What the label lists and what reports show
Tovorafenib side effects
Tovorafenib's FDA label: “The most common adverse reactions (≥30%) were rash, hair color changes, fatigue, viral infection, vomiting, headache, hemorrhage, pyrexia, dry skin, constipation, nausea, dermatitis acneiform, and upper respiratory tract infection.” FAERS holds 292 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 rash (26 reports).
- No generic listed
Check it at the source: the tovorafenib FDA label on DailyMed (effective September 2, 2025, Day One Biopharmaceuticals, Inc.); 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 OJEMDA?OJEMDA may cause serious side effects, including: bleeding problems (hemorrhage) are common during treatment with OJEMDA and can also be serious. Tell your healthcare provider if you develop any signs or symptoms of bleeding, including: headache, dizziness or feeling weak coughing up blood or blood clots vomiting blood or your vomit looks like "coffee grounds" red or black stools that look like tar skin reactions, including sensitivity to sunlight (photosensitivity). OJEMDA can cause skin reactions that can become severe. Tell your healthcare provider if you get new or worsening skin reactions, including: rash bumps or tiny papules acne peeling, redness, or irritation blisters See " What should I avoid while taking OJEMDA? " liver problems. Your healthcare provider will do blood tests to check your liver function before and during treatment with OJEMDA. […]
Source: FDA drug label, NDA217700 (Day One Biopharms), as published by Day One Biopharmaceuticals, Inc., effective September 2, 2025 (SPL set ea3a9631-3a66-6a7c-e053-2995a90ae2ad), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥30%) were rash, hair color changes, fatigue, viral infection, vomiting, headache, hemorrhage, pyrexia, dry skin, constipation, nausea, dermatitis acneiform, and upper respiratory tract infection.
Table 6 Adverse Reactions (≥20%) in Patients with Pediatric LGG Who Received OJEMDA in FIREFLY-1 (Arms 1 and 2)
| Reaction | Adverse Reaction All Grades (%) | OJEMDA (N=137) Grade 3 or 4 (%) |
|---|---|---|
| Rash Includes terms erythema multiforme, eczema, rash erythematous, rash macular, rash… | 77 | 12 |
| Hair color changes | 76 | 0 |
| Dry skin | 36 | 0 |
| Dermatitis acneiform | 31 | 1 |
| Pruritus | 26 | 1 |
| Fatigue | 55 | 4 |
| Pyrexia | 39 | 4 |
| Edema Includes terms lip edema, periorbital edema, edema peripheral, localized edema,… | 26 | 0 |
| Viral infection Includes terms viral infection, rhinovirus infection, enterovirus… | 55 | 7 |
| Upper respiratory tract infection | 31 | 1.5 |
| Paronychia | 26 | 1.5 |
| Vomiting Includes terms retching, hematemesis. | 50 | 4 |
| Constipation | 33 | 0 |
| Nausea | 33 | 0 |
| Abdominal pain | 28 | 0 |
| Diarrhea Includes terms colitis, enterocolitis. | 22 | 1.5 |
| Stomatitis Includes terms mouth ulceration, mucosal inflammation, aphthous ulcer,… | 20 | 0 |
| Headache | 45 | 1 |
| Hemorrhage Includes terms tumor hemorrhage, gastrointestinal hemorrhage, subdural… | 42 | 5 Includes one Grade 5 event. |
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: Hemorrhage [see Warnings and Precautions (5.1) ] Skin Toxicity Including Photosensitivity [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.3) ] Effect on Growth [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥30%) were rash, hair color changes, fatigue, viral infection, vomiting, headache, hemorrhage, pyrexia, dry skin, constipation, nausea, dermatitis acneiform, and upper respiratory tract infection. ( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased phosphate, decreased hemoglobin, increased creatine phosphokinase, increased alanine aminotransferase, decreased albumin, decreased lymphocytes, decreased leukocytes, increased aspartate aminotransferase, decreased potassium, and decreased sodium. To report SUSPECTED ADVERSE REACTIONS, contact Day One Biopharmaceuticals at toll-free phone # 1-877-204-2820 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Source: FDA drug label, NDA217700 (Day One Biopharms), as published by Day One Biopharmaceuticals, Inc., effective September 2, 2025 (SPL set ea3a9631-3a66-6a7c-e053-2995a90ae2ad), via openFDA; the full label on DailyMed
What do FAERS reports show?
292 reports list tovorafenib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 12 are coded as a death and 34 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 21 reactions below, 8 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.
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?
- Tovorafenib: 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