roflumilast
Brand names: Daliresp
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.
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.
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.
Pregnancy & Breastfeeding
It is not known if roflumilast is safe during pregnancy. Do not breastfeed while taking roflumilast.
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.
Storage
Store roflumilast tablets at room temperature (68°F to 77°F).
Side Effects (from patient reports)
Based on 5,435 FDA adverse event reports.
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
Death-Related Reports
943
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 |
| 9 | OFF LABEL USE | 393 |
| 10 | DRUG INEFFECTIVE | 349 |
| 11 | COUGH | 346 |
| 12 | INSOMNIA | 313 |
| 13 | DIZZINESS | 300 |
| 14 | ASTHMA | 284 |
| 15 | DECREASED APPETITE | 282 |
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.
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?
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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
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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 5,435 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.
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