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.
How to Take It
The usual dose is one 500 mcg tablet daily. You can take it with or without food. You might start with a 250 mcg tablet for the first 4 weeks. Then, increase to the 500 mcg dose.
This is a plain-language summary of roflumilast's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if roflumilast is safe during pregnancy. Do not breastfeed while taking roflumilast.
This is a plain-language summary of roflumilast's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.
This is a plain-language summary of roflumilast's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store roflumilast tablets at room temperature (68°F to 77°F).
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
- Difficulty breathing
Difficulty breathing
1,011 reports
- Death
Death
729 reports
- Chronic lung disease
Chronic lung disease
631 reports
- Diarrhea
Diarrhea
567 reports
- Nausea
Nausea
465 reports
- Pneumonia
Pneumonia
450 reports
- Weight loss
Weight loss
436 reports
- Headache 404
Headache
404 reports
- Cough 346
Cough
346 reports
- Trouble sleeping 313
Trouble sleeping
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) 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.
What to do: Using these two medications together is not recommended. Your doctor may need to adjust your treatment plan.
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.
What to do: This combination is not recommended. Consult your healthcare provider to see if a different medication is right for you.
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.
What to do: Avoid taking these two drugs at the same time. Your doctor should evaluate other options for your care.
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.
What to do: Watch for increased side effects if you take these together. Your doctor may need to monitor your health more closely.
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.
What to do: Your doctor should monitor you for increased side effects. They may need to adjust your treatment plan.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is roflumilast safe during pregnancy?
Related Medications in PDE4 Inhibitor
Other drugs grouped near roflumilast - same-class peers and common alternatives.
aclidinium
Tudorza Pressair
Compare with roflumilast →
albuterol
Ventolin, ProAir
Albuterol is a drug that helps you breathe easier.
Compare with roflumilast →
albuterol/ipratropium
Combivent Respimat, DuoNeb
Combivent Respimat is a combination medicine that helps open your airways.
Compare with roflumilast →
beclomethasone
Qvar
Qvar Redihaler is an inhaled medicine that helps control asthma symptoms.
Compare with roflumilast →
benralizumab
Fasenra
Fasenra is a medicine that can help treat severe asthma and EGPA.
Compare with roflumilast →
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
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on roflumilast
Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.
Disclosure: This link may earn us a commission at no extra cost to you. See our terms.
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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: March 21, 2025
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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