roflumilast Side Effects
Also known as: Daliresp
Analysis of 6,450 adverse event reports submitted to the FDA from 2010 to 2025.
Total Reports
6,450
Death-Related
943
14.6% of reports
Hospitalizations
1,974
30.6% of reports
Top Indication
Chronic Obstructive Pulmonary Disease
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 943 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 729 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 85 |
| PNEUMONIA | 46 |
| DYSPNOEA | 35 |
| WEIGHT DECREASED | 25 |
| ASTHENIA | 21 |
| RESPIRATORY FAILURE | 20 |
| MALAISE | 18 |
| DIARRHOEA | 17 |
| FALL | 17 |
| FATIGUE | 17 |
| CARDIAC ARREST | 16 |
| CARDIAC FAILURE CONGESTIVE | 14 |
| ATRIAL FIBRILLATION | 13 |
| DECREASED APPETITE | 13 |
| HEADACHE | 13 |
| NAUSEA | 13 |
| OFF LABEL USE | 13 |
| ANAEMIA | 12 |
| COMPLETED SUICIDE | 11 |
Reactions in Hospitalization Reports
Top reactions in 1,974 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 520 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 402 |
| PNEUMONIA | 346 |
| ASTHMA | 170 |
| DIARRHOEA | 168 |
| COUGH | 164 |
| WEIGHT DECREASED | 162 |
| WHEEZING | 123 |
| OFF LABEL USE | 117 |
| NAUSEA | 114 |
| FATIGUE | 111 |
| MALAISE | 111 |
| DECREASED APPETITE | 104 |
| HEADACHE | 95 |
| DIZZINESS | 94 |
| ASTHENIA | 90 |
| DRUG INEFFECTIVE | 88 |
| FALL | 88 |
| THERAPEUTIC PRODUCT EFFECT INCOMPLETE | 78 |
| INFLUENZA | 75 |
Nearby — Related Medications
What the FAERS Data Reveals About roflumilast Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 6,450 voluntary reports linked to roflumilast and its brand equivalents (Daliresp), spanning 2010 through 2025. Of those, 943 (14.6%) listed death as an outcome and 1,974 (30.6%) involved hospitalization. The most common indication reported alongside adverse events was Chronic Obstructive Pulmonary Disease.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 54% were female and 46% male; age distribution skews toward 65-74, with 1,229 reports in that bracket. The single most reported reaction is dyspnoea with 1,011 submissions, followed by death and chronic obstructive pulmonary disease.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.