What the label lists and what reports show
Entrectinib side effects
Entrectinib's FDA label: “The most common adverse reactions (≥ 20%) were fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, myalgia, cognitive impairment, increased weight, cough, vomiting, pyrexia, arthralgia, and vision disorders.” FAERS holds 1,653 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 dizziness (150 reports).
- No generic listed
Check it at the source: the entrectinib FDA label on DailyMed (effective December 4, 2025, Genentech, 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 ROZLYTREK?ROZLYTREK may cause serious side effects, including: See " What is the most important information I should know about ROZLYTREK? " The most common side effects of ROZLYTREK include: tiredness constipation change in taste swelling dizziness diarrhea nausea abnormal touch sensation shortness of breath muscle pain confusion, mental status changes, memory problems, and hallucinations weight gain cough vomiting fever joint pain vision changes These are not all the possible side effects of ROZLYTREK. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Genentech, Inc., effective December 4, 2025 (SPL set c7c71b0c-2549-4495-86b6-c2807fa54908), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 20%) were fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, myalgia, cognitive impairment, increased weight, cough, vomiting, pyrexia, arthralgia, and vision disorders.
Table 7. Adverse Reactions (≥ 10%) in Patients Receiving ROZLYTREK in ALKA, STARTRK-1, STARTRK-2, and STARTRK-NG
| Reaction | Adverse Reactions All Grades (%) | ROZLYTREK n = 355 Grade ≥ 3 Grades 3 – 5, inclusive of fatal adverse reactions, including 2 events of… |
|---|---|---|
| Fatigue Includes fatigue, asthenia | 48 | 5 |
| Edema Includes face edema, fluid retention, generalized edema, localized edema, edema,… | 40 | 1.1 |
| Pyrexia | 21 | 0.8 |
| Constipation | 46 | 0.6 |
| Diarrhea | 35 | 2.0 |
| Nausea | 34 | 0.3 |
| Vomiting | 24 | 0.8 |
| Abdominal pain Includes abdominal pain upper, abdominal pain, lower abdominal discomfort,… | 16 | 0.6 |
| Dysgeusia | 44 | 0.3 |
| Dizziness Includes dizziness, vertigo, dizziness postural | 38 | 0.8 |
| Dysesthesia Includes paresthesia, hyperesthesia, hypoesthesia, dysesthesia, oral… | 34 | 0.3 |
| Cognitive impairment Includes amnesia, aphasia, cognitive disorder, confusional state,… | 27 | 4.5 |
| Peripheral sensory neuropathy Includes neuralgia, neuropathy peripheral, peripheral motor… | 18 | 1.1 |
| Headache | 18 | 0.3 |
| Ataxia Includes ataxia, balance disorder, gait disturbances | 17 | 0.8 |
| Sleep Includes hypersomnia, insomnia, sleep disorder, somnolence | 14 | 0.6 |
| Mood disorders Includes anxiety, affect lability, affective disorder, agitation,… | 10 | 0.6 |
| Dyspnea | 30 | 6 |
| Cough | 24 | 0.3 |
| Myalgia Includes musculoskeletal pain, musculoskeletal chest pain, myalgia, neck pain | 28 | 1.1 |
| Arthralgia | 21 | 0.6 |
| Muscular weakness | 12 | 0.8 |
| Back pain | 12 | 1 |
| Pain in extremity | 11 | 0.3 |
| Increased weight | 25 | 7 |
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: Congestive Heart Failure [see Warnings and Precautions (5.1) ] Central Nervous System Effects [see Warnings and Precautions (5.2) ] Skeletal Fractures [see Warnings and Precautions (5.3) ] Hepatotoxicity [see Warnings and Precautions (5.4) ] Hyperuricemia [see Warnings and Precautions (5.5) ] QT Interval Prolongation [see Warnings and Precautions (5.6) ] Vision Disorders [see Warnings and Precautions (5.7) ] The most common adverse reactions (≥ 20%) were fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, myalgia, cognitive impairment, increased weight, cough, vomiting, pyrexia, arthralgia, and vision disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 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. Data in WARNINGS AND PRECAUTIONS and below reflect exposure to ROZLYTREK in 355 patients, including 172 (48%) patients exposed for 6 months or longer and 84 (24%) patients exposed for 1 year or longer.
Source: FDA drug label, Genentech, Inc., effective December 4, 2025 (SPL set c7c71b0c-2549-4495-86b6-c2807fa54908), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,653 reports list entrectinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 271 are coded as a death and 350 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, 12 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?
- Entrectinib: 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