OpenClaim

Dabrafenib Side Effects

The most commonly reported side effects of dabrafenib include pyrexia, death, and malignant neoplasm progression, based on 20,606 FDA adverse event reports from 2012 to 2025. 2.3% of reports found the drug to be ineffective.

Dabrafenib side effects

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

1
Pyrexia19.6%4,040
2
Death13.8%2,842
3
Malignant Neoplasm Progression8.4%1,730
4
Fatigue6.8%1,391
5
Nausea6.7%1,374
6
Chills6.3%1,301
7
Rash5.6%1,156
8
Vomiting4.7%966
9
Diarrhoea4.6%948
10
Headache3.5%730
11
Asthenia3.4%702
12
Malaise3.0%619
13
Decreased Appetite2.8%578
14
Arthralgia2.8%568
15
Product Use In Unapproved Indication2.6%530

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

Report severity

74.2%Serious15,280 reports
27.8%Hospitalizations5,733 reports
21.1%Fatal4,345 reports

Seriousness is determined by the reporter, not by OpenClaim.

Dabrafenib drug interactions

Other drugs that appear in adverse event reports alongside dabrafenib. 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
Trametinib82.4%16,973
2
Nivolumab2.6%527
3
Ipilimumab1.8%371
4
Vemurafenib1.4%287
5
Pembrolizumab1.1%235
6
Encorafenib0.8%157
7
Binimetinib0.7%152
8
Cobimetinib-fumarate0.6%129
9
Panitumumab0.5%112
10
Carboplatin0.5%104
11
Prednisone0.4%80
12
Dexamethasone0.4%75
13
Cisplatin0.3%65
14
Cyclophosphamide0.3%65
15
Bortezomib0.3%65

Taken alongside

1
Trametinib3.1%649
2
Acetaminophen2.6%531
3
Levothyroxine-sodium2.2%450
4
Ondansetron1.7%343
5
Prednisone1.6%329
6
Pantoprazole-sodium1.5%304
7
Aspirin1.5%301
8
Omeprazole1.4%281
9
Dexamethasone1.3%261
10
Amlodipine1.3%260
11
Metformin1.2%243
12
Levetiracetam1.1%234
13
Oxycodone1.1%223
14
Ergocalciferol1.1%217
15
Ibuprofen1.0%208

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 dabrafenib side effects

42.1% of dabrafenib adverse event reports involve female patients and 47.7% involve male patients. The largest age group is adult at 57%. These figures reflect who reports side effects, not underlying risk.

Sex

Female42.1%
Male47.7%
Unknown10.2%

Age group

< 20.4%
2–111.8%
12–171.0%
18–6457.2%
65+39.6%

What is dabrafenib used for

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

Abdominal Pain UpperAccidentAcinar Cell Carcinoma Of PancreasAcquired Immunodeficiency SyndromeAcral Lentiginous MelanomaAcute Myeloid LeukaemiaAdenocarcinomaAdenocarcinoma MetastaticAdenocarcinoma Of ColonAdenocarcinoma PancreasAdjuvant TherapyAdrenal Gland CancerAmeloblastomaAnaemiaAnal Cancer

Showing 15 of 575 indications

Dabrafenib brand names and reporting trend

Dabrafenib is sold under the brand name Tafinlar.

Brand names

Tafinlar7,493

Quarterly reports (20122025)

20122016202020242025

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

Taking dabrafenib with another medication?

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