Prescription medicine
Regorafenib Brand names: Stivarga
Regorafenib (Stivarga) is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the regorafenib FDA label on DailyMed (effective February 9, 2026, Bayer HealthCare Pharmaceuticals Inc.); the NDA 203085 record on Drugs@FDA; every regorafenib label on DailyMed.
Highlights of the record
FDA label of February 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HEPATOTOXICITY •.
Severe and sometimes fatal hepatotoxicity has occurred in clinical trials [see Warnings and Precautions ( 5.1 )].
Monitor hepatic function prior to and during treatment [see Warnings and Precautions ( 5.1 )].
Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence [see Dosage and Administration ( 2.2 )]. WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning.
Severe and sometimes fatal hepatotoxicity has occurred in clinical trials. ( 5.1 )
Monitor hepatic function prior to and during treatment. ( 5.1 )
Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence.
Used for
From the label: indications and usageSTIVARGA 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.
Forms and strengths
- 40 mg
Film-coated tablet.
On the market
- Earliest approval on file
- September 27, 2012 Stivarga, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first January 13, 2025; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 9, 2032 Stivarga 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
- 11,542 through July 30, 2026
What is regorafenib used for?
From the label: indications and usageSTIVARGA 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. ( 1.1 )
Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. […]
Conditions named in the indications of regorafenib's FDA labels, with every medicine labeled for each:
From other regorafenib labelsColorectal cancer: Colorectal Cancer STIVARGA is 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 …
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Stivarga), Bayer HealthCare Pharmaceuticals Inc., effective February 9, 2026 (SPL set 824f19c9-0546-4a8a-8d8f-c4055c04f7c7), via openFDA; the full label on DailyMed
What does the patient leaflet for regorafenib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about STIVARGA?STIVARGA can cause serious side effects, including: liver problems. STIVARGA can cause severe liver problems, including increased blood ammonia, which can sometimes lead to death. Your healthcare provider will do blood tests to check your liver function before you start taking STIVARGA and during your treatment with STIVARGA to check for liver problems. Tell your healthcare provider right away if you get any of these signs or symptoms of liver problems during treatment: yellowing of your skin or the white part of your eyes (jaundice) pain on the upper right side of your stomach area (abdomen) nausea or vomiting loss of appetite light-colored stools (bowel movements) dark "tea-colored" urine severe headache or headaches that persist vision changes seizures feeling more tired than usual drowsiness trembling confusion memory loss or disorientation See " What are the possible side effects of STIVARGA? " for more information about side effects.
From the patient leaflet: What should I avoid while taking STIVARGA?Avoid drinking grapefruit juice and taking St. John's Wort during treatment with STIVARGA. These can affect the way STIVARGA works.
Source: FDA drug label (Stivarga), Bayer HealthCare Pharmaceuticals Inc., effective February 9, 2026 (SPL set 824f19c9-0546-4a8a-8d8f-c4055c04f7c7), via openFDA; the full label on DailyMed
Is there a generic for regorafenib (Stivarga)?
The FDA approved the first generic regorafenib on January 13, 2025. 1 generic application is approved; 0 of it carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 4 patents for Stivarga tablets: the compound patent runs to July 9, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2025 first generic approved
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the regorafenib label say about other medicines?
The regorafenib label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name regorafenib. 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 |
|---|---|---|
| Atorvastatin | drug interactions | Monitor patients closely for signs and symptoms of exposure related toxicity to the BCRP substrate (e.g. methotrexate, fluvastatin, atorvastatin). |
| Carbamazepine | drug interactions | Avoid concomitant use of STIVARGA with strong CYP3A4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort). |
| Clarithromycin | drug interactions | Avoid concomitant use of STIVARGA with strong CYP3A4 inhibitors (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, and voriconazole). |
| Fluvastatin | drug interactions | Monitor patients closely for signs and symptoms of exposure related toxicity to the BCRP substrate (e.g. methotrexate, fluvastatin, atorvastatin). |
| Itraconazole | drug interactions | Avoid concomitant use of STIVARGA with strong CYP3A4 inhibitors (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, and voriconazole). |
| Ketoconazole | drug interactions | Avoid concomitant use of STIVARGA with strong CYP3A4 inhibitors (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, and voriconazole). |
| Methotrexate | drug interactions | Monitor patients closely for signs and symptoms of exposure related toxicity to the BCRP substrate (e.g. methotrexate, fluvastatin, atorvastatin). |
| Nefazodone | drug interactions | Avoid concomitant use of STIVARGA with strong CYP3A4 inhibitors (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, and voriconazole). |
| Phenobarbital | drug interactions | Avoid concomitant use of STIVARGA with strong CYP3A4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort). |
| Phenytoin | drug interactions | Avoid concomitant use of STIVARGA with strong CYP3A4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort). |
| Posaconazole | drug interactions | Avoid concomitant use of STIVARGA with strong CYP3A4 inhibitors (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, and voriconazole). |
| Rifampin | drug interactions | Avoid concomitant use of STIVARGA with strong CYP3A4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort). |
| Voriconazole | drug interactions | Avoid concomitant use of STIVARGA with strong CYP3A4 inhibitors (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, and voriconazole). |
| Warfarin | warnings and precautions | Monitor INR levels more frequently in patients receiving warfarin [see Clinical Pharmacology ( 12.3 )]. |
Other labels that name regorafenib
Source: FDA drug label (Stivarga), Bayer HealthCare Pharmaceuticals Inc., effective February 9, 2026 (SPL set 824f19c9-0546-4a8a-8d8f-c4055c04f7c7), via openFDA; the full label on DailyMed
What do FAERS reports show for regorafenib?
The FDA Adverse Event Reporting System holds 11,542 reports that list regorafenib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,363 are coded as a death and 4,042 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 else is labeled for the same conditions as regorafenib?
5 other medicines are given the same way (oral) and in the same FDA class as regorafenib or labeled mainly for the same use (colorectal cancer), the same class first. Colorectal cancer lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tucatinib | Colorectal cancer | none listed | n/a | No current entry |
| Capecitabine | Colorectal cancer | 18 labelers | $0.456 per tablet 500 mg tablet | No current entry |
| Fruquintinib | Colorectal cancer | none listed | n/a | No current entry |
| Tipiracil and trifluridine | Colorectal cancer | none listed | n/a | No current entry |
| Encorafenib | Colorectal cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as regorafenib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to regorafenib
- 5 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Regorafenib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other