Drug · FAERS side-effect profile with label screen
Pyrilamine side effects: what 60 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Pyrilamine Maleate (Childrens Pediaclear 8)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
60 reports · 95% serious · 1 with death outcome · 95% female
openFDA FAERS counts, all years, deduplication not applied
Used for
■ temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.
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 18 strongest signals
Reporting / coding artifact 1Lab value / disease marker 1No label text to screen 16
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 0 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 |
|---|---|---|---|---|---|---|
| Sputum discoloured | 44 | 1,634.3 1,401.1–1,906.3ROR 6,125.9 · χ² 69,898 / p <1e-300 | 949.3 EB05 736.4 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1,290.3 | no trial data cached |
| Aspiration | 47 | 1,522.7 1,331.2–1,741.8ROR 7,024.3 · χ² 69,688 / p <1e-300 | 934.4 EB05 730.9 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 943.8 | no trial data cached |
| Obstructive airways disorder | 45 | 1,414.6 1,220.9–1,639.1ROR 5,655.4 · χ² 61,940 / p <1e-300 | 878.3 EB05 683.3 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 887.8 | no trial data cached |
| Pulmonary mass | 48 | 1,131.7 996.2–1,285.6ROR 5,654.4 · χ² 52,963 / p <1e-300 | 776.2 EB05 608.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 745.3 | no trial data cached |
| Blood test abnormal | 44 | 1,098.7 942.3–1,280.9ROR 4,117.2 · χ² 47,043 / p <1e-300 | 740.1 EB05 574.1 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious PRR 1,016.0 | no trial data cached |
| Pulmonary fibrosis | 48 | 879.9 774.7–999.4ROR 4,395.4 · χ² 41,197 / p <1e-300 | 649.0 EB05 509.0 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 537.6 | no trial data cached |
| Liver function test increased | 44 | 722.5 619.9–842.1ROR 2,706.5 · χ² 30,950 / p <1e-300 | 548.1 EB05 425.2 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 682.2 | no trial data cached |
| Transaminases increased | 44 | 693.5 595.1–808.3ROR 2,598.0 · χ² 29,711 / p <1e-300 | 531.3 EB05 412.2 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 447.6 | no trial data cached |
| Haemoptysis | 44 | 550.9 472.7–642.0ROR 2,063.1 · χ² 23,599 / p <1e-300 | 443.5 EB05 344.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 375.2 | no trial data cached |
| Hypoxia (low oxygen) | 45 | 449.0 387.8–519.8ROR 1,793.0 · χ² 19,677 / p <1e-300 | 376.5 EB05 292.9 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 276.5 | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 47 | 356.3 311.8–407.1ROR 1,640.6 · χ² 16,316 / p <1e-300 | 310.8 EB05 243.2 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 367.3 | no trial data cached |
| Lower respiratory tract infection | 46 | 355.1 308.7–408.4ROR 1,518.6 · χ² 15,908 / p <1e-300 | 309.1 EB05 241.2 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 227.5 | no trial data cached |
| Pleural effusion | 47 | 269.9 236.2–308.3ROR 1,241.9 · χ² 12,348 / p <1e-300 | 243.0 EB05 190.1 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 168.9 | no trial data cached |
| Wheezing | 43 | 254.2 216.8–298.1ROR 894.6 · χ² 10,615 / p <1e-300 | 228.3 EB05 176.6 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 212.3 | no trial data cached |
| Blood creatinine increased | 44 | 235.2 201.9–274.0ROR 879.3 · χ² 10,053 / p <1e-300 | 213.4 EB05 165.5 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious PRR 163.9 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 47 | 205.0 179.4–234.2ROR 942.3 · χ² 9,366 / p <1e-300 | 189.2 EB05 148.0 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 198.1 | no trial data cached |
| Musculoskeletal stiffness | 48 | 191.4 168.7–217.3ROR 953.2 · χ² 8,937 / p <1e-300 | 177.9 EB05 139.5 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 189.6 | no trial data cached |
| Asthma | 48 | 149.7 131.9–169.9ROR 744.6 · χ² 6,977 / p <1e-300 | 141.3 EB05 110.9 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 127.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Asthma | 48 | 149.7 131.9–169.9ROR 744.6 · χ² 6,977 / p <1e-300 | 141.3 EB05 110.9 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 127.6 | no trial data cached |
| Musculoskeletal stiffness | 48 | 191.4 168.7–217.3ROR 953.2 · χ² 8,937 / p <1e-300 | 177.9 EB05 139.5 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 189.6 | no trial data cached |
| Pulmonary fibrosis | 48 | 879.9 774.7–999.4ROR 4,395.4 · χ² 41,197 / p <1e-300 | 649.0 EB05 509.0 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 537.6 | no trial data cached |
| Pulmonary mass | 48 | 1,131.7 996.2–1,285.6ROR 5,654.4 · χ² 52,963 / p <1e-300 | 776.2 EB05 608.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 745.3 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 47 | 205.0 179.4–234.2ROR 942.3 · χ² 9,366 / p <1e-300 | 189.2 EB05 148.0 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 198.1 | no trial data cached |
| Pleural effusion | 47 | 269.9 236.2–308.3ROR 1,241.9 · χ² 12,348 / p <1e-300 | 243.0 EB05 190.1 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 168.9 | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 47 | 356.3 311.8–407.1ROR 1,640.6 · χ² 16,316 / p <1e-300 | 310.8 EB05 243.2 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 367.3 | no trial data cached |
| Aspiration | 47 | 1,522.7 1,331.2–1,741.8ROR 7,024.3 · χ² 69,688 / p <1e-300 | 934.4 EB05 730.9 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 943.8 | no trial data cached |
| Lower respiratory tract infection | 46 | 355.1 308.7–408.4ROR 1,518.6 · χ² 15,908 / p <1e-300 | 309.1 EB05 241.2 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 227.5 | no trial data cached |
| Hypoxia (low oxygen) | 45 | 449.0 387.8–519.8ROR 1,793.0 · χ² 19,677 / p <1e-300 | 376.5 EB05 292.9 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 276.5 | no trial data cached |
| Obstructive airways disorder | 45 | 1,414.6 1,220.9–1,639.1ROR 5,655.4 · χ² 61,940 / p <1e-300 | 878.3 EB05 683.3 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 887.8 | no trial data cached |
| Blood creatinine increased | 44 | 235.2 201.9–274.0ROR 879.3 · χ² 10,053 / p <1e-300 | 213.4 EB05 165.5 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious PRR 163.9 | no trial data cached |
| Haemoptysis | 44 | 550.9 472.7–642.0ROR 2,063.1 · χ² 23,599 / p <1e-300 | 443.5 EB05 344.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 375.2 | no trial data cached |
| Transaminases increased | 44 | 693.5 595.1–808.3ROR 2,598.0 · χ² 29,711 / p <1e-300 | 531.3 EB05 412.2 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 447.6 | no trial data cached |
| Liver function test increased | 44 | 722.5 619.9–842.1ROR 2,706.5 · χ² 30,950 / p <1e-300 | 548.1 EB05 425.2 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 682.2 | no trial data cached |
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 Pyrilamine?
In FDA FAERS, the most frequently co-reported reaction terms for Pyrilamine are asthma, musculoskeletal stiffness, pulmonary fibrosis, pulmonary mass, gastrooesophageal reflux disease, pleural effusion. 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 Pyrilamine have an FDA boxed warning?
No. The FDA label retrieved for Pyrilamine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pyrilamine 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 8e524967-d01c-4c93-9198-c42f15fe3fe0, effective 20251003; matched on
openfda.generic_name.exact:"PYRILAMINE MALEATE") - 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, 18 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
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.