Drug · FAERS side-effect profile with label screen
Carisoprodol side effects: what 18,961 FDA adverse event reports show
Who reports
18,961 reports · 69% serious · 4,011 with death outcome · 71% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Carisoprodol tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol tablets, USP should only be used for short periods (up to two or three weeks) because adequate evidenc.
FDA label, Indications and Usage
What it is
Carisoprodol tablets, USP are available as 350 mg round, white tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor. It is very slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH.
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 adverse reaction 1Labeled (related wording) 2Reporting / coding artifact 3Lab value / disease marker 1Outcome field, not a reaction 1Not in label — unassessed 32
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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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). 1,119 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 |
|---|---|---|---|---|---|---|
| Purpura senile | 14 | 146.7 84.0–256.3ROR 146.8 · calibrated p 6e-8 ✓ | 110.4 EB05 69.9 · IC025 +3.7 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Narcotic bowel syndrome | 14 | 109.0 62.9–188.8ROR 109.1 · calibrated p 4e-7 ✓ | 87.7 EB05 55.5 · IC025 +3.6 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Urinary bladder rupture | 15 | 69.6 41.3–117.2ROR 69.6 · calibrated p 6e-6 ✓ | 60.7 EB05 39.0 · IC025 +3.5 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Multiple drug overdose accidental | 26 | 65.6 44.2–97.4ROR 65.7 · calibrated p 5e-6 ✓ | 59.4 EB05 42.6 · IC025 +4.2 3/3 methods agree vs other Muscle Relaxants: only this drug | Labeled (related wording) related wording | serious n=26 · ♀ 42% (drug 71%) · 100% clinician | not reported in cached trials |
| Multiple drug overdose | 217 | 49.8 43.5–57.0ROR 50.3 · calibrated p 1e-5 ✓ | 47.5 EB05 42.4 · IC025 +5.2 3/3 methods agree vs other Muscle Relaxants: PRR 21.7 (15.5–30.4) | Labeled adverse reaction exact term | serious n=217 · 96% clinician | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 40 | 42.7 31.1–58.5ROR 42.7 · calibrated p 5e-5 ✓ | 40.4 EB05 30.9 · IC025 +4.3 3/3 methods agree vs other Muscle Relaxants: PRR 2.1 (1.4–3.1) | Not in label — unassessed | serious n=40 | not reported in cached trials |
| Accidental death | 68 | 42.1 33.0–53.6ROR 42.2 · calibrated p 5e-5 ✓ | 40.1 EB05 32.8 · IC025 +4.6 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=68 · 100% clinician | not reported in cached trials |
| Coronary artery atherosclerosis | 14 | 37.1 21.8–63.2ROR 37.2 · calibrated p 2e-4 ✓ | 34.4 EB05 21.8 · IC025 +3.1 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Multiple drug overdose intentional | 101 | 35.3 29.0–43.0ROR 35.5 · calibrated p 1e-4 ✓ | 34.0 EB05 28.8 · IC025 +4.5 3/3 methods agree vs other Muscle Relaxants: only this drug | Labeled (related wording) related wording | serious n=101 · 100% clinician | not reported in cached trials |
| Myofascial pain syndrome | 21 | 33.5 21.7–51.6ROR 33.5 · calibrated p 3e-4 ✓ | 31.7 EB05 21.8 · IC025 +3.5 3/3 methods agree vs other Muscle Relaxants: PRR 4.7 (2.5–8.8) | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Drug tolerance increased | 23 | 33.3 22.0–50.5ROR 33.4 · calibrated p 3e-4 ✓ | 31.6 EB05 22.2 · IC025 +3.6 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Polysubstance abuse | 18 | 31.7 19.9–50.7ROR 31.8 · calibrated p 4e-4 ✓ | 30.0 EB05 20.1 · IC025 +3.3 3/3 methods agree vs other Muscle Relaxants: only this drug | Reporting / coding artifact | serious n=18 | not reported in cached trials |
| Drug abuser | 130 | 23.5 19.8–28.0ROR 23.7 · calibrated p 1e-3 ✓ | 23.0 EB05 19.9 · IC025 +4.1 3/3 methods agree vs other Muscle Relaxants: PRR 13.7 (9.5–19.6) | Not in label — unassessed | serious n=129 · ♀ 46% (drug 71%) · 91% clinician | not reported in cached trials |
| Respiratory arrest | 571 | 23.2 21.3–25.1ROR 23.8 · calibrated p 9e-4 ✓ | 22.7 EB05 21.2 · IC025 +4.3 3/3 methods agree vs other Muscle Relaxants: PRR 11.0 (9.4–12.9) | Not in label — unassessed | serious PRR 19.1 · 95% clinician | not reported in cached trials |
| Intentional misuse | 37 | 21.5 15.5–29.8ROR 21.6 · calibrated p 0.002 ✓ | 20.9 EB05 15.8 · IC025 +3.5 3/3 methods agree vs other Muscle Relaxants: only this drug | Reporting / coding artifact | serious n=36 · ♀ 37% (drug 71%) · 100% clinician | not reported in cached trials |
| Joint sprain | 20 | 21.2 13.7–33.1ROR 21.3 · calibrated p 0.002 ✓ | 20.4 EB05 13.9 · IC025 +3.1 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Resorption bone increased | 15 | 20.6 12.4–34.3ROR 20.6 · calibrated p 0.003 ✓ | 19.6 EB05 12.3 · IC025 +2.8 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Nephrogenic anaemia | 85 | 20.5 16.5–25.3ROR 20.5 · calibrated p 0.002 ✓ | 20.0 EB05 16.7 · IC025 +3.8 3/3 methods agree vs other Muscle Relaxants: PRR 1.6 (1.3–2.1) | Not in label — unassessed | serious n=85 | not reported in cached trials |
| Rebound acid hypersecretion | 55 | 20.2 15.5–26.3ROR 20.2 · calibrated p 0.002 ✓ | 19.7 EB05 15.7 · IC025 +3.6 3/3 methods agree vs other Muscle Relaxants: PRR 1.6 (1.2–2.1) | Not in label — unassessed | serious n=55 | not reported in cached trials |
| Completed suicide (death by suicide) | 1,458 | 19.5 18.5–20.5ROR 21.0 · calibrated p 0.002 ✓ | 19.2 EB05 18.3 · IC025 +4.2 3/3 methods agree vs other Muscle Relaxants: PRR 6.0 (5.5–6.5) | Outcome field, not a reaction | serious PRR 16.0 · 97% clinician | not reported in cached trials |
| Lumbar radiculopathy | 20 | 19.2 12.4–29.9ROR 19.3 · calibrated p 0.004 ✓ | 18.5 EB05 12.5 · IC025 +3.0 3/3 methods agree vs other Muscle Relaxants: PRR 2.4 (1.4–4.2) | Not in label — unassessed | serious n=20 · ♀ 50% (drug 71%) | not reported in cached trials |
| Drug toxicity | 225 | 18.3 16.0–20.9ROR 18.5 · calibrated p 0.003 ✓ | 18.0 EB05 16.1 · IC025 +3.9 3/3 methods agree vs other Muscle Relaxants: PRR 10.2 (8.0–13.1) | Not in label — unassessed | serious PRR 15.7 | not reported in cached trials |
| Hyperparathyroidism secondary | 41 | 18.2 13.4–24.7ROR 18.2 · calibrated p 0.004 ✓ | 17.7 EB05 13.6 · IC025 +3.4 3/3 methods agree vs other Muscle Relaxants: PRR 1.4 (1.0–2.1) | Not in label — unassessed | serious n=41 | not reported in cached trials |
| Exposure via ingestion | 38 | 16.7 12.1–23.0ROR 16.7 · calibrated p 0.005 ✓ | 16.3 EB05 12.3 · IC025 +3.2 3/3 methods agree vs other Muscle Relaxants: only this drug | Reporting / coding artifact | serious n=37 · 100% clinician | not reported in cached trials |
| Intervertebral disc degeneration | 138 | 16.6 14.1–19.7ROR 16.7 · calibrated p 0.005 ✓ | 16.3 EB05 14.2 · IC025 +3.7 3/3 methods agree vs other Muscle Relaxants: PRR 3.0 (2.4–3.7) | Not in label — unassessed | serious PRR 14.4 | not reported in cached trials |
| Hypertensive heart disease | 26 | 15.5 10.5–22.8ROR 15.5 · calibrated p 0.008 ✓ | 14.9 EB05 10.4 · IC025 +2.9 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=26 · ♀ 42% (drug 71%) | not reported in cached trials |
| Poisoning | 171 | 15.2 13.1–17.6ROR 15.3 · calibrated p 0.007 ✓ | 14.9 EB05 13.1 · IC025 +3.6 3/3 methods agree vs other Muscle Relaxants: PRR 9.2 (7.0–12.1) | Not in label — unassessed | serious PRR 12.7 · 100% clinician | not reported in cached trials |
| Blood ph decreased | 23 | 15.0 9.9–22.6ROR 15.0 · calibrated p 0.010 ✓ | 14.3 EB05 9.7 · IC025 +2.8 3/3 methods agree vs other Muscle Relaxants: only this drug | Lab value / disease marker | serious n=23 · 100% clinician | not reported in cached trials |
| Radiculopathy | 35 | 14.9 10.6–20.7ROR 14.9 · calibrated p 0.009 ✓ | 14.4 EB05 10.7 · IC025 +3.1 3/3 methods agree vs other Muscle Relaxants: PRR 3.0 (2.0–4.7) | Not in label — unassessed | serious n=33 · ♀ 47% (drug 71%) | not reported in cached trials |
| Calcium deficiency | 17 | 14.6 9.1–23.6ROR 14.6 · calibrated p 0.012 ✓ | 13.6 EB05 8.4 · IC025 +2.6 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Breakthrough pain | 29 | 13.9 9.7–20.1ROR 13.9 · calibrated p 0.012 ✓ | 13.4 EB05 9.5 · IC025 +2.9 3/3 methods agree vs other Muscle Relaxants: PRR 3.4 (2.1–5.6) | Not in label — unassessed | serious n=20 · 100% consumer | not reported in cached trials |
| Essential hypertension | 32 | 13.8 9.8–19.6ROR 13.8 · calibrated p 0.012 ✓ | 13.3 EB05 9.6 · IC025 +2.9 3/3 methods agree vs other Muscle Relaxants: PRR 2.4 (1.5–3.7) | Not in label — unassessed | serious n=31 | not reported in cached trials |
| Generalised anxiety disorder | 18 | 13.7 8.6–21.8ROR 13.7 · calibrated p 0.014 ✓ | 12.7 EB05 8.0 · IC025 +2.5 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Chronic fatigue syndrome | 17 | 13.7 8.5–22.1ROR 13.7 · calibrated p 0.015 ✓ | 12.6 EB05 7.8 · IC025 +2.5 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=15 | NCT00671502: 5/280 (1.8%) on Carisoprodol; 2/275 (0.7%) control |
| Complex regional pain syndrome | 18 | 13.5 8.5–21.5ROR 13.5 · calibrated p 0.015 ✓ | 12.5 EB05 7.8 · IC025 +2.5 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Tobacco user | 18 | 13.4 8.4–21.4ROR 13.4 · calibrated p 0.015 ✓ | 12.4 EB05 7.8 · IC025 +2.5 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Spinal osteoarthritis | 104 | 13.2 10.9–16.0ROR 13.2 · calibrated p 0.012 ✓ | 12.9 EB05 10.9 · IC025 +3.3 3/3 methods agree vs other Muscle Relaxants: PRR 2.5 (2.0–3.2) | Not in label — unassessed | serious PRR 10.8 | not reported in cached trials |
| Pre-existing condition improved | 74 | 13.1 10.4–16.5ROR 13.2 · calibrated p 0.013 ✓ | 12.8 EB05 10.5 · IC025 +3.2 3/3 methods agree vs other Muscle Relaxants: PRR 2.0 (1.5–2.6) | Not in label — unassessed | serious n=34 | not reported in cached trials |
| Excoriation | 29 | 12.6 8.7–18.1ROR 12.6 · calibrated p 0.017 ✓ | 11.9 EB05 8.4 · IC025 +2.8 3/3 methods agree vs other Muscle Relaxants: only this drug | Not in label — unassessed | serious n=26 | not reported in cached trials |
| Lumbar spinal stenosis | 32 | 12.2 8.6–17.3ROR 12.2 · calibrated p 0.019 ✓ | 11.6 EB05 8.3 · IC025 +2.8 3/3 methods agree vs other Muscle Relaxants: PRR 2.7 (1.7–4.3) | Not in label — unassessed | serious n=31 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Carisoprodol as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).
- NCT00671502 — A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back (N=840, PHASE3; 6 AE terms posted; arms: Carisoprodol 700mg; Carisoprodol 500mg Tablet; Placebo Tablet)
- NCT00671879 — Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back (N=830, PHASE3; 18 AE terms posted; arms: Carisprodol SR 700 mg; Carisoprodol SR 500mg; Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 | 1,620 | 2.9 2.8–3.1ROR 3.1 · calibrated p 0.596 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other Muscle Relaxants: PRR 2.2 (2.1–2.3) | Likely indication confounding term in indications; also in warnings | serious PRR 2.9 | NCT00671879: 3/281 (1.1%) on Carisoprodol; 1/274 (0.4%) control |
| Completed suicide (death by suicide) | 1,458 | 19.5 18.5–20.5ROR 21.0 · calibrated p 0.002 ✓ | 19.2 EB05 18.3 · IC025 +4.2 3/3 methods agree vs other Muscle Relaxants: PRR 6.0 (5.5–6.5) | Outcome field, not a reaction | serious PRR 16.0 · 97% clinician | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,323 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.386 | 1.1 EB05 1.1 · IC025 +0.1 vs other Muscle Relaxants: PRR 2.0 (1.9–2.2) | Reporting / coding artifact | serious PRR 1.2 | not reported in cached trials |
| Nausea | 1,291 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.871 | 1.8 EB05 1.7 · IC025 +0.8 vs other Muscle Relaxants: PRR 1.8 (1.7–1.9) | Labeled adverse reaction exact term | serious PRR 1.7 | NCT00671502: 12/280 (4.3%) on Carisoprodol; 6/275 (2.2%) control |
| Headache | 1,099 | 1.9 1.8–2.1ROR 2.0 · calibrated p 0.944 | 1.9 EB05 1.8 · IC025 +0.9 vs other Muscle Relaxants: PRR 2.0 (1.8–2.1) | Labeled adverse reaction exact term | serious PRR 2.0 | NCT00671502: 4/280 (1.4%) on Carisoprodol; 5/275 (1.8%) control |
| Anxiety | 993 | 3.9 3.6–4.1ROR 4.0 · calibrated p 0.375 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree vs other Muscle Relaxants: PRR 2.6 (2.4–2.8) | Not in label — unassessed | serious PRR 4.0 | NCT00671879: 1/275 (0.4%) on Carisoprodol; 1/274 (0.4%) control |
| Depression | 990 | 4.8 4.5–5.1ROR 5.0 · calibrated p 0.233 | 4.8 EB05 4.5 · IC025 +2.2 3/3 methods agree vs other Muscle Relaxants: PRR 2.8 (2.6–3.1) | Labeled adverse reaction exact term | serious PRR 4.7 | not reported in cached trials |
| Fatigue (tiredness) | 983 | 1.4 1.3–1.5ROR 1.4 · calibrated p 0.590 | 1.4 EB05 1.3 · IC025 +0.4 vs other Muscle Relaxants: PRR 1.4 (1.3–1.5) | Not in label — unassessed | serious PRR 1.3 | NCT00671502: 5/280 (1.8%) on Carisoprodol; 2/275 (0.7%) control |
| Toxicity to various agents | 907 | 6.0 5.6–6.4ROR 6.3 · calibrated p 0.135 | 6.0 EB05 5.6 · IC025 +2.5 3/3 methods agree vs other Muscle Relaxants: PRR 5.5 (5.0–6.1) | Not in label — unassessed | serious PRR 5.1 | not reported in cached trials |
| Insomnia (trouble sleeping) | 829 | 3.4 3.2–3.7ROR 3.6 · calibrated p 0.472 | 3.4 EB05 3.2 · IC025 +1.7 3/3 methods agree vs other Muscle Relaxants: PRR 3.2 (2.9–3.5) | Labeled adverse reaction exact term | serious PRR 3.7 | NCT00671879: 3/275 (1.1%) on Carisoprodol; 3/274 (1.1%) control |
| Vomiting | 816 | 1.9 1.8–2.1ROR 2.0 · calibrated p 0.926 | 1.9 EB05 1.8 · IC025 +0.8 vs other Muscle Relaxants: PRR 2.2 (2.1–2.4) | Labeled adverse reaction exact term | serious PRR 1.8 | NCT00671879: 1/275 (0.4%) on Carisoprodol |
| Drug dependence | 796 | 5.4 5.1–5.8ROR 5.6 · calibrated p 0.177 | 5.4 EB05 5.1 · IC025 +2.3 3/3 methods agree vs other Muscle Relaxants: PRR 6.2 (5.6–6.9) | Reporting / coding artifact | serious PRR 4.6 · ♀ 48% (drug 71%) | not reported in cached trials |
| Fall | 789 | 2.6 2.5–2.8ROR 2.7 · calibrated p 0.733 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Muscle Relaxants: PRR 1.5 (1.4–1.7) | Not in label — unassessed | serious PRR 2.3 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 743 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.623 | 1.5 EB05 1.4 · IC025 +0.4 vs other Muscle Relaxants: PRR 1.6 (1.5–1.8) | Not in label — unassessed | serious PRR 1.3 | not reported in cached trials |
| Overdose | 736 | 3.8 3.5–4.0ROR 3.9 · calibrated p 0.402 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree vs other Muscle Relaxants: PRR 5.0 (4.5–5.6) | Reporting / coding artifact | serious PRR 3.8 | not reported in cached trials |
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.
- Chronic kidney disease-mineral and bone disorder — n=40, PRR 42.7
- Accidental death — n=68, PRR 42.1
- Myofascial pain syndrome — n=21, PRR 33.5
- Drug tolerance increased — n=23, PRR 33.3
- Drug abuser — n=130, PRR 23.5
- Respiratory arrest — n=571, PRR 23.2
- Joint sprain — n=20, PRR 21.2
- Nephrogenic anaemia — n=85, PRR 20.5
- Rebound acid hypersecretion — n=55, PRR 20.2
- Lumbar radiculopathy — n=20, PRR 19.2
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 Carisoprodol?
In FDA FAERS, the most frequently co-reported reaction terms for Carisoprodol are pain, nausea, headache, anxiety, depression, fatigue. 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 Carisoprodol have an FDA boxed warning?
No. The FDA label retrieved for Carisoprodol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Carisoprodol 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 2178e805-8189-459f-a447-21bf1547744a, effective 20220501; matched on
openfda.generic_name.exact:"CARISOPRODOL") - 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, 1,159 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
CARISOPRODOL, 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.