ESTRAMUSTINE: 268 Adverse Event Reports & Safety Profile
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268
Total FAERS Reports
73 (27.2%)
Deaths Reported
85
Hospitalizations
268
As Primary/Secondary Suspect
12
Life-Threatening
2
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Active Ingredient: ESTRAMUSTINE PHOSPHATE SODIUM · FDA Application: 018045 ·
First Report: 19970217 · Latest Report: 20241211
What Are the Most Common ESTRAMUSTINE Side Effects?
#1 Most Reported
Nausea
17 reports (6.3%)
#2 Most Reported
Interstitial lung disease
16 reports (6.0%)
#3 Most Reported
Cardiac failure
15 reports (5.6%)
All ESTRAMUSTINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Nausea | 17 | 6.3% | 3 | 7 |
| Interstitial lung disease | 16 | 6.0% | 10 | 8 |
| Cardiac failure | 15 | 5.6% | 3 | 5 |
| Death | 14 | 5.2% | 14 | 1 |
| Prostatic specific antigen increased | 14 | 5.2% | 9 | 5 |
| Pleural effusion | 10 | 3.7% | 3 | 6 |
| Disease progression | 9 | 3.4% | 5 | 2 |
| Product use issue | 9 | 3.4% | 0 | 0 |
| Anaemia | 8 | 3.0% | 5 | 2 |
| Angioedema | 8 | 3.0% | 0 | 5 |
| Constipation | 8 | 3.0% | 1 | 5 |
| Osteonecrosis of jaw | 8 | 3.0% | 3 | 4 |
| Thrombocytopenia | 8 | 3.0% | 0 | 2 |
| Neutropenia | 7 | 2.6% | 1 | 1 |
| Platelet count decreased | 7 | 2.6% | 0 | 6 |
| Pulmonary embolism | 7 | 2.6% | 3 | 3 |
| Second primary malignancy | 7 | 2.6% | 1 | 0 |
| Vomiting | 7 | 2.6% | 2 | 3 |
| Decreased appetite | 6 | 2.2% | 0 | 4 |
| Diarrhoea | 6 | 2.2% | 1 | 5 |
Who Reports ESTRAMUSTINE Side Effects? Age & Gender Data
Gender: 6.1% female, 93.9% male. Average age: 73.3 years. Most reports from: JP. View detailed demographics →
Is ESTRAMUSTINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 0 | 1 |
| 2004 | 1 | 0 | 0 |
| 2006 | 1 | 1 | 0 |
| 2007 | 4 | 4 | 2 |
| 2009 | 1 | 0 | 0 |
| 2010 | 3 | 1 | 1 |
| 2011 | 3 | 0 | 3 |
| 2012 | 4 | 0 | 1 |
| 2013 | 4 | 1 | 1 |
| 2014 | 11 | 3 | 3 |
| 2015 | 20 | 4 | 14 |
| 2016 | 7 | 2 | 3 |
| 2017 | 8 | 2 | 3 |
| 2018 | 8 | 1 | 5 |
| 2019 | 10 | 3 | 7 |
| 2020 | 1 | 0 | 1 |
| 2021 | 7 | 1 | 4 |
| 2022 | 7 | 1 | 4 |
| 2023 | 3 | 0 | 3 |
| 2024 | 5 | 0 | 4 |
What Is ESTRAMUSTINE Used For?
| Indication | Reports |
|---|---|
| Prostate cancer | 105 |
| Prostate cancer metastatic | 29 |
| Product used for unknown indication | 23 |
| Hormone-refractory prostate cancer | 22 |
| Breast cancer metastatic | 10 |
| Neoplasm malignant | 10 |
| Metastases to bone | 6 |
ESTRAMUSTINE vs Alternatives: Which Is Safer?
ESTRAMUSTINE vs ESTRING
ESTRAMUSTINE vs ESTRIOL
ESTRAMUSTINE vs ESTROGENS
ESTRAMUSTINE vs ESTROGENS, CONJUGATED
ESTRAMUSTINE vs ESTROGENS, CONJUGATED\MEDROXYPROGESTERONE
ESTRAMUSTINE vs ESTROGENS, ESTERIFIED
ESTRAMUSTINE vs ESZOPICLONE
ESTRAMUSTINE vs ETANERCEPT
ESTRAMUSTINE vs ETANERCEPT-SZZS
ESTRAMUSTINE vs ETELCALCETIDE
Official FDA Label for ESTRAMUSTINE
Official prescribing information from the FDA-approved drug label.