Naproxen and Pseudoephedrine side effects: what 20,453 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug
Label matched
Naproxen (Naproxen)
Who reports
20,453 reports · 47% serious · 1,259 with death outcome · 66% 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 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.
- 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.
- 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. 1,094 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 |
|---|---|---|---|---|---|---|
| Increased viscosity of upper respiratory secretion | 17 | 23.6 14.6–38.2ROR 23.6 · χ² 338 / p 9e-76 | 22.5 EB05 14.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Infusion site discharge | 33 | 20.1 14.3–28.4ROR 20.2 · χ² 570 / p 3e-126 | 19.5 EB05 14.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 66%) · 79% consumer | not reported in cached trials |
| Infusion site mass | 19 | 18.5 11.8–29.2ROR 18.6 · χ² 293 / p 7e-66 | 17.8 EB05 11.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=13 | NCT00346216: 2/8,030 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Chronic respiratory failure | 17 | 14.8 9.2–23.9ROR 14.8 · χ² 203 / p 3e-46 | 13.9 EB05 8.6 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=17 | NCT00346216: 4/7,933 (0.1%) on Naproxen and Pseudoephedrine (serious AE) |
| Seasonal allergy | 199 | 14.6 12.7–16.8ROR 14.8 · χ² 2,480 / p <1e-300 | 14.4 EB05 12.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=106 · 76% consumer | not reported in cached trials |
| Pneumonia pseudomonal | 21 | 14.3 9.3–22.1ROR 14.4 · χ² 244 / p 3e-55 | 13.6 EB05 8.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=21 | NCT00346216: 1/7,992 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Rhonchi | 19 | 14.2 9.0–22.4ROR 14.2 · χ² 218 / p 2e-49 | 13.3 EB05 8.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Lower respiratory tract congestion | 23 | 14.0 9.3–21.1ROR 14.0 · χ² 261 / p 4e-59 | 13.3 EB05 8.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=16 · 100% consumer | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 14 | 13.5 8.0–22.9ROR 13.5 · χ² 148 / p 3e-34 | 12.1 EB05 7.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Infusion site pruritus | 40 | 13.3 9.7–18.2ROR 13.3 · χ² 437 / p 2e-97 | 12.9 EB05 9.7 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=28 | NCT00346216: 1/7,933 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Multiple allergies | 100 | 13.2 10.9–16.1ROR 13.3 · χ² 1,103 / p 4e-242 | 13.0 EB05 10.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=82 | not reported in cached trials |
| Nephrogenic anaemia | 59 | 13.1 10.1–16.9ROR 13.1 · χ² 638 / p 4e-141 | 12.7 EB05 10.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=58 | not reported in cached trials |
| Infusion site rash | 17 | 12.9 8.0–20.9ROR 12.9 · χ² 173 / p 8e-40 | 11.8 EB05 7.2 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | NCT00346216: 1/8,030 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Sputum increased | 26 | 12.7 8.7–18.7ROR 12.8 · χ² 266 / p 4e-60 | 12.0 EB05 8.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 · 100% consumer | not reported in cached trials |
| Acute sinusitis | 21 | 12.6 8.2–19.4ROR 12.7 · χ² 211 / p 4e-48 | 11.7 EB05 7.7 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=20 | NCT00346216: 1/8,030 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Rebound acid hypersecretion | 37 | 12.5 9.0–17.3ROR 12.5 · χ² 375 / p 6e-84 | 12.0 EB05 8.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=37 | not reported in cached trials |
| Infusion site haemorrhage | 37 | 11.8 8.5–16.3ROR 11.8 · χ² 352 / p 9e-79 | 11.3 EB05 8.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=21 · 70% consumer | NCT00346216: 1/8,030 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Incorrect drug administration duration | 324 | 11.8 10.5–13.1ROR 11.9 · χ² 3,146 / p <1e-300 | 11.6 EB05 10.6 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 · 93% consumer | not reported in cached trials |
| Infusion site bruising | 24 | 11.7 7.8–17.5ROR 11.7 · χ² 221 / p 2e-50 | 10.8 EB05 7.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=17 · ♀ 100% (drug 66%) | not reported in cached trials |
| Hyperparathyroidism secondary | 28 | 11.4 7.9–16.6ROR 11.5 · χ² 254 / p 2e-57 | 10.7 EB05 7.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=28 | NCT00346216: 3/8,030 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Paranasal sinus discomfort | 40 | 11.0 8.0–15.0ROR 11.0 · χ² 349 / p 3e-78 | 10.4 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 87% (drug 66%) · 71% consumer | not reported in cached trials |
| Paranasal sinus hypersecretion | 40 | 10.8 7.9–14.7ROR 10.8 · χ² 341 / p 2e-76 | 10.2 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=27 | not reported in cached trials |
| Upper-airway cough syndrome | 85 | 10.7 8.7–13.3ROR 10.8 · χ² 733 / p 1e-161 | 10.4 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=48 | not reported in cached trials |
| Infusion site swelling | 62 | 10.4 8.1–13.4ROR 10.4 · χ² 513 / p 7e-114 | 10.0 EB05 8.0 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=43 · 70% consumer | NCT00346216: 1/7,992 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Foreign body in respiratory tract | 13 | 10.1 5.9–17.5ROR 10.2 · χ² 97 / p 3e-23 | 8.4 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Infusion site erythema | 79 | 9.8 7.9–12.3ROR 9.9 · χ² 613 / p 1e-135 | 9.5 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=48 | NCT00346216: 1/8,030 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Respiratory tract congestion | 150 | 9.7 8.3–11.4ROR 9.8 · χ² 1,158 / p 4e-254 | 9.5 EB05 8.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 · 79% consumer | not reported in cached trials |
| Middle ear effusion | 20 | 9.4 6.1–14.6ROR 9.4 · χ² 141 / p 1e-32 | 8.3 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=14 · 75% consumer | not reported in cached trials |
| Chronic obstructive pulmonary disease | 466 | 9.2 8.4–10.1ROR 9.4 · χ² 3,390 / p <1e-300 | 9.1 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.7 | NCT00346216: 1/7,992 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Productive cough (cough with phlegm) | 416 | 9.1 8.2–10.0ROR 9.2 · χ² 2,961 / p <1e-300 | 9.0 EB05 8.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · 70% consumer | not reported in cached trials |
| Sinus disorder | 174 | 9.1 7.8–10.5ROR 9.1 · χ² 1,230 / p 1e-269 | 8.9 EB05 7.8 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.6 · 75% consumer | NCT00346216: 3/7,933 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Incorrect product administration duration | 174 | 8.9 7.6–10.3ROR 8.9 · χ² 1,195 / p 4e-262 | 8.7 EB05 7.6 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=23 · 94% consumer | not reported in cached trials |
| Infusion site induration | 12 | 8.7 4.9–15.4ROR 8.7 · χ² 74 / p 4e-18 | 7.0 EB05 4.1 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Sinus congestion | 111 | 8.5 7.0–10.2ROR 8.5 · χ² 718 / p 2e-158 | 8.2 EB05 7.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=64 | not reported in cached trials |
| Increased bronchial secretion | 21 | 8.4 5.5–13.0ROR 8.5 · χ² 129 / p 3e-30 | 7.4 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Obstruction | 32 | 8.3 5.8–11.7ROR 8.3 · χ² 195 / p 1e-44 | 7.6 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=31 | NCT00346216: 1/7,933 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Infusion site pain | 102 | 8.2 6.8–10.0ROR 8.3 · χ² 637 / p 8e-141 | 8.0 EB05 6.7 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=66 · ♀ 86% (drug 66%) | NCT00346216: 13/7,933 (0.2%) on Naproxen and Pseudoephedrine (serious AE) |
| Breath sounds abnormal | 39 | 8.2 6.0–11.2ROR 8.2 · χ² 236 / p 2e-53 | 7.6 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=32 · 72% consumer | not reported in cached trials |
| Kyphosis | 14 | 8.1 4.8–13.8ROR 8.1 · χ² 80 / p 2e-19 | 6.7 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=13 | NCT00346216: 1/7,933 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Bronchitis chronic | 19 | 8.0 5.1–12.5ROR 8.0 · χ² 108 / p 1e-25 | 6.9 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=16 | NCT00346216: 17/7,933 (0.2%) on Naproxen and Pseudoephedrine (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Naproxen and Pseudoephedrine 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 (16 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) | 1,755 | 1.4 1.3–1.4ROR 1.4 · χ² 183 / p 5e-42 | 1.4 EB05 1.3 · IC025 +0.4 | Reporting / coding artifact | serious PRR 0.8 · 87% consumer | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,651 | 3.0 2.9–3.1ROR 3.2 · χ² 2,249 / p <1e-300 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | NCT00346216: 24/7,933 (0.3%) on Naproxen and Pseudoephedrine (serious AE) |
| Fatigue (tiredness) | 1,371 | 1.8 1.7–1.9ROR 1.9 · χ² 514 / p 4e-114 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.5 | NCT00346216: 2/7,933 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Nausea | 1,272 | 1.7 1.6–1.7ROR 1.7 · χ² 340 / p 4e-76 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.2 | NCT00346216: 6/7,933 (0.1%) on Naproxen and Pseudoephedrine (serious AE) |
| Cough | 1,238 | 4.5 4.3–4.8ROR 4.8 · χ² 3,455 / p <1e-300 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 71% consumer | NCT00346216: 1/8,030 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Diarrhoea (diarrhea) | 1,233 | 2.0 1.9–2.1ROR 2.0 · χ² 601 / p 4e-133 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.1 | NCT00346216: 5/7,933 (0.1%) on Naproxen and Pseudoephedrine (serious AE) |
| Pneumonia (lung infection) | 1,175 | 3.7 3.5–3.9ROR 3.9 · χ² 2,378 / p <1e-300 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | NCT00346216: 2/7,933 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Headache | 1,127 | 1.8 1.7–2.0ROR 1.9 · χ² 448 / p 8e-100 | 1.8 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.3 | NCT00346216: 4/8,030 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Dizziness | 1,012 | 2.1 2.0–2.2ROR 2.1 · χ² 583 / p 4e-129 | 2.1 EB05 2.0 · IC025 +1.0 | Labeled adverse reaction exact term | serious PRR 2.3 · 76% consumer | NCT00346216: 6/7,933 (0.1%) on Naproxen and Pseudoephedrine (serious AE) |
| Pain | 852 | 1.4 1.3–1.5ROR 1.4 · χ² 108 / p 1e-25 | 1.4 EB05 1.3 · IC025 +0.4 | Likely indication confounding term in indications; also in warnings | serious PRR 1.9 | NCT00346216: 13/7,933 (0.2%) on Naproxen and Pseudoephedrine (serious AE) |
| Sinusitis | 701 | 7.0 6.5–7.6ROR 7.2 · χ² 3,612 / p <1e-300 | 7.0 EB05 6.5 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 | NCT00346216: 1/8,030 (0.0%) on Naproxen and Pseudoephedrine (serious AE) |
| Asthenia (weakness) | 678 | 1.8 1.7–2.0ROR 1.9 · χ² 268 / p 2e-60 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.4 | NCT00346216: 4/7,933 (0.1%) on Naproxen and Pseudoephedrine (serious AE) |
| Fall | 653 | 2.0 1.9–2.2ROR 2.0 · χ² 337 / p 1e-75 | 2.0 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.5 | NCT00346216: 10/7,933 (0.1%) on Naproxen and Pseudoephedrine (serious AE) |
| Vomiting | 647 | 1.4 1.3–1.5ROR 1.4 · χ² 80 / p 2e-19 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT00346216: 7/7,933 (0.1%) on Naproxen and Pseudoephedrine (serious AE) |
| Death | 634 | 0.8 0.7–0.8ROR 0.7 · χ² 53 / p 2e-13 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.9 · ♀ 43% (drug 66%) | NCT00346216: 1/7,992 (0.0%) on Naproxen and Pseudoephedrine (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.
- Infusion site discharge — n=33, PRR 20.1
- Seasonal allergy — n=199, PRR 14.6
- Pneumonia pseudomonal — n=21, PRR 14.3 (also seen in trial arm)
- Lower respiratory tract congestion — n=23, PRR 14.0
- Multiple allergies — n=100, PRR 13.2
- Nephrogenic anaemia — n=59, PRR 13.1
- Sputum increased — n=26, PRR 12.7
- Rebound acid hypersecretion — n=37, PRR 12.5
- Infusion site haemorrhage — n=37, PRR 11.8 (also seen in trial arm)
- Infusion site bruising — n=24, PRR 11.7
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 and Pseudoephedrine?
In FDA FAERS, the most frequently co-reported reaction terms for Naproxen and Pseudoephedrine are dyspnoea, fatigue, nausea, cough, diarrhoea, pneumonia. 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 and Pseudoephedrine 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 and Pseudoephedrine 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, 1,134 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 2026-10-08. 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.