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Lorlatinib Side Effects

Medically reviewed by Drugs.com. Last updated on April 24, 2020.

For the Consumer

Applies to lorlatinib: oral tablet

Side effects requiring immediate medical attention

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

  • 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, numbness, 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
  • ear congestion
  • false or unusual sense of well-being
  • feeling sad or empty
  • fever
  • headache
  • hoarseness
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • nervousness
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • runny nose
  • seeing, hearing, or feeling things that are not there
  • skin rash
  • sneezing
  • sore throat
  • swelling
  • talking, feeling, and acting with excitement
  • thoughts of killing oneself
  • tightness in the chest
  • trouble concentrating
  • trouble sleeping
  • troubled breathing with exertion
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Side effects not requiring immediate medical attention

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

  • Abnormal dreams
  • back pain
  • constipation
  • difficulty in moving
  • difficulty in speaking
  • dizziness
  • drowsiness
  • headache
  • joint pain
  • muscle pain or stiffness
  • nausea
  • pain in the arms or legs
  • sleep talking
  • trouble sleeping
  • vomiting

For Healthcare Professionals

Applies to lorlatinib: oral tablet

Hematologic

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

General

The most common (20% or more) adverse reactions are edema, peripheral neuropathy, cognitive effects, dyspnea, 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]

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]

References

1. "Product Information. Lorbrena (lorlatinib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.