Quick answers
- What is Regorafenib used for?
- The FDA-approved label (Stivarga, Bayer HealthCare Pharmaceuticals Inc., February 9, 2026) says: “STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: • Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Regorafenib have a boxed warning?
- Yes. The FDA label for Stivarga has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Regorafenib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Regorafenib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Regorafenib?
- 1 company lists prescription products of Regorafenib in the FDA NDC Directory, including Bayer HealthCare Pharmaceuticals Inc..
What Regorafenib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: • Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. …
— FDA label: Stivarga, Bayer HealthCare Pharmaceuticals Inc., effective February 9, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Stivarga |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA203085 STIVARGA | Bayer Hlthcare | September 27, 2012 | 15, latest February 3, 2026 2026: Labeling · 2025: Labeling · 2020: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1312402, 1312408 |
|---|---|
| SPL set ID of the quoted label | 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA203085 |
| Active ingredients (FDA) | REGORAFENIB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Stivarga, Bayer HealthCare Pharmaceuticals Inc., effective February 9, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →