Drug · FAERS side-effect profile with label screen
Guaifenesin and Pseudoephedrine side effects: what 1,911 FDA adverse event reports show
Drug class
Expectorant
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Guaifenesin (Mucus Relief)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
1,911 reports · 37% serious · 61 with death outcome · 67% female
openFDA FAERS counts, all years, deduplication not applied
Used for
(S) helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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 23 strongest signals
Reporting / coding artifact 9Lab value / disease marker 1No label text to screen 13
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. 19 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 |
|---|---|---|---|---|---|---|
| Accidental overdose | 76 | 22.7 18.2–28.3ROR 23.6 · χ² 1,554 / p <1e-300 | 22.5 EB05 18.6 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 100% consumer | no trial data cached |
| Incorrect drug administration duration | 53 | 20.3 15.5–26.4ROR 20.8 · χ² 951 / p 3e-209 | 20.1 EB05 15.9 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 37.2 · 89% consumer | no trial data cached |
| Incorrect product administration duration | 25 | 13.4 9.1–19.8ROR 13.6 · χ² 275 / p 4e-62 | 12.9 EB05 8.8 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=2 · 100% consumer | no trial data cached |
| Feeling jittery | 20 | 11.4 7.4–17.7ROR 11.5 · χ² 180 / p 3e-41 | 10.5 EB05 6.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 | no trial data cached |
| Expired product administered | 29 | 9.5 6.6–13.7ROR 9.7 · χ² 213 / p 1e-48 | 8.8 EB05 6.3 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=3 · 93% consumer | no trial data cached |
| Dysuria (painful urination) | 30 | 8.9 6.2–12.7ROR 9.0 · χ² 202 / p 4e-46 | 8.2 EB05 5.9 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 · ♀ 10% (drug 67%) · 93% consumer | no trial data cached |
| Seasonal allergy | 11 | 8.5 4.7–15.3ROR 8.5 · χ² 65 / p 3e-16 | 6.8 EB05 3.9 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 | no trial data cached |
| Sinus congestion | 10 | 8.1 4.3–14.9ROR 8.1 · χ² 55 / p 6e-14 | 6.3 EB05 3.5 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=5 | no trial data cached |
| Sinusitis | 72 | 7.6 6.1–9.6ROR 7.9 · χ² 410 / p 2e-91 | 7.3 EB05 6.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.1 | no trial data cached |
| Bronchitis | 47 | 6.9 5.2–9.1ROR 7.0 · χ² 231 / p 2e-52 | 6.5 EB05 5.1 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 | no trial data cached |
| Respiratory tract congestion | 10 | 6.9 3.7–12.7ROR 6.9 · χ² 44 / p 1e-11 | 5.4 EB05 3.1 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 | no trial data cached |
| Nervousness | 33 | 6.8 4.9–9.6ROR 7.0 · χ² 159 / p 8e-37 | 6.3 EB05 4.7 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 · 91% consumer | no trial data cached |
| Insomnia (trouble sleeping) | 165 | 6.7 5.8–7.8ROR 7.3 · χ² 811 / p 1e-178 | 6.6 EB05 5.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 · 90% consumer | no trial data cached |
| Heart rate increased | 55 | 6.1 4.7–7.9ROR 6.2 · χ² 228 / p 9e-52 | 5.8 EB05 4.6 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 8.8 · 88% consumer | no trial data cached |
| Ear infection | 14 | 5.7 3.4–9.7ROR 5.8 · χ² 50 / p 7e-13 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.4 | no trial data cached |
| Restlessness | 17 | 5.1 3.1–8.1ROR 5.1 · χ² 51 / p 4e-13 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Disease recurrence | 22 | 5.0 3.3–7.6ROR 5.1 · χ² 67 / p 1e-16 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 · 91% consumer | no trial data cached |
| Epistaxis (nosebleed) | 33 | 4.8 3.4–6.7ROR 4.9 · χ² 96 / p 7e-23 | 4.5 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 · 84% consumer | no trial data cached |
| Drug effective for unapproved indication | 12 | 4.5 2.5–7.9ROR 4.5 · χ² 29 / p 4e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Underdose | 23 | 3.4 2.3–5.1ROR 3.5 · χ² 37 / p 5e-10 | 3.2 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | 96% consumer | no trial data cached |
| Wrong technique in drug usage process | 11 | 3.3 1.8–5.9ROR 3.3 · χ² 15 / p 5e-5 | 2.9 EB05 1.8 · IC025 +0.5 | Reporting / coding artifact | serious PRR 13.9 | no trial data cached |
| Overdose | 64 | 3.2 2.5–4.1ROR 3.3 · χ² 97 / p 4e-23 | 3.2 EB05 2.6 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 · 95% consumer | no trial data cached |
| No adverse event | 34 | 2.1 1.5–2.9ROR 2.1 · χ² 18 / p 9e-6 | 2.1 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.6 · 100% consumer | 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 |
|---|---|---|---|---|---|---|
| Insomnia (trouble sleeping) | 165 | 6.7 5.8–7.8ROR 7.3 · χ² 811 / p 1e-178 | 6.6 EB05 5.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 · 90% consumer | no trial data cached |
| Accidental overdose | 76 | 22.7 18.2–28.3ROR 23.6 · χ² 1,554 / p <1e-300 | 22.5 EB05 18.6 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 100% consumer | no trial data cached |
| Sinusitis | 72 | 7.6 6.1–9.6ROR 7.9 · χ² 410 / p 2e-91 | 7.3 EB05 6.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.1 | no trial data cached |
| Overdose | 64 | 3.2 2.5–4.1ROR 3.3 · χ² 97 / p 4e-23 | 3.2 EB05 2.6 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 · 95% consumer | no trial data cached |
| Heart rate increased | 55 | 6.1 4.7–7.9ROR 6.2 · χ² 228 / p 9e-52 | 5.8 EB05 4.6 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 8.8 · 88% consumer | no trial data cached |
| Incorrect drug administration duration | 53 | 20.3 15.5–26.4ROR 20.8 · χ² 951 / p 3e-209 | 20.1 EB05 15.9 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 37.2 · 89% consumer | no trial data cached |
| Bronchitis | 47 | 6.9 5.2–9.1ROR 7.0 · χ² 231 / p 2e-52 | 6.5 EB05 5.1 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 | no trial data cached |
| No adverse event | 34 | 2.1 1.5–2.9ROR 2.1 · χ² 18 / p 9e-6 | 2.1 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.6 · 100% consumer | no trial data cached |
| Epistaxis (nosebleed) | 33 | 4.8 3.4–6.7ROR 4.9 · χ² 96 / p 7e-23 | 4.5 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 · 84% consumer | no trial data cached |
| Nervousness | 33 | 6.8 4.9–9.6ROR 7.0 · χ² 159 / p 8e-37 | 6.3 EB05 4.7 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 · 91% consumer | no trial data cached |
| Dysuria (painful urination) | 30 | 8.9 6.2–12.7ROR 9.0 · χ² 202 / p 4e-46 | 8.2 EB05 5.9 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 · ♀ 10% (drug 67%) · 93% consumer | no trial data cached |
| Expired product administered | 29 | 9.5 6.6–13.7ROR 9.7 · χ² 213 / p 1e-48 | 8.8 EB05 6.3 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=3 · 93% consumer | no trial data cached |
| Incorrect product administration duration | 25 | 13.4 9.1–19.8ROR 13.6 · χ² 275 / p 4e-62 | 12.9 EB05 8.8 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=2 · 100% consumer | no trial data cached |
| Underdose | 23 | 3.4 2.3–5.1ROR 3.5 · χ² 37 / p 5e-10 | 3.2 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | 96% consumer | no trial data cached |
| Disease recurrence | 22 | 5.0 3.3–7.6ROR 5.1 · χ² 67 / p 1e-16 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 · 91% consumer | 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 Guaifenesin and Pseudoephedrine?
In FDA FAERS, the most frequently co-reported reaction terms for Guaifenesin and Pseudoephedrine are insomnia, sinusitis, heart rate increased, bronchitis, epistaxis, nervousness. 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 Guaifenesin and Pseudoephedrine have an FDA boxed warning?
No. The FDA label retrieved for Guaifenesin and Pseudoephedrine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Guaifenesin 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 c648e711-e944-4574-83b3-ccce8732384e, effective 20250602; matched on
openfda.generic_name.exact:"GUAIFENESIN" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 42 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.