Drug · FAERS side-effect profile with label screen
Roflumilast side effects: what 6,919 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Who reports
6,919 reports · 61% serious · 954 with death outcome · 54% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Roflumilast Tablets are indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of Use Roflumilast Tablets are not a bronchodilator and is not indicated for the relief of acute bronchospasm.
FDA label, Indications and Usage
What it is
The active ingredient in Roflumilast Tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 31
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 350 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | 657 | 38.6 35.9–41.6ROR 42.6 · χ² 23,794 / p <1e-300 | 38.1 EB05 35.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 36.1 | no trial data cached |
| Full blood count abnormal | 101 | 29.3 24.1–35.6ROR 29.7 · χ² 2,704 / p <1e-300 | 28.9 EB05 24.4 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 36.5 | no trial data cached |
| Obstructive airways disorder | 103 | 28.2 23.2–34.2ROR 28.6 · χ² 2,650 / p <1e-300 | 27.8 EB05 23.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 27.5 | no trial data cached |
| Sputum discoloured | 86 | 27.8 22.5–34.3ROR 28.1 · χ² 2,175 / p <1e-300 | 27.4 EB05 22.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 31.7 | no trial data cached |
| Emphysema | 87 | 26.2 21.3–32.4ROR 26.6 · χ² 2,069 / p <1e-300 | 25.9 EB05 21.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 25.6 | no trial data cached |
| Sleep disorder due to a general medical condition | 82 | 15.4 12.4–19.1ROR 15.6 · χ² 1,087 / p 1e-238 | 15.3 EB05 12.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 21.4 | no trial data cached |
| Pulmonary mass | 69 | 14.1 11.1–17.8ROR 14.2 · χ² 824 / p 2e-181 | 13.9 EB05 11.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Wheezing | 228 | 11.7 10.3–13.3ROR 12.1 · χ² 2,220 / p <1e-300 | 11.6 EB05 10.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 | no trial data cached |
| Wrist fracture | 39 | 9.9 7.2–13.5ROR 9.9 · χ² 301 / p 8e-68 | 9.3 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · ♀ 92% (drug 54%) | no trial data cached |
| Respiratory tract infection | 82 | 9.6 7.7–11.9ROR 9.7 · χ² 621 / p 2e-137 | 9.3 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Productive cough (cough with phlegm) | 139 | 8.9 7.6–10.5ROR 9.1 · χ² 968 / p 9e-213 | 8.7 EB05 7.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Body height decreased | 30 | 8.4 5.9–12.0ROR 8.5 · χ² 188 / p 4e-43 | 7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=19 · 100% consumer | no trial data cached |
| Asthma | 300 | 8.1 7.3–9.1ROR 8.4 · χ² 1,871 / p <1e-300 | 8.0 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Secretion discharge | 32 | 7.9 5.6–11.1ROR 7.9 · χ² 184 / p 3e-42 | 7.2 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Acute respiratory failure | 45 | 7.1 5.3–9.5ROR 7.2 · χ² 231 / p 2e-52 | 6.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Poor venous access | 24 | 7.1 4.7–10.5ROR 7.1 · χ² 118 / p 7e-28 | 6.3 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 92% (drug 54%) | no trial data cached |
| Therapeutic product effect incomplete | 159 | 6.8 5.8–8.0ROR 7.0 · χ² 785 / p 6e-173 | 6.7 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 11.0 · ♀ 76% (drug 54%) | no trial data cached |
| Respiratory tract congestion | 33 | 6.3 4.5–8.8ROR 6.3 · χ² 141 / p 7e-33 | 5.8 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Lung disorder | 101 | 6.3 5.2–7.6ROR 6.3 · χ² 441 / p 4e-98 | 6.1 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Bronchitis | 140 | 5.7 4.8–6.7ROR 5.8 · χ² 539 / p 1e-119 | 5.6 EB05 4.9 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 6.5 | no trial data cached |
| Dyspnoea (shortness of breath) | 1,054 | 5.7 5.3–6.0ROR 6.5 · χ² 4,133 / p <1e-300 | 5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Upper limb fracture | 37 | 5.6 4.1–7.7ROR 5.6 · χ² 135 / p 1e-31 | 5.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · ♀ 100% (drug 54%) | no trial data cached |
| Insurance issue | 27 | 5.5 3.8–8.0ROR 5.5 · χ² 95 / p 9e-23 | 5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · ♀ 83% (drug 54%) | no trial data cached |
| Candida infection (yeast infection) | 30 | 5.5 3.8–7.8ROR 5.5 · χ² 105 / p 8e-25 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Dyspnoea exertional | 67 | 5.4 4.3–6.9ROR 5.5 · χ² 237 / p 1e-53 | 5.2 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Blood test abnormal | 25 | 5.4 3.6–8.0ROR 5.4 · χ² 85 / p 1e-20 | 4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 | no trial data cached |
| Pneumothorax | 27 | 5.2 3.5–7.5ROR 5.2 · χ² 86 / p 7e-21 | 4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 19% (drug 54%) | no trial data cached |
| Loss of personal independence in daily activities | 79 | 5.0 4.0–6.3ROR 5.1 · χ² 252 / p 6e-57 | 4.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Intervertebral disc protrusion | 36 | 5.0 3.6–6.9ROR 5.0 · χ² 110 / p 4e-26 | 4.7 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 89% (drug 54%) | no trial data cached |
| Weight decreased (weight loss) | 447 | 4.9 4.4–5.3ROR 5.1 · χ² 1,381 / p <1e-300 | 4.8 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Oxygen saturation decreased | 88 | 4.8 3.9–5.9ROR 4.8 · χ² 259 / p 1e-58 | 4.7 EB05 3.9 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 3.9 | no trial data cached |
| Tachypnoea | 21 | 4.7 3.1–7.2ROR 4.7 · χ² 57 / p 2e-14 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · ♀ 25% (drug 54%) | no trial data cached |
| Inability to afford medication | 15 | 4.6 2.8–7.7ROR 4.6 · χ² 39 / p 2e-10 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Hyperthyroidism | 22 | 4.6 3.0–7.0ROR 4.6 · χ² 59 / p 1e-14 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 100% clinician | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 69 | 4.5 3.6–5.7ROR 4.6 · χ² 186 / p 9e-43 | 4.4 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · ♀ 77% (drug 54%) | no trial data cached |
| Seasonal allergy | 21 | 4.5 2.9–6.9ROR 4.5 · χ² 54 / p 1e-13 | 4.1 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Pain of skin | 40 | 4.5 3.3–6.1ROR 4.5 · χ² 105 / p 6e-25 | 4.3 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Pneumonia (lung infection) | 476 | 4.5 4.1–4.9ROR 4.7 · χ² 1,294 / p 1e-283 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Sleep apnoea syndrome | 28 | 4.4 3.1–6.4ROR 4.5 · χ² 71 / p 2e-17 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Therapeutic response shortened | 46 | 4.4 3.3–5.8ROR 4.4 · χ² 117 / p 2e-27 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 1,054 | 5.7 5.3–6.0ROR 6.5 · χ² 4,133 / p <1e-300 | 5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Death | 740 | 2.6 2.4–2.8ROR 2.8 · χ² 759 / p 2e-167 | 2.6 EB05 2.4 · IC025 +1.3 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.5 | no trial data cached |
| Chronic obstructive pulmonary disease | 657 | 38.6 35.9–41.6ROR 42.6 · χ² 23,794 / p <1e-300 | 38.1 EB05 35.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 36.1 | no trial data cached |
| Diarrhoea (diarrhea) | 596 | 2.8 2.6–3.0ROR 3.0 · χ² 713 / p 3e-157 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Nausea | 491 | 1.9 1.7–2.1ROR 2.0 · χ² 211 / p 5e-48 | 1.9 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Pneumonia (lung infection) | 476 | 4.5 4.1–4.9ROR 4.7 · χ² 1,294 / p 1e-283 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Weight decreased (weight loss) | 447 | 4.9 4.4–5.3ROR 5.1 · χ² 1,381 / p <1e-300 | 4.8 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Off label use (used outside approved label) | 427 | 1.5 1.4–1.6ROR 1.5 · χ² 71 / p 2e-17 | 1.5 EB05 1.4 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.3 | no trial data cached |
| Headache | 426 | 2.1 1.9–2.3ROR 2.1 · χ² 238 / p 4e-54 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Cough | 367 | 4.0 3.6–4.4ROR 4.1 · χ² 824 / p 2e-181 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Insomnia (trouble sleeping) | 331 | 3.8 3.4–4.2ROR 3.9 · χ² 675 / p 3e-149 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Dizziness | 309 | 1.9 1.7–2.1ROR 1.9 · χ² 129 / p 3e-30 | 1.9 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Asthma | 300 | 8.1 7.3–9.1ROR 8.4 · χ² 1,871 / p <1e-300 | 8.0 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Malaise (feeling unwell) | 291 | 2.0 1.8–2.2ROR 2.0 · χ² 149 / p 2e-34 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Decreased appetite (loss of appetite) | 289 | 3.8 3.4–4.2ROR 3.9 · χ² 594 / p 2e-131 | 3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Chronic obstructive pulmonary disease — n=657, PRR 38.6
- Obstructive airways disorder — n=103, PRR 28.2
- Sputum discoloured — n=86, PRR 27.8
- Emphysema — n=87, PRR 26.2
- Sleep disorder due to a general medical condition — n=82, PRR 15.4
- Pulmonary mass — n=69, PRR 14.1
- Wheezing — n=228, PRR 11.7
- Wrist fracture — n=39, PRR 9.9
- Respiratory tract infection — n=82, PRR 9.6
- Productive cough — n=139, PRR 8.9
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Roflumilast?
In FDA FAERS, the most frequently co-reported reaction terms for Roflumilast are dyspnoea, chronic obstructive pulmonary disease, diarrhoea, nausea, pneumonia, weight decreased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Roflumilast have an FDA boxed warning?
No. The FDA label retrieved for Roflumilast has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Roflumilast causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 4d25f69c-58b7-4e2a-b835-4d0c76a83c7c, effective 20240827; matched on
openfda.generic_name.exact:"ROFLUMILAST") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 390 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.