Naproxen Sodium, Coated Tablets side effects: what 13,460 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug
Label matched
Naproxen (Naproxen)
Who reports
13,460 reports · 77% serious · 3,768 with death outcome · 77% female
Used for
Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets and naproxen sodium.
What it is
Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen Tablets, USP are available as follows for oral administration: 25.
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.
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). 1,041 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 |
|---|---|---|---|---|---|---|
| Hepatic enzyme | 71 | 1,627.8 1,166.3–2,272.0ROR 1,636.5 · calibrated p 5e-19 ✓ | 651.1 EB05 533.6 · IC025 +6.5 3/3 methods agree | Labeled (related wording) related wording | serious n=71 · ♀ 100% (drug 77%) · 100% clinician | NCT00346216: 1/7,933 (0.0%) on Naproxen Sodium, Coated Tablets (serious AE) |
| C-reactive protein | 427 | 1,398.6 1,228.1–1,592.7ROR 1,444.3 · calibrated p 4e-19 ✓ | 709.1 EB05 654.4 · IC025 +8.5 3/3 methods agree | Lab value / disease marker | serious n=427 · ♀ 100% (drug 77%) · 96% clinician | not reported in cached trials |
| Grip strength | 104 | 1,278.1 985.8–1,656.9ROR 1,288.0 · calibrated p 4e-18 ✓ | 618.2 EB05 524.7 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=104 · ♀ 100% (drug 77%) · 95% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 870 | 1,253.7 1,148.1–1,368.9ROR 1,340.2 · calibrated p 8e-19 ✓ | 680.3 EB05 643.2 · IC025 +8.8 3/3 methods agree | Not in label — unassessed | serious n=870 · ♀ 100% (drug 77%) · 96% clinician | NCT03161093: 1/352 (0.3%) control (serious AE) |
| Lupus vulgaris | 523 | 1,232.2 1,099.6–1,380.7ROR 1,282.0 · calibrated p 2e-18 ✓ | 667.4 EB05 620.7 · IC025 +8.5 3/3 methods agree | Not in label — unassessed | serious n=523 · ♀ 100% (drug 77%) · 96% clinician | not reported in cached trials |
| Swollen joint count | 106 | 1,188.5 922.9–1,530.7ROR 1,198.0 · calibrated p 9e-18 ✓ | 597.7 EB05 508.2 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=106 · ♀ 100% (drug 77%) · 96% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 259 | 994.6 851.5–1,161.9ROR 1,014.1 · calibrated p 3e-17 ✓ | 578.2 EB05 521.4 · IC025 +7.9 3/3 methods agree | Lab value / disease marker | serious n=259 · ♀ 100% (drug 77%) · 98% clinician | not reported in cached trials |
| Facet joint syndrome | 1,214 | 982.5 916.1–1,053.8ROR 1,079.8 · calibrated p 1e-17 ✓ | 594.0 EB05 566.5 · IC025 +8.8 3/3 methods agree | Not in label — unassessed | serious n=1,214 · ♀ 100% (drug 77%) · 94% clinician | NCT00346216: 1/7,933 (0.0%) on Naproxen Sodium, Coated Tablets (serious AE) |
| Swollen joint count increased | 1,114 | 870.9 810.7–935.4ROR 949.3 · calibrated p 5e-17 ✓ | 550.8 EB05 524.2 · IC025 +8.7 3/3 methods agree | Lab value / disease marker | serious n=1,114 · ♀ 100% (drug 77%) · 95% clinician | not reported in cached trials |
| Rheumatic fever | 1,382 | 724.5 681.2–770.6ROR 807.3 · calibrated p 3e-16 ✓ | 489.3 EB05 468.0 · IC025 +8.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=1,382 · ♀ 100% (drug 77%) · 94% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 625 | 703.4 640.8–772.0ROR 737.5 · calibrated p 9e-16 ✓ | 475.7 EB05 445.2 · IC025 +8.3 3/3 methods agree | Not in label — unassessed | serious n=624 · ♀ 100% (drug 77%) · 96% clinician | not reported in cached trials |
| Hypocholesterolaemia | 93 | 677.1 530.8–863.6ROR 681.8 · calibrated p 5e-15 ✓ | 428.6 EB05 360.3 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=93 · ♀ 100% (drug 77%) · 98% clinician | not reported in cached trials |
| Dislocation of vertebra | 664 | 665.8 608.8–728.1ROR 700.3 · calibrated p 2e-15 ✓ | 458.6 EB05 430.1 · IC025 +8.3 3/3 methods agree | Not in label — unassessed | serious n=664 · ♀ 100% (drug 77%) · 95% clinician | not reported in cached trials |
| X-ray abnormal | 464 | 549.1 494.6–609.7ROR 568.7 · calibrated p 2e-14 ✓ | 398.1 EB05 368.6 · IC025 +8.0 3/3 methods agree | Lab value / disease marker | serious n=464 · ♀ 100% (drug 77%) · 97% clinician | not reported in cached trials |
| Peripheral venous disease | 957 | 492.5 458.8–528.6ROR 530.1 · calibrated p 3e-14 ✓ | 370.4 EB05 351.1 · IC025 +8.2 3/3 methods agree | Not in label — unassessed | serious n=957 · ♀ 100% (drug 77%) · 95% clinician | NCT00346216: 1/7,992 (0.0%) on Naproxen Sodium, Coated Tablets (serious AE) |
| Duodenal ulcer perforation | 1,751 | 489.5 465.1–515.1ROR 562.5 · calibrated p 2e-14 ✓ | 369.9 EB05 355.6 · IC025 +8.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 277.8 · ♀ 99% (drug 77%) · 95% clinician | NCT00346216: 2/7,933 (0.0%) on Naproxen Sodium, Coated Tablets (serious AE) |
| Rheumatoid factor positive | 1,332 | 469.0 442.1–497.5ROR 520.4 · calibrated p 4e-14 ✓ | 357.7 EB05 341.8 · IC025 +8.2 3/3 methods agree | Lab value / disease marker | serious n=1,332 · ♀ 100% (drug 77%) · 96% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 1,604 | 455.4 431.8–480.2ROR 516.8 · calibrated p 4e-14 ✓ | 350.0 EB05 335.9 · IC025 +8.2 3/3 methods agree | Lab value / disease marker | serious PRR 264.1 · ♀ 100% (drug 77%) · 94% clinician | not reported in cached trials |
| Joint laxity | 67 | 443.6 338.2–581.9ROR 445.8 · calibrated p 5e-13 ✓ | 313.6 EB05 255.5 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=67 · ♀ 100% (drug 77%) | not reported in cached trials |
| Synovial fluid analysis | 19 | 435.6 261.8–724.8ROR 436.2 · calibrated p 5e-12 ✓ | 253.2 EB05 171.3 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=19 | not reported in cached trials |
| Retinitis | 362 | 432.4 385.3–485.3ROR 444.3 · calibrated p 2e-13 ✓ | 331.7 EB05 304.0 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious n=362 · ♀ 100% (drug 77%) · 95% clinician | not reported in cached trials |
| Congenital hiatus hernia | 46 | 408.4 295.2–565.1ROR 409.8 · calibrated p 2e-12 ✓ | 284.7 EB05 222.1 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 0% (drug 77%) | not reported in cached trials |
| Human antichimeric antibody positive | 69 | 398.5 305.9–519.0ROR 400.5 · calibrated p 1e-12 ✓ | 291.1 EB05 237.8 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=69 · ♀ 100% (drug 77%) | not reported in cached trials |
| C-reactive protein abnormal | 1,282 | 390.6 368.2–414.3ROR 431.6 · calibrated p 3e-13 ✓ | 310.2 EB05 296.2 · IC025 +8.0 3/3 methods agree | Lab value / disease marker | serious n=1,282 · ♀ 100% (drug 77%) · 92% clinician | not reported in cached trials |
| Tender joint count | 17 | 389.8 229.0–663.5ROR 390.3 · calibrated p 2e-11 ✓ | 230.7 EB05 152.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Sleep disorder due to general medical condition, hypersomnia type | 20 | 388.9 238.2–635.0ROR 389.5 · calibrated p 1e-11 ✓ | 239.6 EB05 163.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 100% (drug 77%) | not reported in cached trials |
| Seronegative arthritis | 220 | 380.6 328.7–440.7ROR 386.9 · calibrated p 1e-12 ✓ | 297.3 EB05 265.8 · IC025 +7.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=219 · ♀ 100% (drug 77%) · 93% clinician | not reported in cached trials |
| Muscle injury | 1,464 | 338.8 321.0–357.6ROR 380.1 · calibrated p 1e-12 ✓ | 276.8 EB05 265.1 · IC025 +7.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 225.2 · ♀ 100% (drug 77%) · 95% clinician | not reported in cached trials |
| Porphyria acute | 242 | 331.6 288.9–380.6ROR 337.7 · calibrated p 4e-12 ✓ | 267.2 EB05 240.1 · IC025 +7.2 3/3 methods agree | Labeled (related wording) related wording | serious n=242 · ♀ 100% (drug 77%) · 95% clinician | not reported in cached trials |
| Helicobacter infection | 1,742 | 321.6 306.3–337.7ROR 369.3 · calibrated p 1e-12 ✓ | 265.3 EB05 255.0 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | serious PRR 210.6 · ♀ 100% (drug 77%) · 95% clinician | not reported in cached trials |
| Acquired porphyria | 12 | 317.8 170.7–591.6ROR 318.1 · calibrated p 3e-10 ✓ | 186.0 EB05 113.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Folliculitis | 1,731 | 314.2 299.2–329.9ROR 360.4 · calibrated p 2e-12 ✓ | 260.2 EB05 250.1 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious PRR 229.7 · ♀ 100% (drug 77%) · 95% clinician | not reported in cached trials |
| Breast cancer stage iii | 985 | 282.0 264.0–301.2ROR 304.2 · calibrated p 9e-12 ✓ | 237.3 EB05 225.1 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=985 · ♀ 100% (drug 77%) · 95% clinician | NCT00346216: 1/7,933 (0.0%) on Naproxen Sodium, Coated Tablets (serious AE) |
| Pemphigus | 1,831 | 269.4 257.1–282.3ROR 311.7 · calibrated p 7e-12 ✓ | 228.8 EB05 220.2 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious PRR 172.3 · ♀ 100% (drug 77%) · 95% clinician | not reported in cached trials |
| Hand deformity | 1,900 | 265.0 253.2–277.4ROR 308.4 · calibrated p 7e-12 ✓ | 225.7 EB05 217.3 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious PRR 184.2 · ♀ 99% (drug 77%) · 95% clinician | not reported in cached trials |
| Lip dry | 1,254 | 253.8 239.7–268.8ROR 279.8 · calibrated p 2e-11 ✓ | 217.2 EB05 207.3 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=1,253 · ♀ 100% (drug 77%) · 95% clinician | not reported in cached trials |
| Red blood cell sedimentation rate abnormal | 309 | 238.8 212.0–268.8ROR 244.3 · calibrated p 7e-11 ✓ | 204.2 EB05 185.8 · IC025 +7.1 3/3 methods agree | Lab value / disease marker | serious n=309 · ♀ 99% (drug 77%) | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 850 | 237.2 221.1–254.4ROR 253.1 · calibrated p 5e-11 ✓ | 204.7 EB05 193.4 · IC025 +7.4 3/3 methods agree | Labeled (related wording) related wording | serious n=848 · ♀ 100% (drug 77%) · 96% clinician | not reported in cached trials |
| Short stature | 34 | 233.2 162.6–334.3ROR 233.7 · calibrated p 3e-10 ✓ | 182.0 EB05 136.2 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 100% (drug 77%) | not reported in cached trials |
| Loose body in joint | 32 | 212.8 147.1–307.9ROR 213.3 · calibrated p 8e-10 ✓ | 168.4 EB05 124.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 100% (drug 77%) | 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 |
|---|---|---|---|
| Interstitial lung disease | 873 | 14.313.4–15.3 | signal |
| Liver injury | 2,728 | 14.213.7–14.7 | signal |
| Hyperglycaemia / diabetes | 1,809 | 8.27.8–8.5 | signal |
| Depression | 1,349 | 7.57.1–7.9 | signal |
| Serious infection | 2,624 | 5.35.1–5.5 | signal |
| Pancreatitis | 242 | 4.74.1–5.3 | signal |
| Gi bleeding | 482 | 4.13.8–4.5 | signal |
| Tendon disorder | 75 | 3.12.4–3.8 | signal |
| Fall / fracture | 703 | 2.92.7–3.1 | signal |
| Severe cutaneous reaction | 121 | 2.52.1–3.0 | signal |
| Anaphylaxis / angioedema | 162 | 2.01.7–2.3 | raised |
| Rhabdomyolysis / myopathy | 89 | 1.71.4–2.1 | raised |
| Anaemia | 301 | 1.61.4–1.7 | raised |
| Myocardial infarction | 193 | 1.51.3–1.7 | raised |
| Thrombocytopenia | 191 | 1.41.2–1.6 | raised |
| Suicidality | 206 | 1.31.1–1.5 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Naproxen Sodium, Coated Tablets 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 (6 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)
- NCT03161093 — A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment o (N=3307, PHASE3; 221 AE terms posted; arms: Placebo; Naproxen; Fasinumab 1mg Q8W; Fasinumab 1mg Q4W)
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) | 2,935 | 3.5 3.4–3.6ROR 4.2 · calibrated p 0.348 | 3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 4.3 · serious PRR 6.2 | not reported in cached trials |
| Fatigue (tiredness) | 2,689 | 5.4 5.2–5.6ROR 6.5 · calibrated p 0.121 | 5.4 EB05 5.2 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 5.3 · serious PRR 7.4 | NCT00346216: 2/7,933 (0.0%) on Naproxen Sodium, Coated Tablets (serious AE) |
| Off label use (used outside approved label) | 2,568 | 4.6 4.5–4.8ROR 5.5 · calibrated p 0.189 | 4.6 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 5.0 · serious PRR 6.4 · 91% clinician | not reported in cached trials |
| Pain | 2,536 | 6.4 6.2–6.7ROR 7.7 · calibrated p 0.075 | 6.4 EB05 6.2 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | age-adj. PRR 6.8 · serious PRR 7.3 | NCT00346216: 13/7,933 (0.2%) on Naproxen Sodium, Coated Tablets (serious AE) |
| Rash | 2,331 | 8.4 8.1–8.7ROR 10.0 · calibrated p 0.033 ✓ | 8.4 EB05 8.1 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 9.0 · serious PRR 13.7 · ♀ 98% (drug 77%) | NCT00346216: 1/8,030 (0.0%) on Naproxen Sodium, Coated Tablets (serious AE) |
| Arthralgia (joint pain) | 2,262 | 8.5 8.2–8.9ROR 10.1 · calibrated p 0.032 ✓ | 8.5 EB05 8.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | age-adj. PRR 8.1 · serious PRR 11.3 | NCT00346216: 39/7,933 (0.5%) on Naproxen Sodium, Coated Tablets (serious AE) |
| Diarrhoea (diarrhea) | 2,260 | 5.5 5.3–5.7ROR 6.4 · calibrated p 0.127 | 5.5 EB05 5.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 5.4 · serious PRR 6.9 | NCT00346216: 5/7,933 (0.1%) on Naproxen Sodium, Coated Tablets (serious AE) |
| Vomiting | 2,205 | 7.4 7.1–7.6ROR 8.6 · calibrated p 0.053 | 7.3 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 6.6 · serious PRR 8.0 | NCT00346216: 7/7,933 (0.1%) on Naproxen Sodium, Coated Tablets (serious AE) |
| Condition aggravated | 2,153 | 11.2 10.8–11.6ROR 13.1 · calibrated p 0.012 ✓ | 11.1 EB05 10.7 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 10.3 · serious PRR 12.3 | not reported in cached trials |
| Joint swelling | 2,134 | 28.1 27.0–29.2ROR 33.2 · calibrated p 2e-4 ✓ | 27.6 EB05 26.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | age-adj. PRR 25.0 · serious PRR 35.3 · ♀ 98% (drug 77%) · 93% clinician | NCT00346216: 1/7,933 (0.0%) on Naproxen Sodium, Coated Tablets (serious AE) |
| Fibromyalgia | 2,089 | 146.7 140.7–152.9ROR 173.4 · calibrated p 1e-9 ✓ | 133.8 EB05 129.1 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 131.7 · ♀ 100% (drug 77%) | not reported in cached trials |
| Synovitis | 2,086 | 203.8 195.3–212.6ROR 240.9 · calibrated p 7e-11 ✓ | 179.7 EB05 173.3 · IC025 +7.4 3/3 methods agree | Not in label — unassessed | serious PRR 141.1 · ♀ 99% (drug 77%) · 93% clinician | NCT00346216: 1/8,030 (0.0%) on Naproxen Sodium, Coated Tablets (serious AE) |
| Rheumatoid arthritis | 2,074 | 29.1 28.0–30.3ROR 34.2 · calibrated p 1e-4 ✓ | 28.6 EB05 27.5 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | age-adj. PRR 28.7 · serious PRR 26.0 · ♀ 98% (drug 77%) · 92% clinician | NCT00346216: 3/7,933 (0.0%) on Naproxen Sodium, Coated Tablets (serious AE) |
| Dizziness | 2,036 | 6.4 6.1–6.7ROR 7.4 · calibrated p 0.086 | 6.4 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 6.2 · serious PRR 8.2 | NCT00346216: 6/7,933 (0.1%) on Naproxen Sodium, Coated Tablets (serious AE) |
| Abdominal discomfort | 1,999 | 18.8 18.1–19.6ROR 22.0 · calibrated p 0.001 ✓ | 18.6 EB05 17.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | age-adj. PRR 20.1 · serious PRR 30.1 | NCT00346216: 1/7,933 (0.0%) on Naproxen Sodium, Coated Tablets (serious AE) |
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=104, PRR 1,278.1
- Deep vein thrombosis postoperative — n=870, PRR 1,253.7 (also seen in trial arm)
- Lupus vulgaris — n=523, PRR 1,232.2
- Swollen joint count — n=106, PRR 1,188.5
- Facet joint syndrome — n=1,214, PRR 982.5 (also seen in trial arm)
- Adjustment disorder with depressed mood — n=625, PRR 703.4
- Hypocholesterolaemia — n=93, PRR 677.1
- Dislocation of vertebra — n=664, PRR 665.8
- Peripheral venous disease — n=957, PRR 492.5 (also seen in trial arm)
- Joint laxity — n=67, PRR 443.6
✓ A hand-written Bradford Hill causality assessment exists for this drug: Methotrexate Sodium ↔ Rheumatoid Arthritis.
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 Naproxen Sodium, Coated Tablets?
In FDA FAERS, the most frequently co-reported reaction terms for Naproxen Sodium, Coated Tablets are fatigue, pain, rash, arthralgia, diarrhoea, vomiting. 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 Naproxen Sodium, Coated Tablets 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.
Do FAERS signals prove that Naproxen Sodium, Coated Tablets 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 000155a8-709c-44e5-a75f-cd890f3a7caf, effective 20260129; matched on
openfda.generic_name.exact:"NAPROXEN") - 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, 1,081 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
NAPROXEN, 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.