Drug · FAERS side-effect profile with label screen
Cough Suppressant side effects: what 1,002 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Menthol
openFDA label
Who reports
1,002 reports · 81% serious · 126 with death outcome · 62% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Temporarily relieves cough as may occur with a cold or inhaled irritants occasional minor irritation and sore throat
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 2No label text to screen 36
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. 29 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 |
|---|---|---|---|---|---|---|
| Hypercholesterolaemia | 36 | 79.0 57.3–109.0ROR 81.9 · χ² 2,687 / p <1e-300 | 75.7 EB05 57.1 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 59.6 · ♀ 100% (drug 62%) · 100% clinician | no trial data cached |
| Joint dislocation | 23 | 45.8 30.6–68.6ROR 46.9 · χ² 962 / p 2e-211 | 44.2 EB05 31.0 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.6 · 91% clinician | no trial data cached |
| Dizziness postural | 20 | 43.7 28.3–67.4ROR 44.5 · χ² 790 / p 3e-174 | 42.0 EB05 28.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 · ♀ 100% (drug 62%) | no trial data cached |
| Helicobacter infection | 21 | 43.2 28.3–66.0ROR 44.1 · χ² 822 / p 4e-181 | 41.6 EB05 28.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.4 · ♀ 100% (drug 62%) · 100% clinician | no trial data cached |
| Secretion discharge | 25 | 42.4 28.8–62.5ROR 43.5 · χ² 969 / p 6e-213 | 41.1 EB05 29.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.5 · ♀ 96% (drug 62%) | no trial data cached |
| Scratch | 20 | 40.5 26.2–62.5ROR 41.3 · χ² 730 / p 4e-161 | 39.0 EB05 26.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 · ♀ 100% (drug 62%) | no trial data cached |
| Autoimmune disorder | 15 | 32.8 19.9–54.3ROR 33.3 · χ² 431 / p 4e-96 | 31.6 EB05 20.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.0 | no trial data cached |
| Hip arthroplasty | 22 | 30.4 20.1–45.9ROR 31.0 · χ² 595 / p 1e-131 | 29.6 EB05 20.6 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.3 · 91% clinician | no trial data cached |
| Irritable bowel syndrome | 29 | 28.4 19.9–40.7ROR 29.3 · χ² 740 / p 3e-163 | 27.9 EB05 20.4 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.8 · 97% clinician | no trial data cached |
| Joint range of motion decreased | 18 | 28.2 17.8–44.6ROR 28.7 · χ² 445 / p 4e-99 | 27.4 EB05 18.3 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.6 | no trial data cached |
| Erythema multiforme | 12 | 27.0 15.4–47.3ROR 27.3 · χ² 274 / p 6e-62 | 25.9 EB05 15.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.8 | no trial data cached |
| Sciatica | 18 | 23.8 15.0–37.6ROR 24.2 · χ² 370 / p 9e-83 | 23.2 EB05 15.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.7 | no trial data cached |
| Folliculitis | 11 | 22.3 12.4–40.2ROR 22.5 · χ² 203 / p 2e-46 | 21.3 EB05 12.2 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.7 | no trial data cached |
| Prescribed overdose | 19 | 20.6 13.2–32.1ROR 20.9 · χ² 334 / p 6e-75 | 20.1 EB05 13.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.0 | no trial data cached |
| Fibromyalgia | 23 | 19.8 13.2–29.7ROR 20.3 · χ² 393 / p 1e-87 | 19.5 EB05 13.6 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.0 · ♀ 100% (drug 62%) · 96% clinician | no trial data cached |
| Pemphigus | 11 | 18.5 10.3–33.4ROR 18.7 · χ² 165 / p 4e-38 | 17.4 EB05 9.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.2 | no trial data cached |
| Joint stiffness | 23 | 18.4 12.3–27.5ROR 18.8 · χ² 360 / p 1e-80 | 18.0 EB05 12.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.7 · 100% clinician | no trial data cached |
| C-reactive protein increased | 31 | 17.9 12.6–25.2ROR 18.4 · χ² 477 / p 5e-106 | 17.6 EB05 12.9 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 12.8 · ♀ 93% (drug 62%) · 97% clinician | no trial data cached |
| Lip swelling | 28 | 17.6 12.2–25.4ROR 18.1 · χ² 424 / p 2e-94 | 17.4 EB05 12.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.1 · 100% clinician | no trial data cached |
| Hand deformity | 11 | 17.6 9.8–31.7ROR 17.8 · χ² 156 / p 4e-36 | 16.4 EB05 8.8 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.6 | no trial data cached |
| Bronchospasm (airway tightening) | 12 | 17.6 10.0–30.8ROR 17.8 · χ² 171 / p 2e-39 | 16.5 EB05 9.3 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.8 | no trial data cached |
| Impaired healing | 27 | 17.2 11.9–25.0ROR 17.7 · χ² 397 / p 1e-88 | 16.9 EB05 12.1 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 14.8 · 96% clinician | no trial data cached |
| End stage renal disease | 15 | 17.1 10.3–28.2ROR 17.3 · χ² 211 / p 4e-48 | 16.3 EB05 9.9 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.1 | no trial data cached |
| Synovitis | 14 | 16.2 9.7–27.3ROR 16.5 · χ² 185 / p 2e-42 | 15.4 EB05 9.0 · 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 |
| Hallucination, visual | 16 | 16.0 9.8–26.0ROR 16.2 · χ² 210 / p 8e-48 | 15.2 EB05 9.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.0 | no trial data cached |
| Pulmonary fibrosis | 14 | 15.3 9.1–25.8ROR 15.5 · χ² 174 / p 6e-40 | 14.4 EB05 8.4 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.0 | no trial data cached |
| Pericarditis | 12 | 15.1 8.6–26.5ROR 15.2 · χ² 144 / p 2e-33 | 13.8 EB05 7.5 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.8 | no trial data cached |
| Knee arthroplasty | 14 | 14.1 8.4–23.7ROR 14.2 · χ² 157 / p 2e-36 | 12.9 EB05 7.4 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.4 | no trial data cached |
| Liver injury | 16 | 13.9 8.5–22.5ROR 14.1 · χ² 178 / p 6e-41 | 12.9 EB05 7.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 | no trial data cached |
| Type 2 diabetes mellitus | 22 | 13.6 9.0–20.6ROR 13.9 · χ² 245 / p 1e-55 | 13.0 EB05 8.7 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 · ♀ 100% (drug 62%) · 95% clinician | no trial data cached |
| Blood cholesterol increased | 29 | 13.0 9.1–18.6ROR 13.4 · χ² 310 / p 9e-70 | 12.6 EB05 8.9 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 14.1 · ♀ 96% (drug 62%) · 97% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 41 | 13.0 9.6–17.5ROR 13.5 · χ² 443 / p 1e-98 | 12.7 EB05 9.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 · ♀ 100% (drug 62%) · 95% clinician | no trial data cached |
| Osteoarthritis | 26 | 12.8 8.8–18.7ROR 13.1 · χ² 272 / p 2e-61 | 12.3 EB05 8.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 · ♀ 100% (drug 62%) · 92% clinician | no trial data cached |
| Prescribed underdose | 12 | 12.6 7.2–22.1ROR 12.7 · χ² 117 / p 2e-27 | 11.0 EB05 6.0 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.3 | no trial data cached |
| Tubulointerstitial nephritis | 11 | 12.3 6.8–22.1ROR 12.4 · χ² 103 / p 2e-24 | 10.5 EB05 5.5 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 | no trial data cached |
| Haematoma | 15 | 12.1 7.3–20.0ROR 12.2 · χ² 142 / p 6e-33 | 10.8 EB05 6.4 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.3 | no trial data cached |
| Lower limb fracture | 11 | 12.1 6.7–21.7ROR 12.2 · χ² 101 / p 5e-24 | 10.2 EB05 5.4 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.4 | no trial data cached |
| Therapeutic product effect decreased | 25 | 11.8 8.0–17.4ROR 12.1 · χ² 237 / p 1e-53 | 11.1 EB05 7.6 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 15.9 · ♀ 95% (drug 62%) · 92% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 11 | 10.3 5.7–18.5ROR 10.4 · χ² 83 / p 3e-20 | 8.4 EB05 4.6 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.6 | no trial data cached |
| Wound | 13 | 9.8 5.7–16.8ROR 9.9 · χ² 94 / p 2e-22 | 8.2 EB05 4.8 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 | 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 |
|---|---|---|---|---|---|---|
| Infusion related reaction (reaction during infusion) | 41 | 13.0 9.6–17.5ROR 13.5 · χ² 443 / p 1e-98 | 12.7 EB05 9.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 · ♀ 100% (drug 62%) · 95% clinician | no trial data cached |
| Hypercholesterolaemia | 36 | 79.0 57.3–109.0ROR 81.9 · χ² 2,687 / p <1e-300 | 75.7 EB05 57.1 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 59.6 · ♀ 100% (drug 62%) · 100% clinician | no trial data cached |
| C-reactive protein increased | 31 | 17.9 12.6–25.2ROR 18.4 · χ² 477 / p 5e-106 | 17.6 EB05 12.9 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 12.8 · ♀ 93% (drug 62%) · 97% clinician | no trial data cached |
| Blood cholesterol increased | 29 | 13.0 9.1–18.6ROR 13.4 · χ² 310 / p 9e-70 | 12.6 EB05 8.9 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 14.1 · ♀ 96% (drug 62%) · 97% clinician | no trial data cached |
| Irritable bowel syndrome | 29 | 28.4 19.9–40.7ROR 29.3 · χ² 740 / p 3e-163 | 27.9 EB05 20.4 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.8 · 97% clinician | no trial data cached |
| Lip swelling | 28 | 17.6 12.2–25.4ROR 18.1 · χ² 424 / p 2e-94 | 17.4 EB05 12.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.1 · 100% clinician | no trial data cached |
| Injury | 27 | 8.0 5.5–11.6ROR 8.2 · χ² 159 / p 1e-36 | 7.3 EB05 5.2 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 · 96% clinician | no trial data cached |
| Impaired healing | 27 | 17.2 11.9–25.0ROR 17.7 · χ² 397 / p 1e-88 | 16.9 EB05 12.1 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 14.8 · 96% clinician | no trial data cached |
| Osteoarthritis | 26 | 12.8 8.8–18.7ROR 13.1 · χ² 272 / p 2e-61 | 12.3 EB05 8.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 · ♀ 100% (drug 62%) · 92% clinician | no trial data cached |
| Nasal congestion (stuffy nose) | 25 | 8.9 6.1–13.2ROR 9.1 · χ² 169 / p 7e-39 | 8.1 EB05 5.6 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.0 · ♀ 92% (drug 62%) | no trial data cached |
| Therapeutic product effect decreased | 25 | 11.8 8.0–17.4ROR 12.1 · χ² 237 / p 1e-53 | 11.1 EB05 7.6 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 15.9 · ♀ 95% (drug 62%) · 92% clinician | no trial data cached |
| Secretion discharge | 25 | 42.4 28.8–62.5ROR 43.5 · χ² 969 / p 6e-213 | 41.1 EB05 29.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.5 · ♀ 96% (drug 62%) | no trial data cached |
| Joint stiffness | 23 | 18.4 12.3–27.5ROR 18.8 · χ² 360 / p 1e-80 | 18.0 EB05 12.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.7 · 100% clinician | no trial data cached |
| Fibromyalgia | 23 | 19.8 13.2–29.7ROR 20.3 · χ² 393 / p 1e-87 | 19.5 EB05 13.6 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.0 · ♀ 100% (drug 62%) · 96% clinician | no trial data cached |
| Joint dislocation | 23 | 45.8 30.6–68.6ROR 46.9 · χ² 962 / p 2e-211 | 44.2 EB05 31.0 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.6 · 91% clinician | 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 Cough Suppressant?
In FDA FAERS, the most frequently co-reported reaction terms for Cough Suppressant are infusion related reaction, hypercholesterolaemia, c-reactive protein increased, blood cholesterol increased, irritable bowel syndrome, lip swelling. 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 Cough Suppressant have an FDA boxed warning?
No. The FDA label retrieved for Cough Suppressant has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cough Suppressant 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 9d4def70-480f-f2fa-e053-2995a90a9877, effective 20241010; matched on
openfda.generic_name.exact:"COUGH SUPPRESSANT") - 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, 69 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.