Pseudoephedrine side effects: what 10,953 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Pseudoephedrine Hcl (Sudogest Nasal Decongestant)
Who reports
10,953 reports · 88% serious · 3,852 with death outcome · 89% female
Used for
• temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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). 936 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 |
|---|---|---|---|---|---|---|
| Swollen joint count increased | 1,711 | 2,361.4 2,204.9–2,529.1ROR 2,798.4 · calibrated p 5e-23 ✓ | 1,037.5 EB05 996.8 · IC025 +9.6 3/3 methods agree | Lab value / disease marker | serious n=1,710 · 95% clinician | not reported in cached trials |
| Hepatic enzyme | 76 | 2,314.4 1,655.7–3,235.1ROR 2,330.6 · calibrated p 7e-21 ✓ | 823.0 EB05 679.1 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=76 · 100% clinician | not reported in cached trials |
| Rheumatic fever | 2,310 | 2,178.5 2,058.1–2,305.9ROR 2,760.4 · calibrated p 6e-23 ✓ | 1,003.5 EB05 969.6 · IC025 +9.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2,309 · 94% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 3,575 | 1,962.1 1,879.8–2,048.2ROR 2,912.3 · calibrated p 3e-23 ✓ | 957.7 EB05 931.7 · IC025 +9.7 3/3 methods agree | Lab value / disease marker | serious PRR 628.4 · 93% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 327 | 1,859.6 1,598.1–2,163.9ROR 1,916.8 · calibrated p 1e-20 ✓ | 888.2 EB05 810.3 · IC025 +8.4 3/3 methods agree | Lab value / disease marker | serious n=327 · 94% clinician | not reported in cached trials |
| Lupus vulgaris | 552 | 1,672.9 1,494.1–1,873.1ROR 1,761.6 · calibrated p 3e-20 ✓ | 860.8 EB05 802.1 · IC025 +8.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=552 · 96% clinician | not reported in cached trials |
| Rheumatoid factor positive | 2,540 | 1,520.0 1,447.7–1,596.0ROR 1,978.6 · calibrated p 5e-21 ✓ | 837.2 EB05 810.2 · IC025 +9.4 3/3 methods agree | Lab value / disease marker | serious n=2,538 · 93% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 850 | 1,477.8 1,353.6–1,613.3ROR 1,602.0 · calibrated p 9e-20 ✓ | 814.1 EB05 769.2 · IC025 +9.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=850 · 93% clinician | not reported in cached trials |
| Pemphigus | 5,214 | 1,395.2 1,353.3–1,438.4ROR 2,661.6 · calibrated p 1e-22 ✓ | 800.4 EB05 782.3 · IC025 +9.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 523.9 · 92% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 3,067 | 1,385.7 1,327.8–1,446.1ROR 1,924.1 · calibrated p 8e-21 ✓ | 795.6 EB05 772.2 · IC025 +9.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 519.6 · 93% clinician | not reported in cached trials |
| C-reactive protein | 324 | 1,069.5 934.4–1,224.0ROR 1,102.0 · calibrated p 1e-17 ✓ | 656.4 EB05 598.6 · IC025 +8.2 3/3 methods agree | Lab value / disease marker | serious n=324 · 95% clinician | not reported in cached trials |
| Hand deformity | 4,505 | 1,011.6 980.8–1,043.4ROR 1,717.6 · calibrated p 3e-20 ✓ | 657.2 EB05 641.2 · IC025 +9.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 466.4 · 93% clinician | not reported in cached trials |
| Facet joint syndrome | 1,068 | 986.5 918.4–1,059.7ROR 1,093.0 · calibrated p 9e-18 ✓ | 640.8 EB05 609.2 · IC025 +8.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1,068 · 94% clinician | not reported in cached trials |
| Hypocholesterolaemia | 99 | 911.8 717.9–1,158.1ROR 920.1 · calibrated p 2e-16 ✓ | 549.5 EB05 464.5 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=99 · 98% clinician | not reported in cached trials |
| Helicobacter infection | 2,989 | 797.9 767.8–829.1ROR 1,096.9 · calibrated p 8e-18 ✓ | 559.1 EB05 542.5 · IC025 +8.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 385.9 · 93% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 586 | 788.0 716.9–866.2ROR 832.5 · calibrated p 2e-16 ✓ | 546.3 EB05 510.2 · IC025 +8.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=586 · 95% clinician | not reported in cached trials |
| Retinitis | 475 | 764.6 688.4–849.1ROR 799.2 · calibrated p 4e-16 ✓ | 532.7 EB05 493.7 · IC025 +8.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=475 · 96% clinician | not reported in cached trials |
| X-ray abnormal | 494 | 735.6 664.1–814.8ROR 770.3 · calibrated p 6e-16 ✓ | 518.9 EB05 481.6 · IC025 +8.3 3/3 methods agree | Lab value / disease marker | serious n=494 · 97% clinician | not reported in cached trials |
| Dislocation of vertebra | 605 | 718.0 655.0–786.9ROR 759.9 · calibrated p 7e-16 ✓ | 512.0 EB05 478.6 · IC025 +8.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=605 · 94% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 142 | 677.0 559.4–819.4ROR 685.9 · calibrated p 3e-15 ✓ | 467.1 EB05 406.1 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=142 · 100% clinician | not reported in cached trials |
| Pericarditis | 4,261 | 660.2 641.0–679.9ROR 1,079.8 · calibrated p 1e-17 ✓ | 488.3 EB05 476.1 · IC025 +8.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 321.1 · 93% clinician | not reported in cached trials |
| Muscle injury | 2,017 | 625.9 597.4–655.9ROR 767.0 · calibrated p 5e-16 ✓ | 468.2 EB05 451.3 · IC025 +8.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 331.6 · 94% clinician | not reported in cached trials |
| Swollen joint count | 60 | 619.0 462.7–828.1ROR 622.4 · calibrated p 2e-14 ✓ | 405.9 EB05 326.8 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=60 · 92% clinician | not reported in cached trials |
| Peripheral venous disease | 960 | 607.8 566.6–652.1ROR 666.1 · calibrated p 3e-15 ✓ | 455.8 EB05 432.2 · IC025 +8.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=960 · 95% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, hypersomnia type | 24 | 604.2 381.7–956.4ROR 605.5 · calibrated p 1e-13 ✓ | 335.4 EB05 237.2 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · 92% clinician | not reported in cached trials |
| Synovitis | 4,248 | 591.3 574.4–608.7ROR 965.2 · calibrated p 4e-17 ✓ | 449.6 EB05 438.4 · IC025 +8.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 307.0 · 93% clinician | not reported in cached trials |
| Folliculitis | 2,296 | 548.8 525.9–572.6ROR 694.1 · calibrated p 2e-15 ✓ | 423.9 EB05 409.6 · IC025 +8.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 325.5 · 94% clinician | not reported in cached trials |
| Seronegative arthritis | 249 | 547.3 475.9–629.4ROR 560.0 · calibrated p 2e-14 ✓ | 411.1 EB05 370.0 · IC025 +7.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=249 · 94% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 1,383 | 525.2 496.3–555.7ROR 600.9 · calibrated p 8e-15 ✓ | 408.8 EB05 391.0 · IC025 +8.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1,382 · 93% clinician | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 4,787 | 523.1 509.7–536.9ROR 928.4 · calibrated p 6e-17 ✓ | 409.2 EB05 399.5 · IC025 +8.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 386.0 · 93% clinician | not reported in cached trials |
| Grip strength | 43 | 436.5 313.4–607.8ROR 438.2 · calibrated p 9e-13 ✓ | 306.4 EB05 236.9 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=43 | not reported in cached trials |
| Wound | 4,630 | 383.3 373.6–393.1ROR 663.1 · calibrated p 3e-15 ✓ | 318.3 EB05 310.7 · IC025 +8.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 293.8 · serious PRR 246.9 · 94% clinician | not reported in cached trials |
| Tender joint count | 14 | 377.6 212.8–670.1ROR 378.1 · calibrated p 4e-11 ✓ | 220.5 EB05 139.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | not reported in cached trials |
| C-reactive protein abnormal | 1,009 | 358.4 336.0–382.4ROR 394.7 · calibrated p 7e-13 ✓ | 299.7 EB05 284.5 · IC025 +7.9 3/3 methods agree | Lab value / disease marker | serious n=1,009 · 95% clinician | not reported in cached trials |
| Acquired porphyria | 11 | 352.0 185.0–669.9ROR 352.4 · calibrated p 1e-10 ✓ | 196.3 EB05 117.0 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | not reported in cached trials |
| Systemic lupus erythematosus | 5,337 | 340.7 333.2–348.4ROR 663.5 · calibrated p 3e-15 ✓ | 288.5 EB05 282.0 · IC025 +8.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 249.7 · serious PRR 192.8 · 93% clinician | not reported in cached trials |
| Onychomadesis | 566 | 302.3 277.2–329.7ROR 318.7 · calibrated p 6e-12 ✓ | 258.4 EB05 241.1 · IC025 +7.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=565 · 94% clinician | not reported in cached trials |
| Breast cancer stage iii | 868 | 298.9 278.9–320.3ROR 324.5 · calibrated p 5e-12 ✓ | 256.7 EB05 242.7 · IC025 +7.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=868 · 94% clinician | not reported in cached trials |
| Nail operation | 55 | 295.8 222.8–392.9ROR 297.3 · calibrated p 2e-11 ✓ | 235.1 EB05 187.4 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious n=55 | not reported in cached trials |
| Contraindicated product administered | 3,896 | 284.3 276.5–292.4ROR 440.7 · calibrated p 2e-13 ✓ | 246.9 EB05 240.5 · IC025 +7.9 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 225.7 · serious PRR 200.1 · 93% clinician | 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 |
|---|---|---|---|
| Liver injury | 4,753 | 30.630.0–31.3 | signal |
| Interstitial lung disease | 942 | 19.017.8–20.2 | signal |
| Hyperglycaemia / diabetes | 2,647 | 14.814.3–15.3 | signal |
| Depression | 1,073 | 7.36.9–7.8 | signal |
| Serious infection | 2,846 | 7.16.9–7.3 | signal |
| Rhabdomyolysis / myopathy | 148 | 3.53.0–4.1 | signal |
| Pancreatitis | 126 | 3.02.5–3.6 | signal |
| Gi bleeding | 193 | 2.01.8–2.3 | raised |
| Fall / fracture | 300 | 1.51.4–1.7 | raised |
| Anaphylaxis / angioedema | 95 | 1.51.2–1.8 | raised |
| Severe cutaneous reaction | 48 | 1.20.9–1.6 | no difference |
| Suicidality | 130 | 1.00.9–1.2 | no difference |
| Thrombocytopenia | 102 | 0.90.7–1.1 | no difference |
| Anaemia | 81 | 0.50.4–0.6 | lower than other drugs |
| Venous thromboembolism | 54 | 0.50.4–0.6 | lower than other drugs |
| Arrhythmia / qt | 43 | 0.40.3–0.6 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list 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 (0 of 40 signal terms matched).
- NCT01202279 — Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI (N=1179, PHASE4; 4 AE terms posted; arms: Mucinex D; Placebo)
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 |
|---|---|---|---|---|---|---|
| Systemic lupus erythematosus | 5,337 | 340.7 333.2–348.4ROR 663.5 · calibrated p 3e-15 ✓ | 288.5 EB05 282.0 · IC025 +8.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 249.7 · serious PRR 192.8 · 93% clinician | not reported in cached trials |
| Pain | 5,310 | 16.7 16.3–17.0ROR 31.4 · calibrated p 2e-4 ✓ | 16.5 EB05 16.2 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 13.4 · serious PRR 16.9 · 92% clinician | not reported in cached trials |
| Drug ineffective (drug did not work) | 5,277 | 7.7 7.6–7.9ROR 13.9 · calibrated p 0.009 ✓ | 7.7 EB05 7.5 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 7.6 · serious PRR 13.6 | not reported in cached trials |
| Pemphigus | 5,214 | 1,395.2 1,353.3–1,438.4ROR 2,661.6 · calibrated p 1e-22 ✓ | 800.4 EB05 782.3 · IC025 +9.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 523.9 · 92% clinician | not reported in cached trials |
| Rheumatoid arthritis | 5,213 | 92.5 90.6–94.4ROR 175.6 · calibrated p 1e-9 ✓ | 88.2 EB05 86.2 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 67.0 · serious PRR 70.2 · 93% clinician | not reported in cached trials |
| Abdominal discomfort | 5,117 | 60.4 59.2–61.7ROR 112.6 · calibrated p 5e-8 ✓ | 58.6 EB05 57.3 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 49.3 · serious PRR 85.6 · 92% clinician | not reported in cached trials |
| Alopecia (hair loss) | 5,011 | 50.0 49.0–51.1ROR 91.3 · calibrated p 2e-7 ✓ | 48.7 EB05 47.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 37.1 · serious PRR 67.8 · 92% clinician | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 4,787 | 523.1 509.7–536.9ROR 928.4 · calibrated p 6e-17 ✓ | 409.2 EB05 399.5 · IC025 +8.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 386.0 · 93% clinician | not reported in cached trials |
| Fatigue (tiredness) | 4,648 | 11.5 11.3–11.8ROR 19.3 · calibrated p 0.002 ✓ | 11.5 EB05 11.2 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 9.0 · serious PRR 14.1 · 91% clinician | not reported in cached trials |
| Wound | 4,630 | 383.3 373.6–393.1ROR 663.1 · calibrated p 3e-15 ✓ | 318.3 EB05 310.7 · IC025 +8.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 293.8 · serious PRR 246.9 · 94% clinician | not reported in cached trials |
| Swelling | 4,606 | 99.3 97.1–101.6ROR 170.7 · calibrated p 2e-9 ✓ | 94.4 EB05 92.1 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 76.9 · serious PRR 99.7 · 93% clinician | not reported in cached trials |
| Rash | 4,566 | 20.4 19.9–20.8ROR 34.2 · calibrated p 1e-4 ✓ | 20.2 EB05 19.7 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 17.4 · serious PRR 29.2 · 92% clinician | not reported in cached trials |
| Hand deformity | 4,505 | 1,011.6 980.8–1,043.4ROR 1,717.6 · calibrated p 3e-20 ✓ | 657.2 EB05 641.2 · IC025 +9.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 466.4 · 93% clinician | not reported in cached trials |
| Pericarditis | 4,261 | 660.2 641.0–679.9ROR 1,079.8 · calibrated p 1e-17 ✓ | 488.3 EB05 476.1 · IC025 +8.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 321.1 · 93% clinician | not reported in cached trials |
| Synovitis | 4,248 | 591.3 574.4–608.7ROR 965.2 · calibrated p 4e-17 ✓ | 449.6 EB05 438.4 · IC025 +8.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 307.0 · 93% clinician | not reported in cached trials |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Pseudoephedrine?
In FDA FAERS, the most frequently co-reported reaction terms for Pseudoephedrine are systemic lupus erythematosus, pain, pemphigus, rheumatoid arthritis, abdominal discomfort, alopecia. 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 Pseudoephedrine have an FDA boxed warning?
No. The FDA label retrieved for Pseudoephedrine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that 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 09feb5f0-c22d-4a1b-97a0-d5767e5f7730, effective 20241107; matched on
openfda.generic_name.exact:"PSEUDOEPHEDRINE HCL") - 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, 976 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
PSEUDOEPHEDRINE, 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.