| Drug Report: AROMASIN (EXEMESTANE) | ||||||||
| Primary Suspect Reports: 2,041 Total Reports: 3,347 FDA AERS Reports from 11/01/1997 to 08/27/2012 | ||||||||
| Drug Description : | ||||||||
Aromasin (exemestane) is an aromatase inhibitor indicated for the adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and switched to Aromasin for completion of a total of five years of adjuvant hormonal therapy. Aromasin is also indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. Manufactured by Pfizer, Aromasin was approved by the FDA on October 21, 1999. |
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| Drug Safety Monitor News : | ||||||||
07/23/2012 - FDA Approves Afinitor in Combination with Aromasin for Advanced Breast Cancer |
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| Other Names : | Generic Name : | Report Info: | ||||||
Exemestane |
EXEMESTANE | Average Age: 64 Years |
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FDA Listed Names (62) :
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Manufacturer: | Common Conditions: | ||||||
Aramasen |
Pfizer, Inc. (1,750) |
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| Top AROMASIN Adverse Events/Side Effects |
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| Side Effects MedDRA Preferred Terms |
AROMASIN Primary Suspect Reports | AROMASIN Total Reports |
ROR Score
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PRR Score
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Compare Top Drugs |
| Arthralgia | 209 (10%) | 324 (10%) | Premium Feature | Premium Feature |
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| Fatigue | 102 (5%) | 205 (6%) | Premium Feature | Premium Feature |
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| Death | 79 (4%) | 134 (4%) | Premium Feature | Premium Feature |
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| Pulmonary Embolism | 66 (3%) | 102 (3%) | Premium Feature | Premium Feature |
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| Weight Increased | 65 (3%) | 85 (3%) | Premium Feature | Premium Feature |
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| Nausea | 63 (3%) | 151 (5%) | Premium Feature | Premium Feature |
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| Headache | 62 (3%) | 131 (4%) | Premium Feature | Premium Feature |
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| Dyspnoea | 61 (3%) | 169 (5%) | Premium Feature | Premium Feature |
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| Myalgia | 59 (3%) | 98 (3%) | Premium Feature | Premium Feature |
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| Alopecia | 57 (3%) | 87 (3%) | Premium Feature | Premium Feature |
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| Reported Report Outcomes for AROMASIN Adverse Events |
| Report Outcomes |
AROMASIN Primary Suspect (# of Reports) (11/01/1997 to 08/27/2012) |
AROMASIN Total (# of Reports) (11/01/1997 to 08/27/2012) |
| Other | 1,006 (49%) | 1,713 (51%) |
| Hospitalization - Initial or Prolonged | 541 (27%) | 1,014 (30%) |
| Death | 135 (7%) | 305 (9%) |
| Life-Threatening | 89 (4%) | 165 (5%) |
| Disability | 87 (4%) | 167 (5%) |
| Required Intervention to Prevent Permanent Impairment/Damage | 17 (1%) | 34 (1%) |
| Congenital Anomaly | 2 (0%) | 2 (0%) |
| Most Recent AROMASIN Report Reviews/FDA Reports (Primary Suspect) |
| Report Date | Age | Gender | Conditions | Adverse Events | Outcome |
| 08/24/2012 | 75 YR | F |
Breast Cancer |
Metastatic Malignant Melanoma Neoplasm Malignant |
Hospitalization - Initial or Prolonged |
| 08/21/2012 | 65 YR | F |
Breast Cancer Stage I |
Diarrhoea Dehydration Weight Decreased |
Hospitalization - Initial or Prolonged |
| 08/21/2012 | 62 YR | F |
Breast Cancer |
Disease Progression Breast Cancer |
Death |
| 08/21/2012 | 52 YR | F |
Breast Cancer |
Suicide Attempt |
Hospitalization - Initial or Prolonged |
| 08/17/2012 | 69 YR | F |
Breast Cancer |
Tumour Marker Increased |
Not Stated |
| 08/16/2012 | 88 YR | F |
Breast Cancer Ulcer |
Vascular Purpura Skin Necrosis |
Hospitalization - Initial or Prolonged |
| 08/14/2012 | Not Stated | F |
Breast Cancer Female |
Dyspnoea |
Not Stated |
| 08/14/2012 | 54 YR | F |
Breast Cancer |
Retinal Tear |
Other |
| 08/13/2012 | 58 YR | F |
Breast Cancer |
Fall Osteopenia Femur Fracture |
Other |
| 08/09/2012 | 66 YR | F |
Breast Cancer |
Pulmonary Alveolar Haemorrhage |
Hospitalization - Initial or Prolonged Other |
