What the label lists and what reports show
Nerandomilast side effects
Nerandomilast's FDA label: “Most common adverse reactions (≥5%) are diarrhea, COVID-19, upper respiratory tract infection, depression, weight decreased, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness.” FAERS holds 1,163 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 diarrhoea (337 reports).
- No generic listed
Check it at the source: the nerandomilast FDA label on DailyMed (effective August 14, 2026, Boehringer Ingelheim Pharmaceuticals, Inc.); 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 JASCAYD?The most common side effects of JASCAYD include: diarrhea COVID-19 upper respiratory tract infection depression weight loss decreased appetite nausea fatigue headache vomiting back pain dizziness These are not all of the possible side effects of JASCAYD. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective August 14, 2026 (SPL set fa1b14c6-957f-d326-5099-911bfe33e391), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥5%) are diarrhea, COVID-19, upper respiratory tract infection, depression, weight decreased, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness.
Table 1 Adverse Reactions with JASCAYD with Incidence of ≥5% and More Common than Placebo in Patients 1 with IPF (FIBRONEER-IPF Trial)
| Reaction | JASCAYD 18 mg BID n=392 | JASCAYD 9 mg BID n=392 | Placebo n=393 |
|---|---|---|---|
| Diarrhea | 42% | 31% | 17% |
| COVID-19 | 13% | 16% | 12% |
| Upper respiratory tract infection | 13% | 11% | 10% |
| Depression 2 | 12% | 11% | 10% |
| Weight decreased | 11% | 10% | 8% |
| Decreased appetite | 9% | 9% | 5% |
| Nausea | 8% | 9% | 7% |
| Fatigue | 7% | 8% | 6% |
| Headache | 7% | 6% | 5% |
| Vomiting | 6% | 5% | 5% |
| Back pain | 6% | 5% | 4% |
| Dizziness | 5% | 6% | 5% |
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, continuedMost common adverse reactions (≥5%) are diarrhea, COVID-19, upper respiratory tract infection, depression, weight decreased, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or FDA at 1-800-FDA-1088 or 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 clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions for Idiopathic Pulmonary Fibrosis The safety of JASCAYD was based on a randomized, placebo-controlled, double-blind trial (FIBRONEER-IPF), which included 1,177 adult patients with IPF who were randomized in a 1:1:1 ratio to receive JASCAYD 9 mg twice daily, JASCAYD 18 mg twice daily, or matching placebo. Patients received JASCAYD or placebo with or without background antifibrotic treatment (nintedanib or pirfenidone) for at least 52 weeks [see Clinical Studies (14.1) ]. The median duration of exposure was 14 months in each treatment arm. …
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective August 14, 2026 (SPL set fa1b14c6-957f-d326-5099-911bfe33e391), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,163 reports list nerandomilast among the medicines taken, each a report of something that happened, not proof the medicine caused it; 92 are coded as a death and 193 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 23 reactions below, 10 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?
- Nerandomilast: 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