What the FDA labels say about taking them together
Azacitidine and ivosidenib
Ivosidenib's FDA label of December 22, 2025 names azacitidine in its warnings and precautions section; the azacitidine labels PlainMeds reads (3) do not name ivosidenib. The ivosidenib label: “Of the 71 patients with newly diagnosed AML treated with TIBSOVO in combination with azacitidine in the clinical trial (Study AG120-C-009), 10 (14%) were found to have a heart-rate corrected QT interval (QTcF) greater …”
Check it at the source: the azacitidine FDA label on DailyMed (effective January 29, 2024, Celgene Corporation); the ivosidenib FDA label on DailyMed (effective December 22, 2025, Servier Pharmaceutical LLC).
What does the azacitidine label say about ivosidenib?
Azacitidine's label (effective January 29, 2024) and its 2 other brand-application labels do not name ivosidenib in these sections. A label lists what its studies and reports found; it is not a complete list.
Source: FDA drug label (VIDAZA), NDA050794 (Bristol-Myers), as published by Celgene Corporation, effective January 29, 2024 (SPL set 3495a71a-cc04-4776-851f-f185956f32af), via openFDA; the full label on DailyMed
What does the ivosidenib label say about azacitidine?
Ivosidenib label, warnings and precautionsOf the 71 patients with newly diagnosed AML treated with TIBSOVO in combination with azacitidine in the clinical trial (Study AG120-C-009), 10 (14%) were found to have a heart-rate corrected QT interval (using Fridericia's method) (QTcF) greater than 500 msec and 15 out of 69 (22%) had an increase from baseline QTcF greater than 60 msec [see Adverse Reactions (6.1) ].
Source: FDA drug label (TIBSOVO), Servier Pharmaceutical LLC, effective December 22, 2025 (SPL set 65d254c0-67ad-42c4-b972-ad463b755b2d), 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
| Azacitidine | Ivosidenib | |
|---|---|---|
| Labeled for | Leukemia, lymphoma and myeloma | Leukemia, lymphoma and myeloma |
| Boxed warning | No | Yes |
| Pharmacy cost (NADAC) | n/a | n/a |
| Shortage now | In shortage | No 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?
- Check more medicines together
- up to five at once