The FDA label retrieved for Methocarbamol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Methocarbamol 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 01e7e2c7-49eb-4afb-a496-f2bd901622e9, effective 20250929; matched on
openfda.generic_name.exact:"METHOCARBAMOL") - 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, 1,165 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 2026-10-14. 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.