What the label lists and what reports show
Larotrectinib side effects
Larotrectinib's FDA label: “The most common (≥ 20%) adverse reactions, including laboratory abnormalities, with VITRAKVI were increased AST, increased ALT, anemia, hypoalbuminemia, musculoskeletal pain, increased alkaline phosphatase, leukopenia, lymphopenia, neutropenia, hypocalcemia …” FAERS holds 874 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 fatigue (62 reports).
- No generic listed
Check it at the source: the larotrectinib FDA label on DailyMed (effective May 22, 2026, Bayer HealthCare Pharmaceuticals 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 VITRAKVI?VITRAKVI may cause serious side effects, including: Central nervous system (CNS) problems. VITRAKVI may cause dizziness, confusion, problems with concentration, attention, and memory, changes in your mood, and sleep problems. Tell your healthcare provider if you develop any of these symptoms or they get worse. Bone fractures. Bone fractures can happen with VITRAKVI. Tell your healthcare provider if you develop pain, changes in your ability to move around, or bone abnormalities. Liver problems. Abnormal liver blood tests may occur with VITRAKVI and can sometimes become serious. Your healthcare provider will do blood tests to check your liver function before starting and during treatment with VITRAKVI as needed. […]
Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective May 22, 2026 (SPL set 0c8ca614-58b2-4aa4-83d3-0387a8f782fd), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common (≥ 20%) adverse reactions, including laboratory abnormalities, with VITRAKVI were increased AST, increased ALT, anemia, hypoalbuminemia, musculoskeletal pain, increased alkaline phosphatase, leukopenia, lymphopenia, neutropenia, hypocalcemia, fatigue, vomiting, cough, constipation, pyrexia, diarrhea, nausea, abdominal pain, dizziness, and rash ( 6 ).
Table 3 Adverse Reactions Occurring in ≥ 10% of Patients Treated with VITRAKVI
| Reaction | Adverse Reaction The adverse reaction identifies a composite term: All Grades National Cancer Institute-Common Terminology Criteria for Adverse Events… | VITRAKVI N = 444 Grade 3-4 Grade 4 adverse reaction: 1 of cognitive impairment, 1 of pyrexia. (%) |
|---|---|---|
| Musculoskeletal Pain Includes: arthralgia, back pain, bone pain, flank pain, groin pain,… | 41 | 3.6 |
| Fatigue Includes: fatigue, asthenia | 31 | 2.5 |
| Pyrexia | 26 | 2.3 |
| Edema Includes: face edema, generalized edema, lip edema, localized edema, edema, edema… | 17 | 0.7 |
| Cough Includes: cough, productive cough, and upper-airway cough syndrome | 29 | 0.5 |
| Dyspnea Includes: dyspnea, and dyspnea exertional | 17 | 2.7 |
| Nasal congestion | 10 | 0 |
| Dizziness Includes: dizziness, dizziness postural, and vertigo | 22 | 0.9 |
| Headache | 17 | 0.9 |
| Cognitive Impairment Includes: amnesia, aphasia, cognitive disorder, confusional state,… | 11 | 2 |
| Vomiting | 30 | 1.1 |
| Constipation | 27 | 0.5 |
| Diarrhea | 26 | 2.9 |
| Nausea | 25 | 0.5 |
| Abdominal pain Includes: abdominal discomfort, abdominal pain, abdominal pain lower,… | 24 | 1.4 |
| Rash Includes: dermatitis, dermatitis acneiform, dermatitis bullous, dermatitis… | 21 | 0.2 |
| Mood disorders Includes: agitation, anxiety, depression, depressed mood, euphoric mood,… | 14 | 0.9 |
| Sleep Disturbance Includes: insomnia, sleep disorder, somnolence | 12 | 0.2 |
| Increased weight | 17 | 4.1 |
| Decreased appetite | 14 | 1.1 |
| Upper respiratory tract infection | 18 | 0.7 |
| Urinary tract infection Includes: cystitis, cystitis escherichia, escherichia urinary… | 14 | 1.8 |
| Nasopharyngitis | 11 | 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: Central Nervous System Effects [see Warnings and Precautions (5.1) ] Skeletal Fractures [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.3) ] The most common (≥ 20%) adverse reactions, including laboratory abnormalities, with VITRAKVI were increased AST, increased ALT, anemia, hypoalbuminemia, musculoskeletal pain, increased alkaline phosphatase, leukopenia, lymphopenia, neutropenia, hypocalcemia, fatigue, vomiting, cough, constipation, pyrexia, diarrhea, nausea, abdominal pain, dizziness, and rash ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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. Unless noted, data in WARNINGS AND PRECAUTIONS and below reflects exposure to VITRAKVI in 444 patients, including 62% patients exposed for greater than 6 months, 44% patients exposed for greater than 1 year, and 30% patients exposed for greater than 2 years. …
Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective May 22, 2026 (SPL set 0c8ca614-58b2-4aa4-83d3-0387a8f782fd), via openFDA; the full label on DailyMed
What do FAERS reports show?
874 reports list larotrectinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 161 are coded as a death and 170 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, 13 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?
- Larotrectinib: 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