Sorafenib
Other Protein Kinase Inhibitors
Sold as Nexavar
- Drug class
- Other Protein Kinase Inhibitors
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 11
- FDA reports (12 mo)
- 243
Overview
Plain-language summary, compiled from the cited regulatory records
Sorafenib is a kinase inhibitor [1]. It belongs to the drug class of Other Protein Kinase Inhibitors (L01EX) [1].
Sorafenib tablets are approved for the treatment of unresectable hepatocellular carcinoma (HCC) [1]. They are also indicated for patients with locally recurrent or metastatic, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment [1].
In the past 12 months, there have been 243 adverse event reports for sorafenib [2]. The most frequently reported reactions include death, off-label use, product use in an unapproved indication, product prescribing issues, and diarrhea [2]. Sorafenib is available under various brand names [1].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 6 | May 1, 2026 |
| EU European Union | EMA | 2 | April 9, 2026 |
| US United States | FDA | 1 | December 22, 2025 |
| CA Canada | Health Canada | 2 | April 2, 2026 |
GBUnited Kingdom· MHRA
6 products
Uses
1). Renal cell carcinoma Sorafenib is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Differentiated thyroid carcinoma Sorafenib is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
How to take
EUEuropean Union· EMA
2 products
Uses
1). Renal cell carcinoma Sorafenib Accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
Differentiated thyroid carcinoma Sorafenib Accord is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
How to take
USUnited States· FDA
1 product
Uses
1 Hepatocellular Carcinoma Sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 3 Differentiated Thyroid Carcinoma Sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive,differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.
How to take
CACanada· Health Canada
2 products
2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [4].
Brands in Canada (1)
Drug interactions
Known interactions involving Sorafenib. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 476. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL366870484 · revised November 14, 2025
- [2]European Medicines Agency · EMEA/H/C/005921 · revised April 9, 2026
- [3]FDA DailyMed · 06f442d6-071e-40… · revised December 22, 2025 [PDF]
- [4]Health Canada (DPD) · 02284227 · revised July 2, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.