Prescription medicine
Roflumilast Brand names: Zoryve, Daliresp
Roflumilast (Zoryve) is a prescription medicine with an FDA approval on record since 2011. FDA's NDC Directory lists it from 15 generic labelers, and pharmacies paid $0.311 per roflumilast 500 mcg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the roflumilast FDA label on DailyMed (effective March 12, 2020, AstraZeneca Pharmaceuticals LP); the NDA 22522 record on Drugs@FDA; every roflumilast label on DailyMed.
Highlights of the record
FDA label of March 12, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDALIRESP ® is 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.
Forms and strengths
- 0.5 mg/g
- 1.5 mg/g
- 3 mg/g
Tablet; cream; aerosol (foam).
On the market
- Earliest approval on file
- February 28, 2011 Daliresp, Astrazeneca; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first July 13, 2018; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 15 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- August 25, 2037 Zoryve cream; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.311 per tablet Roflumilast 500 mcg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 6,927 through July 30, 2026
What is roflumilast used for?
From the label: indications and usageDALIRESP ® is 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. DALIRESP is a selective phosphodiesterase 4 inhibitor 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. ( 1 , 14 ) Limitations of Use:
DALIRESP is not a bronchodilator and is not indicated for the relief of acute bronchospasm. ( 1, 14 )
DALIRESP 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. […]
Conditions named in the indications of roflumilast's FDA labels, with every medicine labeled for each:
From other roflumilast labelsPsoriasis and Eczema (atopic dermatitis): Plaque Psoriasis ZORYVE cream, 0.3%, is indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 2 years of age and older. …
FDA pharmacologic class: Phosphodiesterase 4 Inhibitor.
Source: FDA drug label (Daliresp), AstraZeneca Pharmaceuticals LP, effective March 12, 2020 (SPL set c9a1d0a8-581f-4f91-a2b8-f419192d0ebf), via openFDA; the full label on DailyMed
What does the patient leaflet for roflumilast say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about DALIRESP?DALIRESP can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking DALIRESP. 1. DALIRESP may cause mental health problems including suicidal thoughts and behavior. Some people taking DALIRESP may develop mood or behavior problems including: • thoughts of suicide or dying • attempt to commit suicide • trouble sleeping (insomnia) • new or worse anxiety • new or worse depression • acting on dangerous impulses • other unusual changes in your behavior or mood 2. Weight loss. DALIRESP can cause weight loss. You should check your weight on a regular basis. You will also need to see your healthcare provider regularly to have your weight checked. If you notice that you are losing weight, call your healthcare provider. Your healthcare provider may ask you to stop taking DALIRESP if you lose too much weight. DALIRESP may affect the way other medicines work, and other medicines may affect how DALIRESP works. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Source: FDA drug label (Daliresp), AstraZeneca Pharmaceuticals LP, effective March 12, 2020 (SPL set c9a1d0a8-581f-4f91-a2b8-f419192d0ebf), via openFDA; the full label on DailyMed
Is there a generic for roflumilast (Zoryve)?
The FDA approved the first generic roflumilast on July 13, 2018. 11 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists roflumilast from 15 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 16 patents for Zoryve cream, the last expiring on August 25, 2037; a patent listed only for Zoryve foam runs to August 19, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2011 earliest approval on file
- 2018 first generic approved
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for roflumilast (Zoryve)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.311 per Roflumilast 500 mcg tablet, down 1% from $0.315 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Roflumilast 500 mcg tablet (generic)
- Daliresp 500 mcg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Roflumilast 250 mcg tablet | Generic | $1.98 per tablet | $59.44 | -16% |
| Roflumilast 500 mcg tablet | Generic | $0.311 per tablet | $9.34 | -1% |
| Daliresp 250 mcg tablet | Brand | $14.98 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $449.48 | +3% |
| Daliresp 500 mcg tablet | Brand | $14.90 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $447.11 | +2% |
| Zoryve 0.05% cream | Brand | $15.41 per gram | n/a | n/a |
| Zoryve 0.15% cream | Brand | $15.40 per gram | n/a | +4% |
| Zoryve 0.3% cream | Brand | $15.38 per gram | n/a | +4% |
| Zoryve 0.3% foam | Brand | $15.38 per gram | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the roflumilast label say about other medicines?
The roflumilast label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name roflumilast. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Therefore the use of strong cytochrome P450 inducers (e.g., rifampicin, phenobarbital, carbamazepine, and phenytoin) with DALIRESP is not recommended [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) ]. |
| Cimetidine | drug interactions | 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. |
| Erythromycin | drug interactions | 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. |
| Fluvoxamine | drug interactions | 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. |
| Ketoconazole | drug interactions | 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. |
| Phenobarbital | drug interactions | Therefore the use of strong cytochrome P450 inducers (e.g., rifampicin, phenobarbital, carbamazepine, and phenytoin) with DALIRESP is not recommended [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) ]. |
| Phenytoin | drug interactions | Therefore the use of strong cytochrome P450 inducers (e.g., rifampicin, phenobarbital, carbamazepine, and phenytoin) with DALIRESP is not recommended [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) ]. |
Source: FDA drug label (Daliresp), AstraZeneca Pharmaceuticals LP, effective March 12, 2020 (SPL set c9a1d0a8-581f-4f91-a2b8-f419192d0ebf), via openFDA; the full label on DailyMed
What do FAERS reports show for roflumilast?
The FDA Adverse Event Reporting System holds 6,927 reports that list roflumilast among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 954 are coded as a death and 2,063 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as roflumilast?
3 other medicines are given the same way (oral) and in the same FDA class as roflumilast or labeled mainly for the same use (COPD), the same class first. COPD lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Apremilast | Psoriasis | none listed | $90.57 per tablet 30 mg tablet | No current entry |
| Tiotropium | COPD | 1 labeler | $11.81 per capsule 18 mcg capsule-inhaler | No current entry |
| Umeclidinium | COPD | none listed | $7.35 per inhaler 62.5 mcg inhaler | No current entry |
Every medicine labeled for the same conditions as roflumilast
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does roflumilast compare with medicines for the same use?
1 side-by-side page set roflumilast beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to roflumilast
- 3 medicines for the same use
- Other phosphodiesterase 4 inhibitors
- the pharmacologic class, with prices and generics
- Roflumilast side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other