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What the FDA labels say about taking them together

Cimetidine and roflumilast

Roflumilast's FDA label of March 12, 2020 names cimetidine in its drug interactions section; the cimetidine label PlainMeds reads does not name roflumilast. The roflumilast label: “Use with inhibitors of CYP3A4 or dual inhibitors of CYP3A4 and CYP1A2 will increase roflumilast systemic exposure and may result in increased adverse reactions.”

Check it at the source: the cimetidine FDA label on DailyMed (effective July 15, 2026, Mylan Pharmaceuticals Inc.); the roflumilast FDA label on DailyMed (effective March 12, 2020, AstraZeneca Pharmaceuticals LP).

What does the cimetidine label say about roflumilast?

Cimetidine's label (effective July 15, 2026) does not name roflumilast in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Cimetidine), Mylan Pharmaceuticals Inc., effective July 15, 2026 (SPL set 06c0a509-026f-44e0-9975-a94a8de51d43), via openFDA; the full label on DailyMed

What does the roflumilast label say about cimetidine?

Roflumilast label, 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.

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

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

18Cimetidine generic labelers
15Roflumilast generic labelers
CimetidineRoflumilast
Labeled forAcid reflux and ulcersCOPD, Psoriasis, Eczema (atopic dermatitis)
Boxed warningNoNo
Pharmacy cost (NADAC)$0.236 per tablet 300 mg tablet$0.311 per tablet 500 mcg tablet
Shortage nowNo current entryNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?