Celecoxib side effects: what 130,858 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug
Who reports
130,858 reports · 70% serious · 12,399 with death outcome · 70% female
Used for
1. INDICATIONS AND USAGE Celecoxib capsules are indicated Celecoxib capsules are nonsteroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years an.
What it is
Celecoxib is a member of the class of pyrazoles that is 1H-pyrazole which is substituted at positions 1, 3 and 5 by 4-sulfamoylphenyl, trifluoromethyl and p-tolyl groups, respectively.
Boxed warning
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.
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 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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,169 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 |
|---|---|---|---|---|---|---|
| Grip strength | 140 | 247.1 189.5–322.3ROR 247.4 · χ² 13,242 / p <1e-300 | 95.4 EB05 82.9 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=140 · ♀ 100% (drug 70%) · 100% clinician | not reported in cached trials |
| C-reactive protein | 507 | 204.8 179.4–233.7ROR 205.6 · χ² 44,545 / p <1e-300 | 89.2 EB05 82.8 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=506 · ♀ 100% (drug 70%) · 100% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 1,060 | 190.1 173.9–207.9ROR 191.6 · χ² 90,145 / p <1e-300 | 86.4 EB05 82.2 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=1,060 · ♀ 100% (drug 70%) · 96% clinician | not reported in cached trials |
| Lupus vulgaris | 603 | 165.6 147.7–185.7ROR 166.4 · χ² 47,954 / p <1e-300 | 80.9 EB05 75.7 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=603 · ♀ 100% (drug 70%) · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 1,517 | 149.4 139.3–160.3ROR 151.2 · χ² 114,569 / p <1e-300 | 77.0 EB05 73.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=1,516 · ♀ 100% (drug 70%) · 95% clinician | NCT00346216: 1/7,933 (0.0%) on Celecoxib (serious AE) |
| Swollen joint count | 116 | 143.5 111.6–184.6ROR 143.6 · χ² 8,504 / p <1e-300 | 74.6 EB05 63.9 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=116 · ♀ 100% (drug 70%) · 100% clinician | not reported in cached trials |
| Presbyacusis | 144 | 138.8 110.9–173.7ROR 138.9 · χ² 10,386 / p <1e-300 | 73.5 EB05 63.9 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=144 · ♀ 100% (drug 70%) | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 304 | 134.5 115.4–156.8ROR 134.8 · χ² 21,634 / p <1e-300 | 72.6 EB05 66.0 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=304 · ♀ 100% (drug 70%) · 100% clinician | not reported in cached trials |
| Swollen joint count increased | 1,335 | 120.3 112.0–129.1ROR 121.5 · χ² 89,377 / p <1e-300 | 68.5 EB05 65.5 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious n=1,334 · ♀ 100% (drug 70%) · 95% clinician | not reported in cached trials |
| Rheumatic fever | 1,848 | 117.8 111.0–125.1ROR 119.5 · χ² 122,283 / p <1e-300 | 67.7 EB05 65.2 · IC025 +6.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=1,848 · ♀ 100% (drug 70%) · 95% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 696 | 84.5 77.1–92.6ROR 84.9 · χ² 37,293 / p <1e-300 | 55.2 EB05 51.9 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=693 · ♀ 100% (drug 70%) · 94% clinician | not reported in cached trials |
| Dislocation of vertebra | 702 | 73.8 67.5–80.7ROR 74.2 · χ² 34,261 / p <1e-300 | 50.5 EB05 47.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=701 · ♀ 100% (drug 70%) · 93% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 2,204 | 68.7 65.3–72.2ROR 69.8 · χ² 102,265 / p <1e-300 | 48.1 EB05 46.4 · IC025 +5.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 39.4 · ♀ 100% (drug 70%) · 96% clinician | NCT00346216: 2/7,933 (0.0%) on Celecoxib (serious AE) |
| C-reactive protein abnormal | 1,816 | 63.3 59.9–66.8ROR 64.2 · χ² 79,339 / p <1e-300 | 45.4 EB05 43.7 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious n=1,815 · ♀ 100% (drug 70%) · 92% clinician | not reported in cached trials |
| Rheumatoid factor positive | 1,608 | 61.8 58.4–65.5ROR 62.6 · χ² 69,015 / p <1e-300 | 44.6 EB05 42.8 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious n=1,608 · ♀ 100% (drug 70%) · 95% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 1,905 | 58.6 55.6–61.7ROR 59.4 · χ² 78,507 / p <1e-300 | 42.9 EB05 41.3 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious PRR 35.3 · ♀ 100% (drug 70%) · 95% clinician | not reported in cached trials |
| X-ray abnormal | 470 | 57.2 51.4–63.5ROR 57.4 · χ² 18,973 / p <1e-300 | 42.1 EB05 39.0 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=470 · ♀ 100% (drug 70%) · 100% clinician | not reported in cached trials |
| Granuloma skin | 210 | 54.3 46.4–63.5ROR 54.3 · χ² 8,121 / p <1e-300 | 40.5 EB05 36.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=209 · ♀ 100% (drug 70%) · 100% clinician | not reported in cached trials |
| Peripheral venous disease | 999 | 53.3 49.6–57.3ROR 53.7 · χ² 38,265 / p <1e-300 | 40.0 EB05 38.0 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=997 · ♀ 100% (drug 70%) · 94% clinician | NCT00346216: 1/7,992 (0.0%) on Celecoxib (serious AE) |
| Retinitis | 404 | 51.0 45.6–57.1ROR 51.2 · χ² 14,919 / p <1e-300 | 38.7 EB05 35.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=404 · ♀ 100% (drug 70%) · 100% clinician | not reported in cached trials |
| Amaurosis fugax | 241 | 46.5 40.2–53.6ROR 46.5 · χ² 8,238 / p <1e-300 | 36.0 EB05 32.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=241 · 100% clinician | not reported in cached trials |
| Pleural thickening | 148 | 44.3 36.9–53.1ROR 44.3 · χ² 4,851 / p <1e-300 | 34.6 EB05 30.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=148 | not reported in cached trials |
| Helicobacter infection | 2,172 | 43.2 41.3–45.3ROR 44.0 · χ² 70,293 / p <1e-300 | 34.1 EB05 32.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 29.5 · ♀ 100% (drug 70%) · 95% clinician | not reported in cached trials |
| Folliculitis | 2,133 | 41.6 39.6–43.6ROR 42.2 · χ² 66,779 / p <1e-300 | 33.1 EB05 31.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 31.8 · ♀ 100% (drug 70%) · 96% clinician | not reported in cached trials |
| Seronegative arthritis | 230 | 41.2 35.6–47.6ROR 41.2 · χ² 7,109 / p <1e-300 | 32.7 EB05 29.3 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=229 · ♀ 100% (drug 70%) · 100% clinician | not reported in cached trials |
| Muscle injury | 1,677 | 41.0 38.9–43.3ROR 41.5 · χ² 51,902 / p <1e-300 | 32.7 EB05 31.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 29.0 · ♀ 100% (drug 70%) · 95% clinician | not reported in cached trials |
| Breast cancer stage iii | 1,278 | 39.6 37.2–42.1ROR 40.0 · χ² 38,368 / p <1e-300 | 31.8 EB05 30.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=1,278 · ♀ 100% (drug 70%) · 96% clinician | NCT00346216: 1/7,933 (0.0%) on Celecoxib (serious AE) |
| Hand deformity | 2,540 | 38.5 36.8–40.2ROR 39.2 · χ² 74,482 / p <1e-300 | 31.1 EB05 30.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 27.5 · ♀ 99% (drug 70%) · 93% clinician | not reported in cached trials |
| Bone erosion | 670 | 37.2 34.2–40.5ROR 37.4 · χ² 19,072 / p <1e-300 | 30.3 EB05 28.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=666 · ♀ 100% (drug 70%) | NCT00346216: 1/7,933 (0.0%) on Celecoxib (serious AE) |
| Pemphigus | 2,203 | 34.4 32.8–36.0ROR 35.0 · χ² 58,585 / p <1e-300 | 28.4 EB05 27.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 · ♀ 100% (drug 70%) · 96% clinician | not reported in cached trials |
| Synovitis | 3,119 | 33.4 32.1–34.7ROR 34.1 · χ² 80,779 / p <1e-300 | 27.7 EB05 26.9 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 23.6 · ♀ 94% (drug 70%) · 91% clinician | NCT00346216: 1/8,030 (0.0%) on Celecoxib (serious AE) |
| Pleural fibrosis | 174 | 32.4 27.5–38.2ROR 32.5 · χ² 4,367 / p <1e-300 | 27.0 EB05 23.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=174 · ♀ 100% (drug 70%) | not reported in cached trials |
| Overlap syndrome | 116 | 32.3 26.4–39.4ROR 32.3 · χ² 2,889 / p <1e-300 | 26.8 EB05 23.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=116 · ♀ 100% (drug 70%) · 100% clinician | NCT00346216: 1/7,992 (0.0%) on Celecoxib (serious AE) |
| Sleep disorder due to general medical condition, insomnia type | 1,072 | 31.9 29.9–34.0ROR 32.1 · χ² 26,638 / p <1e-300 | 26.7 EB05 25.3 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=1,062 · ♀ 100% (drug 70%) · 96% clinician | not reported in cached trials |
| Red blood cell sedimentation rate abnormal | 379 | 31.0 27.8–34.7ROR 31.1 · χ² 9,178 / p <1e-300 | 26.1 EB05 23.9 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=377 · ♀ 100% (drug 70%) | not reported in cached trials |
| Porphyria acute | 224 | 30.9 26.8–35.7ROR 30.9 · χ² 5,390 / p <1e-300 | 25.9 EB05 23.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=224 · ♀ 100% (drug 70%) · 100% clinician | not reported in cached trials |
| Enthesopathy | 255 | 30.8 26.9–35.2ROR 30.8 · χ² 6,117 / p <1e-300 | 25.9 EB05 23.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=252 | not reported in cached trials |
| Lip dry | 1,440 | 30.6 28.9–32.3ROR 30.9 · χ² 34,454 / p <1e-300 | 25.7 EB05 24.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=1,426 · ♀ 100% (drug 70%) · 95% clinician | not reported in cached trials |
| Blood parathyroid hormone decreased | 237 | 30.1 26.2–34.6ROR 30.2 · χ² 5,580 / p <1e-300 | 25.4 EB05 22.8 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=237 · ♀ 100% (drug 70%) | not reported in cached trials |
| Drug tolerance decreased | 445 | 30.1 27.2–33.4ROR 30.2 · χ² 10,498 / p <1e-300 | 25.4 EB05 23.5 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=441 · ♀ 100% (drug 70%) | 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 Celecoxib 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 (7 of 40 signal terms matched).
- NCT00346216 — Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen (N=24081, PHASE4; 1238 AE terms posted; arms: Celecoxib; Ibuprofen; Naproxen)
- NCT00373685 — GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (N=8067, PHASE4; 185 AE terms posted; arms: Celecoxib; nsNSAIDs)
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) | 18,078 | 2.2 2.2–2.2ROR 2.4 · χ² 12,702 / p <1e-300 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 | not reported in cached trials |
| Pain | 12,602 | 3.3 3.3–3.4ROR 3.6 · χ² 20,724 / p <1e-300 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.3 | NCT00346216: 14/8,030 (0.2%) on Celecoxib (serious AE) |
| Arthralgia (joint pain) | 11,255 | 4.4 4.4–4.5ROR 4.8 · χ² 29,829 / p <1e-300 | 4.4 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | NCT00346216: 44/8,030 (0.5%) on Celecoxib (serious AE) |
| Fatigue (tiredness) | 10,097 | 2.1 2.1–2.1ROR 2.2 · χ² 5,936 / p <1e-300 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | NCT00346216: 2/8,030 (0.0%) on Celecoxib (serious AE) |
| Nausea | 9,771 | 2.0 2.0–2.0ROR 2.1 · χ² 4,988 / p <1e-300 | 2.0 EB05 2.0 · IC025 +1.0 | Labeled adverse reaction exact term | serious PRR 2.5 | NCT00346216: 5/8,030 (0.1%) on Celecoxib (serious AE) |
| Off label use (used outside approved label) | 8,086 | 1.5 1.5–1.5ROR 1.5 · χ² 1,381 / p <1e-300 | 1.5 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 2.0 | not reported in cached trials |
| Drug hypersensitivity | 7,938 | 6.8 6.6–6.9ROR 7.2 · χ² 37,901 / p <1e-300 | 6.5 EB05 6.4 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.3 | NCT00346216: 3/7,933 (0.0%) on Celecoxib (serious AE) |
| Diarrhoea (diarrhea) | 7,597 | 1.9 1.9–1.9ROR 2.0 · χ² 3,318 / p <1e-300 | 1.9 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.2 | NCT00346216: 3/8,030 (0.0%) on Celecoxib (serious AE) |
| Headache | 7,506 | 1.9 1.9–2.0ROR 2.0 · χ² 3,436 / p <1e-300 | 1.9 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.6 | NCT00346216: 4/8,030 (0.0%) on Celecoxib (serious AE) |
| Rheumatoid arthritis | 7,458 | 11.3 11.0–11.5ROR 11.9 · χ² 65,355 / p <1e-300 | 10.6 EB05 10.4 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 10.2 · ♀ 91% (drug 70%) | NCT00346216: 8/8,030 (0.1%) on Celecoxib (serious AE) |
| Myocardial infarction (heart attack) | 7,048 | 6.7 6.5–6.8ROR 7.0 · χ² 32,737 / p <1e-300 | 6.4 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.3 · ♀ 49% (drug 70%) | NCT00346216: 22/8,030 (0.3%) on Celecoxib (serious AE) |
| Rash | 6,548 | 2.4 2.4–2.5ROR 2.5 · χ² 5,603 / p <1e-300 | 2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | NCT00346216: 1/8,030 (0.0%) on Celecoxib (serious AE) |
| Malaise (feeling unwell) | 6,475 | 2.4 2.3–2.4ROR 2.5 · χ² 5,216 / p <1e-300 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | NCT00346216: 1/7,992 (0.0%) on Celecoxib (serious AE) |
| Dizziness | 6,443 | 2.1 2.0–2.1ROR 2.1 · χ² 3,690 / p <1e-300 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | NCT00346216: 6/8,030 (0.1%) on Celecoxib (serious AE) |
| Condition aggravated | 6,417 | 3.5 3.4–3.5ROR 3.6 · χ² 11,126 / p <1e-300 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree | 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.
- Grip strength — n=140, PRR 247.1
- Deep vein thrombosis postoperative — n=1,060, PRR 190.1
- Lupus vulgaris — n=603, PRR 165.6
- Facet joint syndrome — n=1,517, PRR 149.4 (also seen in trial arm)
- Swollen joint count — n=116, PRR 143.5
- Presbyacusis — n=144, PRR 138.8
- Adjustment disorder with depressed mood — n=696, PRR 84.5
- Dislocation of vertebra — n=702, PRR 73.8
- Granuloma skin — n=210, PRR 54.3
- Retinitis — n=404, PRR 51.0
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 Celecoxib?
In FDA FAERS, the most frequently co-reported reaction terms for Celecoxib are pain, arthralgia, fatigue, nausea, drug hypersensitivity, 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 Celecoxib have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.
Do FAERS signals prove that Celecoxib 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 06076494-62ad-4f58-b8bb-7038fcfe3b12, effective 20260717; matched on
openfda.generic_name.exact:"CELECOXIB" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 2662 description (ChEBI)
- 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, 1,209 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
CELECOXIB, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.