Drug · FAERS side-effect profile with label screen
Naproxen 220Mg side effects: what 13,479 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Naproxen Sodium 220Mg (Naproxen Sodium 220Mg)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
13,479 reports · 77% serious · 3,768 with death outcome · 77% female
openFDA FAERS counts, all years, deduplication not applied
Used for
(s) temporarily relieves minor aches and pains due to: headache minor pain of arthritis muscular aches backache menstrual cramps toothache the common cold temporarily reduces fever
FDA label, Indications and Usage
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
Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 9Not in label — unassessed 29
What the badges mean
- 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). 1,043 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 |
|---|---|---|---|---|---|---|
| Hepatic enzyme | 71 | 1,625.5 1,164.7–2,268.8ROR 1,634.1 · calibrated p 5e-19 ✓ | 650.4 EB05 533.0 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=71 · ♀ 100% (drug 77%) · 100% clinician | not reported in cached trials |
| C-reactive protein | 427 | 1,396.6 1,226.3–1,590.5ROR 1,442.2 · calibrated p 4e-19 ✓ | 708.1 EB05 653.5 · 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 | 1,276.2 984.5–1,654.5ROR 1,286.2 · calibrated p 4e-18 ✓ | 617.4 EB05 524.1 · 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 | 1,251.9 1,146.5–1,367.0ROR 1,338.2 · calibrated p 8e-19 ✓ | 679.4 EB05 642.3 · IC025 +8.8 3/3 methods agree | Not in label — unassessed | serious n=870 · ♀ 100% (drug 77%) · 96% clinician | not reported in cached trials |
| Lupus vulgaris | 523 | 1,230.5 1,098.1–1,378.8ROR 1,280.1 · calibrated p 2e-18 ✓ | 666.4 EB05 619.9 · 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 | 1,186.9 921.6–1,528.5ROR 1,196.3 · calibrated p 9e-18 ✓ | 597.0 EB05 507.5 · 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 | 993.2 850.3–1,160.2ROR 1,012.7 · calibrated p 3e-17 ✓ | 577.4 EB05 520.7 · 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 | 981.1 914.8–1,052.3ROR 1,078.1 · calibrated p 1e-17 ✓ | 593.2 EB05 565.7 · IC025 +8.8 3/3 methods agree | Not in label — unassessed | serious n=1,214 · ♀ 100% (drug 77%) · 94% clinician | not reported in cached trials |
| Swollen joint count increased | 1,114 | 869.6 809.6–934.1ROR 947.9 · calibrated p 5e-17 ✓ | 550.1 EB05 523.5 · 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 | 723.5 680.2–769.6ROR 806.1 · calibrated p 3e-16 ✓ | 488.6 EB05 467.4 · IC025 +8.6 3/3 methods agree | Not in label — unassessed | serious n=1,382 · ♀ 100% (drug 77%) · 94% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 625 | 702.4 639.9–770.9ROR 736.5 · calibrated p 9e-16 ✓ | 475.0 EB05 444.6 · 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 | 676.1 530.1–862.4ROR 680.8 · calibrated p 5e-15 ✓ | 428.1 EB05 359.9 · 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 | 664.8 607.9–727.1ROR 699.2 · calibrated p 2e-15 ✓ | 458.0 EB05 429.5 · 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 | 548.3 493.9–608.8ROR 567.9 · calibrated p 2e-14 ✓ | 397.6 EB05 368.1 · 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 | 491.8 458.2–527.9ROR 529.3 · calibrated p 3e-14 ✓ | 369.9 EB05 350.6 · IC025 +8.2 3/3 methods agree | Not in label — unassessed | serious n=957 · ♀ 100% (drug 77%) · 95% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 1,751 | 488.8 464.5–514.4ROR 561.6 · calibrated p 2e-14 ✓ | 369.4 EB05 355.1 · IC025 +8.3 3/3 methods agree | Not in label — unassessed | serious PRR 277.7 · ♀ 99% (drug 77%) · 95% clinician | not reported in cached trials |
| Rheumatoid factor positive | 1,332 | 468.3 441.5–496.8ROR 519.5 · calibrated p 4e-14 ✓ | 357.2 EB05 341.4 · 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 | 454.7 431.2–479.5ROR 516.0 · calibrated p 4e-14 ✓ | 349.5 EB05 335.4 · IC025 +8.2 3/3 methods agree | Lab value / disease marker | serious PRR 264.0 · ♀ 100% (drug 77%) · 94% clinician | not reported in cached trials |
| Joint laxity | 67 | 443.0 337.7–581.1ROR 445.2 · calibrated p 5e-13 ✓ | 313.2 EB05 255.1 · 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 | 435.0 261.4–723.8ROR 435.6 · calibrated p 5e-12 ✓ | 253.0 EB05 171.2 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=19 | not reported in cached trials |
| Retinitis | 362 | 431.8 384.7–484.6ROR 443.7 · calibrated p 2e-13 ✓ | 331.3 EB05 303.6 · 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 | 407.9 294.8–564.3ROR 409.3 · calibrated p 2e-12 ✓ | 284.3 EB05 221.8 · 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 | 397.9 305.5–518.3ROR 399.9 · calibrated p 1e-12 ✓ | 290.7 EB05 237.5 · 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 | 390.0 367.7–413.7ROR 430.9 · calibrated p 3e-13 ✓ | 309.7 EB05 295.8 · 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 | 389.2 228.6–662.6ROR 389.7 · calibrated p 2e-11 ✓ | 230.4 EB05 152.4 · 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 | 388.3 237.8–634.1ROR 388.9 · calibrated p 1e-11 ✓ | 239.3 EB05 163.6 · 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 | 380.0 328.2–440.1ROR 386.3 · calibrated p 1e-12 ✓ | 296.9 EB05 265.4 · 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 | 338.4 320.6–357.1ROR 379.5 · calibrated p 1e-12 ✓ | 276.4 EB05 264.7 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | serious PRR 225.1 · ♀ 100% (drug 77%) · 95% clinician | not reported in cached trials |
| Porphyria acute | 242 | 331.1 288.5–380.1ROR 337.2 · calibrated p 4e-12 ✓ | 266.8 EB05 239.7 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=242 · ♀ 100% (drug 77%) · 95% clinician | not reported in cached trials |
| Helicobacter infection | 1,742 | 321.2 305.9–337.2ROR 368.7 · calibrated p 1e-12 ✓ | 265.0 EB05 254.7 · 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 | 317.4 170.5–590.8ROR 317.7 · calibrated p 3e-10 ✓ | 185.8 EB05 113.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Folliculitis | 1,731 | 313.7 298.8–329.4ROR 359.8 · calibrated p 2e-12 ✓ | 259.9 EB05 249.8 · 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 | 281.6 263.6–300.7ROR 303.7 · calibrated p 9e-12 ✓ | 237.0 EB05 224.8 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=985 · ♀ 100% (drug 77%) · 95% clinician | not reported in cached trials |
| Pemphigus | 1,831 | 269.1 256.8–281.9ROR 311.2 · calibrated p 7e-12 ✓ | 228.5 EB05 219.9 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious PRR 172.2 · ♀ 100% (drug 77%) · 95% clinician | not reported in cached trials |
| Hand deformity | 1,900 | 264.6 252.8–277.0ROR 307.9 · calibrated p 7e-12 ✓ | 225.3 EB05 217.0 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious PRR 184.1 · ♀ 99% (drug 77%) · 95% clinician | not reported in cached trials |
| Lip dry | 1,254 | 253.4 239.3–268.4ROR 279.3 · calibrated p 2e-11 ✓ | 216.9 EB05 207.0 · 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 | 238.4 211.7–268.5ROR 244.0 · calibrated p 8e-11 ✓ | 203.9 EB05 185.5 · 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 | 236.9 220.8–254.1ROR 252.7 · calibrated p 5e-11 ✓ | 204.4 EB05 193.1 · IC025 +7.4 3/3 methods agree | Not in label — unassessed | serious n=848 · ♀ 100% (drug 77%) · 96% clinician | not reported in cached trials |
| Short stature | 34 | 232.8 162.4–333.8ROR 233.4 · calibrated p 4e-10 ✓ | 181.8 EB05 136.0 · 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 | 212.5 146.9–307.4ROR 213.0 · calibrated p 8e-10 ✓ | 168.2 EB05 124.7 · 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 | 14.313.4–15.2 | 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 | 302 | 1.61.4–1.8 | raised |
| Myocardial infarction | 193 | 1.51.3–1.7 | raised |
| Thrombocytopenia | 191 | 1.31.2–1.6 | 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 220Mg 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).
- NCT03566979 — Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain (N=501, PHASE3; 2 AE terms posted; arms: Placebo; Test Naproxen Sodium 440 Milligram (mg); Commercial Naproxen Sodium Tablet 440 mg; Commercial Naproxen Sodium Liquid Gel Ca)
- NCT01118273 — Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine (N=162, PHASE4; 12 AE terms posted; arms: Naproxen Sodium 440 mg (BAYH6689) / DPH ; Naproxen Sodium 440 mg (BAYH6689); Naproxen Sodium 220 mg (BAYH6689) / DPH ; Naproxen Sodium 220 mg (BAYH6689))
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) | 2,941 | 3.5 3.4–3.6ROR 4.2 · calibrated p 0.347 | 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 0.122 | 5.4 EB05 5.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | age-adj. PRR 5.3 · serious PRR 7.4 | not reported in cached trials |
| Off label use (used outside approved label) | 2,568 | 4.6 4.5–4.8ROR 5.5 · calibrated p 0.190 | 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 | 2,537 | 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 | NCT01118273: 1/27 (3.7%) on Naproxen 220Mg |
| Rash | 2,331 | 8.4 8.1–8.7ROR 9.9 · 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%) | not reported in cached trials |
| 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 | not reported in cached trials |
| Diarrhoea (diarrhea) | 2,261 | 5.5 5.3–5.7ROR 6.4 · calibrated p 0.127 | 5.5 EB05 5.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | age-adj. PRR 5.4 · serious PRR 6.9 | not reported in cached trials |
| Vomiting | 2,205 | 7.3 7.1–7.6ROR 8.6 · calibrated p 0.053 | 7.3 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 6.6 · serious PRR 8.0 | NCT03566979: 3/149 (2.0%) on Naproxen 220Mg; 3/58 (5.2%) control |
| Condition aggravated | 2,153 | 11.2 10.7–11.6ROR 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 | 28.0 27.0–29.2ROR 33.1 · calibrated p 2e-4 ✓ | 27.5 EB05 26.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | age-adj. PRR 24.9 · serious PRR 35.3 · ♀ 98% (drug 77%) · 93% clinician | not reported in cached trials |
| Fibromyalgia | 2,089 | 146.5 140.5–152.7ROR 173.1 · calibrated p 1e-9 ✓ | 133.6 EB05 128.9 · 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 | 203.5 195.0–212.3ROR 240.5 · calibrated p 8e-11 ✓ | 179.5 EB05 173.1 · IC025 +7.4 3/3 methods agree | Not in label — unassessed | serious PRR 141.0 · ♀ 99% (drug 77%) · 93% clinician | not reported in cached trials |
| Rheumatoid arthritis | 2,074 | 29.1 27.9–30.2ROR 34.2 · calibrated p 1e-4 ✓ | 28.5 EB05 27.5 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | age-adj. PRR 28.7 · serious PRR 26.0 · ♀ 98% (drug 77%) · 92% clinician | not reported in cached trials |
| Dizziness | 2,037 | 6.4 6.1–6.6ROR 7.3 · calibrated p 0.086 | 6.4 EB05 6.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | age-adj. PRR 6.2 · serious PRR 8.2 | NCT01118273: 1/27 (3.7%) on Naproxen 220Mg |
| Abdominal discomfort | 2,001 | 18.8 18.1–19.6ROR 21.9 · 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 | 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.
- Hepatic enzyme — n=71, PRR 1,625.5
- Grip strength — n=104, PRR 1,276.2
- Deep vein thrombosis postoperative — n=870, PRR 1,251.9
- Lupus vulgaris — n=523, PRR 1,230.5
- Swollen joint count — n=106, PRR 1,186.9
- Facet joint syndrome — n=1,214, PRR 981.1
- Rheumatic fever — n=1,382, PRR 723.5
- Adjustment disorder with depressed mood — n=625, PRR 702.4
- Hypocholesterolaemia — n=93, PRR 676.1
- Dislocation of vertebra — n=664, PRR 664.8
✓ 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 220Mg?
In FDA FAERS, the most frequently co-reported reaction terms for Naproxen 220Mg 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 220Mg have an FDA boxed warning?
No. The FDA label retrieved for Naproxen 220Mg has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Naproxen 220Mg 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 14554f05-14e1-4c52-99ce-94561c42c0da, effective 20210421; matched on
openfda.generic_name.exact:"NAPROXEN SODIUM 220MG") - 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, 1,083 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 220MG, 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.