OpenClaim

Ensifentrine Side Effects

The most commonly reported side effects of ensifentrine include dyspnoea, back pain, and chronic obstructive pulmonary disease, based on 789 FDA adverse event reports from 2021 to 2025. 5.2% of reports found the drug to be ineffective.

Ensifentrine side effects

Percentages show how often each reaction appears relative to total reports for ensifentrine.

1
Dyspnoea23.1%182
2
Back Pain7.2%57
3
Chronic Obstructive Pulmonary Disease6.3%50
4
Diarrhoea6.2%49
5
Cough5.6%44
6
Pneumonia5.3%42
7
Drug Ineffective5.2%41
8
Headache4.7%37
9
Chest Discomfort4.4%35
10
Anxiety3.5%28
11
Hypertension3.2%25
12
Dizziness3.2%25
13
Fatigue3.2%25
14
Nausea3.0%24
15
Insomnia2.9%23

These are voluntary reports and do not establish that ensifentrine caused these reactions.

Report severity

37.8%Serious298 reports
20.5%Hospitalizations162 reports
1.1%Fatal9 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ensifentrine drug interactions

Other drugs that appear in adverse event reports alongside ensifentrine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Dupilumab18.5%146
2
Treprostinil2.5%20
3
Budesonide1.6%13
4
Formoterol1.1%9
5
Glycopyrrolate0.9%7
6
Prednisone0.8%6
7
Revefenacin0.8%6
8
Fluticasone0.6%5
9
Arformoterol-tartrate0.6%5
10
Albuterol0.5%4
11
Umeclidinium-bromide0.5%4
12
Vilanterol-trifenatate0.5%4
13
Sildenafil-citrate0.4%3
14
Mepolizumab0.4%3
15
Abaloparatide0.4%3

Taken alongside

1
Albuterol21.8%172
2
Budesonide13.1%103
3
Fluticasone11.9%94
4
Formoterol10.9%86
5
Umeclidinium-bromide9.0%71
6
Vilanterol-trifenatate8.7%69
7
Prednisone7.2%57
8
Glycopyrrolate6.2%49
9
Ipratropium-bromide6.0%47
10
Furosemide5.2%41
11
Montelukast-sodium5.1%40
12
Oxygen4.9%39
13
Atorvastatin-calcium4.8%38
14
Metoprolol4.6%36
15
Aspirin4.6%36

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports ensifentrine side effects

42.1% of ensifentrine adverse event reports involve female patients and 37.9% involve male patients. The largest age group is elderly at 77%. These figures reflect who reports side effects, not underlying risk.

Sex

Female42.1%
Male37.9%
Unknown20.0%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6422.8%
65+77.2%

What is ensifentrine used for

Conditions and purposes for which patients were taking ensifentrine when the adverse event was reported.

Arteriosclerosis Coronary ArteryAsthmaAtrial FibrillationBody Mass IndexBronchiectasisBronchitisBronchitis ChronicChronic Obstructive Pulmonary DiseaseChronic Kidney DiseaseChronic Obstructive Pulmonary DiseaseChronic Respiratory FailureCoccidioidomycosisDyspnoeaEmphysemaLung Disorder

Showing 15 of 29 indications

Ensifentrine brand names and reporting trend

Ensifentrine is sold under the brand name Ohtuvayre.

Brand names

Ohtuvayre17

Quarterly reports (20212025)

20212025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking ensifentrine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.