What the label lists and what reports show
Brensocatib side effects
Brensocatib's FDA label: “Most common adverse reactions (incidence ≥2%): upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, hypertension.” FAERS holds 2,017 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is cough (221 reports).
- No generic listed
Check it at the source: the brensocatib FDA label on DailyMed (effective March 16, 2026, Insmed Incorporated); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of BRINSUPRI?BRINSUPRI may cause serious side effects including: Skin problems. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist for an examination if needed. Dental problems. Get regular dental checkups while taking BRINSUPRI. Brush and clean your teeth as recommended by your dentist. Tell your healthcare provider and contact your dentist if you experience new gum (gingival) or teeth (dental) symptoms. Common side effects of BRINSUPRI include: upper respiratory tract infection headache rash dry skin small areas of skin thickening (hyperkeratosis) high blood pressure (hypertension) Less common side effects include abnormal liver blood test, hair loss (alopecia), and skin cancers. These are not all of the possible side effects of BRINSUPRI. Call your doctor for medical advice about side effects. […]
Source: FDA drug label, Insmed Incorporated, effective March 16, 2026 (SPL set b56986ae-e7db-421e-b622-a7f41e321f3d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥2%): upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, hypertension.
Table 1 Adverse Reactions with BRINSUPRI with an Incidence of ≥2% and More Common than Placebo in ASPEN
| Adverse Reaction | Placebo (N=563) n (%) | BRINSUPRI 10 mg QD (N=582) n (%) | BRINSUPRI 25 mg QD (N=574) n (%) |
|---|---|---|---|
| Upper respiratory tract infection Upper respiratory tract infection includes coronavirus… | 141 (25) | 157 (27) | 169 (29) |
| Headache | 39 (7) | 39 (7) | 49 (9) |
| Rash Rash includes rash, rash maculo-papular, rash pruritic, rash erythematous,… | 22 (4) | 25 (4) | 35 (6) |
| Dry skin Dry skin includes dry skin, chapped lips, cheilitis, lip dry, skin exfoliation,… | 8 (1) | 17 (3) | 25 (4) |
| Hyperkeratosis Hyperkeratosis includes hyperkeratosis, palmoplantar keratoderma, and skin… | 5 (1) | 8 (1) | 16 (3) |
| Hypertension | 17 (3) | 28 (5) | 13 (2) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are described elsewhere in the labeling: Dermatologic Adverse Reactions [see Warnings and Precautions (5.1) ] Gingival and Periodontal Adverse Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥2%): upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, hypertension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Insmed Incorporated at 1-844-4-INSMED or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data below reflect the safety of BRINSUPRI in adult and pediatric patients aged 12 years and older with non-cystic fibrosis bronchiectasis (NCFB). A total of 1721 patients with NCFB were randomized in a double-blind, placebo-controlled clinical trial of 52 weeks duration (ASPEN) [see Clinical Studies (14) ]. The safety of BRINSUPRI was based on data from 1719 adult and pediatric patients aged 12 years and older who received at least one dose of BRINSUPRI or placebo. A total of 1156 patients received at least one dose of BRINSUPRI 10 mg or 25 mg orally once daily. …
Source: FDA drug label, Insmed Incorporated, effective March 16, 2026 (SPL set b56986ae-e7db-421e-b622-a7f41e321f3d), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,017 reports list brensocatib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 62 are coded as a death and 257 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Brensocatib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions