Prescription medicine
Sorafenib Brand names: Nexavar
Sorafenib (Nexavar) is a prescription medicine with an FDA approval on record since 2005. FDA's NDC Directory lists it from 7 generic labelers.
- Generic listed
Check it at the source: the sorafenib FDA label on DailyMed (effective August 28, 2023, Bayer HealthCare Pharmaceuticals Inc.); the NDA 21923 record on Drugs@FDA; every sorafenib label on DailyMed.
Highlights of the record
FDA label of August 28, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageNEXAVAR is a kinase inhibitor indicated for the treatment of
Unresectable hepatocellular carcinoma ( 1.1 )
Advanced renal cell carcinoma ( 1.2 )
Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment ( 1.3 ) 1.1 Hepatocellular Carcinoma NEXAVAR ® is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC).
Forms and strengths
- 200 mg
Film-coated tablet.
On the market
- Earliest approval on file
- December 1, 2005 Nexavar, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first September 10, 2020; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 7 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 10, 2028 Nexavar 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
- 20,648 through July 30, 2026
What is sorafenib used for?
From the label: indications and usageNEXAVAR is a kinase inhibitor indicated for the treatment of
Unresectable hepatocellular carcinoma ( 1.1 )
Advanced renal cell carcinoma ( 1.2 )
Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment ( 1.3 ) 1.1 Hepatocellular Carcinoma NEXAVAR ® is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.2 Renal Cell Carcinoma NEXAVAR is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). 1.3 Differentiated Thyroid Carcinoma NEXAVAR is indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment. […]
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Nexavar), Bayer HealthCare Pharmaceuticals Inc., effective August 28, 2023 (SPL set b50667e4-5ebc-4968-a646-d605058dbef0), via openFDA; the full label on DailyMed
Is there a generic for sorafenib (Nexavar)?
The FDA approved the first generic sorafenib on September 10, 2020. 6 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sorafenib from 7 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Nexavar tablets: the compound patent runs to December 24, 2027, and the last listed entry to September 10, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2005 earliest approval on file
- 2020 first generic approved
- 2028 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the sorafenib label say about other medicines?
The sorafenib label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name sorafenib. 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 |
|---|---|---|
| Carboplatin | contraindications | NEXAVAR in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer [see Warnings and Precautions ( 5.8 )]. |
| Cisplatin | warnings and precautions | Observed with NEXAVAR Administered in Combination with Carboplatin/Paclitaxel and Gemcitabine/Cisplatin in Squamous Cell Lung Cancer In a subset analysis of two randomized controlled trials in chemo-naive patients with Stage IIIB-IV non-small cell lung cancer, patients with squamous cell carcinoma experienced higher … |
| Gemcitabine | warnings and precautions | Observed with NEXAVAR Administered in Combination with Carboplatin/Paclitaxel and Gemcitabine/Cisplatin in Squamous Cell Lung Cancer In a subset analysis of two randomized controlled trials in chemo-naive patients with Stage IIIB-IV non-small cell lung cancer, patients with squamous cell carcinoma experienced higher … |
| Neomycin | drug interactions | Neomycin The concomitant use of NEXAVAR with neomycin decreased the mean AUC of sorafenib, which may decrease the antitumor activity. |
| Paclitaxel | contraindications | NEXAVAR in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer [see Warnings and Precautions ( 5.8 )]. |
| Rifampin | drug interactions | Drugs on NEXAVAR Strong CYP3A4 Inducers The concomitant use of NEXAVAR with rifampin, a strong CYP3A4 inducer decreased the mean AUC of sorafenib, which may decrease the antitumor activity [see Clinical Pharmacology ( 12.3 )]. |
| Warfarin | drug interactions | Use of Warfarin The concomitant use of NEXAVAR and warfarin may increase the risk of bleeding or increased the INR. |
Other labels that name sorafenib
Source: FDA drug label (Nexavar), Bayer HealthCare Pharmaceuticals Inc., effective August 28, 2023 (SPL set b50667e4-5ebc-4968-a646-d605058dbef0), via openFDA; the full label on DailyMed
What do FAERS reports show for sorafenib?
The FDA Adverse Event Reporting System holds 20,648 reports that list sorafenib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,087 are coded as a death and 7,772 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?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Sorafenib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other