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Aromasin (Exemestane) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Aromasin (Exemestane) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (326)
Death (41)
Life Threatening Events (2)
Disability (16)

Reports by Reaction Type

Arthralgia (31)Alopecia (20)Disease Progression (19)Breast Cancer (18)Fatigue (14)Pain (13)Abdominal Distension (12)Rash (12)Bone Pain (11)Headache (11)Pyrexia (11)Hot Flush (11)

Below are a few examples of reports where side effects / adverse reactions may be related to Aromasin (Exemestane). For a complete list or a specific selection of reports, please use the links above.

Possible Aromasin side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 65 year old female

Reactions: Weight Decreased, Diarrhoea, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aromasin



Possible Aromasin side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 62 year old female

Reactions: Breast Cancer, Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Aromasin



Possible Aromasin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Liver Function Test Abnormal, Oropharyngeal Pain

Drug(s) suspected as cause:
Aromasin



Possible Aromasin side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 69 year old female, weighing 101.0 kg (222.2 pounds)

Reactions: Tumour Marker Increased

Drug(s) suspected as cause:
Aromasin
    Dosage: 25 mg, daily
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-01-01
    End date: 2012-01-01

Tamoxifen Citrate
    Dosage: unk
    Start date: 2002-01-01



Possible Aromasin side effects in 88 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-16

Patient: 88 year old female

Reactions: Vascular Purpura, Skin Necrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aromasin

Other drugs received by patient: Lansoprazole



Possible Aromasin side effects in 54 year old female

Reported by a consumer/non-health professional from Germany on 2012-08-14

Patient: 54 year old female

Reactions: Retinal Tear

Drug(s) suspected as cause:
Aromasin



Possible Aromasin side effects in female

Reported by a pharmacist from United States on 2012-08-14

Patient: female

Reactions: Dyspnoea

Drug(s) suspected as cause:
Aromasin



Possible Aromasin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: female

Reactions: Adverse Drug Reaction

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral

Aromasin

Tamoxifen Citrate



Possible Aromasin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: female

Reactions: Nausea, Headache, Metastases To Bone, Liver Disorder

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Start date: 2012-01-01

Arimidex
    Administration route: Oral
    Indication: Breast Cancer

Aromasin
    Administration route: Oral



Possible Aromasin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient:

Reactions: Dyspnoea, Bronchitis, Cough

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral

Aromasin



Possible Aromasin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: female

Reactions: Night Sweats, Stomatitis, Chapped Lips, Conjunctivitis, Rheumatoid Arthritis, Weight Increased, Hot Flush, Fibromyalgia, Systemic Lupus Erythematosus, DRY Eye

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Indication: Breast Cancer

Aromasin
    Indication: Breast Cancer

Nolvadex
    Administration route: Oral
    Indication: Breast Cancer



Possible Aromasin side effects in 66 year old female

Reported by a pharmacist from Japan on 2012-08-09

Patient: 66 year old female

Reactions: Pulmonary Alveolar Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aromasin



Possible Aromasin side effects in 82 year old female

Reported by a physician from Japan on 2012-08-09

Patient: 82 year old female, weighing 47.3 kg (104.1 pounds)

Reactions: Interstitial Lung Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aromasin



Possible Aromasin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: female

Reactions: Liver Function Test Abnormal, Oropharyngeal Pain

Drug(s) suspected as cause:
Aromasin



Possible Aromasin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female

Reactions: Impaired Driving Ability, Hot Flush, Dizziness, DRY Skin

Drug(s) suspected as cause:
Aromasin
    Dosage: unk
    Start date: 2012-01-01
    End date: 2012-01-01

Aromasin
    Dosage: unk
    Start date: 2012-01-01
    End date: 2012-01-01

Other drugs received by patient: Norvasc



Possible Aromasin side effects in 58 year old female

Reported by a physician from Germany on 2012-08-06

Patient: 58 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Haemolysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aromasin
    Dosage: 25 mg, unk
    Administration route: Oral
    Indication: Breast Cancer Female
    Start date: 2010-01-25

Zoledronic Acid
    Dosage: unk
    Indication: Osteoporosis
    Start date: 2012-07-09
    End date: 2012-07-09



Possible Aromasin side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 71 year old female, weighing 72.6 kg (159.6 pounds)

Reactions: Muscle Strain, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aromasin
    Indication: Neoplasm Malignant

Lisinopril
    Indication: Hypertension
    End date: 2012-01-01



Possible Aromasin side effects in 73 year old female

Reported by a physician from Italy on 2012-08-06

Patient: 73 year old female

Reactions: Agranulocytosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Allopurinol
    Dosage: 300 mg, 1x/day
    Administration route: Oral
    Start date: 2012-07-04
    End date: 2012-07-15

Aromasin
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2012-06-30
    End date: 2012-07-18

Ciprofloxacin HCL
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Pyrexia
    Start date: 2012-07-14
    End date: 2012-07-16

Omeprazole
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Start date: 2012-07-04
    End date: 2012-07-18

Other drugs received by patient: Rocaltrol; Lasix; Methylprednisolone; Amiodarone Hydrochloride; Irbesartan; Calcium Carbonate; Becozym; Aranesp; Enalapril Maleate



Possible Aromasin side effects in

Reported by a pharmacist from Japan on 2012-08-03

Patient:

Reactions: Osteonecrosis

Drug(s) suspected as cause:
Aromasin



Possible Aromasin side effects in 73 year old female

Reported by a physician from Netherlands on 2012-08-03

Patient: 73 year old female

Reactions: Hypoglycaemia

Drug(s) suspected as cause:
Aromasin

Other drugs received by patient: Levothyroxine Sodium; Insulatard NPH Human; Humalog; Enalapril



Possible Aromasin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female

Reactions: Alopecia, Liver Function Test Abnormal, Arthritis

Drug(s) suspected as cause:
Aromasin



Possible Aromasin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: female, weighing 101.0 kg (222.2 pounds)

Reactions: Tumour Marker Increased

Drug(s) suspected as cause:
Aromasin
    Dosage: 25 mg, daily
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-01-01
    End date: 2012-01-01

Tamoxifen Citrate
    Dosage: unk
    Start date: 2002-01-01



Possible Aromasin side effects in 49 year old female

Reported by a physician from Japan on 2012-07-31

Patient: 49 year old female, weighing 66.0 kg (145.2 pounds)

Reactions: Hepatic Function Abnormal, Fatigue, Pyrexia

Drug(s) suspected as cause:
Aromasin
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Indication: Breast Cancer
    End date: 2012-02-16

Exemestane
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2012-02-17
    End date: 2012-03-06

Other drugs received by patient: Warkmin



Possible Aromasin side effects in 82 year old female

Reported by a physician from Japan on 2012-07-30

Patient: 82 year old female

Reactions: Interstitial Lung Disease

Drug(s) suspected as cause:
Aromasin



Possible Aromasin side effects in 50 year old female

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-07-30

Patient: 50 year old female, weighing 58.3 kg (128.3 pounds)

Reactions: Hepatic Failure, Asthenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Aromasin
    Dosage: 25 mg, 1x/day
    Indication: Breast Cancer
    Start date: 2012-06-08
    End date: 2012-06-22

Aromasin
    Dosage: 25 mg, 1x/day
    Start date: 2012-06-25
    End date: 2012-07-13

Other drugs received by patient: Ranitidine; Alprazolam



Possible Aromasin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Breast Cancer, Metastases To Liver, Disease Progression

Drug(s) suspected as cause:
Aromasin
    Dosage: unk
    Indication: Breast Cancer

Tamoxifen Citrate
    Dosage: unk
    Indication: Breast Cancer



Possible Aromasin side effects in female

Reported by a pharmacist from United States on 2012-07-27

Patient: female

Reactions: Rash Macular

Drug(s) suspected as cause:
Aromasin

Other drugs received by patient: Fish OIL



Possible Aromasin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: female, weighing 72.6 kg (159.6 pounds)

Reactions: Muscle Strain, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aromasin
    Dosage: unk
    Indication: Neoplasm Malignant

Lisinopril
    Dosage: unk
    Indication: Hypertension
    End date: 2012-01-01



Possible Aromasin side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-25

Patient: 60 year old female

Reactions: Pulmonary Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arimidex
    Dosage: unk
    Indication: Breast Cancer

Aromasin
    Dosage: 25 mg, unk
    Indication: Breast Cancer
    End date: 2010-10-01

Cyclophosphamide
    Dosage: unk
    Indication: Breast Cancer

Epirubicin Hydrochloride
    Dosage: unk
    Indication: Breast Cancer

Fluorouracil
    Dosage: unk
    Indication: Breast Cancer

Tamoxifen
    Dosage: unk
    Indication: Breast Cancer



Possible Aromasin side effects in female

Reported by a pharmacist from Japan on 2012-07-25

Patient: female

Reactions: Lung Disorder

Drug(s) suspected as cause:
Aromasin

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