OMACETAXINE MEPESUCCINATE: 957 Adverse Event Reports & Safety Profile
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957
Total FAERS Reports
94 (9.8%)
Deaths Reported
316
Hospitalizations
957
As Primary/Secondary Suspect
25
Life-Threatening
10
Disabilities
Oct 26, 2012
FDA Approved
Discontinued
Status
FDA Application: 203585 ·
Patent Expires: Oct 26, 2026 · First Report: 2007 · Latest Report: 20250923
What Are the Most Common OMACETAXINE MEPESUCCINATE Side Effects?
#1 Most Reported
Myelosuppression
178 reports (18.6%)
#2 Most Reported
Nausea
154 reports (16.1%)
#3 Most Reported
Platelet count decreased
105 reports (11.0%)
All OMACETAXINE MEPESUCCINATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Myelosuppression | 178 | 18.6% | 7 | 94 |
| Nausea | 154 | 16.1% | 7 | 43 |
| Platelet count decreased | 105 | 11.0% | 5 | 43 |
| Fatigue | 76 | 7.9% | 3 | 19 |
| Diarrhoea | 73 | 7.6% | 4 | 17 |
| White blood cell count decreased | 71 | 7.4% | 3 | 34 |
| Vomiting | 63 | 6.6% | 4 | 21 |
| Injection site erythema | 61 | 6.4% | 1 | 9 |
| Death | 60 | 6.3% | 60 | 24 |
| Asthenia | 57 | 6.0% | 6 | 22 |
| Pyrexia | 56 | 5.9% | 4 | 36 |
| Headache | 47 | 4.9% | 2 | 7 |
| Neutropenia | 43 | 4.5% | 3 | 16 |
| Haemoglobin decreased | 40 | 4.2% | 4 | 23 |
| Off label use | 40 | 4.2% | 4 | 10 |
| Drug ineffective | 35 | 3.7% | 4 | 4 |
| Infection | 35 | 3.7% | 3 | 7 |
| Alopecia | 32 | 3.3% | 0 | 7 |
| Blood count abnormal | 32 | 3.3% | 1 | 10 |
| Neutrophil count decreased | 32 | 3.3% | 0 | 19 |
Who Reports OMACETAXINE MEPESUCCINATE Side Effects? Age & Gender Data
Gender: 50.0% female, 50.0% male. Average age: 53.3 years. Most reports from: US. View detailed demographics →
Is OMACETAXINE MEPESUCCINATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2007 | 1 | 0 | 1 |
| 2011 | 1 | 0 | 1 |
| 2013 | 1 | 0 | 0 |
| 2014 | 23 | 0 | 8 |
| 2015 | 63 | 3 | 16 |
| 2016 | 74 | 9 | 29 |
| 2017 | 62 | 9 | 30 |
| 2018 | 38 | 3 | 21 |
| 2019 | 33 | 9 | 14 |
| 2020 | 31 | 0 | 13 |
| 2021 | 29 | 0 | 14 |
| 2022 | 31 | 0 | 13 |
| 2023 | 35 | 0 | 18 |
| 2024 | 69 | 1 | 49 |
| 2025 | 36 | 0 | 29 |
What Is OMACETAXINE MEPESUCCINATE Used For?
| Indication | Reports |
|---|---|
| Chronic myeloid leukaemia | 500 |
| Acute myeloid leukaemia | 193 |
| Chemotherapy | 38 |
| Product used for unknown indication | 29 |
| Myelodysplastic syndrome | 19 |
| Acute leukaemia | 17 |
| Leukaemia | 15 |
| Acute promyelocytic leukaemia | 13 |
| T-cell type acute leukaemia | 13 |
| Philadelphia chromosome positive | 10 |
OMACETAXINE MEPESUCCINATE vs Alternatives: Which Is Safer?
OMACETAXINE MEPESUCCINATE vs OMADACYCLINE
OMACETAXINE MEPESUCCINATE vs OMALIZUMAB
OMACETAXINE MEPESUCCINATE vs OMAVELOXOLONE
OMACETAXINE MEPESUCCINATE vs OMBITASVIR
OMACETAXINE MEPESUCCINATE vs OMBITASVIR\PARITAPREVIR\RITONAVIR
OMACETAXINE MEPESUCCINATE vs OMEGA-3-ACID ETHYL ESTERS
OMACETAXINE MEPESUCCINATE vs OMEGA-3-CARBOXYLIC ACIDS
OMACETAXINE MEPESUCCINATE vs OMEGA-3 FATTY ACIDS
OMACETAXINE MEPESUCCINATE vs OMEPRAZOLE
OMACETAXINE MEPESUCCINATE vs OMEPRAZOLE\SODIUM BICARBONATE
Official FDA Label for OMACETAXINE MEPESUCCINATE
Official prescribing information from the FDA-approved drug label.