Drug · FAERS side-effect profile with label screen
Pseudoephedrine Hydrochloride side effects: what 10,215 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Pseudoephedrine Hydrochloride (Nasal Decongestant)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
10,215 reports · 88% serious · 3,554 with death outcome · 92% female
openFDA FAERS counts, all years, deduplication not applied
Used for
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily relieves sinus congestion and pressure
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
Reporting / coding artifact 2Lab value / disease marker 7No label text to screen 31
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). 744 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 |
|---|---|---|---|---|---|---|
| Swollen joint count increased | 1,701 | 2,499.3 2,334.2–2,676.1ROR 2,998.4 · calibrated p 2e-23 ✓ | 1,105.1 EB05 1,061.7 · IC025 +9.6 3/3 methods agree | Lab value / disease marker | serious n=1,700 · 95% clinician | not reported in cached trials |
| Hepatic enzyme | 76 | 2,481.9 1,775.7–3,469.1ROR 2,500.5 · calibrated p 3e-21 ✓ | 869.4 EB05 717.4 · 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 | 2,299 | 2,312.4 2,185.1–2,447.0ROR 2,983.7 · calibrated p 2e-23 ✓ | 1,070.3 EB05 1,034.1 · IC025 +9.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2,298 · 95% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 3,542 | 2,064.9 1,978.8–2,154.8ROR 3,160.5 · calibrated p 9e-24 ✓ | 1,017.1 EB05 989.3 · IC025 +9.7 3/3 methods agree | Lab value / disease marker | serious PRR 674.4 · 93% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 327 | 1,994.2 1,713.9–2,320.4ROR 2,060.1 · calibrated p 5e-21 ✓ | 948.9 EB05 865.6 · IC025 +8.4 3/3 methods agree | Lab value / disease marker | serious n=327 · 94% clinician | not reported in cached trials |
| Lupus vulgaris | 552 | 1,794.0 1,602.4–2,008.4ROR 1,896.4 · calibrated p 1e-20 ✓ | 921.0 EB05 858.3 · IC025 +8.9 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 | 2,506 | 1,591.1 1,515.6–1,670.3ROR 2,108.0 · calibrated p 2e-21 ✓ | 885.3 EB05 856.6 · IC025 +9.5 3/3 methods agree | Lab value / disease marker | serious n=2,504 · 93% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 850 | 1,584.7 1,451.8–1,729.9ROR 1,728.5 · calibrated p 3e-20 ✓ | 871.8 EB05 823.7 · IC025 +9.1 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 |
| Duodenal ulcer perforation | 3,060 | 1,480.1 1,418.7–1,544.2ROR 2,112.6 · calibrated p 2e-21 ✓ | 850.9 EB05 825.9 · IC025 +9.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 561.6 · 93% clinician | not reported in cached trials |
| Pemphigus | 5,101 | 1,440.7 1,397.8–1,484.8ROR 2,876.7 · calibrated p 3e-23 ✓ | 839.5 EB05 820.3 · IC025 +9.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 555.2 · 93% clinician | not reported in cached trials |
| C-reactive protein | 324 | 1,146.9 1,002.1–1,312.5ROR 1,184.4 · calibrated p 5e-18 ✓ | 701.9 EB05 640.1 · IC025 +8.2 3/3 methods agree | Lab value / disease marker | serious n=324 · 95% clinician | not reported in cached trials |
| Hand deformity | 4,461 | 1,068.7 1,036.4–1,101.9ROR 1,896.4 · calibrated p 9e-21 ✓ | 697.7 EB05 680.7 · IC025 +9.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 500.2 · 93% clinician | not reported in cached trials |
| Facet joint syndrome | 1,068 | 1,057.9 985.0–1,136.2ROR 1,181.3 · calibrated p 4e-18 ✓ | 686.6 EB05 652.7 · 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 | 977.8 769.9–1,241.9ROR 987.3 · calibrated p 8e-17 ✓ | 584.7 EB05 494.2 · 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 | 2,980 | 852.0 820.1–885.1ROR 1,202.5 · calibrated p 3e-18 ✓ | 597.6 EB05 579.8 · IC025 +9.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 416.8 · 93% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 586 | 845.1 768.9–928.8ROR 896.4 · calibrated p 1e-16 ✓ | 585.1 EB05 546.4 · IC025 +8.5 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 | 471 | 810.2 729.4–900.0ROR 849.3 · calibrated p 2e-16 ✓ | 565.6 EB05 524.0 · IC025 +8.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=471 · 96% clinician | not reported in cached trials |
| X-ray abnormal | 494 | 788.8 712.2–873.6ROR 828.8 · calibrated p 3e-16 ✓ | 555.6 EB05 515.7 · 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 | 769.9 702.5–843.8ROR 818.3 · calibrated p 3e-16 ✓ | 548.4 EB05 512.6 · 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 | 726.0 600.0–878.6ROR 736.3 · calibrated p 1e-15 ✓ | 498.6 EB05 433.4 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=142 · 99% clinician | not reported in cached trials |
| Pericarditis | 4,215 | 697.7 677.7–718.3ROR 1,187.1 · calibrated p 3e-18 ✓ | 517.9 EB05 504.9 · IC025 +8.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 344.1 · 93% clinician | not reported in cached trials |
| Muscle injury | 2,017 | 671.2 640.8–703.2ROR 836.1 · calibrated p 2e-16 ✓ | 502.0 EB05 483.8 · IC025 +8.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 359.2 · 94% clinician | not reported in cached trials |
| Swollen joint count | 60 | 663.8 496.3–888.0ROR 667.8 · calibrated p 9e-15 ✓ | 431.1 EB05 347.1 · 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 | 651.8 607.7–699.2ROR 719.3 · calibrated p 1e-15 ✓ | 488.5 EB05 463.1 · IC025 +8.5 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 | 647.9 409.3–1,025.6ROR 649.4 · calibrated p 6e-14 ✓ | 352.7 EB05 249.5 · 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 | 4,209 | 626.5 608.8–644.7ROR 1,064.8 · calibrated p 1e-17 ✓ | 477.6 EB05 465.6 · IC025 +8.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 329.5 · 93% clinician | not reported in cached trials |
| Folliculitis | 2,295 | 588.2 563.9–613.6ROR 758.3 · calibrated p 6e-16 ✓ | 454.3 EB05 438.9 · IC025 +8.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 352.4 · 94% clinician | not reported in cached trials |
| Seronegative arthritis | 249 | 586.9 510.4–674.9ROR 601.5 · calibrated p 1e-14 ✓ | 439.8 EB05 395.8 · IC025 +7.7 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 | 563.2 532.3–595.8ROR 651.2 · calibrated p 3e-15 ✓ | 438.2 EB05 419.1 · IC025 +8.5 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) | 4,739 | 553.8 539.8–568.2ROR 1,032.3 · calibrated p 2e-17 ✓ | 434.3 EB05 424.0 · IC025 +8.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 414.0 · 93% clinician | not reported in cached trials |
| Grip strength | 43 | 468.1 336.1–651.8ROR 470.1 · calibrated p 4e-13 ✓ | 325.3 EB05 251.6 · 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 | 4,586 | 406.3 396.2–416.6ROR 736.5 · calibrated p 8e-16 ✓ | 338.1 EB05 330.0 · IC025 +8.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 314.9 · serious PRR 264.9 · 94% clinician | not reported in cached trials |
| Tender joint count | 14 | 404.9 228.2–718.6ROR 405.5 · calibrated p 2e-11 ✓ | 231.3 EB05 146.5 · 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 | 384.4 360.4–410.0ROR 426.4 · calibrated p 3e-13 ✓ | 321.2 EB05 304.9 · IC025 +8.0 3/3 methods agree | Lab value / disease marker | serious n=1,009 · 95% clinician | not reported in cached trials |
| Acquired porphyria | 11 | 377.5 198.4–718.3ROR 377.9 · calibrated p 8e-11 ✓ | 205.4 EB05 122.4 · 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 | 5,224 | 356.3 348.5–364.2ROR 728.1 · calibrated p 9e-16 ✓ | 302.8 EB05 295.9 · IC025 +8.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 265.6 · serious PRR 204.5 · 93% clinician | not reported in cached trials |
| Onychomadesis | 565 | 323.5 296.7–352.8ROR 342.4 · calibrated p 3e-12 ✓ | 276.5 EB05 257.9 · IC025 +7.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=564 · 94% clinician | not reported in cached trials |
| Breast cancer stage iii | 868 | 320.5 299.2–343.4ROR 350.2 · calibrated p 2e-12 ✓ | 275.2 EB05 260.2 · IC025 +7.8 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 | 54 | 310.6 233.4–413.4ROR 312.3 · calibrated p 2e-11 ✓ | 246.0 EB05 195.7 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious n=54 | not reported in cached trials |
| Contraindicated product administered | 3,857 | 301.4 293.2–309.9ROR 483.6 · calibrated p 8e-14 ✓ | 262.1 EB05 255.3 · IC025 +7.9 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 242.5 · serious PRR 214.6 · 94% 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 | 4,702 | 32.531.8–33.2 | signal |
| Interstitial lung disease | 938 | 20.319.1–21.5 | signal |
| Hyperglycaemia / diabetes | 2,616 | 15.615.1–16.2 | signal |
| Depression | 1,051 | 7.77.3–8.1 | signal |
| Serious infection | 2,813 | 7.57.3–7.7 | signal |
| Rhabdomyolysis / myopathy | 145 | 3.73.1–4.3 | signal |
| Pancreatitis | 125 | 3.22.7–3.8 | signal |
| Gi bleeding | 185 | 2.11.8–2.4 | raised |
| Fall / fracture | 283 | 1.51.4–1.7 | raised |
| Anaphylaxis / angioedema | 87 | 1.41.2–1.8 | raised |
| Severe cutaneous reaction | 43 | 1.20.9–1.6 | no difference |
| Thrombocytopenia | 97 | 0.90.7–1.1 | no difference |
| Anaemia | 72 | 0.50.4–0.6 | lower than other drugs |
| Suicidality | 51 | 0.40.3–0.6 | lower than other drugs |
| Venous thromboembolism | 44 | 0.40.3–0.6 | lower than other drugs |
| Tendon disorder | 7 | 0.40.2–0.8 | 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 Hydrochloride 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 | 5,224 | 356.3 348.5–364.2ROR 728.1 · calibrated p 9e-16 ✓ | 302.8 EB05 295.9 · IC025 +8.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 265.6 · serious PRR 204.5 · 93% clinician | not reported in cached trials |
| Pain | 5,168 | 17.4 17.0–17.7ROR 34.2 · calibrated p 1e-4 ✓ | 17.2 EB05 16.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 14.2 · serious PRR 17.9 · 93% clinician | not reported in cached trials |
| Drug ineffective (drug did not work) | 5,155 | 8.1 7.9–8.2ROR 15.3 · calibrated p 0.006 ✓ | 8.0 EB05 7.9 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 8.2 · serious PRR 14.4 | not reported in cached trials |
| Pemphigus | 5,101 | 1,440.7 1,397.8–1,484.8ROR 2,876.7 · calibrated p 3e-23 ✓ | 839.5 EB05 820.3 · IC025 +9.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 555.2 · 93% clinician | not reported in cached trials |
| Rheumatoid arthritis | 5,100 | 97.0 95.0–99.0ROR 192.7 · calibrated p 5e-10 ✓ | 92.6 EB05 90.4 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 71.2 · serious PRR 74.4 · 93% clinician | not reported in cached trials |
| Abdominal discomfort | 5,004 | 63.3 62.1–64.6ROR 123.2 · calibrated p 2e-8 ✓ | 61.4 EB05 60.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 52.7 · serious PRR 90.6 · 92% clinician | not reported in cached trials |
| Alopecia (hair loss) | 4,896 | 52.4 51.3–53.5ROR 99.7 · calibrated p 1e-7 ✓ | 51.1 EB05 49.9 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 39.6 · serious PRR 71.8 · 92% clinician | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 4,739 | 553.8 539.8–568.2ROR 1,032.3 · calibrated p 2e-17 ✓ | 434.3 EB05 424.0 · IC025 +8.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 414.0 · 93% clinician | not reported in cached trials |
| Wound | 4,586 | 406.3 396.2–416.6ROR 736.5 · calibrated p 8e-16 ✓ | 338.1 EB05 330.0 · IC025 +8.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 314.9 · serious PRR 264.9 · 94% clinician | not reported in cached trials |
| Fatigue (tiredness) | 4,577 | 12.2 11.9–12.4ROR 21.2 · calibrated p 0.001 ✓ | 12.1 EB05 11.8 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 9.6 · serious PRR 15.0 · 92% clinician | not reported in cached trials |
| Swelling | 4,569 | 105.6 103.3–108.0ROR 190.3 · calibrated p 6e-10 ✓ | 100.4 EB05 98.0 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 82.6 · serious PRR 107.1 · 93% clinician | not reported in cached trials |
| Rash | 4,508 | 21.6 21.1–22.0ROR 37.8 · calibrated p 7e-5 ✓ | 21.3 EB05 20.8 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 18.8 · serious PRR 31.2 · 93% clinician | not reported in cached trials |
| Hand deformity | 4,461 | 1,068.7 1,036.4–1,101.9ROR 1,896.4 · calibrated p 9e-21 ✓ | 697.7 EB05 680.7 · IC025 +9.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 500.2 · 93% clinician | not reported in cached trials |
| Arthropathy | 4,219 | 168.0 163.9–172.3ROR 285.6 · calibrated p 2e-11 ✓ | 155.1 EB05 151.2 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 139.6 · serious PRR 124.4 · 93% clinician | not reported in cached trials |
| Pericarditis | 4,215 | 697.7 677.7–718.3ROR 1,187.1 · calibrated p 3e-18 ✓ | 517.9 EB05 504.9 · IC025 +8.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 344.1 · 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.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Oxycodone Hydrochloride ↔ Drug Dependence.
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 Hydrochloride?
In FDA FAERS, the most frequently co-reported reaction terms for Pseudoephedrine Hydrochloride 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 Hydrochloride have an FDA boxed warning?
No. The FDA label retrieved for Pseudoephedrine Hydrochloride has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pseudoephedrine Hydrochloride 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 06092347-33fe-46b8-829c-70e4ca15ecf2, effective 20260401; matched on
openfda.generic_name.exact:"PSEUDOEPHEDRINE HYDROCHLORIDE") - 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, 784 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.