Prescription medicine
Belumosudil Brand names: Rezurock
Belumosudil (Rezurock) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the belumosudil FDA label on DailyMed (effective April 7, 2026, Kadmon Pharmaceuticals, LLC); the NDA 214783 record on Drugs@FDA; every belumosudil label on DailyMed.
Highlights of the record
FDA label of April 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageREZUROCK is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.
Forms and strengths
- 200 mg
Tablet.
On the market
- Earliest approval on file
- July 16, 2021 Rezurock, Kadmon Pharms Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 14, 2042 Rezurock tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,183 through July 30, 2026
What is belumosudil used for?
From the label: indications and usageREZUROCK is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. REZUROCK is a kinase inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.
Source: FDA drug label (Rezurock), Kadmon Pharmaceuticals, LLC, effective April 7, 2026 (SPL set 102e4ef4-7f84-4e34-8df1-479c24d1575d), via openFDA; the full label on DailyMed
Is there a generic for belumosudil (Rezurock)?
No generic belumosudil is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Rezurock tablets: the compound patent runs to June 20, 2034, and the last listed entry to July 14, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the belumosudil label say about other medicines?
The belumosudil label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name belumosudil. 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 |
|---|---|---|
| Caffeine | drug interactions | Concomitant use of REZUROCK with sensitive CYP1A2 substrates (e.g., caffeine) is predicted to increase CYP1A2 substrate exposure [see Clinical Pharmacology (12.3) ], which may increase the risk of adverse reactions related to these substrates. |
| Midazolam | drug interactions | Concomitant use of REZUROCK with sensitive CYP3A substrates (e.g., midazolam) is predicted to increase CYP3A substrate exposure [see Clinical Pharmacology (12.3) ], which may increase the risk of adverse reactions related to these substrates. |
Other labels that name belumosudil
Source: FDA drug label (Rezurock), Kadmon Pharmaceuticals, LLC, effective April 7, 2026 (SPL set 102e4ef4-7f84-4e34-8df1-479c24d1575d), via openFDA; the full label on DailyMed
What do FAERS reports show for belumosudil?
The FDA Adverse Event Reporting System holds 3,183 reports that list belumosudil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 287 are coded as a death and 816 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 next?
- Belumosudil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other