Meloxicam side effects: what 57,729 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug
Who reports
57,729 reports · 58% serious · 3,732 with death outcome · 72% female
Used for
Meloxicam tablet USP is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3 ) 1.1 Osteoarthritis (OA Meloxicam tablets USP are indicated for relief of the signs and symptoms of osteoarthritis .
What it is
Meloxicam, is a nonsteroidal anti-inflammatory drug (NSAID). Each light yellow meloxicam tablet USP contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N -(5-methyl-2-thiazolyl)-2 H -1,2-benzothiazine-3-carboxamide-1,1-dioxide.
Boxed warning
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning . Nonsteroidal anti-inflammat.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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.
- 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, 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). 1,142 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Synovial fluid analysis | 64 | 1,039.4 640.4–1,687.0ROR 1,040.5 · calibrated p 7e-16 ✓ | 247.0 EB05 200.3 · IC025 +6.0 3/3 methods agree vs other NSAIDs: PRR 46.8 (33.1–66.0) | Reporting / coding artifact | serious n=64 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Grip strength | 127 | 444.9 342.8–577.2ROR 445.8 · calibrated p 4e-13 ✓ | 193.0 EB05 166.4 · IC025 +6.5 3/3 methods agree vs other NSAIDs: PRR 20.5 (16.7–25.3) | Not in label — unassessed | serious n=127 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Swollen joint count | 82 | 182.0 139.5–237.4ROR 182.2 · calibrated p 2e-9 ✓ | 117.7 EB05 97.8 · IC025 +5.8 3/3 methods agree vs other NSAIDs: PRR 14.3 (11.2–18.3) | Not in label — unassessed | serious n=82 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| C-reactive protein | 251 | 139.0 120.2–160.8ROR 139.6 · calibrated p 1e-8 ✓ | 99.6 EB05 89.7 · IC025 +6.2 3/3 methods agree vs other NSAIDs: PRR 3.4 (3.0–3.8) | Lab value / disease marker | serious n=250 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 491 | 121.4 109.6–134.4ROR 122.4 · calibrated p 3e-8 ✓ | 90.6 EB05 84.0 · IC025 +6.2 3/3 methods agree vs other NSAIDs: PRR 3.0 (2.8–3.3) | Not in label — unassessed | serious n=491 · ♀ 100% (drug 72%) · 95% clinician | not reported in cached trials |
| Lupus vulgaris | 274 | 108.7 94.9–124.4ROR 109.2 · calibrated p 7e-8 ✓ | 83.1 EB05 75.1 · IC025 +6.0 3/3 methods agree vs other NSAIDs: PRR 2.9 (2.6–3.3) | Not in label — unassessed | serious n=274 · ♀ 100% (drug 72%) · 94% clinician | not reported in cached trials |
| Vital capacity decreased | 101 | 104.9 84.0–130.9ROR 105.1 · calibrated p 1e-7 ✓ | 80.1 EB05 67.8 · IC025 +5.5 3/3 methods agree vs other NSAIDs: only this drug | Not in label — unassessed | serious n=101 · ♀ 100% (drug 72%) | not reported in cached trials |
| Reversible airways obstruction | 103 | 90.9 73.2–112.8ROR 91.0 · calibrated p 3e-7 ✓ | 71.7 EB05 60.8 · IC025 +5.4 3/3 methods agree vs other NSAIDs: only this drug | Not in label — unassessed | serious n=103 · ♀ 100% (drug 72%) | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 108 | 70.0 57.0–86.1ROR 70.2 · calibrated p 2e-6 ✓ | 58.1 EB05 49.5 · IC025 +5.2 3/3 methods agree vs other NSAIDs: PRR 2.0 (1.6–2.4) | Lab value / disease marker | serious n=108 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| X-ray abnormal | 283 | 68.4 60.2–77.6ROR 68.7 · calibrated p 2e-6 ✓ | 57.3 EB05 51.9 · IC025 +5.5 3/3 methods agree vs other NSAIDs: PRR 2.8 (2.4–3.1) | Lab value / disease marker | serious n=283 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Swollen joint count increased | 493 | 68.1 61.9–75.0ROR 68.7 · calibrated p 2e-6 ✓ | 57.2 EB05 53.1 · IC025 +5.6 3/3 methods agree vs other NSAIDs: PRR 2.2 (2.0–2.4) | Lab value / disease marker | serious n=492 · ♀ 100% (drug 72%) · 94% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 283 | 59.2 52.2–67.2ROR 59.5 · calibrated p 5e-6 ✓ | 50.8 EB05 46.0 · IC025 +5.4 3/3 methods agree vs other NSAIDs: PRR 2.1 (1.9–2.4) | Not in label — unassessed | serious n=282 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Tenosynovitis stenosans | 77 | 57.9 45.5–73.7ROR 58.0 · calibrated p 7e-6 ✓ | 49.4 EB05 40.8 · IC025 +4.9 3/3 methods agree vs other NSAIDs: PRR 19.0 (14.6–24.8) | Not in label — unassessed | serious n=77 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Rheumatic fever | 557 | 53.0 48.5–57.9ROR 53.5 · calibrated p 9e-6 ✓ | 46.2 EB05 43.1 · IC025 +5.3 3/3 methods agree vs other NSAIDs: PRR 1.9 (1.7–2.0) | Likely indication confounding shares a disease stem with the indications wording | serious n=557 · ♀ 100% (drug 72%) · 94% clinician | not reported in cached trials |
| Sputum culture positive | 102 | 51.2 41.6–63.0ROR 51.3 · calibrated p 1e-5 ✓ | 44.5 EB05 37.8 · IC025 +4.9 3/3 methods agree vs other NSAIDs: only this drug | Lab value / disease marker | serious n=102 · ♀ 100% (drug 72%) | not reported in cached trials |
| Porphyria acute | 163 | 48.5 41.2–57.1ROR 48.7 · calibrated p 2e-5 ✓ | 42.6 EB05 37.4 · IC025 +5.0 3/3 methods agree vs other NSAIDs: PRR 3.7 (3.2–4.4) | Not in label — unassessed | serious n=163 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Dislocation of vertebra | 260 | 48.0 42.2–54.6ROR 48.2 · calibrated p 2e-5 ✓ | 42.3 EB05 38.2 · IC025 +5.1 3/3 methods agree vs other NSAIDs: PRR 2.0 (1.7–2.2) | Not in label — unassessed | serious n=259 · ♀ 100% (drug 72%) · 90% clinician | not reported in cached trials |
| Retinitis | 185 | 45.2 38.8–52.6ROR 45.3 · calibrated p 3e-5 ✓ | 40.1 EB05 35.5 · IC025 +4.9 3/3 methods agree vs other NSAIDs: PRR 2.6 (2.3–3.1) | Not in label — unassessed | serious n=185 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Allergy to chemicals | 134 | 43.7 36.6–52.3ROR 43.8 · calibrated p 3e-5 ✓ | 38.9 EB05 33.6 · IC025 +4.8 3/3 methods agree vs other NSAIDs: only this drug | Not in label — unassessed | serious n=133 · ♀ 100% (drug 72%) | not reported in cached trials |
| Facet joint syndrome | 315 | 40.2 35.8–45.2ROR 40.5 · calibrated p 5e-5 ✓ | 36.2 EB05 33.0 · IC025 +4.9 3/3 methods agree vs other NSAIDs: PRR 1.5 (1.4–1.7) | Not in label — unassessed | serious n=314 · ♀ 97% (drug 72%) · 92% clinician | not reported in cached trials |
| Rheumatoid factor positive | 554 | 38.5 35.3–42.0ROR 38.9 · calibrated p 6e-5 ✓ | 34.8 EB05 32.4 · IC025 +4.9 3/3 methods agree vs other NSAIDs: PRR 1.8 (1.7–2.0) | Lab value / disease marker | serious n=553 · ♀ 100% (drug 72%) · 94% clinician | not reported in cached trials |
| C-reactive protein abnormal | 611 | 38.2 35.2–41.5ROR 38.6 · calibrated p 7e-5 ✓ | 34.6 EB05 32.3 · IC025 +4.9 3/3 methods agree vs other NSAIDs: PRR 2.1 (1.9–2.3) | Lab value / disease marker | serious n=611 · ♀ 100% (drug 72%) · 92% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 648 | 35.1 32.4–38.0ROR 35.5 · calibrated p 1e-4 ✓ | 32.0 EB05 30.0 · IC025 +4.8 3/3 methods agree vs other NSAIDs: PRR 1.2 (1.1–1.3) | Labeled — boxed warning synonym match | serious PRR 31.9 · ♀ 97% (drug 72%) · 94% clinician | not reported in cached trials |
| Rebound acid hypersecretion | 267 | 34.6 30.5–39.2ROR 34.7 · calibrated p 1e-4 ✓ | 31.5 EB05 28.5 · IC025 +4.7 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.2–5.4) | Not in label — unassessed | serious n=267 · 100% consumer | not reported in cached trials |
| Bronchial secretion retention | 105 | 32.8 26.9–40.1ROR 32.9 · calibrated p 2e-4 ✓ | 30.0 EB05 25.5 · IC025 +4.4 3/3 methods agree vs other NSAIDs: only this drug | Not in label — unassessed | serious n=105 · ♀ 100% (drug 72%) | not reported in cached trials |
| Tenosynovitis | 227 | 32.4 28.3–37.1ROR 32.5 · calibrated p 2e-4 ✓ | 29.7 EB05 26.6 · IC025 +4.6 3/3 methods agree vs other NSAIDs: PRR 4.6 (4.0–5.3) | Not in label — unassessed | serious n=226 · ♀ 100% (drug 72%) | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 571 | 31.7 29.1–34.5ROR 32.0 · calibrated p 2e-4 ✓ | 29.1 EB05 27.2 · IC025 +4.7 3/3 methods agree vs other NSAIDs: PRR 1.1 (1.1–1.2) | Lab value / disease marker | serious PRR 29.2 · ♀ 100% (drug 72%) · 95% clinician | not reported in cached trials |
| Peripheral venous disease | 305 | 30.0 26.7–33.7ROR 30.1 · calibrated p 3e-4 ✓ | 27.7 EB05 25.2 · IC025 +4.5 3/3 methods agree vs other NSAIDs: PRR 1.8 (1.6–2.0) | Labeled (related wording) related wording | serious n=303 · ♀ 100% (drug 72%) · 92% clinician | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 81 | 29.5 23.5–37.0ROR 29.5 · calibrated p 3e-4 ✓ | 27.2 EB05 22.6 · IC025 +4.2 3/3 methods agree vs other NSAIDs: PRR 3.1 (2.5–3.9) | Not in label — unassessed | serious n=81 | not reported in cached trials |
| Seronegative arthritis | 79 | 27.4 21.8–34.5ROR 27.5 · calibrated p 5e-4 ✓ | 25.4 EB05 21.0 · IC025 +4.1 3/3 methods agree vs other NSAIDs: PRR 2.3 (1.8–2.9) | Likely indication confounding shares a disease stem with the indications wording | serious n=79 | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 443 | 26.8 24.3–29.5ROR 27.0 · calibrated p 5e-4 ✓ | 25.0 EB05 23.1 · IC025 +4.4 3/3 methods agree vs other NSAIDs: PRR 1.2 (1.1–1.4) | Labeled (related wording) related wording | serious n=433 · ♀ 100% (drug 72%) · 93% clinician | not reported in cached trials |
| Bone erosion | 243 | 26.7 23.4–30.4ROR 26.8 · calibrated p 5e-4 ✓ | 24.9 EB05 22.3 · IC025 +4.4 3/3 methods agree vs other NSAIDs: PRR 2.9 (2.5–3.3) | Not in label — unassessed | serious n=243 · ♀ 95% (drug 72%) | not reported in cached trials |
| Rheumatoid lung | 66 | 26.6 20.8–34.2ROR 26.7 · calibrated p 6e-4 ✓ | 24.7 EB05 20.1 · IC025 +4.0 3/3 methods agree vs other NSAIDs: PRR 10.3 (7.9–13.4) | Labeled (related wording) related wording | serious n=64 · ♀ 100% (drug 72%) | not reported in cached trials |
| Blood folate decreased | 47 | 25.1 18.7–33.8ROR 25.2 · calibrated p 8e-4 ✓ | 23.4 EB05 18.3 · IC025 +3.8 3/3 methods agree vs other NSAIDs: only this drug | Lab value / disease marker | serious n=47 · ♀ 100% (drug 72%) · 100% clinician | not reported in cached trials |
| Synovial cyst | 299 | 24.9 22.2–28.0ROR 25.1 · calibrated p 7e-4 ✓ | 23.3 EB05 21.2 · IC025 +4.3 3/3 methods agree vs other NSAIDs: PRR 9.4 (8.3–10.7) | Not in label — unassessed | serious n=287 · ♀ 93% (drug 72%) | not reported in cached trials |
| Muscle injury | 509 | 24.0 21.9–26.2ROR 24.2 · calibrated p 8e-4 ✓ | 22.5 EB05 20.9 · IC025 +4.3 3/3 methods agree vs other NSAIDs: PRR 1.0 (0.9–1.1) | Not in label — unassessed | serious PRR 24.0 · ♀ 100% (drug 72%) · 93% clinician | not reported in cached trials |
| Rheumatoid nodule | 171 | 23.7 20.3–27.7ROR 23.8 · calibrated p 9e-4 ✓ | 22.2 EB05 19.6 · IC025 +4.1 3/3 methods agree vs other NSAIDs: PRR 3.1 (2.7–3.6) | Likely indication confounding shares a disease stem with the indications wording | serious n=168 · ♀ 100% (drug 72%) | not reported in cached trials |
| Hyperparathyroidism secondary | 153 | 23.3 19.8–27.4ROR 23.4 · calibrated p 0.001 ✓ | 21.9 EB05 19.1 · IC025 +4.1 3/3 methods agree vs other NSAIDs: PRR 2.4 (2.1–2.9) | Not in label — unassessed | serious n=153 | not reported in cached trials |
| Helicobacter infection | 615 | 23.3 21.4–25.2ROR 23.5 · calibrated p 9e-4 ✓ | 21.9 EB05 20.5 · IC025 +4.3 3/3 methods agree vs other NSAIDs: PRR 1.1 (1.0–1.2) | Not in label — unassessed | serious PRR 23.0 · ♀ 100% (drug 72%) · 93% clinician | not reported in cached trials |
| Hand deformity | 787 | 23.2 21.6–24.9ROR 23.5 · calibrated p 9e-4 ✓ | 21.8 EB05 20.6 · IC025 +4.3 3/3 methods agree vs other NSAIDs: PRR 1.4 (1.3–1.5) | Not in label — unassessed | serious PRR 23.4 · ♀ 100% (drug 72%) | not reported in cached trials |
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 |
|---|---|---|---|
| Tendon disorder | 326 | 3.12.8–3.5 | signal |
| Depression | 1,907 | 2.52.4–2.6 | signal |
| Kidney injury | 2,960 | 2.42.3–2.4 | signal |
| Interstitial lung disease | 614 | 2.32.2–2.5 | signal |
| Fall / fracture | 2,120 | 2.01.9–2.1 | raised |
| Serious infection | 4,291 | 2.02.0–2.1 | raised |
| Gi bleeding | 1,010 | 2.01.9–2.1 | raised |
| Liver injury | 1,507 | 1.81.7–1.9 | raised |
| Hyperglycaemia / diabetes | 1,506 | 1.61.5–1.7 | raised |
| Pancreatitis | 351 | 1.61.4–1.8 | raised |
| Opportunistic infection | 562 | 1.51.4–1.6 | raised |
| Suicidality | 904 | 1.31.3–1.4 | raised |
| Venous thromboembolism | 706 | 1.21.1–1.3 | raised |
| Hyponatraemia | 257 | 1.21.0–1.3 | raised |
| Anaemia | 946 | 1.11.1–1.2 | raised |
| Osteonecrosis | 176 | 1.11.0–1.3 | no difference |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Meloxicam 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 (0 of 40 signal terms matched).
- NCT03896009 — Maximizing Outcomes in Treating Acute Migraine (N=1594, PHASE3; 5 AE terms posted; arms: AXS-07; Meloxicam; Rizatriptan; 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 6,105 | 1.7 1.6–1.7ROR 1.8 · calibrated p 0.811 | 1.7 EB05 1.6 · IC025 +0.7 vs other NSAIDs: PRR 1.5 (1.4–1.5) | Reporting / coding artifact | age-adj. PRR 1.9 · serious PRR 2.7 | not reported in cached trials |
| Pain | 4,823 | 2.9 2.8–2.9ROR 3.0 · calibrated p 0.616 | 2.8 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other NSAIDs: PRR 1.4 (1.4–1.5) | Labeled adverse reaction exact term | age-adj. PRR 3.1 · serious PRR 3.1 | not reported in cached trials |
| Fatigue (tiredness) | 4,758 | 2.2 2.2–2.3ROR 2.3 · calibrated p 0.883 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other NSAIDs: PRR 1.3 (1.3–1.4) | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 2.7 | not reported in cached trials |
| Arthralgia (joint pain) | 4,367 | 3.9 3.7–4.0ROR 4.1 · calibrated p 0.361 | 3.8 EB05 3.7 · IC025 +1.9 3/3 methods agree vs other NSAIDs: PRR 1.7 (1.6–1.7) | Labeled adverse reaction exact term | age-adj. PRR 3.5 · serious PRR 5.1 | not reported in cached trials |
| Nausea | 3,978 | 1.8 1.8–1.9ROR 1.9 · calibrated p 0.886 | 1.8 EB05 1.8 · IC025 +0.8 vs other NSAIDs: PRR 1.2 (1.2–1.3) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.2 | NCT03896009: 14/433 (3.2%) on Meloxicam; 8/218 (3.7%) control |
| Headache | 3,470 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.989 | 2.0 EB05 2.0 · IC025 +1.0 vs other NSAIDs: PRR 1.2 (1.2–1.3) | Labeled adverse reaction exact term | age-adj. PRR 1.9 · serious PRR 2.5 | not reported in cached trials |
| Diarrhoea (diarrhea) | 3,372 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.925 | 1.9 EB05 1.8 · IC025 +0.9 vs other NSAIDs: PRR 1.3 (1.3–1.4) | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 2.2 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 2,782 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.847 | 1.8 EB05 1.7 · IC025 +0.8 vs other NSAIDs: PRR 1.1 (1.0–1.1) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 1.9 | not reported in cached trials |
| Dizziness | 2,736 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.971 | 2.0 EB05 1.9 · IC025 +0.9 vs other NSAIDs: PRR 1.3 (1.2–1.3) | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 2.5 | NCT03896009: 5/433 (1.2%) on Meloxicam; 2/218 (0.9%) control |
| Off label use (used outside approved label) | 2,707 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.399 | 1.1 EB05 1.1 · IC025 +0.1 vs other NSAIDs: PRR 1.1 (1.1–1.1) | Reporting / coding artifact | age-adj. PRR 1.2 · serious PRR 1.4 | not reported in cached trials |
| Pain in extremity | 2,658 | 3.3 3.2–3.4ROR 3.4 · calibrated p 0.510 | 3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree vs other NSAIDs: PRR 1.7 (1.6–1.8) | Not in label — unassessed | age-adj. PRR 3.0 · serious PRR 4.2 | not reported in cached trials |
| Malaise (feeling unwell) | 2,570 | 2.1 2.1–2.2ROR 2.2 · calibrated p 0.960 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other NSAIDs: PRR 1.5 (1.5–1.6) | Labeled adverse reaction exact term | age-adj. PRR 2.1 · serious PRR 2.7 | not reported in cached trials |
| Chronic kidney disease | 2,340 | 11.4 11.0–11.9ROR 11.8 · calibrated p 0.018 ✓ | 11.1 EB05 10.7 · IC025 +3.4 3/3 methods agree vs other NSAIDs: PRR 2.5 (2.4–2.6) | Labeled (related wording) related wording | age-adj. PRR 9.9 · serious PRR 11.2 | not reported in cached trials |
| Vomiting | 2,339 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.859 | 1.8 EB05 1.8 · IC025 +0.8 vs other NSAIDs: PRR 1.0 (1.0–1.1) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.1 | not reported in cached trials |
| Rheumatoid arthritis | 2,318 | 7.6 7.3–7.9ROR 7.9 · calibrated p 0.070 | 7.4 EB05 7.2 · IC025 +2.8 3/3 methods agree vs other NSAIDs: PRR 2.0 (1.9–2.0) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 7.1 · serious PRR 8.3 · ♀ 92% (drug 72%) | 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.
- Grip strength — n=127, PRR 444.9
- Swollen joint count — n=82, PRR 182.0
- Deep vein thrombosis postoperative — n=491, PRR 121.4
- Lupus vulgaris — n=274, PRR 108.7
- Vital capacity decreased — n=101, PRR 104.9
- Reversible airways obstruction — n=103, PRR 90.9
- Adjustment disorder with depressed mood — n=283, PRR 59.2
- Tenosynovitis stenosans — n=77, PRR 57.9
- Porphyria acute — n=163, PRR 48.5
- Dislocation of vertebra — n=260, PRR 48.0
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 Meloxicam?
In FDA FAERS, the most frequently co-reported reaction terms for Meloxicam are pain, fatigue, arthralgia, nausea, headache, diarrhoea. 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 Meloxicam have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning . Nonsteroidal anti-inflammat.
Do FAERS signals prove that Meloxicam 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 06a401f0-4380-4081-86ed-a309a25abf6b, effective 20240808; matched on
openfda.generic_name.exact:"MELOXICAM") - 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, 1,182 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
MELOXICAM, 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.