REGORAFENIB\REGORAFENIB: 106 Adverse Event Reports & Safety Profile

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106

Total FAERS Reports

32 (30.2%)

Deaths Reported

Hospitalizations

106

As Primary/Secondary Suspect

Life-Threatening

Active Ingredient: REGORAFENIB\REGORAFENIB MONOHYDRATE ·

First Report: 20130213 · Latest Report: 20240605

What Are the Most Common REGORAFENIB\REGORAFENIB Side Effects?

#1 Most Reported

Off label use

40 reports (37.7%)

#2 Most Reported

Fatigue

18 reports (17.0%)

#3 Most Reported

Death

17 reports (16.0%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Off label use	40	37.7%	4	22
Fatigue	18	17.0%	5	7
Death	17	16.0%	17	1
Asthenia	15	14.2%	8	6
Diarrhoea	11	10.4%	1	6
Decreased appetite	10	9.4%	4	5
Pain in extremity	9	8.5%	0	3
Palmar-plantar erythrodysaesthesia syndrome	9	8.5%	0	3
Constipation	8	7.6%	0	3
Dysphonia	7	6.6%	2	3
Weight decreased	7	6.6%	0	4
Blister	6	5.7%	2	1
Dizziness	6	5.7%	3	3
Fall	6	5.7%	0	5
Gait disturbance	6	5.7%	0	0
Myelosuppression	6	5.7%	0	4
Nausea	6	5.7%	2	2
Dry skin	5	4.7%	0	1
Headache	5	4.7%	0	3
Skin exfoliation	5	4.7%	0	1

Gender: 41.5% female, 58.5% male. Average age: 60.5 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2013	2	2	0
2019	2	0	1
2020	1	0	1
2021	1	0	0
2022	3	1	1
2023	10	4	3
2024	50	12	24

Indication	Reports
Colon cancer	17
Colorectal cancer	15
Hepatocellular carcinoma	13
Colorectal cancer metastatic	6
Colon cancer metastatic	5

Official prescribing information from the FDA-approved drug label.