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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

TRAMETINIB: 5,840 Adverse Event Reports & Safety Profile

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5,840
Total FAERS Reports
938 (16.1%)
Deaths Reported
2,587
Hospitalizations
5,840
As Primary/Secondary Suspect
299
Life-Threatening
121
Disabilities
Prescription
Status

FDA Application: 217513 ·

First Report: 1991 · Latest Report: 20250801

What Are the Most Common TRAMETINIB Side Effects?

#1 Most Reported
Pyrexia
1,096 reports (18.8%)
#2 Most Reported
Malignant neoplasm progression
807 reports (13.8%)
#3 Most Reported
Product use in unapproved indication
349 reports (6.0%)

All TRAMETINIB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pyrexia 1,096 18.8% 113 640
Malignant neoplasm progression 807 13.8% 320 205
Product use in unapproved indication 349 6.0% 33 36
Diarrhoea 325 5.6% 42 183
Nausea 301 5.2% 67 172
Rash 290 5.0% 25 96
Vomiting 289 5.0% 59 187
Fatigue 269 4.6% 39 127
Death 240 4.1% 240 40
Chills 227 3.9% 29 128
Asthenia 193 3.3% 42 92
Drug ineffective 192 3.3% 77 53
Anaemia 184 3.2% 32 124
Off label use 176 3.0% 37 38
Metastatic malignant melanoma 173 3.0% 119 75
Headache 171 2.9% 31 89
Disease progression 155 2.7% 57 28
Metastases to central nervous system 155 2.7% 83 56
General physical health deterioration 151 2.6% 85 92
Ejection fraction decreased 150 2.6% 11 50

Who Reports TRAMETINIB Side Effects? Age & Gender Data

Gender: 49.4% female, 50.6% male. Average age: 51.4 years. Most reports from: US. View detailed demographics →

Is TRAMETINIB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 1 1
2010 3 1 2
2011 33 2 19
2012 40 2 16
2013 210 2 110
2014 469 40 301
2015 552 59 350
2016 359 85 258
2017 312 87 198
2018 485 66 317
2019 390 56 224
2020 285 48 153
2021 251 51 134
2022 230 39 121
2023 99 17 39
2024 93 12 39
2025 36 0 19

View full timeline →

What Is TRAMETINIB Used For?

IndicationReports
Metastatic malignant melanoma 1,604
Malignant melanoma 1,448
Product used for unknown indication 505
Non-small cell lung cancer 191
Colorectal cancer 158
Glioma 139
Braf gene mutation 94
Neoplasm 84
Neoplasm malignant 81
Braf v600e mutation positive 80

TRAMETINIB vs Alternatives: Which Is Safer?

TRAMETINIB vs TRAMETINIB DIMETHYL SULFOXIDE TRAMETINIB vs TRANDOLAPRIL TRAMETINIB vs TRANDOLAPRIL\VERAPAMIL TRAMETINIB vs TRANEXAMIC ACID TRAMETINIB vs TRANYLCYPROMINE TRAMETINIB vs TRASTUZUMAB TRAMETINIB vs TRASTUZUMAB-ANNS TRAMETINIB vs TRASTUZUMAB DERUXTECAN TRAMETINIB vs TRASTUZUMAB-DKST TRAMETINIB vs TRASTUZUMAB-DTTB

Official FDA Label for TRAMETINIB

Official prescribing information from the FDA-approved drug label.