Benzonatate side effects: what 16,411 FDA adverse event reports show

Benzonatate · 1,125 reaction terms · 69,305 drug–reaction co-reports · data 2026-09-14

Drug class

Non-narcotic Antitussive

FDA label (Established Pharmacologic Class)

Who reports

16,411 reports · 65% serious · 1,952 with death outcome · 66% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Benzonatate capsules, USP are indicated for the symptomatic relief of cough.

FDA label, Indications and Usage

What it is

DESCRIPTION Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP.

FDA label, Description section

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

Labeled (related wording) 1Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 36

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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.

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. 1,085 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Angiokeratoma	10	174.8 90.2–338.6ROR 174.9 · χ² 1,368 / p 8e-300	119.3 EB05 69.2 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=9	no trial arm names this drug
Chronic kidney disease-mineral and bone disorder	71	90.2 70.9–114.6ROR 90.5 · χ² 5,759 / p <1e-300	82.4 EB05 67.5 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=71	no trial arm names this drug
Hyperparathyroidism secondary	133	70.7 59.4–84.2ROR 71.3 · χ² 8,592 / p <1e-300	66.4 EB05 57.5 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=133	no trial arm names this drug
Nephrogenic anaemia	232	66.6 58.4–76.0ROR 67.6 · χ² 14,183 / p <1e-300	63.0 EB05 56.5 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=232	no trial arm names this drug
Rebound acid hypersecretion	125	54.2 45.3–64.8ROR 54.6 · χ² 6,208 / p <1e-300	51.6 EB05 44.5 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=125	no trial arm names this drug
Genital abscess	11	35.5 19.5–64.6ROR 35.5 · χ² 326 / p 4e-73	32.8 EB05 19.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Bone demineralisation	27	33.3 22.7–48.8ROR 33.3 · χ² 792 / p 1e-174	31.8 EB05 22.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=23	no trial arm names this drug
Conduction disorder	44	31.5 23.3–42.4ROR 31.6 · χ² 1,237 / p 2e-271	30.4 EB05 23.6 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=44 · ♀ 42% (drug 66%) · 100% clinician	no trial arm names this drug
Renal tubular injury	27	30.5 20.8–44.6ROR 30.5 · χ² 723 / p 2e-159	29.2 EB05 21.1 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=27	no trial arm names this drug
Electrocardiogram change	20	27.3 17.5–42.5ROR 27.3 · χ² 470 / p 2e-104	26.1 EB05 17.8 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=20 · 100% clinician	no trial arm names this drug
End stage renal disease	372	26.3 23.8–29.1ROR 26.9 · χ² 8,848 / p <1e-300	25.7 EB05 23.6 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 22.9	no trial arm names this drug
Chronic kidney disease	1,234	20.9 19.8–22.0ROR 22.5 · χ² 23,027 / p <1e-300	20.5 EB05 19.6 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.5	no trial arm names this drug
Increased viscosity of bronchial secretion	10	20.5 11.0–38.3ROR 20.5 · χ² 164 / p 8e-38	19.0 EB05 10.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	–	no trial arm names this drug
Bundle branch block	13	17.7 10.2–30.6ROR 17.7 · χ² 186 / p 1e-42	16.6 EB05 9.6 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Adenocarcinoma gastric	11	15.4 8.5–27.9ROR 15.4 · χ² 133 / p 6e-31	13.8 EB05 7.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Oxygen consumption increased	26	14.2 9.7–20.9ROR 14.2 · χ² 303 / p 5e-68	13.6 EB05 9.5 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious n=21	no trial arm names this drug
Obstructive sleep apnoea syndrome	15	13.8 8.3–23.0ROR 13.9 · χ² 164 / p 6e-38	12.7 EB05 7.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Infusion site discharge	17	12.8 7.9–20.6ROR 12.8 · χ² 172 / p 2e-39	11.7 EB05 7.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Palmar erythema	11	12.3 6.8–22.4ROR 12.4 · χ² 103 / p 2e-24	10.4 EB05 5.5 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=9	no trial arm names this drug
Economic problem	142	11.9 10.1–14.0ROR 12.0 · χ² 1,389 / p <1e-300	11.7 EB05 10.1 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 11.0 · 83% consumer	no trial arm names this drug
Seasonal allergy	128	11.7 9.8–13.9ROR 11.8 · χ² 1,227 / p 4e-269	11.5 EB05 9.9 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=80 · 71% consumer	no trial arm names this drug
Essential hypertension	23	11.4 7.6–17.2ROR 11.4 · χ² 207 / p 4e-47	10.5 EB05 7.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=21 · ♀ 41% (drug 66%)	no trial arm names this drug
Rhonchi	12	11.1 6.3–19.7ROR 11.1 · χ² 100 / p 8e-24	9.3 EB05 5.2 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=9	no trial arm names this drug
Anhedonia	225	10.9 9.6–12.4ROR 11.1 · χ² 2,004 / p <1e-300	10.8 EB05 9.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.1 · ♀ 42% (drug 66%) · 83% consumer	no trial arm names this drug
Infusion site irritation	10	10.3 5.6–19.3ROR 10.3 · χ² 75 / p 3e-18	8.2 EB05 4.3 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	–	no trial arm names this drug
Renal injury	230	9.8 8.7–11.2ROR 10.0 · χ² 1,808 / p <1e-300	9.7 EB05 8.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.7 · 71% consumer	no trial arm names this drug
Acute sinusitis	13	9.7 5.6–16.7ROR 9.7 · χ² 92 / p 4e-22	8.0 EB05 4.7 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=9	no trial arm names this drug
Infusion site haemorrhage	24	9.5 6.4–14.2ROR 9.5 · χ² 173 / p 8e-40	8.6 EB05 5.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=14 · 79% consumer	no trial arm names this drug
Tubulointerstitial nephritis	133	9.1 7.7–10.8ROR 9.2 · χ² 947 / p 2e-208	8.9 EB05 7.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial arm names this drug
Fanconi syndrome acquired	12	8.8 5.0–15.5ROR 8.8 · χ² 75 / p 3e-18	7.1 EB05 4.1 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Infusion site pruritus	21	8.6 5.6–13.3ROR 8.7 · χ² 134 / p 3e-31	7.6 EB05 5.1 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious n=18 · ♀ 100% (drug 66%) · 71% consumer	no trial arm names this drug
Impaired gastric emptying	85	8.6 6.9–10.6ROR 8.6 · χ² 556 / p 3e-123	8.3 EB05 6.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 8.5 · 91% consumer	no trial arm names this drug
Upper-airway cough syndrome	54	8.5 6.5–11.1ROR 8.5 · χ² 346 / p 2e-77	8.0 EB05 6.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=39	no trial arm names this drug
Renal failure (kidney failure)	871	8.4 7.8–8.9ROR 8.8 · χ² 5,633 / p <1e-300	8.3 EB05 7.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial arm names this drug
Multiple allergies	51	8.3 6.3–11.0ROR 8.4 · χ² 320 / p 6e-72	7.9 EB05 6.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=37	no trial arm names this drug
Infusion site swelling	40	8.3 6.1–11.4ROR 8.4 · χ² 249 / p 2e-56	7.8 EB05 5.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=27 · ♀ 92% (drug 66%)	no trial arm names this drug
Electrocardiogram qrs complex prolonged	33	8.3 5.9–11.7ROR 8.3 · χ² 203 / p 3e-46	7.6 EB05 5.6 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious n=33 · ♀ 39% (drug 66%) · 100% clinician	no trial arm names this drug
Shoulder fracture	10	8.2 4.4–15.3ROR 8.2 · χ² 56 / p 3e-14	6.4 EB05 3.6 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious n=9	no trial arm names this drug
Infusion site bruising	13	7.8 4.5–13.5ROR 7.8 · χ² 70 / p 2e-17	6.4 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Osteopenia	93	7.8 6.4–9.6ROR 7.9 · χ² 543 / p 2e-120	7.6 EB05 6.3 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.8 · 70% consumer	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Benzonatate (searched BENZONATATE).

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
Fatigue (tiredness)	1,263	2.1 2.0–2.2ROR 2.2 · χ² 730 / p 5e-161	2.1 EB05 2.0 · IC025 +1.0	Not in label — unassessed	serious PRR 2.1	no trial arm names this drug
Cough	1,236	5.7 5.4–6.0ROR 6.0 · χ² 4,778 / p <1e-300	5.6 EB05 5.4 · IC025 +2.4 3/3 methods agree	Likely indication confounding term in indications	serious PRR 4.8	no trial arm names this drug
Chronic kidney disease	1,234	20.9 19.8–22.0ROR 22.5 · χ² 23,027 / p <1e-300	20.5 EB05 19.6 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.5	no trial arm names this drug
Dyspnoea (shortness of breath)	1,180	2.7 2.5–2.8ROR 2.8 · χ² 1,258 / p 7e-276	2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 2.5	no trial arm names this drug
Diarrhoea (diarrhea)	1,124	2.2 2.1–2.4ROR 2.3 · χ² 786 / p 3e-173	2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 1.9	no trial arm names this drug
Pneumonia (lung infection)	1,120	4.4 4.2–4.7ROR 4.7 · χ² 3,011 / p <1e-300	4.4 EB05 4.2 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.0	no trial arm names this drug
Nausea	1,100	1.8 1.7–1.9ROR 1.8 · χ² 390 / p 5e-87	1.8 EB05 1.7 · IC025 +0.7	Labeled adverse reaction exact term	serious PRR 1.9	no trial arm names this drug
Pain	939	1.9 1.8–2.1ROR 2.0 · χ² 445 / p 4e-99	1.9 EB05 1.8 · IC025 +0.9	Not in label — unassessed	serious PRR 2.1	no trial arm names this drug
Renal failure (kidney failure)	871	8.4 7.8–8.9ROR 8.8 · χ² 5,633 / p <1e-300	8.3 EB05 7.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial arm names this drug
Headache	844	1.7 1.6–1.8ROR 1.8 · χ² 262 / p 3e-59	1.7 EB05 1.6 · IC025 +0.7	Labeled adverse reaction exact term	serious PRR 1.8	no trial arm names this drug
Death	840	1.2 1.2–1.3ROR 1.3 · χ² 42 / p 5e-11	1.2 EB05 1.2 · IC025 +0.2	Outcome field, not a reaction	serious PRR 1.1	no trial arm names this drug
Acute kidney injury (sudden kidney damage)	804	6.8 6.3–7.2ROR 7.1 · χ² 3,954 / p <1e-300	6.7 EB05 6.3 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial arm names this drug
Off label use (used outside approved label)	667	1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.312	1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 0.9	no trial arm names this drug
Dizziness	655	1.7 1.6–1.8ROR 1.7 · χ² 184 / p 4e-42	1.7 EB05 1.6 · IC025 +0.6	Labeled adverse reaction exact term	serious PRR 1.7	no trial arm names this drug
Drug ineffective (drug did not work)	599	0.6 0.5–0.6ROR 0.6 · χ² 193 / p 3e-44	0.6 EB05 0.5 · IC025 -0.9 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 0.5	no trial arm names this drug

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Chronic kidney disease-mineral and bone disorder — n=71, PRR 90.2
Hyperparathyroidism secondary — n=133, PRR 70.7
Nephrogenic anaemia — n=232, PRR 66.6
Rebound acid hypersecretion — n=125, PRR 54.2
Bone demineralisation — n=27, PRR 33.3
Conduction disorder — n=44, PRR 31.5
Renal tubular injury — n=27, PRR 30.5
Electrocardiogram change — n=20, PRR 27.3
End stage renal disease — n=372, PRR 26.3
Chronic kidney disease — n=1,234, PRR 20.9

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 Benzonatate?

In FDA FAERS, the most frequently co-reported reaction terms for Benzonatate are fatigue, cough, chronic kidney disease, dyspnoea, diarrhoea, pneumonia. 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 Benzonatate have an FDA boxed warning?

No. The FDA label retrieved for Benzonatate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Benzonatate 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 0e8f2562-2449-430f-85bb-f9195644cdfa, effective 20260407; matched on openfda.generic_name.exact:"BENZONATATE")
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, field patient.drug.openfda.generic_name.exact, 1,125 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 BENZONATATE, results-bearing studies sorted by enrollment)

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.