LORLATINIB

N/A

Manufactured by Pfizer Laboratories Div Pfizer Inc

11,506 FDA adverse event reports analyzed

Last updated: 2026-04-15

About LORLATINIB

LORLATINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. The most commonly reported adverse reactions for LORLATINIB include DEATH, NEOPLASM PROGRESSION, OFF LABEL USE, WEIGHT INCREASED, HALLUCINATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LORLATINIB.

Top Adverse Reactions

DEATH1,071 reports
NEOPLASM PROGRESSION630 reports
OFF LABEL USE434 reports
WEIGHT INCREASED333 reports
HALLUCINATION314 reports
BLOOD CHOLESTEROL INCREASED313 reports
DYSPNOEA233 reports
OEDEMA224 reports
FATIGUE220 reports
OEDEMA PERIPHERAL218 reports
MALIGNANT NEOPLASM PROGRESSION180 reports
PERIPHERAL SWELLING179 reports
COGNITIVE DISORDER165 reports
HYPERCHOLESTEROLAEMIA165 reports
NEUROPATHY PERIPHERAL162 reports
ASTHENIA159 reports
PLEURAL EFFUSION159 reports
BLOOD TRIGLYCERIDES INCREASED158 reports
MEMORY IMPAIRMENT152 reports
DIARRHOEA151 reports
HYPERLIPIDAEMIA148 reports
DISEASE PROGRESSION145 reports
PAIN137 reports
PNEUMONIA127 reports
HEADACHE126 reports
CONFUSIONAL STATE115 reports
HAEMOGLOBIN DECREASED114 reports
PAIN IN EXTREMITY113 reports
PYREXIA112 reports
HYPERTRIGLYCERIDAEMIA110 reports
DIZZINESS109 reports
ARTHRALGIA107 reports
DRUG INEFFECTIVE106 reports
ANXIETY100 reports
COUGH99 reports
METASTASES TO CENTRAL NERVOUS SYSTEM99 reports
PULMONARY EMBOLISM99 reports
BLOOD GLUCOSE INCREASED95 reports
NAUSEA95 reports
CONSTIPATION93 reports
BLOOD PRESSURE INCREASED92 reports
MALAISE87 reports
NERVOUS SYSTEM DISORDER87 reports
SPEECH DISORDER87 reports
HALLUCINATION, AUDITORY86 reports
LOW DENSITY LIPOPROTEIN INCREASED85 reports
GAIT DISTURBANCE80 reports
HALLUCINATION, VISUAL79 reports
PERICARDIAL EFFUSION77 reports
INSOMNIA76 reports
VOMITING76 reports
DYSLIPIDAEMIA75 reports
PSYCHOTIC DISORDER74 reports
ANAEMIA73 reports
WEIGHT DECREASED73 reports
DEPRESSION71 reports
HEART RATE INCREASED70 reports
RASH69 reports
BACK PAIN68 reports
HYPOAESTHESIA68 reports
CARDIAC FAILURE66 reports
ABDOMINAL DISTENSION65 reports
HYPERTENSION65 reports
PARAESTHESIA65 reports
DECREASED APPETITE64 reports
VISUAL IMPAIRMENT64 reports
CONDITION AGGRAVATED63 reports
FALL63 reports
LIPIDS INCREASED63 reports
PNEUMONITIS60 reports
MENTAL DISORDER58 reports
MYALGIA57 reports
FEELING ABNORMAL54 reports
IRRITABILITY54 reports
GENERAL PHYSICAL HEALTH DETERIORATION52 reports
CEREBROVASCULAR ACCIDENT51 reports
PLATELET COUNT DECREASED51 reports
SLEEP DISORDER51 reports
DYSPHAGIA50 reports
PANCYTOPENIA50 reports
SWELLING50 reports
COVID 1949 reports
MOOD ALTERED49 reports
ASPARTATE AMINOTRANSFERASE INCREASED48 reports
METASTASES TO LIVER48 reports
RENAL IMPAIRMENT48 reports
SEIZURE48 reports
CHEST PAIN47 reports
SOMNOLENCE46 reports
DIABETES MELLITUS45 reports
MUSCULAR WEAKNESS45 reports
PULMONARY OEDEMA45 reports
THROMBOSIS45 reports
AMNESIA44 reports
DYSPNOEA EXERTIONAL44 reports
JOINT SWELLING44 reports
THROMBOCYTOPENIA44 reports
BALANCE DISORDER43 reports
DELIRIUM43 reports
DYSARTHRIA43 reports

Demographics Breakdown

Reports by Sex

Female2,714 (52.6%)
Male2,445 (47.4%)

Reports by Age

Age 52145 reports
Age 65133 reports
Age 53115 reports
Age 64115 reports
Age 61111 reports
Age 60108 reports
Age 70105 reports
Age 56104 reports
Age 69100 reports
Age 5799 reports
Age 6699 reports
Age 6899 reports
Age 5496 reports
Age 5593 reports
Age 6392 reports
Age 5890 reports
Age 7290 reports
Age 4988 reports
Age 6786 reports
Age 5985 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with LORLATINIB?

This profile reflects 11,506 FDA FAERS reports that mention LORLATINIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LORLATINIB?

Frequently reported terms in FAERS include DEATH, NEOPLASM PROGRESSION, OFF LABEL USE, WEIGHT INCREASED, HALLUCINATION, BLOOD CHOLESTEROL INCREASED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures LORLATINIB?

Labeling and FAERS entries often list Pfizer Laboratories Div Pfizer Inc in connection with LORLATINIB. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.