Dabrafenib

Common brands: Tafinlar, Mekinist, Opdivo, Yervoy, Keytruda

Top reporter: Novartis Pharmaceuticals Corporation

Corticosteroid [EPC]Programmed Death Receptor-1 Blocking Antibody [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Kinase Inhibitor [EPC]CTLA-4-directed Blocking Antibody [EPC]
20,691
Total Reports
10,115
Serious Reports
4,365
Death Reports
30
Reported Reactions
Death Report Ratio: High (21.10%)

Patient Demographics

Male
9,879
Female
8,714

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Dabrafenib.

# Reaction Reports % of Total
1 PYREXIA 4,045
15.7%
2 DEATH 2,862
11.1%
3 MALIGNANT NEOPLASM PROGRESSION 1,737
6.8%
4 FATIGUE 1,407
5.5%
5 NAUSEA 1,382
5.4%
6 CHILLS 1,314
5.1%
7 RASH 1,156
4.5%
8 VOMITING 971
3.8%
9 DIARRHOEA 957
3.7%
10 HEADACHE 737
2.9%
11 ASTHENIA 709
2.8%
12 MALAISE 620
2.4%
13 DECREASED APPETITE 579
2.3%
14 ARTHRALGIA 569
2.2%
15 PRODUCT USE IN UNAPPROVED INDICATION 532
2.1%
16 VISUAL IMPAIRMENT 520
2.0%
17 PAIN 492
1.9%
18 METASTASES TO CENTRAL NERVOUS SYSTEM 490
1.9%
19 DRUG INEFFECTIVE 479
1.9%
20 METASTATIC MALIGNANT MELANOMA 471
1.8%
21 MALIGNANT MELANOMA 435
1.7%
22 DISEASE PROGRESSION 415
1.6%
23 DYSPNOEA 408
1.6%
24 DIZZINESS 378
1.5%
25 COUGH 356
1.4%
26 PNEUMONIA 347
1.3%
27 DEHYDRATION 346
1.3%
28 OFF LABEL USE 345
1.3%
29 GENERAL PHYSICAL HEALTH DETERIORATION 332
1.3%
30 VISION BLURRED 332
1.3%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.