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Pralsetinib Side Effects

The most commonly reported side effects of pralsetinib include death, product prescribing issue, and fatigue, based on 1,676 FDA adverse event reports from 2004 to 2025.

Pralsetinib side effects

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

1
Death8.2%137
2
Product Prescribing Issue7.8%130
3
Fatigue7.3%122
4
Asthenia6.7%112
5
Off Label Use6.6%111
6
Hypertension5.7%95
7
Anaemia5.5%92
8
Disease Progression5.3%88
9
Diarrhoea5.2%87
10
Blood Pressure Increased5.0%83
11
Constipation4.8%80
12
White Blood Cell Count Decreased4.8%80
13
Pyrexia4.7%78
14
Pneumonia4.2%71
15
Platelet Count Decreased3.2%53

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

Report severity

61.8%Serious1,035 reports
28.5%Hospitalizations477 reports
14.3%Fatal240 reports

Seriousness is determined by the reporter, not by OpenClaim.

Pralsetinib drug interactions

Other drugs that appear in adverse event reports alongside pralsetinib. 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
Pemetrexed1.0%17
2
Selpercatinib0.8%13
3
Venetoclax0.7%12
4
Carboplatin0.7%11
5
Osimertinib-mesylate0.5%9
6
Pembrolizumab0.5%9
7
Bevacizumab0.5%9
8
Ciprofloxacin0.5%8
9
Entrectinib0.5%8
10
Alectinib-hydrochloride0.4%6
11
Lorlatinib0.4%6
12
Denosumab0.3%5
13
Docetaxel0.3%5
14
Cisplatin0.2%4
15
Atezolizumab0.2%4

Taken alongside

1
Levothyroxine-sodium7.0%118
2
Amlodipine3.8%64
3
Acetaminophen3.5%59
4
Pantoprazole-sodium3.2%53
5
Ergocalciferol3.0%51
6
Ondansetron2.7%46
7
Rosuvastatin2.6%43
8
Aspirin2.1%35
9
Omeprazole2.1%35
10
Folic-acid2.0%34
11
Lorazepam1.9%32
12
Metoprolol1.8%30
13
Tramadol-hydrochloride1.6%27
14
Apixaban1.6%26
15
Gabapentin1.6%26

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 pralsetinib side effects

45.5% of pralsetinib adverse event reports involve female patients and 34.8% involve male patients. The largest age group is adult at 50%. These figures reflect who reports side effects, not underlying risk.

Sex

Female45.5%
Male34.8%
Unknown19.7%

Age group

< 20.0%
2–110.1%
12–170.2%
18–6450.0%
65+49.7%

What is pralsetinib used for

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

Acute Myeloid LeukaemiaAdenocarcinomaAdenosquamous Cell Lung CancerAdenosquamous Cell Lung Cancer Stage IvAdrenal Gland Cancer MetastaticAdrenal NeoplasmApocrine Breast CarcinomaBrain Neoplasm MalignantBronchial CarcinomaBone CancerBrain NeoplasmBrain Neoplasm MalignantBreast CancerBreast Cancer FemaleBreast Cancer Metastatic

Showing 15 of 103 indications

Pralsetinib brand names and reporting trend

Pralsetinib is sold under the brand name Gavreto.

Brand names

Gavreto569

Quarterly reports (20042025)

200420202025

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

Taking pralsetinib with another medication?

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