What the label lists and what reports show
Dabrafenib side effects
Dabrafenib's FDA label: “Most common adverse reactions (≥ 20%) for TAFINLAR as a single agent are hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, and palmar-plantar erythrodysesthesia syndrome.” FAERS holds 20,946 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (4,104 reports).
- No generic listed
Check it at the source: the dabrafenib FDA label on DailyMed (effective May 20, 2026, Novartis Pharmaceuticals Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of TAFINLAR?TAFINLAR may cause serious side effects, including: See “What is the most important information I should know about TAFINLAR?” bleeding problems. TAFINLAR, when taken or given with trametinib, can cause serious bleeding problems, especially in your brain or stomach, that can lead to death. Call your healthcare provider and get medical help right away if you have any signs of bleeding, including: ○ headaches, dizziness, or feeling weak ○ cough up blood or blood clots ○ vomit blood or your vomit looks like “coffee grounds” ○ red or black stool that looks like tar heart problems, including heart failure. Your healthcare provider should check your heart function before and during treatment with TAFINLAR. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective May 20, 2026 (SPL set fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 20%) for TAFINLAR as a single agent are hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, and palmar-plantar erythrodysesthesia syndrome.
Table 6. Select Adverse Reactions Occurring in ≥ 10% (All Grades) or ≥ 2% (Grades 3 or 4) of Patients Treated with TAFINLAR in the BREAK-3 Study a
| Adverse Reactions | All Grades (%) | Grades 3 and 4 b (%) | All Grades (%) | Grades 3 and 4 (%) |
|---|---|---|---|---|
| Hyperkeratosis | 37 | 1 | 0 | 0 |
| Alopecia | 22 | NA | 2 | NA |
| Palmar-plantar erythrodysesthesia syndrome | 20 | 2 | 2 | 0 |
| Rash | 17 | 0 | 0 | 0 |
| Headache | 32 | 0 | 8 | 0 |
| Pyrexia | 28 | 3 | 10 | 0 |
| Arthralgia | 27 | 1 | 2 | 0 |
| Back pain | 12 | 3 | 7 | 0 |
| Myalgia | 11 | 0 | 0 | 0 |
| Papilloma c | 27 | 0 | 2 | 0 |
| cuSCC d | 7 | 4 | 0 | 0 |
| Cough | 12 | 0 | 5 | 0 |
| Constipation | 11 | 2 | 14 | 0 |
| Nasopharyngitis | 10 | 0 | 3 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: New Primary Malignancies [see Warnings and Precautions (5.1)] Tumor Promotion in BRAF Wild-Type Tumors [see Warnings and Precautions (5.2)] Hemorrhage [see Warnings and Precautions (5.3)] Cardiomyopathy [see Warnings and Precautions (5.4)] Uveitis [see Warnings and Precautions (5.5)] Serious Febrile Reactions [see Warnings and Precautions (5.6)] Serious Skin Toxicities [see Warnings and Precautions (5.7)] Hyperglycemia [see Warnings and Precautions (5.8)] Glucose-6-Phosphate Dehydrogenase Deficiency [see Warnings and Precautions (5.9)] Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions (5.11)] There are additional adverse reactions associated with trametinib. Refer to the trametinib prescribing information for additional information. Most common adverse reactions (≥ 20%) for TAFINLAR as a single agent are hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, and palmar-plantar erythrodysesthesia syndrome. ( 6.1 ) Most common adverse reactions (≥ 20%) for TAFINLAR in combination with trametinib include: Unresectable or metastatic melanoma: pyrexia, rash, chills, headache, arthralgia, and cough. ( 6.1 ) Adjuvant treatment of melanoma: pyrexia, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia. …
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective May 20, 2026 (SPL set fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea), via openFDA; the full label on DailyMed
What do FAERS reports show?
20,946 reports list dabrafenib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,394 are coded as a death and 5,837 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Dabrafenib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions