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Regorafenib Side Effects

The most commonly reported side effects of regorafenib include off label use, fatigue, and palmar-plantar erythrodysaesthesia syndrome, based on 11,512 FDA adverse event reports from 2010 to 2025.

Regorafenib side effects

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

1
Off Label Use17.8%2,051
2
Fatigue15.3%1,763
3
Palmar-plantar Erythrodysaesthesia Syndrome12.5%1,437
4
Diarrhoea12.3%1,412
5
Decreased Appetite9.5%1,089
6
Death8.6%995
7
Asthenia8.2%944
8
Dysphonia7.2%825
9
Nausea7.1%818
10
Pain In Extremity6.7%771
11
Pyrexia6.6%755
12
Hypertension6.0%693
13
Weight Decreased5.5%635
14
Vomiting5.0%573
15
Rash4.9%560

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

Report severity

89.9%Serious10,351 reports
34.9%Hospitalizations4,014 reports
20.5%Fatal2,357 reports

Seriousness is determined by the reporter, not by OpenClaim.

Regorafenib drug interactions

Other drugs that appear in adverse event reports alongside regorafenib. 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
Sorafenib-tosylate4.1%472
2
Bevacizumab3.6%420
3
Trifluridine3.0%348
4
Tipiracil2.9%337
5
Oxaliplatin2.3%270
6
Fluorouracil2.3%266
7
Irinotecan-hydrochloride2.0%234
8
Capecitabine1.9%217
9
Nivolumab1.6%183
10
Sunitinib-malate1.4%161
11
Imatinib-mesylate1.2%133
12
Levoleucovorin0.9%103
13
Panitumumab0.8%96
14
Cetuximab0.6%71
15
Cabozantinib0.5%60

Taken alongside

1
Amlodipine3.4%386
2
Acetaminophen3.3%385
3
Oxycodone3.2%374
4
Ondansetron3.2%368
5
Omeprazole2.3%267
6
Gabapentin2.2%257
7
Furosemide2.0%232
8
Prochlorperazine2.0%228
9
Pantoprazole-sodium1.9%224
10
Loperamide-hydrochloride1.9%222
11
Levothyroxine-sodium1.8%210
12
Lisinopril1.8%208
13
Ergocalciferol1.7%198
14
Aspirin1.7%196
15
Metformin1.6%186

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 regorafenib side effects

36.4% of regorafenib adverse event reports involve female patients and 55.0% involve male patients. The largest age group is adult at 54%. These figures reflect who reports side effects, not underlying risk.

Sex

Female36.4%
Male55.0%
Unknown8.5%

Age group

< 2<0.1%
2–110.3%
12–170.6%
18–6453.5%
65+45.6%

What is regorafenib used for

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

Acinic Cell Carcinoma Of Salivary GlandAdenocarcinomaAdenocarcinoma GastricAdenocarcinoma MetastaticAdenocarcinoma Of AppendixAdenocarcinoma Of ColonAdenocarcinoma PancreasAdenoid Cystic CarcinomaAnaemiaAnaemia Of Chronic DiseaseAnal CancerAnal Cancer Stage IvAnal Squamous Cell CarcinomaAnaplastic AstrocytomaAnaplastic Oligodendroglioma

Showing 15 of 458 indications

Regorafenib brand names and reporting trend

Regorafenib is sold under the brand name Regorafenib.

Brand names

Regorafenib3,502

Quarterly reports (20102025)

20102016202020242025

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

Taking regorafenib with another medication?

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