What the label lists and what reports show
Lorlatinib side effects
Lorlatinib's FDA label: “Most common (incidence ≥20%) adverse reactions and Grade 3–4 laboratory abnormalities are edema, peripheral neuropathy, weight gain, cognitive effects, fatigue, dyspnea, arthralgia, diarrhea, mood effects, hypercholesterolemia, hypertriglyceridemia, and cough.” FAERS holds 6,977 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is neoplasm progression (621 reports).
- No generic listed
- A presentation discontinued
Check it at the source: the lorlatinib FDA label on DailyMed (effective June 26, 2026, Pfizer Laboratories Div Pfizer Inc); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of LORBRENA?See " What is the most important information I should know about LORBRENA? " The most common side effects of LORBRENA include: • swelling in your arms, legs, hands and feet (edema) • numbness and tingling feeling in your joints or arms and legs (peripheral neuropathy) • weight gain • problems with thinking, such as forgetfulness or confusion • tiredness (fatigue) • difficulty breathing • pain in your joints • diarrhea • changes in mood, such as depression and irritability • increased cholesterol and triglyceride levels in the blood • cough LORBRENA may cause decreased fertility in males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all of the possible side effects of LORBRENA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088. […] Tell your healthcare provider right away if you get signs or symptoms of high blood pressure, including: headaches, dizziness, blurred vision, chest pain or shortness of breath. • High blood sugar (hyperglycemia). LORBRENA can cause new or worsening increases in your blood sugar levels. Your healthcare provider will do blood tests to check your blood sugar levels before starting and during treatment with LORBRENA. Your healthcare provider may start or change your blood sugar medicine if you get high blood sugar.
Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective June 26, 2026 (SPL set 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common (incidence ≥20%) adverse reactions and Grade 3–4 laboratory abnormalities are edema, peripheral neuropathy, weight gain, cognitive effects, fatigue, dyspnea, arthralgia, diarrhea, mood effects, hypercholesterolemia, hypertriglyceridemia, and cough.
Table 2 Adverse Reactions (≥10% for all NCI CTCAE Grades or ≥2% for Grades 3–4) in Patients Treated with LORBRENA in Study B7461006 Adverse reactions were graded using NCI CTCAE version 4.03.
| Reaction | All Grades (%) | Grade 3 or 4 (%) | All Grades (%) | Grade 3 or 4 (%) |
|---|---|---|---|---|
| Mood effects Mood effects (including affective disorder, affect lability, agitation,… | 16 | 2 | 5 | 0 |
| Peripheral neuropathy Peripheral neuropathy (including dysesthesia, gait disturbance,… | 34 | 2 | 15 | 0.7 |
| Cognitive effects Cognitive effects (including events from SOC Nervous system disorders:… | 21 | 2 | 6 | 0 |
| Headache | 17 | 0 | 18 | 0.7 |
| Dizziness | 11 | 0 | 14 | 0 |
| Sleep effects Sleep effects (including insomnia, nightmare, sleep disorder, somnambulism). | 11 | 1.3 | 10 | 0 |
| Dyspnea | 20 | 2.7 | 16 | 2.1 |
| Cough | 16 | 0 | 18 | 0 |
| Respiratory failure | 2.7 | 2 | 0 | 0 |
| Hypertension | 18 | 10 | 2.1 | 0 |
| Vision disorder Vision disorder (including diplopia, photophobia, photopsia, vision… | 18 | 0 | 39 | 0.7 |
| Diarrhea | 21 | 1.3 | 52 | 0.7 |
| Nausea | 15 | 0.7 | 52 | 2.1 |
| Constipation | 17 | 0 | 30 | 0.7 |
| Vomiting | 13 | 0.7 | 39 | 1.4 |
| Arthralgia | 19 | 0.7 | 11 | 0 |
| Myalgia Myalgia (including musculoskeletal pain, myalgia). | 15 | 0.7 | 7 | 0 |
| Back pain | 15 | 0.7 | 11 | 0 |
| Pain in extremity | 17 | 0 | 8 | 0 |
| Edema Edema (including edema, edema peripheral, eyelid edema, face edema, generalized… | 56 | 4 | 40 | 1.4 |
| Weight gain | 38 | 17 | 13 | 2.1 |
| Fatigue Fatigue (including asthenia, fatigue). | 19 | 1.3 | 32 | 2.8 |
| Pyrexia | 17 | 1.3 | 13 | 1.4 |
| Chest pain | 11 | 1.3 | 14 | 0.7 |
| Upper respiratory tract infection Upper respiratory tract infection (including upper… | 11 | 0.7 | 7.7 | 1.4 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are described elsewhere in the labeling: • Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers [see Warnings and Precautions (5.1) ] • Central Nervous System Effects [see Warnings and Precautions (5.2) ] • Hyperlipidemia [see Warnings and Precautions (5.3) ] • Atrioventricular Block [see Warnings and Precautions (5.4) ] • Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.5) ] • Hypertension [see Warnings and Precautions (5.6) ] • Hyperglycemia [see Warnings and Precautions (5.7) ] Most common (incidence ≥20%) adverse reactions and Grade 3–4 laboratory abnormalities are edema, peripheral neuropathy, weight gain, cognitive effects, fatigue, dyspnea, arthralgia, diarrhea, mood effects, hypercholesterolemia, hypertriglyceridemia, and cough. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or www.pfizer.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective June 26, 2026 (SPL set 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,977 reports list lorlatinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,867 are coded as a death and 1,530 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 15 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lorlatinib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions