What the label lists and what reports show
Sorafenib side effects
Sorafenib's FDA label: “The most common adverse reactions (≥20%) are diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, hypertension, and hemorrhage.” FAERS holds 20,648 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (2,959 reports).
- Generic listed
Check it at the source: the sorafenib FDA label on DailyMed (effective August 28, 2023, Bayer HealthCare Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of NEXAVAR?NEXAVAR may cause serious side effects, including: • decreased blood flow to the heart, heart attack and heart failure. Get emergency help right away if you get symptoms such as chest pain, shortness of breath, racing heartbeat, swelling in lower legs, feet and abdomen, feel lightheaded or faint, tiredness, nausea, vomiting, or sweat a lot. • increased risk of bleeding. Bleeding is a common side effect of NEXAVAR that can be serious and can lead to death. Tell your healthcare provider right away if you have any signs of bleeding during treatment with NEXAVAR: o vomiting blood or if your vomit looks like coffee-grounds o pink or brown urine o red or black (looks like tar) stools o coughing up blood or blood clots o heavier than normal menstrual cycle o unusual vaginal bleeding o frequent nose bleeds o bruising • high blood pressure. […]
Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective August 28, 2023 (SPL set b50667e4-5ebc-4968-a646-d605058dbef0), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥20%) are diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, hypertension, and hemorrhage.
Table 8: Selected Adverse Reactions Occurring at a Higher Incidence in NEXAVAR-Treated Patients [Between Arm Difference of ≥ 5% (All Grades)1 or ≥ 2% (Grades 3 and 4)]
| Reaction | All Grades (%) | Grades 3 and 4 (%) | All Grades (%) | Grades 3 and 4 (%) |
|---|---|---|---|---|
| PPES 5 | 69 | 19 | 8 | 0 |
| Alopecia | 67 | 0 | 8 | 0 |
| Rash | 35 | 5 | 7 | 0 |
| Pruritus | 20 | 0.5 | 11 | 0 |
| Dry skin | 13 | 0.5 | 5 | 0 |
| Erythema | 10 | 0 | 0.5 | 0 |
| Hyperkeratosis | 7 | 0 | 0 | 0 |
| Diarrhea | 68 | 6 | 15 | 1 |
| Stomatitis 3 | 24 | 2 | 3 | 0 |
| Nausea | 21 | 0 | 12 | 0 |
| Abdominal pain 2 | 20 | 1 | 7 | 1 |
| Constipation | 16 | 0 | 8 | 0.5 |
| Oral pain 4 | 14 | 0.5 | 6 | 0 |
| Vomiting | 11 | 0 | 3 | 0 |
| Weight loss | 49 | 6 | 14 | 1 |
| Fatigue | 41 | 5 | 20 | 1 |
| Asthenia | 12 | 0 | 7 | 0 |
| Pyrexia | 11 | 1 | 5 | 0 |
| Hypertension 6 | 41 | 10 | 12 | 2 |
| Decreased appetite | 30 | 2 | 5 | 0 |
| Headache | 17 | 0 | 6 | 0 |
| Dysgeusia | 6 | 0 | 0 | 0 |
| Pain in extremity | 15 | 1 | 7 | 0 |
| Muscle spasms | 10 | 0 | 3 | 0 |
| Dysphonia | 13 | 0.5 | 3 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed elsewhere in the labeling: • Cardiovascular events [see Warnings and Precautions ( 5.1 )] • Hemorrhage [see Warnings and Precautions ( 5.2 )] • Hypertension [see Warnings and Precautions ( 5.3 )] • Dermatologic toxicities [see Warnings and Precautions ( 5.4 )] • Gastrointestinal perforation [see Warnings and Precautions ( 5.5 )] • QT interval prolongation [see Warnings and Precautions ( 5.9 ) and Clinical Pharmacology ( 12.2 )] • Drug-induced liver injury [see Warnings and Precautions ( 5.10 )] • Impairment of TSH suppression in DTC [see Warnings and Precautions ( 5.12 )] The most common adverse reactions (≥20%) are diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, hypertension, and hemorrhage. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, 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?
20,648 reports list sorafenib among the medicines taken, 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. Of the 22 reactions below, 19 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Sorafenib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions