Drug side effects
roflumilast Side Effects
The reactions most often reported to the FDA for roflumilast (also sold as Daliresp), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 6,450
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2010 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of roflumilast come from 6,450 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 6,450 reports to the FDA Adverse Event Reporting System (FAERS) for roflumilast (Daliresp): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
6,450
Reports Mentioning Death
943
14.6% of reports — not proof the medicine caused the death
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 |
| 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 |
| NAUSEA | 114 |
| FATIGUE | 111 |
| MALAISE | 111 |
| DECREASED APPETITE | 104 |
| HEADACHE | 95 |
| DIZZINESS | 94 |
| ASTHENIA | 90 |
| 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.
How to read these numbers
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to roflumilast's 6,450.
Read our methodology - how this data is sourced, computed, and verified.