What the label lists and what reports show

Repotrectinib side effects

Repotrectinib's FDA label: “The most common adverse reactions (≥20%) were dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, fatigue, ataxia, cognitive impairment, muscular weakness, and nausea.” FAERS holds 250 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 (42 reports).

No generic listed

Check it at the source: the repotrectinib FDA label on DailyMed (effective June 13, 2024, E.R. Squibb & Sons, L.L.C.); 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 AUGTYRO?
AUGTYRO may cause serious side effects, including: • See “What is the most important information I should know about AUGTYRO?” The most common side effects of AUGTYRO include: • dizziness • change in sense of taste • feeling of numbness or tingling in your arms or legs • constipation • shortness of breath • tiredness • trouble with balance, coordination, and walking • problems with thinking, such as forgetfulness or confusion, memory problems and hallucinations • muscle weakness • nausea These are not all of the possible side effects of AUGTYRO. 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, NDA218213 (Bristol), as published by E.R. Squibb & Sons, L.L.C., effective June 13, 2024 (SPL set fb526827-40ba-4462-94cf-179ae3b0cb8a), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions
The most common adverse reactions (≥20%) were dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, fatigue, ataxia, cognitive impairment, muscular weakness, and nausea.

Table 3: Adverse Reactions (≥10%) in Patients with ROS1-Positive NSCLC or NTRK-Positive Solid Tumors Who Received AUGTYRO in TRIDENT-1

Reaction	Adverse Reaction 1 All Grades (%)	AUGTYRO N=426 Grade 3 or 4 (%)
Dizziness a	65	2.8
Dysgeusia b	54	0
Peripheral neuropathy c	49	1.4
Ataxia d	28	0.5
Cognitive impairment e	25	0.9
Headache f	19	0
Constipation	38	0.2
Nausea	20	0.7
Diarrhea	14	0.7
Vomiting	12	1.2
Dyspnea g	30	6
Cough h	18	0.2
Pneumonia i	11	6
Fatigue j	30	1.2
Edema k	15	0.5
Decreased appetite	11	0.2
Muscular weakness	20	2
Myalgia l	13	0.7
Increased weight	16	3
Vision disorders m	12	0.5

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, continued
The following clinically significant adverse reactions are described elsewhere in the labeling: • Central Nervous System Adverse Reactions [see Warnings and Precautions (5.1) ] • Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.2) ] • Hepatotoxicity [see Warnings and Precautions (5.3) ] • Myalgia with Creatine Phosphokinase Elevation [see Warnings and Precautions (5.4) ] • Hyperuricemia [see Warnings and Precautions (5.5) ] • Skeletal Fractures [see Warnings and Precautions (5.6) ] • Embryo-Fetal Toxicity [see Warnings and Precautions (5.7) ] The most common adverse reactions (≥20%) were dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, fatigue, ataxia, cognitive impairment, muscular weakness, and nausea. ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 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 reported 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. …

What do FAERS reports show?

250 reports list repotrectinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 31 are coded as a death and 61 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, 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.

The 25 most reported reactions

Dizziness (named in the label)42
Death (an outcome recorded in the report)24
Nausea (named in the label)19
Neuropathy Peripheral (named in the label)17
Off Label Use (a use or a product term, not a reaction)16
Fatigue (named in the label)13
Adverse Event12
Pain12
Muscular Weakness (named in the label)11
Paraesthesia (named in the label)10
Balance Disorder (named in the label)9
Gait Disturbance (named in the label)9
Pulmonary Embolism9
Anaemia (named in the label)8
Hospitalisation (an outcome recorded in the report)8
Treatment Noncompliance8
Constipation (named in the label)7
Diarrhoea (named in the label)7
Myalgia (named in the label)7
Taste Disorder7
Adverse Drug Reaction6
Arthralgia6
Condition Aggravated (a use or a product term, not a reaction)6
Dysgeusia (named in the label)6
Dyspnoea (named in the label)6

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Repotrectinib: 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