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Lorlatinib Side Effects

The most commonly reported side effects of lorlatinib include death, neoplasm progression, and off label use, based on 6,099 FDA adverse event reports from 2016 to 2025.

Lorlatinib side effects

Percentages show how often each reaction appears relative to total reports for lorlatinib.

1
Death17.6%1,071
2
Neoplasm Progression10.3%630
3
Off Label Use7.1%434
4
Weight Increased5.5%333
5
Hallucination5.1%314
6
Blood Cholesterol Increased5.1%313
7
Dyspnoea3.8%233
8
Oedema3.7%224
9
Fatigue3.6%220
10
Oedema Peripheral3.6%218
11
Malignant Neoplasm Progression3.0%180
12
Peripheral Swelling2.9%179
13
Hypercholesterolaemia2.7%166
14
Cognitive Disorder2.7%165
15
Neuropathy Peripheral2.7%163

These are voluntary reports and do not establish that lorlatinib caused these reactions.

Report severity

81.4%Serious4,964 reports
21.7%Hospitalizations1,326 reports
26.1%Fatal1,594 reports

Seriousness is determined by the reporter, not by OpenClaim.

Lorlatinib drug interactions

Other drugs that appear in adverse event reports alongside lorlatinib. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Alectinib-hydrochloride6.7%407
2
Pemetrexed2.8%171
3
Bevacizumab2.0%123
4
Brigatinib1.8%112
5
Carboplatin1.7%105
6
Crizotinib1.5%92
7
Pembrolizumab1.4%87
8
Docetaxel1.3%79
9
Gemcitabine1.1%69
10
Ceritinib1.1%68
11
Capecitabine1.1%68
12
Trastuzumab1.1%67
13
Oxaliplatin1.0%63
14
Paclitaxel0.9%52
15
Cyclophosphamide0.7%45

Taken alongside

1
Rosuvastatin3.8%234
2
Levetiracetam1.9%114
3
Furosemide1.7%105
4
Acetaminophen1.7%101
5
Dexamethasone1.5%92
6
Atorvastatin-calcium1.5%92
7
Apixaban1.2%74
8
Levothyroxine-sodium1.1%70
9
Metformin1.1%69
10
Carboplatin1.1%68
11
Ondansetron1.1%67
12
Pantoprazole-sodium1.1%67
13
Alectinib-hydrochloride1.1%65
14
Brigatinib1.0%64
15
Aspirin1.0%60

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports lorlatinib side effects

44.5% of lorlatinib adverse event reports involve female patients and 40.1% involve male patients. The largest age group is adult at 62%. These figures reflect who reports side effects, not underlying risk.

Sex

Female44.5%
Male40.1%
Unknown15.3%

Age group

< 20.4%
2–112.8%
12–170.6%
18–6462.4%
65+33.7%

What is lorlatinib used for

Conditions and purposes for which patients were taking lorlatinib when the adverse event was reported.

AdenocarcinomaAdenocarcinoma MetastaticAdrenal Gland CancerAlk Gene Rearrangement PositiveAlk Gene Rearrangement PositiveAnaplastic Large-cell LymphomaAnaplastic Lymphoma Kinase Gene MutationAdenocarcinomaAdenocarcinoma GastricAdenocarcinoma MetastaticAdenocarcinoma Of ColonAdenosquamous Cell CarcinomaAdrenal Gland CancerAdrenal Gland Cancer MetastaticAnaplastic Astrocytoma

Showing 15 of 200 indications

Lorlatinib brand names and reporting trend

Lorlatinib is sold under the brand name Lorbrena.

Brand names

Lorbrena4,623

Quarterly reports (20162025)

2016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking lorlatinib with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.