Skip to content
Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

OLARATUMAB: 565 Adverse Event Reports & Safety Profile

Boost Your Natural Energy & Metabolism

Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.

Try Mitolyn Now
565
Total FAERS Reports
109 (19.3%)
Deaths Reported
169
Hospitalizations
565
As Primary/Secondary Suspect
99
Life-Threatening
2
Disabilities
Prescription
Status

FDA Application: 761038 ·

First Report: 200811 · Latest Report: 20240228

What Are the Most Common OLARATUMAB Side Effects?

#1 Most Reported
Off label use
124 reports (21.9%)
#2 Most Reported
Neutropenia
66 reports (11.7%)
#3 Most Reported
Infusion related reaction
64 reports (11.3%)

All OLARATUMAB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 124 22.0% 32 29
Neutropenia 66 11.7% 2 11
Infusion related reaction 64 11.3% 2 25
Febrile neutropenia 57 10.1% 6 36
Drug ineffective 49 8.7% 10 12
Death 44 7.8% 44 3
Malignant neoplasm progression 43 7.6% 10 8
Product use in unapproved indication 40 7.1% 7 14
Disease progression 33 5.8% 10 5
Anaphylactic reaction 29 5.1% 0 13
Dyspnoea 27 4.8% 4 12
Diarrhoea 21 3.7% 2 11
Fatigue 20 3.5% 1 2
Nausea 19 3.4% 1 5
Neoplasm recurrence 19 3.4% 1 0
Anaemia 18 3.2% 1 5
Neoplasm progression 18 3.2% 4 0
Hypotension 17 3.0% 0 10
Mucosal inflammation 14 2.5% 0 7
Cardiac arrest 13 2.3% 1 11

Who Reports OLARATUMAB Side Effects? Age & Gender Data

Gender: 48.3% female, 51.7% male. Average age: 55.6 years. Most reports from: US. View detailed demographics →

Is OLARATUMAB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 1 1 0
2015 1 0 1
2016 28 6 11
2017 65 10 22
2018 103 10 69
2019 10 4 5
2020 1 1 0
2024 1 1 0

View full timeline →

What Is OLARATUMAB Used For?

IndicationReports
Soft tissue sarcoma 156
Product used for unknown indication 146
Leiomyosarcoma 33
Undifferentiated sarcoma 27
Sarcoma 26
Sarcoma metastatic 21
Uterine leiomyosarcoma 14
Leiomyosarcoma metastatic 13
Endometrial stromal sarcoma 12
Non-small cell lung cancer 11

OLARATUMAB vs Alternatives: Which Is Safer?

OLARATUMAB vs OLECLUMAB OLARATUMAB vs OLIVE OIL\SOYBEAN OIL OLARATUMAB vs OLMESARTAN OLARATUMAB vs OLMESARTAN MEDOXOMIL OLARATUMAB vs OLMETEC OLARATUMAB vs OLODATEROL OLARATUMAB vs OLODATEROL\TIOTROPIUM OLARATUMAB vs OLOPATADINE OLARATUMAB vs OLUTASIDENIB OLARATUMAB vs OMACETAXINE MEPESUCCINATE

Official FDA Label for OLARATUMAB

Official prescribing information from the FDA-approved drug label.