What the label lists and what reports show
Roflumilast side effects
Roflumilast's FDA label: “Most common adverse reactions (≥2%) are diarrhea, weight decrease, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite.” FAERS holds 6,927 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 dyspnoea (1,054 reports).
- Generic listed
Check it at the source: the roflumilast FDA label on DailyMed (effective March 12, 2020, AstraZeneca Pharmaceuticals LP); 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 DALIRESP?DALIRESP can cause serious side effects, including: See “ What is the most important information I should know about DALIRESP? ” The most common side effects of DALIRESP include: • diarrhea • weight loss • nausea • headache • back pain • flu like symptoms • problems sleeping (insomnia) • dizziness • decreased appetite Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DALIRESP. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How do I store DALIRESP Tablets? • Store DALIRESP at 68°F to 77°F (20°C to 25°C); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature]. Keep DALIRESP Tablets and all medicines out of the reach of children.
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective March 12, 2020 (SPL set c9a1d0a8-581f-4f91-a2b8-f419192d0ebf), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥2%) are diarrhea, weight decrease, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite.
Table 1: Adverse Reactions Reported by ≥2% of Patients Treated with DALIRESP 500 mcg daily and Greater Than Placebo
| Adverse Reactions (Preferred Term) | DALIRESP ( N= 4438) n (%) | Placebo (N= 4192) n (%) |
|---|---|---|
| Diarrhea | 420 (9.5) | 113 (2.7) |
| Weight decreased | 331 (7.5) | 89 (2.1) |
| Nausea | 209 (4.7) | 60 (1.4) |
| Headache | 195 (4.4) | 87 (2.1) |
| Back pain | 142 (3.2) | 92 (2.2) |
| Influenza | 124 (2.8) | 112 (2.7) |
| Insomnia | 105 (2.4) | 41 (1.0) |
| Dizziness | 92 (2.1) | 45 (1.1) |
| Decreased appetite | 91 (2.1) | 15 (0.4) |
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 in greater detail in other sections: • Psychiatric Events Including Suicidality [see Warnings and Precautions (5.2) ] • Weight Decrease [see Warnings and Precautions (5.3) ] Most common adverse reactions (≥2%) are diarrhea, weight decrease, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Adverse Reactions in Clinical Studies 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 described below reflect exposure of 4438 patients to DALIRESP 500 mcg once daily in four 1-year placebo-controlled trials, two 6-month placebo-controlled trials, and two 6-month drug add-on trials [see Clinical Studies (14.1) ]. In these trials, 3136 and 1232 COPD patients were exposed to DALIRESP 500 mcg once daily for 6 months and 1 year, respectively. The population had a median age of 64 years (range 40-91), 73% were male, 92.9% were Caucasian, and had COPD with a mean pre-bronchodilator forced expiratory volume in one second (FEV 1 ) of 8.9 to 89.1% predicted. …
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective March 12, 2020 (SPL set c9a1d0a8-581f-4f91-a2b8-f419192d0ebf), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,927 reports list roflumilast among the medicines taken, each a report of something that happened, not proof the medicine caused it; 954 are coded as a death and 2,063 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 21 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?
- Roflumilast: 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