Ensifentrine side effects: what 1,503 FDA adverse event reports show

Ensifentrine · Ohtuvayre · 35 reaction terms · 924 drug–reaction co-reports · data 2026-09-14

Drug class

Phosphodiesterase 3 Inhibitor, Phosphodiesterase 4 Inhibitor

FDA label (Established Pharmacologic Class)

Brand names

Ohtuvayre

openFDA label

Who reports

1,503 reports · 37% serious · 61 with death outcome · 56% female

openFDA FAERS counts, all years, deduplication not applied

Used for

OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. OHTUVAYRE is a phosphodiesterase 3 (PDE3) inhibitor and phosphodiesterase 4 (PDE4) inhibitor indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. ( 1 )

FDA label, Indications and Usage

What it is

OHTUVAYRE (ensifentrine) is a sterile, yellow to pale yellow aqueous inhalation suspension of ensifentrine for oral inhalation. Ensifentrine, the active component of OHTUVAYRE, is an inhibitor of phosphodiesterases 3 and 4 (PDE3 and PDE4).

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 29 strongest signals

Labeled adverse reaction 1Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 9Not in label — unassessed 16

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
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.
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. 6 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
Chronic obstructive pulmonary disease	104	27.8 23.1–33.5ROR 29.8 · χ² 2,666 / p <1e-300	27.7 EB05 23.5 · IC025 +4.3 3/3 methods agree	Likely indication confounding term in indications	serious PRR 34.5	no trial data cached
Bronchospasm (airway tightening)	28	27.3 18.9–39.4ROR 27.8 · χ² 683 / p 9e-151	26.8 EB05 19.5 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.3	no trial data cached
Drug effect less than expected	17	16.8 10.5–27.0ROR 17.0 · χ² 237 / p 8e-54	16.2 EB05 10.3 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Productive cough (cough with phlegm)	51	15.0 11.5–19.7ROR 15.5 · χ² 655 / p 1e-144	14.9 EB05 11.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 21.4	no trial data cached
Sputum discoloured	9	13.3 6.9–25.5ROR 13.4 · χ² 90 / p 1e-21	11.1 EB05 5.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.1	no trial data cached
Hypertensive crisis	9	11.2 5.9–21.6ROR 11.3 · χ² 74 / p 4e-18	8.9 EB05 4.4 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.8	no trial data cached
Emphysema	8	11.0 5.5–22.0ROR 11.1 · χ² 63 / p 9e-16	8.4 EB05 4.0 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 14.7	no trial data cached
Product dose omission in error	19	9.9 6.3–15.4ROR 10.0 · χ² 143 / p 3e-33	8.8 EB05 5.7 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 25.8	no trial data cached
Dry throat	7	9.6 4.6–20.1ROR 9.7 · χ² 46 / p 7e-12	6.9 EB05 3.3 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Secretion discharge	8	9.0 4.5–18.0ROR 9.1 · χ² 49 / p 1e-12	6.7 EB05 3.4 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 14.6	no trial data cached
Respiratory tract infection	16	8.6 5.3–14.0ROR 8.7 · χ² 100 / p 8e-24	7.3 EB05 4.6 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.4	no trial data cached
Insurance issue	9	8.4 4.4–16.2ROR 8.5 · χ² 52 / p 3e-13	6.4 EB05 3.5 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 12.2	no trial data cached
Poor quality product administered	6	8.2 3.7–18.2ROR 8.2 · χ² 31 / p 1e-8	5.6 EB05 2.7 · IC025 +1.0 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Dyspnoea exertional	22	8.2 5.4–12.4ROR 8.3 · χ² 132 / p 9e-31	7.3 EB05 4.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.6	no trial data cached
Exposure via skin contact	13	8.0 4.7–13.8ROR 8.1 · χ² 73 / p 7e-18	6.6 EB05 4.0 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious n=4	no trial data cached
Haemoptysis	16	8.0 4.9–13.0ROR 8.1 · χ² 91 / p 8e-22	6.8 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.7	no trial data cached
Dyspnoea (shortness of breath)	323	8.0 7.2–8.8ROR 9.9 · χ² 2,012 / p <1e-300	7.9 EB05 7.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Respiratory tract congestion	9	7.9 4.1–15.1ROR 7.9 · χ² 47 / p 3e-12	6.0 EB05 3.3 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 19.2	no trial data cached
Chest discomfort	54	7.4 5.7–9.6ROR 7.6 · χ² 293 / p 6e-66	7.0 EB05 5.6 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Product physical issue	9	6.3 3.3–12.1ROR 6.3 · χ² 35 / p 2e-9	4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Oral discomfort	6	6.0 2.7–13.4ROR 6.0 · χ² 20 / p 3e-6	4.3 EB05 2.2 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Feeling jittery	8	5.8 2.9–11.7ROR 5.9 · χ² 27 / p 8e-8	4.5 EB05 2.5 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Product use complaint	6	5.4 2.4–12.0ROR 5.4 · χ² 17 / p 2e-5	4.0 EB05 2.0 · IC025 +0.6 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Product preparation error	6	4.0 1.8–9.0ROR 4.0 · χ² 11 / p 5e-4	3.2 EB05 1.7 · IC025 +0.3	Reporting / coding artifact	serious n=1	no trial data cached
Suicidal ideation (thoughts of suicide)	26	4.0 2.7–5.8ROR 4.0 · χ² 55 / p 7e-14	3.7 EB05 2.7 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.5 · ♀ 35% (drug 56%)	no trial data cached
Abnormal dreams	7	3.5 1.7–7.3ROR 3.5 · χ² 10 / p 7e-4	3.0 EB05 1.6 · IC025 +0.3	Not in label — unassessed	serious PRR 7.6	no trial data cached
Incorrect product administration duration	5	3.4 1.4–8.2ROR 3.4 · χ² 6 / p 0.006	2.8 EB05 1.4 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached
No adverse event	41	3.2 2.4–4.4ROR 3.3 · χ² 61 / p 3e-15	3.1 EB05 2.4 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	88% consumer	no trial data cached
Incorrect dose administered	46	2.9 2.1–3.8ROR 2.9 · χ² 54 / p 1e-13	2.8 EB05 2.2 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.3 · 72% 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
Dyspnoea (shortness of breath)	323	8.0 7.2–8.8ROR 9.9 · χ² 2,012 / p <1e-300	7.9 EB05 7.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Chronic obstructive pulmonary disease	104	27.8 23.1–33.5ROR 29.8 · χ² 2,666 / p <1e-300	27.7 EB05 23.5 · IC025 +4.3 3/3 methods agree	Likely indication confounding term in indications	serious PRR 34.5	no trial data cached
Chest discomfort	54	7.4 5.7–9.6ROR 7.6 · χ² 293 / p 6e-66	7.0 EB05 5.6 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Productive cough (cough with phlegm)	51	15.0 11.5–19.7ROR 15.5 · χ² 655 / p 1e-144	14.9 EB05 11.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 21.4	no trial data cached
Incorrect dose administered	46	2.9 2.1–3.8ROR 2.9 · χ² 54 / p 1e-13	2.8 EB05 2.2 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.3 · 72% consumer	no trial data cached
No adverse event	41	3.2 2.4–4.4ROR 3.3 · χ² 61 / p 3e-15	3.1 EB05 2.4 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	88% consumer	no trial data cached
Bronchospasm (airway tightening)	28	27.3 18.9–39.4ROR 27.8 · χ² 683 / p 9e-151	26.8 EB05 19.5 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.3	no trial data cached
Suicidal ideation (thoughts of suicide)	26	4.0 2.7–5.8ROR 4.0 · χ² 55 / p 7e-14	3.7 EB05 2.7 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.5 · ♀ 35% (drug 56%)	no trial data cached
Dyspnoea exertional	22	8.2 5.4–12.4ROR 8.3 · χ² 132 / p 9e-31	7.3 EB05 4.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.6	no trial data cached
Product dose omission in error	19	9.9 6.3–15.4ROR 10.0 · χ² 143 / p 3e-33	8.8 EB05 5.7 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 25.8	no trial data cached
Drug effect less than expected	17	16.8 10.5–27.0ROR 17.0 · χ² 237 / p 8e-54	16.2 EB05 10.3 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Haemoptysis	16	8.0 4.9–13.0ROR 8.1 · χ² 91 / p 8e-22	6.8 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.7	no trial data cached
Respiratory tract infection	16	8.6 5.3–14.0ROR 8.7 · χ² 100 / p 8e-24	7.3 EB05 4.6 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.4	no trial data cached
Exposure via skin contact	13	8.0 4.7–13.8ROR 8.1 · χ² 73 / p 7e-18	6.6 EB05 4.0 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious n=4	no trial data cached
Accidental exposure to product	12	1.7 1.0–2.9ROR 1.7 · χ² 3 / p 0.053	1.6 EB05 1.0 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 9.9	no trial data cached

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.

Productive cough — n=51, PRR 15.0
Dyspnoea exertional — n=22, PRR 8.2
Dyspnoea — n=323, PRR 8.0
Chest discomfort — n=54, PRR 7.4

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 Ensifentrine?

In FDA FAERS, the most frequently co-reported reaction terms for Ensifentrine are dyspnoea, chronic obstructive pulmonary disease, chest discomfort, productive cough, bronchospasm, suicidal ideation. 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 Ensifentrine have an FDA boxed warning?

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

Do FAERS signals prove that Ensifentrine 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 e6433c98-41a0-4f99-8f7f-d0e9db6e3f40, effective 20260423; matched on openfda.generic_name.exact:"ENSIFENTRINE")
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, 35 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.