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Sorafenib Side Effects

The most commonly reported side effects of sorafenib include diarrhoea, hepatocellular carcinoma, and off label use, based on 22,272 FDA adverse event reports from 2005 to 2025.

Sorafenib side effects

Percentages show how often each reaction appears relative to total reports for sorafenib.

1
Diarrhoea8.9%1,983
2
Hepatocellular Carcinoma8.9%1,977
3
Off Label Use8.3%1,858
4
Palmar-plantar Erythrodysaesthesia Syndrome5.7%1,270
5
Fatigue5.6%1,258
6
Diarrhoea5.3%1,172
7
Death5.2%1,149
8
Decreased Appetite4.9%1,091
9
Palmar-plantar Erythrodysaesthesia Syndrome4.8%1,064
10
Asthenia4.0%899
11
Nausea4.0%883
12
Rash3.5%773
13
Rash3.5%771
14
Weight Decreased3.2%703
15
Vomiting3.0%669

These are voluntary reports and do not establish that sorafenib caused these reactions.

Report severity

89.4%Serious19,914 reports
38.4%Hospitalizations8,559 reports
24.6%Fatal5,477 reports

Seriousness is determined by the reporter, not by OpenClaim.

Sorafenib drug interactions

Other drugs that appear in adverse event reports alongside sorafenib. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Regorafenib2.1%471
2
Bevacizumab2.1%465
3
Erlotinib-hydrochloride1.7%373
4
Everolimus1.5%335
5
Cytarabine1.4%308
6
Sunitinib-malate1.3%298
7
Cisplatin1.3%293
8
Gemcitabine1.1%255
9
Doxorubicin-hydrochloride1.1%242
10
Etoposide1.1%236
11
Paclitaxel0.9%210
12
Fludarabine-phosphate0.9%210
13
Capecitabine0.9%201
14
Atezolizumab0.9%197
15
Cyclophosphamide0.9%192

Taken alongside

1
Furosemide5.0%1,123
2
Amlodipine4.6%1,022
3
Acetaminophen3.7%827
4
Spironolactone3.5%774
5
Aspirin3.4%755
6
Omeprazole3.3%732
7
Oxycodone3.3%724
8
Levothyroxine-sodium2.9%635
9
Metformin2.3%510
10
Pantoprazole-sodium2.2%492
11
Insulin2.2%483
12
Hydrochlorothiazide2.1%478
13
Metoprolol2.1%476
14
Ondansetron2.0%445
15
Lisinopril1.9%428

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports sorafenib side effects

26.5% of sorafenib adverse event reports involve female patients and 64.8% involve male patients. The largest age group is elderly at 49%. These figures reflect who reports side effects, not underlying risk.

Sex

Female26.5%
Male64.8%
Unknown8.8%

Age group

< 20.1%
2–111.4%
12–171.3%
18–6448.0%
65+49.2%

What is sorafenib used for

Conditions and purposes for which patients were taking sorafenib when the adverse event was reported.

Accidental ExposureAcinar Cell Carcinoma Of PancreasAcral Lentiginous Melanoma Stage IvAcral Lentiginous Melanoma Stage UnspecifiedAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Megakaryocytic LeukaemiaAcute Monocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myeloid Leukaemia (in Remission)Acute Myeloid Leukaemia RecurrentAcute Myeloid Leukaemia RefractoryAcute Myeloid LeukemiaAcute Myeloid Leukemia RecurrentAcute Myelomonocytic Leukaemia

Showing 15 of 743 indications

Sorafenib brand names and reporting trend

Sorafenib is sold under the brand name Nexavar.

Brand names

Nexavar9,421

Quarterly reports (20052025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking sorafenib with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.