Prescription medication · PDE4 Inhibitor
roflumilast
Also sold as Daliresp. Roflumilast is used to lower your chances of COPD flare-ups.
Data updated 2026-05-15
- 6,450
- FDA reportsLightly reported
- 8
- InteractionsFew interactions
- 83% less
- Generic vs brandHuge savings
- $14.11
- Brand price (NADAC)
What the data shows
roflumilast (Daliresp) is a prescription PDE4 Inhibitor, reported less often than most tracked drugs (6,450 FDA reports), whose generic runs roughly half the brand price or less (83% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
roflumilast (Daliresp) is a prescription PDE4 Inhibitor. Roflumilast is used to lower your chances of COPD flare-ups.
Roflumilast (Daliresp) helps to reduce flare-ups in people with severe COPD. It is for people who also have chronic bronchitis and a history of COPD flare-ups.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$14.11/unit
Generic Price
$2.34/unit
Generic Savings
83%
Generic Available
Yes (8 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Roflumilast is used to lower your chances of COPD flare-ups.
Common side effects
Diarrhea, Weight loss, Nausea
Key warnings
Roflumilast is not for sudden breathing problems.
The sections below are summarized in plain English from roflumilast's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Roflumilast blocks an enzyme called phosphodiesterase 4 (PDE4). By blocking PDE4, it reduces lung inflammation. This can help prevent COPD flare-ups.
Side Effects (from patient reports)
Based on 6,450 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for roflumilast, by number of reports
- Dyspnoea
Dyspnoea
1,011 reports
- Death
Death
730 reports
- Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
631 reports
- Diarrhoea
Diarrhoea
567 reports
- Nausea
Nausea
465 reports
- Pneumonia
Pneumonia
450 reports
- Weight Decreased
Weight Decreased
436 reports
- Headache 404
Headache
404 reports
- Cough 346
Cough
346 reports
- Insomnia 313
Insomnia
313 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for roflumilast each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where roflumilast sits
roflumilast has more FDA adverse-event reports than 29% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is roflumilast; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 6,450 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2010–2025.
Total Reports
6,450
Reports Mentioning Death
943
14.6% of reports — not proof of cause
Hospitalization Reports
1,974
Top Indication
Chronic Obstructive Pulmonary Disease
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DYSPNOEA | 1,011 |
| 2 | DEATH | 730 |
| 3 | CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 631 |
| 4 | DIARRHOEA | 567 |
| 5 | NAUSEA | 465 |
| 6 | PNEUMONIA | 450 |
| 7 | WEIGHT DECREASED | 436 |
| 8 | HEADACHE | 404 |
| 11 | COUGH | 346 |
| 12 | INSOMNIA | 313 |
| 13 | DIZZINESS | 300 |
| 14 | ASTHMA | 284 |
| 15 | DECREASED APPETITE | 282 |
| 16 | MALAISE | 282 |
| 17 | FATIGUE | 281 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Roflumilast is not for sudden breathing problems. It may cause mental health problems, including suicidal thoughts. Tell your doctor if you have mood changes or weight loss.
Known Drug Interactions
rifampicin, phenobarbital, carbamazepine, and phenytoin) with roflumilast tablets is not recommended [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) ].
Mechanism: Carbamazepine causes your body to break down roflumilast much faster than usual. This reduces the amount of medicine in your system and makes it less effective.
rifampicin, phenobarbital, carbamazepine, and phenytoin) with roflumilast tablets is not recommended [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) ].
Mechanism: Phenytoin speeds up the process of clearing roflumilast from your body. This can prevent the medication from reaching levels high enough to work properly.
rifampicin, phenobarbital, carbamazepine, and phenytoin) with roflumilast tablets is not recommended [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) ].
Mechanism: Phenobarbital triggers your body to get rid of roflumilast more quickly. This means the drug will not stay in your body long enough to help your condition.
7.3 Oral Contraceptives Containing Gestodene and Ethinyl Estradiol The co-administration of roflumilast tablets (500 mcg) with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased side effects.
Mechanism: Taking these together can raise the amount of roflumilast in your body. This happens because the birth control affects how the body processes the medicine.
Use with inhibitors of CYP3A4 or dual inhibitors of CYP3A4 and CYP1A2 (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) will increase roflumilast systemic exposure and may result in increased adverse reactions. 7.2 Drugs that Inhibit Cytochrome P450 (CYP) Enzymes The co-administration of roflumilast tablets (500 mcg) with CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase roflumilast systemic exposure and may result in increased adverse reactions.
Mechanism: Ketoconazole blocks the enzymes that normally break down roflumilast. This causes the medicine to build up in your body and increases the risk of side effects.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I use roflumilast for sudden breathing problems?
What should I do if I feel depressed or have suicidal thoughts?
Will roflumilast cure my COPD?
Can I take roflumilast if I have liver problems?
Does roflumilast interact with other medications?
Will roflumilast cause weight loss?
Can I take roflumilast if I am pregnant or breastfeeding?
What is the starting dose of roflumilast?
What is the maintenance dose of roflumilast?
What should I do if I have diarrhea while taking roflumilast?
What are the common side effects of roflumilast?
Does roflumilast interact with other medications?
What drug class is roflumilast?
Is there a generic version of roflumilast?
What pregnancy or breastfeeding source fields are listed for roflumilast?
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for roflumilast: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 6,450.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 14.62%.
- diltiazem Δ 0.01 pts · 33,620 reports · Calcium Channel Blocker 14.63%death share
- theophylline Δ 0.05 pts · 11,723 reports · Methylxanthine Bronchodilator 14.57%death share
- quetiapine Δ 0.08 pts · 185,533 reports · Atypical Antipsychotic 14.54%death share
- fluvastatin Δ 0.11 pts · 3,948 reports · HMG-CoA Reductase Inhibitor (Statin) 14.51%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for roflumilast
The FDA label for roflumilast (sold under brand names such as Daliresp) classifies it as a prescription-only medication in the PDE4 Inhibitor class. Roflumilast is used to lower your chances of COPD flare-ups. Official labeling lists 9 commonly reported side effects, including Diarrhea, Weight loss, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 6,450 voluntary reports. The database also lists 8 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $2.34 versus $14.11 for the brand - a 83% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: March 21, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages