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Piroxicam side effects: what 6,344 FDA adverse event reports show

Piroxicam · 631 reaction terms · 79,114 drug–reaction co-reports · data 2026-09-14
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Drug class

Nonsteroidal Anti-inflammatory Drug

FDA label (Established Pharmacologic Class) · compare the class

Who reports

6,344 reports · 84% serious · 1,103 with death outcome · 71% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Piroxicam Capsules are a nonsteroidal anti-inflammatory drug indicated for Relief of the signs and symptoms of osteoarthritis (OA) (1) Relief of the signs and symptoms of rheumatoid arthritis (RA) (1) Piroxicam Capsules are indicated: For relief of the signs and symptoms of osteoarthritis. For relief of the signs and symptoms of rheumatoid arthritis.

FDA label, Indications and Usage

What it is

Piroxicam Capsules USP is a nonsteroidal anti-inflammatory drug, available as maroon and blue #10 mg capsules and maroon #20 mg capsules for oral administration.

FDA label, Description section

Boxed warning

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning . Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.

FDA 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) 3Likely indication confounding 1Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 31
What the badges mean

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. 591 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Helicobacter infection498169.8
155.7–185.1ROR 184.1 · χ² 79,292 / p <1e-300
160.4 EB05 148.9 · IC025 +7.0
3/3 methods agree
Not in label — unassessedserious PRR 117.5 · ♀ 100% (drug 71%) · 94% cliniciannot reported in cached trials
Sciatica772169.1
158.0–181.0ROR 192.4 · χ² 122,603 / p <1e-300
160.2 EB05 150.9 · IC025 +7.1
3/3 methods agree
Not in label — unassessedserious PRR 148.4 · ♀ 99% (drug 71%) · 91% cliniciannot reported in cached trials
Folliculitis480161.1
147.5–176.0ROR 174.2 · χ² 72,651 / p <1e-300
152.6 EB05 141.5 · IC025 +6.9
3/3 methods agree
Not in label — unassessedserious PRR 124.4 · ♀ 100% (drug 71%) · 95% cliniciannot reported in cached trials
Autoimmune disorder430155.5
141.6–170.7ROR 166.7 · χ² 62,874 / p <1e-300
147.5 EB05 136.1 · IC025 +6.8
3/3 methods agree
Not in label — unassessedserious PRR 109.4 · ♀ 100% (drug 71%) · 94% cliniciannot reported in cached trials
Pemphigus500138.5
127.1–150.9ROR 150.3 · χ² 65,379 / p <1e-300
132.2 EB05 122.8 · IC025 +6.7
3/3 methods agree
Not in label — unassessedserious PRR 91.8 · ♀ 99% (drug 71%) · 94% cliniciannot reported in cached trials
Hand deformity507133.2
122.3–145.1ROR 144.7 · χ² 63,842 / p <1e-300
127.4 EB05 118.4 · IC025 +6.7
3/3 methods agree
Not in label — unassessedserious PRR 96.0 · ♀ 100% (drug 71%) · 96% cliniciannot reported in cached trials
Bursitis393111.3
100.9–122.7ROR 118.6 · χ² 41,447 / p <1e-300
107.1 EB05 98.5 · IC025 +6.4
3/3 methods agree
Not in label — unassessedserious PRR 87.1 · ♀ 100% (drug 71%) · 94% cliniciannot reported in cached trials
Pericarditis494101.0
92.6–110.0ROR 109.4 · χ² 47,362 / p <1e-300
97.6 EB05 90.6 · IC025 +6.3
3/3 methods agree
Not in label — unassessedserious PRR 68.0 · ♀ 100% (drug 71%) · 94% cliniciannot reported in cached trials
Synovitis52398.6
90.7–107.2ROR 107.4 · χ² 49,003 / p <1e-300
95.4 EB05 88.8 · IC025 +6.3
3/3 methods agree
Not in label — unassessedserious PRR 69.0 · ♀ 99% (drug 71%) · 94% cliniciannot reported in cached trials
Wound infection30996.7
86.6–108.0ROR 101.6 · χ² 28,344 / p <1e-300
93.4 EB05 85.0 · IC025 +6.2
3/3 methods agree
Not in label — unassessedserious PRR 69.4 · ♀ 99% (drug 71%) · 92% cliniciannot reported in cached trials
Joint range of motion decreased36492.5
83.6–102.4ROR 98.1 · χ² 31,972 / p <1e-300
89.6 EB05 82.1 · IC025 +6.2
3/3 methods agree
Not in label — unassessedserious PRR 79.1 · ♀ 95% (drug 71%) · 93% cliniciannot reported in cached trials
Lower limb fracture46281.9
75.0–89.6ROR 88.3 · χ² 35,983 / p <1e-300
79.7 EB05 73.8 · IC025 +6.0
3/3 methods agree
Not in label — unassessedserious PRR 60.5 · ♀ 100% (drug 71%) · 93% cliniciannot reported in cached trials
Red blood cell sedimentation rate increased24073.1
64.5–82.9ROR 75.9 · χ² 16,628 / p <1e-300
71.1 EB05 63.9 · IC025 +5.7
3/3 methods agree
Lab value / disease markerserious PRR 55.9 · ♀ 99% (drug 71%)not reported in cached trials
Fibromyalgia51471.4
65.7–77.7ROR 77.7 · χ² 34,908 / p <1e-300
69.8 EB05 64.8 · IC025 +5.9
3/3 methods agree
Not in label — unassessedserious PRR 63.2 · ♀ 100% (drug 71%) · 94% cliniciannot reported in cached trials
Obesity33069.8
62.8–77.6ROR 73.6 · χ² 21,854 / p <1e-300
68.1 EB05 62.1 · IC025 +5.8
3/3 methods agree
Not in label — unassessedserious PRR 54.3 · ♀ 98% (drug 71%)not reported in cached trials
Wound57269.4
64.1–75.1ROR 76.2 · χ² 37,746 / p <1e-300
67.8 EB05 63.3 · IC025 +5.9
3/3 methods agree
Not in label — unassessedserious PRR 55.6 · ♀ 100% (drug 71%) · 91% cliniciannot reported in cached trials
Psoriatic arthropathy82068.8
64.5–73.4ROR 78.8 · χ² 53,675 / p <1e-300
67.3 EB05 63.5 · IC025 +5.9
3/3 methods agree
Not in label — unassessedserious PRR 58.3 · ♀ 97% (drug 71%) · 91% cliniciannot reported in cached trials
Irritable bowel syndrome43067.9
61.9–74.4ROR 72.7 · χ² 27,714 / p <1e-300
66.3 EB05 61.2 · IC025 +5.8
3/3 methods agree
Not in label — unassessedserious PRR 58.1 · ♀ 100% (drug 71%) · 95% cliniciannot reported in cached trials
Hypercholesterolaemia19167.3
58.4–77.5ROR 69.4 · χ² 12,164 / p <1e-300
65.6 EB05 58.1 · IC025 +5.6
3/3 methods agree
Not in label — unassessedserious PRR 48.3 · ♀ 98% (drug 71%) · 93% cliniciannot reported in cached trials
Prescribed overdose32556.4
50.7–62.8ROR 59.4 · χ² 17,359 / p <1e-300
55.3 EB05 50.5 · IC025 +5.5
3/3 methods agree
Not in label — unassessedserious PRR 65.0 · ♀ 99% (drug 71%) · 92% cliniciannot reported in cached trials
Pulmonary fibrosis29752.2
46.6–58.3ROR 54.7 · χ² 14,631 / p <1e-300
51.2 EB05 46.5 · IC025 +5.4
3/3 methods agree
Not in label — unassessedserious PRR 35.8 · ♀ 99% (drug 71%) · 96% cliniciannot reported in cached trials
Hip arthroplasty22649.9
43.9–56.8ROR 51.7 · χ² 10,630 / p <1e-300
49.0 EB05 43.9 · IC025 +5.3
3/3 methods agree
Not in label — unassessedserious PRR 34.8 · ♀ 96% (drug 71%) · 91% cliniciannot reported in cached trials
Contraindicated product administered44249.1
44.9–53.8ROR 52.7 · χ² 20,517 / p <1e-300
48.3 EB05 44.7 · IC025 +5.4
3/3 methods agree
Reporting / coding artifactserious PRR 41.4 · ♀ 99% (drug 71%)not reported in cached trials
Systemic lupus erythematosus51749.0
45.1–53.3ROR 53.3 · χ² 23,946 / p <1e-300
48.2 EB05 44.8 · IC025 +5.4
3/3 methods agree
Not in label — unassessedserious PRR 34.1 · ♀ 100% (drug 71%) · 94% cliniciannot reported in cached trials
Impaired healing46847.8
43.8–52.2ROR 51.5 · χ² 21,109 / p <1e-300
47.0 EB05 43.5 · IC025 +5.3
3/3 methods agree
Reporting / coding artifactserious PRR 39.0 · ♀ 99% (drug 71%) · 91% cliniciannot reported in cached trials
Laryngitis14946.0
39.2–53.9ROR 47.1 · χ² 6,423 / p <1e-300
45.1 EB05 39.3 · IC025 +5.0
3/3 methods agree
Not in label — unassessedserious n=148 · ♀ 100% (drug 71%) · 97% cliniciannot reported in cached trials
Foot deformity14443.4
36.9–51.1ROR 44.4 · χ² 5,853 / p <1e-300
42.7 EB05 37.1 · IC025 +5.0
3/3 methods agree
Not in label — unassessedserious PRR 33.6 · ♀ 98% (drug 71%) · 95% cliniciannot reported in cached trials
Night sweats39240.7
37.0–44.8ROR 43.3 · χ² 14,985 / p <1e-300
40.2 EB05 36.9 · IC025 +5.1
3/3 methods agree
Not in label — unassessedserious PRR 47.4 · ♀ 99% (drug 71%) · 93% cliniciannot reported in cached trials
Blood cholesterol increased55940.1
37.0–43.4ROR 43.9 · χ² 21,052 / p <1e-300
39.6 EB05 36.9 · IC025 +5.1
3/3 methods agree
Lab value / disease markerserious PRR 41.0 · ♀ 98% (drug 71%) · 94% cliniciannot reported in cached trials
Prescribed underdose23439.2
34.6–44.5ROR 40.7 · χ² 8,583 / p <1e-300
38.7 EB05 34.7 · IC025 +4.9
3/3 methods agree
Not in label — unassessedserious PRR 45.7 · ♀ 99% (drug 71%)not reported in cached trials
Arthropathy63237.9
35.1–40.8ROR 41.9 · χ² 22,445 / p <1e-300
37.4 EB05 35.0 · IC025 +5.1
3/3 methods agree
Not in label — unassessedserious PRR 31.3 · ♀ 97% (drug 71%) · 92% cliniciannot reported in cached trials
Joint dislocation11636.8
30.7–44.1ROR 37.5 · χ² 3,962 / p <1e-300
36.2 EB05 31.0 · IC025 +4.7
3/3 methods agree
Not in label — unassessedserious PRR 28.0 · ♀ 97% (drug 71%) · 90% cliniciannot reported in cached trials
Osteoarthritis46736.7
33.6–40.1ROR 39.6 · χ² 16,049 / p <1e-300
36.3 EB05 33.6 · IC025 +5.0
3/3 methods agree
Likely indication confounding
term in indications
serious PRR 27.9 · ♀ 94% (drug 71%)not reported in cached trials
Pregnancy22136.5
32.0–41.6ROR 37.8 · χ² 7,518 / p <1e-300
36.0 EB05 32.2 · IC025 +4.8
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 36.4 · ♀ 100% (drug 71%) · 97% cliniciannot reported in cached trials
Road traffic accident45436.2
33.1–39.6ROR 38.9 · χ² 15,377 / p <1e-300
35.8 EB05 33.1 · IC025 +5.0
3/3 methods agree
Not in label — unassessedserious PRR 28.6 · ♀ 99% (drug 71%) · 91% cliniciannot reported in cached trials
Knee arthroplasty22335.7
31.4–40.7ROR 37.0 · χ² 7,417 / p <1e-300
35.2 EB05 31.5 · IC025 +4.8
3/3 methods agree
Not in label — unassessedserious PRR 25.4 · ♀ 99% (drug 71%)not reported in cached trials
Gait inability35335.6
32.2–39.4ROR 37.7 · χ² 11,732 / p <1e-300
35.2 EB05 32.2 · IC025 +4.9
3/3 methods agree
Not in label — unassessedserious PRR 30.1 · ♀ 100% (drug 71%) · 93% cliniciannot reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Piroxicam 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).

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.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Rash9217.0
6.6–7.5ROR 8.1 · χ² 4,850 / p <1e-300
7.0 EB05 6.6 · IC025 +2.7
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 10.3 · ♀ 95% (drug 71%)not reported in cached trials
Arthralgia (joint pain)9157.3
6.9–7.8ROR 8.4 · χ² 5,068 / p <1e-300
7.3 EB05 6.9 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious PRR 8.8not reported in cached trials
Condition aggravated90810.0
9.4–10.6ROR 11.5 · χ² 7,399 / p <1e-300
9.9 EB05 9.4 · IC025 +3.2
3/3 methods agree
Reporting / coding artifactserious PRR 10.2 · ♀ 93% (drug 71%)not reported in cached trials
Drug ineffective (drug did not work)8682.2
2.0–2.3ROR 2.4 · χ² 590 / p 2e-130
2.2 EB05 2.1 · IC025 +1.0
3/3 methods agree
Reporting / coding artifactserious PRR 3.8not reported in cached trials
Fatigue (tiredness)8563.6
3.4–3.9ROR 4.1 · χ² 1,701 / p <1e-300
3.6 EB05 3.4 · IC025 +1.7
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 4.4NCT03614494: 43/418 (10.3%) on Piroxicam; 52/418 (12.4%) control
Rheumatoid arthritis85625.2
23.7–26.8ROR 29.0 · χ² 19,827 / p <1e-300
25.0 EB05 23.6 · IC025 +4.5
3/3 methods agree
Likely indication confounding
term in indications
serious PRR 20.9 · ♀ 96% (drug 71%)not reported in cached trials
Diarrhoea (diarrhea)8464.4
4.1–4.6ROR 4.9 · χ² 2,246 / p <1e-300
4.3 EB05 4.1 · IC025 +2.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 5.1 · ♀ 93% (drug 71%)not reported in cached trials
Pain8434.5
4.3–4.8ROR 5.1 · χ² 2,384 / p <1e-300
4.5 EB05 4.3 · IC025 +2.1
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 4.6NCT03614494: 31/418 (7.4%) on Piroxicam; 29/418 (6.9%) control
Nausea8253.5
3.2–3.7ROR 3.8 · χ² 1,494 / p <1e-300
3.5 EB05 3.3 · IC025 +1.7
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 4.3 · ♀ 92% (drug 71%)NCT03614494: 32/418 (7.7%) on Piroxicam; 34/418 (8.1%) control
Psoriatic arthropathy82068.8
64.5–73.4ROR 78.8 · χ² 53,675 / p <1e-300
67.3 EB05 63.5 · IC025 +5.9
3/3 methods agree
Not in label — unassessedserious PRR 58.3 · ♀ 97% (drug 71%) · 91% cliniciannot reported in cached trials
Sinusitis80926.2
24.6–28.0ROR 29.9 · χ² 19,533 / p <1e-300
26.0 EB05 24.5 · IC025 +4.6
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 35.4 · ♀ 98% (drug 71%) · 91% cliniciannot reported in cached trials
Sciatica772169.1
158.0–181.0ROR 192.4 · χ² 122,603 / p <1e-300
160.2 EB05 150.9 · IC025 +7.1
3/3 methods agree
Not in label — unassessedserious PRR 148.4 · ♀ 99% (drug 71%) · 91% cliniciannot reported in cached trials
Off label use (used outside approved label)7682.9
2.7–3.1ROR 3.2 · χ² 1,013 / p 1e-222
2.9 EB05 2.8 · IC025 +1.4
3/3 methods agree
Reporting / coding artifactserious PRR 3.6 · ♀ 95% (drug 71%)not reported in cached trials
Headache7504.0
3.7–4.2ROR 4.4 · χ² 1,707 / p <1e-300
3.9 EB05 3.7 · IC025 +1.9
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 5.3NCT03614494: 21/418 (5.0%) on Piroxicam; 27/418 (6.5%) control

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.

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 Piroxicam?

In FDA FAERS, the most frequently co-reported reaction terms for Piroxicam are drug hypersensitivity, rash, arthralgia, fatigue, rheumatoid arthritis, 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 Piroxicam have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning . Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.

Do FAERS signals prove that Piroxicam 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

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.