Applies to larotrectinib: oral capsule, oral solution.
Serious side effects of Larotrectinib
Along with its needed effects, larotrectinib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking larotrectinib:
More common
- Being forgetful
- black, tarry, stools
- bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- blurred vision
- chest tightness
- chills
- confusion as to time, place, or person
- cough
- difficult, burning, or painful urination
- discouragement
- dizziness
- falls
- fear, nervousness
- feeling sad or empty
- fever
- frequent urge to urinate
- headache
- holding false beliefs that cannot be changed by fact
- irritability
- lack of appetite
- loss of interest or pleasure
- loss of memory
- lower back or side pain
- nervousness
- painful or difficult urination
- pale skin
- pounding in the ears
- problems with memory
- problems with speech or speaking
- rapid weight gain
- seeing, hearing, or feeling things that are not there
- sleepiness or unusual drowsiness
- slow or fast heartbeat
- sore throat
- tingling of the hands or feet
- trouble breathing
- trouble concentrating
- trouble sleeping
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual excitement, nervousness, or restlessness
- unusual tiredness or weakness
- unusual weight gain or loss
Less common
- Chest pain or discomfort
- confusion
- decreased urination
- diarrhea
- dry mouth
- fainting
- heartburn
- increase in heart rate
- increased thirst
- indigestion
- irregular heartbeat
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- lightheadedness
- loss of consciousness
- muscle pain, cramps, or weakness
- nausea
- problems with movement or walking
- rapid, shallow breathing
- seizures
- severe stomach pain, cramping, or burning
- sunken eyes
- swelling of the face, ankles, or hands
- vomiting
- vomiting of material that looks like coffee grounds, severe and continuing
- wrinkled skin
- yellow skin or eyes
Other side effects of Larotrectinib
Some side effects of larotrectinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
- constipation
- decreased appetite
- difficulty in moving
- increased weight
- joint pain or swelling
- muscle stiffness
- pain in the arms or legs
- stuffy nose
Less common
- Lack or loss of strength
For Healthcare Professionals
Applies to larotrectinib: oral capsule, oral solution.
Hematologic
Very common (10% or more): Anemia (42%), hypoalbuminemia (35%), neutropenia (23%)[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (14%), myalgia (14%), muscular weakness (13%), back pain (12%), pain in extremity (12%)[Ref]
Metabolic
Very common (10% or more): Peripheral edema (15%), increased weight (15%), decreased appetite (13%)[Ref]
Psychiatric
Common (1% to 10%): Delirium, memory impairment[Ref]
Hepatic
Very common (10% or more): Hepatotoxicity (45%), Increased ALT (45%), increased AST (45%), increased alkaline phosphatase (30%)[Ref]
Respiratory
Very common (10% or more): Cough (26%), dyspnea (18%), nasal congestion (10%)[Ref]
Other
Very common (10% or more): Fatigue (37%), pyrexia (18%), fall (10%)[Ref]
General
The most common adverse reactions (20% or greater) were fatigue, nausea, dizziness, vomiting, anemia, increased AST, cough, increased ALT, constipation, and diarrhea.[Ref]
Nervous system
Very common (10% or more): Neurotoxicity (53%), dizziness (28%), headache (14%)
Common (1% to 10%): Dysarthria, gait disturbance, tremor, paresthesia
Uncommon (0.1% to 1%): Grade 4 encephalopathy[Ref]
Cardiovascular
Very common (10% or more): Hypertension (11%)[Ref]
Gastrointestinal
Very common (10% or more): Nausea (29%), vomiting (26%), constipation (23%), diarrhea (22%), abdominal pain (13%)[Ref]
