LOW-VOLUME · HOSP-HEAVY
roflumilast Side Effects
roflumilast (also sold as Daliresp) is a LOW-VOLUME FAERS extract #371 of 524 by FAERS report count. Still opens on HOSP-HEAVY: 30.6% mention hospitalization (1,974 reports).
Data updated 2026-05-15
- 6,450
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
roflumilast: 30.6% mention hospitalization (1,974 reports). Death stamp DEATH-HEAVY; volume band LOW-VOLUME #371 of 524 by FAERS report count.
Thinner FAERS extract for roflumilast (Daliresp) (6,450 reports #371 of 524 by FAERS report count). 30.6% mention hospitalization (1,974 reports). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2010–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
DYSPNOEA leads 1,011 of 6,450 reports
Who reports · age peak 65-74 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 65-74 (1,229 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (943 reports, 14.6%). Top co-reported reactions in that subset - voluntary, not causal.
| 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
Hospitalization is HEAVY (1,974, 30.6% of the book). Top reactions in those rows:
| 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 |
How to read roflumilast FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 6,450 voluntary reports linked to roflumilast (Daliresp), 2010-2025. Death is listed on 943 (14.6%). Hospitalization appears on 1,974 (30.6%). Top co-reported indication: Chronic Obstructive Pulmonary Disease.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with roflumilast
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 6,445 FAERS cases (Δ 5 lighter vs roflumilast); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 6,460 FAERS cases (Δ 10 heavier vs roflumilast); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 6,501 FAERS cases (Δ 51 heavier vs roflumilast); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 6,539 FAERS cases (Δ 89 heavier vs roflumilast); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 47.5 pp vs roflumilast's DEATH-HEAVY): CASELOAD · HOSP-MID.
roflumilast stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.