Lorlatinib Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 19, 2024.

Applies to lorlatinib: oral tablet.

Serious side effects of lorlatinib

Along with its needed effects, lorlatinib 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 lorlatinib:

More common side effects

• actions that are out of control
• aggression
• agitation
• anxiety
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision or other changes in vision
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", tingling, or painful sensations
• changes in behavior
• chills
• cough
• defects in intelligence, short-term memory, learning ability, and attention
• difficult or labored breathing
• difficulty in breathing
• discouragement
• dizziness
• dry mouth
• ear congestion
• false or unusual sense of well-being
• feeling sad or empty
• fever
• flushed, dry skin
• fruit-like breath odor
• headache
• hoarseness
• increased hunger
• increased thirst
• increased urination
• irritability
• lack of appetite
• loss of interest or pleasure
• loss of voice
• lower back or side pain
• nausea
• nervousness
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• runny or stuffy nose
• seeing, hearing, or feeling things that are not there
• skin rash
• slow or fast heartbeat
• sneezing
• sore throat
• stomach pain
• sweating
• swelling
• talking, feeling, and acting with excitement
• thoughts of killing oneself
• tightness in the chest
• trouble concentrating
• trouble sleeping
• trouble breathing
• unexplained weight loss
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• weakness in the arms, hands, legs, or feet

Other side effects of lorlatinib

Some side effects of lorlatinib 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 side effects

• abnormal dreams
• back pain
• constipation
• difficulty in moving
• difficulty in speaking
• drowsiness
• joint pain
• muscle aches, cramps, pains, or stiffness
• pain in the arms or legs
• sleep talking
• swollen joints

For healthcare professionals

Applies to lorlatinib: oral tablet.

General adverse events

The most common (20% or more) adverse reactions are edema, peripheral neuropathy, cognitive effects, dyspnea, cough, fatigue, weight gain, arthralgia, mood effects, and diarrhea. The most common (20% or more) laboratory abnormalities are hypercholesterolemia, hypertriglyceridemia, anemia, hyperglycemia, increased AST, hypoalbuminemia, increased ALT, increased lipase, and increased alkaline phosphatase.^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (23%), myalgia/musculoskeletal pain (17%), back pain (13%), pain in extremity (13%)^[Ref]

Ocular

• Very common (10% or more): Vision disorder (e.g., diplopia, photophobia, photopsia, vision blurred, visual acuity reduced, visual impairment, vitreous floaters) (15%)^[Ref]

Metabolic

• Very common (10% or more): Hypercholesterolemia (96%), hypertriglyceridemia (90%), edema (edema peripheral, eyelid edema, face edema, generalized edema, localized edema, periorbital edema, peripheral swelling, swelling) (57%), hyperglycemia (52%), hypoalbuminemia (33%), weight gain (24%), increased lipase (24%), increased alkaline phosphatase (24%), increased amylase (22%), hypophosphatemia (21%), hyperkalemia (21%), hypomagnesemia (21%), Grade 3 or 4 elevations in total cholesterol 17%), Grade 3 or 4 elevations in triglycerides (17%)^[Ref]

Psychiatric

• Very common (10% or more): Cognitive effects (e.g., amnesia, cognitive disorder, dementia, disturbance in attention, memory impairment, mental impairment, attention deficit/hyperactivity disorder, confusional state, delirium, disorientation, reading disorder) (29%), changes in mood (24%), changes in sleep (e.g., abnormal dreams, insomnia, nightmare, sleep disorder, sleep talking, somnambulism) (10%)
• Common (1% to 10%): Hallucinations, mental status changes, (10%)^[Ref]

Hepatic

• Very common (10% or more): Grade 4 ALT/AST elevation when taken concomitantly with a strong CYP450 3A inducer (50%), Grade 3 ALT/AST elevation when taken concomitantly with a strong CYP450 3A inducer (33%)
• Common (1% to 10%): Grade 2 ALT/AST elevation when taken concomitantly with a strong CYP450 3A inducer^[Ref]

Respiratory

• Very common (10% or more): Dyspnea (27%), cough (18%), upper respiratory tract infection (e.g., fungal upper respiratory infection, viral upper respiratory infection) (12%)
• Common (1% to 10%): Interstitial lung disease (ILD), pneumonitis^[Ref]

Other

• Very common (10% or more): Asthenia/fatigue (26%), pyrexia (12%)

Hematologic

• Very common (10% or more): Anemia (52%), thrombocytopenia (23%), lymphopenia (22%)^[Ref]

Nervous system

• Very common (10% or more): Peripheral neuropathy (e.g., burning sensation, carpal tunnel syndrome, dysesthesia, formication, gait disturbance, hypoesthesia, muscular weakness, neuralgia, neuropathy peripheral, neurotoxicity, paresthesia, peripheral sensory neuropathy, sensory disturbance) (47%), speech disorder (e.g., aphasia, dysarthria, slow speech) (14%)
• Common (1% to 10%): Seizures^[Ref]

Cardiovascular

• Common (1% to 10%): AV block, hypertension^[Ref]

Dermatologic

• Very common (10% or more): Rash (e.g., dermatitis acneiform, maculopapular rash, pruritic rash, rash) (14%)^[Ref]

Frequently asked questions

• What type of drug is Lorbrena?

Further information

Lorlatinib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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