Two medicines, side by side
Roflumilast vs tacrolimus
Roflumilast and tacrolimus are both labeled for eczema (atopic dermatitis). Drugs@FDA records approvals of roflumilast since 2011 and of tacrolimus since 1994. Pharmacies paid $0.311 per roflumilast 500 mcg tablet and $0.970 per gram (Tacrolimus 0.1% ointment) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, roflumilast is a phosphodiesterase 4 inhibitor and tacrolimus a calcineurin inhibitor immunosuppressant.
Check it at the source: the roflumilast FDA label on DailyMed (effective March 12, 2020); the tacrolimus FDA label on DailyMed (effective July 17, 2026).
Highlights of the roflumilast record
Roflumilast (Zoryve) · label of March 12, 2020
Used for
From the label: indicationsDALIRESP ® 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. […]
On the market
- Earliest approval on file
- February 28, 2011
- Generic labelers
- 15 labelers
- Pharmacy cost
- $0.311 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Highlights of the tacrolimus record
Tacrolimus (Prograf) · label of July 17, 2026
MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing serious infections and malignancies with Tacrolimus or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 ) WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Increased risk for developing serious infections and malignancies with tacrolimus or other immunosuppressants that may lead to hospitalization or death.
Used for
From the label: indicationsTacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants. […]
On the market
- Earliest approval on file
- April 8, 1994
- Generic labelers
- 33 labelers
- Pharmacy cost
- $0.970 per gram
Supply and safety
- Shortage
- No current entry
- Recalls
- 9
Source: FDA drug labels via openFDA (Roflumilast label of March 12, 2020, Tacrolimus label of July 17, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do roflumilast and tacrolimus differ on the record?
In FDA's classes, roflumilast is a phosphodiesterase 4 inhibitor and tacrolimus a calcineurin inhibitor immunosuppressant.
Half-life, in each label's words: Roflumilast, “Following an oral dose, the median plasma effective half-life of roflumilast and its N-oxide metabolite are …”; Tacrolimus, “Fecal elimination accounted for 92.4±1.0% and the elimination half-life based on radioactivity was 48.1±15.9 hours …”
Only the tacrolimus label carries a boxed warning.
Generics: roflumilast since 2018; tacrolimus since 2009 (Drugs@FDA).
| Roflumilast | Tacrolimus | |
|---|---|---|
| Labeled for | COPD, Psoriasis, Eczema (atopic dermatitis) | Organ transplant rejection, Eczema (atopic dermatitis) |
| Pharmacologic class | Phosphodiesterase 4 Inhibitor | Calcineurin Inhibitor Immunosuppressant |
| How it works (label) | Roflumilast and its active metabolite (roflumilast N-oxide) are selective inhibitors of phosphodiesterase 4 (PDE4). | n/a |
| Half-life (label) | Following an oral dose, the median plasma effective half-life of roflumilast and its N-oxide metabolite are approximately 17 and 30 hours, respectively. | Fecal elimination accounted for 92.4±1.0% and the elimination half-life based on radioactivity was 48.1±15.9 hours whereas it was 43.5±11.6 hours based on tacrolimus concentrations. |
| Earliest approval on file (Drugs@FDA) | February 28, 2011 | April 8, 1994 |
| First generic approved | July 13, 2018 | August 10, 2009 |
| Generic labelers (NDC) | 15 labelers | 33 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.311 per tablet (Roflumilast 500 mcg tablet) | $0.970 per gram (Tacrolimus 0.1% ointment) |
| 12-month price change | -1% | +3% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 9 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 6,927 | 156,020 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to roflumilast
- every medicine labeled for the same conditions