What the label lists and what reports show
Regorafenib side effects
Regorafenib's FDA label: “The most common adverse reactions (≥20%) are pain (including gastrointestinal and abdominal pain), HFSR, asthenia/fatigue, diarrhea, decreased appetite/food intake, hypertension, infection, dysphonia, hyperbilirubinemia, fever, mucositis, weight loss, rash …” FAERS holds 11,542 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 fatigue (1,769 reports).
- 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 FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of STIVARGA?STIVARGA can cause serious side effects including: See " What is the most important information I should know about STIVARGA? " infection. STIVARGA may lead to a higher risk of infections especially of the urinary tract, nose, throat and lung. STIVARGA may also lead to a higher risk of fungal infections of the mucous membrane, skin or the body. Tell your healthcare provider right away if you get: fever severe cough with or without an increase in mucus (sputum) production severe sore throat shortness of breath burning or pain when urinating unusual vaginal discharge or irritation redness, swelling or pain in any part of the body severe bleeding. STIVARGA can cause bleeding which can be serious and sometimes lead to death. […]
Source: FDA drug label, 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 label list?
From the label: adverse reactionsThe most common adverse reactions (≥20%) are pain (including gastrointestinal and abdominal pain), HFSR, asthenia/fatigue, diarrhea, decreased appetite/food intake, hypertension, infection, dysphonia, hyperbilirubinemia, fever, mucositis, weight loss, rash, and nausea.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed elsewhere in the labeling: • Hepatotoxicity [see Warnings and Precautions ( 5.1 )] • Infections [see Warnings and Precautions ( 5.2 )] • Hemorrhage [see Warnings and Precautions ( 5.3 )] • Gastrointestinal Perforation or Fistula [see Warnings and Precautions ( 5.4 )] • Dermatological Toxicity [see Warnings and Precautions ( 5.5 )] • Hypertension [see Warnings and Precautions ( 5.6 )] • Cardiac Ischemia and Infarction [see Warnings and Precautions ( 5.7 )] • Reversible Posterior Leukoencephalopathy Syndrome (RPLS) [see Warnings and Precautions ( 5.8 )] The most common adverse reactions (≥20%) are pain (including gastrointestinal and abdominal pain), HFSR, asthenia/fatigue, diarrhea, decreased appetite/food intake, hypertension, infection, dysphonia, hyperbilirubinemia, fever, mucositis, weight loss, rash, and nausea. ( 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 rate observed in practice.
Source: FDA drug label, 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?
11,542 reports list regorafenib among the medicines taken, 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. Of the 21 reactions below, 12 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?
- Regorafenib: 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