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Arimidex (Anastrozole) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Arimidex (Anastrozole) 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 (1042)
Death (83)
Life Threatening Events (21)
Disability (46)

Reports by Reaction Type

Arthralgia (123)Neoplasm Malignant (113)Malaise (86)Hot Flush (79)Breast Cancer (78)Pain in Extremity (67)Fall (66)Drug Dose Omission (63)Fatigue (58)Alopecia (56)Pain (45)Nausea (45)

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

Possible Arimidex side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Off Label Use, Disease Progression

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

Zoladex



Possible Arimidex side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 62 year old female

Reactions: Neoplasm Malignant, Musculoskeletal Stiffness, Fibrosis

Drug(s) suspected as cause:
Arimidex



Possible Arimidex side effects in 34 year old female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: 34 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Off Label Use, Ovulation Disorder, Breast Cancer Recurrent

Adverse event resulted in: hospitalization

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

Nolvadex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2007-01-01
    End date: 2010-01-01



Possible Arimidex side effects in 61 year old female

Reported by a consumer/non-health professional from Canada on 2012-08-27

Patient: 61 year old female

Reactions: Weight Decreased, Aphagia, Nausea, Bone Pain, Hepatomegaly, Arthralgia, Blood Pressure Inadequately Controlled, Gait Disturbance

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Arimidex

Other drugs received by patient: Lorazepam; Trazodone Hydrochloride; Clonidine; Atorvastatin; Tramadol HCL; Acetaminophen; Pantoprazole



Possible Arimidex side effects in 800 month old female

Reported by a physician from China on 2012-08-27

Patient: 800 month old female, weighing 64.0 kg (140.8 pounds)

Reactions: Dysgeusia, Parosmia, Renal Failure Acute

Drug(s) suspected as cause:
Arimidex

Other drugs received by patient: Isosorbide Mononitrate; Vitamin; Prednisone; Adalat; Tripterygium Wilfordii



Possible Arimidex side effects in 65 year old female

Reported by a physician from United States on 2012-08-27

Patient: 65 year old female, weighing 70.8 kg (155.8 pounds)

Reactions: Cirrhosis Alcoholic, Urinary Tract Infection, Musculoskeletal Pain, Breast Cancer Female, Mental Status Changes, Fall, Chronic Obstructive Pulmonary Disease, Ascites, Sepsis, Bronchitis, Metabolic Disorder, Blood Pressure Abnormal, Essential Hypertension, Hepatic Cirrhosis, Renal Failure Acute, Ligament Sprain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alcohol

Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2007-09-01

Atenolol
    Administration route: Oral

Omeprazole
    Administration route: Oral

Other drugs received by patient: Amlodipine Besylate; Ensure; Calcium-D; Ipratropium Bromide and Albuterol Sulfate; Nadolol; Cranberry; Vitamin B1 TAB; Albuterol Sulfate Autohaler; Calcium Carbonate; Senna; Remeron; Oxycodone HCL; Multi-Vitamins; Vitamin D; Combivent; Ascorbic Acid



Possible Arimidex side effects in 82 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 82 year old female, weighing 76.2 kg (167.6 pounds)

Reactions: Hepatomegaly, Neoplasm Malignant, Lung Neoplasm Malignant, Chronic Obstructive Pulmonary Disease, Breast Cancer Recurrent

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

Crestor
    Administration route: Oral

Tamoxifen Citrate
    Administration route: Oral

Other drugs received by patient: Nebulizer; Brovana



Possible Arimidex side effects in 73 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient: 73 year old female

Reactions: Drug Intolerance

Drug(s) suspected as cause:
Arimidex

Other drugs received by patient: Levoxyl; Spironolact / Hctz



Possible Arimidex side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female, weighing 70.3 kg (154.6 pounds)

Reactions: Tooth Loss, Contusion, Tinnitus, Oral Cavity Fistula, Chronic Obstructive Pulmonary Disease, Oral Mucosal Exfoliation, Peroneal Nerve Palsy, Balance Disorder, Oedema Peripheral, Hepatosplenomegaly, White Blood Cell Count Increased, Proctalgia, Mitral Valve Prolapse, Back Pain, Lumbar Radiculopathy, Bursitis, Osteitis, Emotional Distress, Staphylococcal Infection, Compression Fracture, Areflexia, Seborrhoeic Keratosis, Rectal Haemorrhage, Lichenoid Keratosis, Fall, Wound Infection Staphylococcal, Dysplastic Naevus, Rectal Fissure, Malignant Melanoma, Bone Disorder, Injury, Exostosis, Decreased Appetite, Haemorrhoids, Musculoskeletal Pain, Muscular Weakness, Posture Abnormal, Gingival Pain, Arthralgia, Impaired Healing, Metastases To Bone, Physical Disability, Walking Disability, Face Injury, Asthma, Night Sweats, Cataract Nuclear, Urinary Incontinence, Hand Fracture, Pyrexia, Tooth Infection, Craniocerebral Injury, Hypoaesthesia Oral, Arthropathy, Ecchymosis, Ingrowing Nail, Urinary Retention, Tenderness, Rectal Abscess, Intervertebral Disc Protrusion, Cellulitis, Pain in Extremity, Faecal Incontinence, Hypoaesthesia, Micturition Urgency, Eating Disorder, Paraesthesia, Tendon Disorder, Haemangioma, Major Depression, Excessive Granulation Tissue, Neuralgia, Scar, Purulent Discharge, Fear, Pain, Eructation, Cystocele, Fatigue, Anger, Dizziness, Toothache, Thrombocytopenia, Pain in JAW, RIB Fracture, Bone Lesion, Urinary Tract Infection, Angiofibroma, Varicose Vein, Musculoskeletal Chest Pain, Plantar Fasciitis, Anxiety, Rectocele, Osteonecrosis of JAW, Radiculitis, Oral Disorder, Peripheral Arterial Occlusive Disease, Nuclear Magnetic Resonance Imaging Abnormal, Bronchitis, Spinal Osteoarthritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alendronate Sodium
    Indication: Hypercalcaemia

Arimidex

Zometa
    Dosage: 4 mg, qmo
    Indication: Breast Cancer Metastatic
    Start date: 2003-09-01
    End date: 2005-02-03

Other drugs received by patient: Lipitor; Hydrocodone Bitartrate; Alprazolam; Hydrocortisone with Lidocaine Hydrochloride; Celebrex; Choline Magnesium Trisalicylate; Megestrol Acetate; Ondansetron; Raloxifene Hydrochloride; Methylprednisolone; Tamoxifen Citrate; Faslodex; Taxotere; Stool Softener; Levaquin; Furosemide; Aromasin; Mirtazapine; Prednisone TAB; Cialis; Mupirocin; Terconazole; Gemcitabine Hydrochloride; Biafine; Xanax; Folic Acid; Zebeta; Miralax; Provocholine; Nystatin; Effexor XR; Morphine Sulfate; Lexapro; Meloxicam; Hormones; Letrozole; Zovirax; Multi-Vitamins; Propoxyphene Napsylate W / Acetaminophen; Glycolax; Actonel; Fluconazole; Clotrimazole; Compro; Temazepam; Gemzar; Protonix; Fentanyl; Omeprazole; Methadone Hydrochloride; Wellbutrin XL; Metoclopramide; Betamethasone Dipropionate W / Clotrimazole; Sulfamethoxazole and Trimethoprim; Etodolac; Ciprofloxacin; Femara; Lotrel; Atenolol; Zoloft; Ambien; Nexium; Neulasta; Dexamethasone; Silver Sulfadiazine; Hydromorphone Hydrochloride; Metronidazole; Naproxen; Bupropion HCL; Cephalexin; Neurontin; Kytril; Fosamax; Calcimate Plus; Compazine; Azithromycin; Potassium Chloride; Iodoquinol; Zocor; Prozac; Doxorubicin Hydrochloride; Mobic; Prochlorperazine; Iron; Xeloda; Zofran; Oxycodone HCL and Acetaminophen; Simvastatin; Citalopram Hydrobromide; Lyrica; Gabapentin; Avelox; Navelbine



Possible Arimidex side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 61 year old female

Reactions: Dyspnoea, Chills, Heart Valve Incompetence, Osteopenia, Constipation, Atrioventricular Block Second Degree, Cardiomegaly, Intracardiac Mass, Hot Flush, Heart Rate Decreased, RED Blood Cell Count Decreased, Coronary Artery Occlusion, Insomnia, Alopecia, Blood Cholesterol Increased

Drug(s) suspected as cause:
Arimidex

Other drugs received by patient: Beta Blockers; Statin; Simvastatin; Metoprolol Tartrate; Aspirin



Possible Arimidex side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 65 year old female

Reactions: Accident, Breast Cancer, Upper Limb Fracture

Drug(s) suspected as cause:
Arimidex



Possible Arimidex side effects in 67 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 67 year old female, weighing 88.0 kg (193.6 pounds)

Reactions: Breast Pain, Pain in Extremity, Pain, Headache, Myalgia, Fatigue, Arthralgia, Throat Irritation, Breast Tenderness, DRY Mouth, Alopecia, Insomnia, Musculoskeletal Stiffness, Dizziness, Gait Disturbance, Epistaxis

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-11-14
    End date: 2012-06-21

Arimidex
    Administration route: Oral
    Indication: Antioestrogen Therapy
    Start date: 2011-11-14
    End date: 2012-06-21



Possible Arimidex side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 63 year old female

Reactions: Breast Cancer Female

Drug(s) suspected as cause:
Arimidex



Possible Arimidex side effects in 81 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 81 year old female

Reactions: Oedema Peripheral, Erythema, Blister

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arimidex



Possible Arimidex side effects in 84 year old female

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

Patient: 84 year old female

Reactions: Arthralgia, Insomnia, Adverse Event, Depression

Drug(s) suspected as cause:
Arimidex

Other drugs received by patient: Elidel; Verapamil; Synthroid; Warfarin Sodium; Cephalexin



Possible Arimidex side effects in female

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

Patient: female

Reactions: Dysphonia, Arthralgia, Oedema Peripheral, Musculoskeletal Stiffness, Trigger Finger, Muscle Spasms

Drug(s) suspected as cause:
Arimidex



Possible Arimidex side effects in 57 year old female

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

Patient: 57 year old female

Reactions: Lymphadenopathy

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

Crestor
    Administration route: Oral



Possible Arimidex side effects in 70 year old female

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

Patient: 70 year old female

Reactions: Nervous System Disorder, Memory Impairment

Drug(s) suspected as cause:
Arimidex



Possible Arimidex side effects in 68 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 68 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Breast Cancer Female

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

Crestor
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Other drugs received by patient: Lopressor; Fosamax



Possible Arimidex side effects in 72 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 72 year old female, weighing 104.3 kg (229.5 pounds)

Reactions: Myalgia, Arthralgia, Drug Intolerance, Sleep Disorder DUE To General Medical Condition, Insomnia Type, Intentional Drug Misuse, Arthritis, Cerebrovascular Accident, Muscle Spasms

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Start date: 2003-01-01

Crestor
    Administration route: Oral

Crestor
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Other drugs received by patient: Zocor; High Blood Pressure Pills; Diovan; Lipitor; Hydrochlorothiazide



Possible Arimidex side effects in 56 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 56 year old female

Reactions: HIP Fracture, Chest Pain

Drug(s) suspected as cause:
Arimidex



Possible Arimidex side effects in 67 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-20

Patient: 67 year old female

Reactions: Neoplasm Malignant, Laryngitis

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

Nexium
    Administration route: Oral

Pulmicort Flexhaler

Symbicort



Possible Arimidex side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: female, weighing 70.3 kg (154.6 pounds)

Reactions: Tooth Loss, Tinnitus, Contusion, Oral Cavity Fistula, Chronic Obstructive Pulmonary Disease, Oral Mucosal Exfoliation, Balance Disorder, Peroneal Nerve Palsy, Oedema Peripheral, White Blood Cell Count Increased, Proctalgia, Back Pain, Mitral Valve Prolapse, Lumbar Radiculopathy, Bursitis, Osteitis, Emotional Distress, Staphylococcal Infection, Compression Fracture, Areflexia, Seborrhoeic Keratosis, Rectal Haemorrhage, Lichenoid Keratosis, Fall, Wound Infection Staphylococcal, Dysplastic Naevus, Rectal Fissure, Malignant Melanoma, Injury, Bone Disorder, Exostosis, Decreased Appetite, Musculoskeletal Pain, Haemorrhoids, Muscular Weakness, Posture Abnormal, Gingival Pain, Impaired Healing, Arthralgia, Memory Impairment, Metastases To Bone, Physical Disability, Face Injury, Walking Disability, Asthma, Cataract Nuclear, Night Sweats, Urinary Incontinence, Hand Fracture, Tooth Infection, Pyrexia, Craniocerebral Injury, Arthropathy, Hypoaesthesia Oral, Ecchymosis, Ingrowing Nail, Tenderness, Urinary Retention, Rectal Abscess, Intervertebral Disc Protrusion, Cellulitis, Pain in Extremity, Anaemia, Faecal Incontinence, Hypoaesthesia, Micturition Urgency, Eating Disorder, Paraesthesia, Tendon Disorder, Haemangioma, Major Depression, Scar, Neuralgia, Purulent Discharge, Excessive Granulation Tissue, Fear, Pain, Eructation, Cystocele, Fatigue, Dizziness, Anger, Toothache, RIB Fracture, Pain in JAW, Bone Lesion, Urinary Tract Infection, Angiofibroma, Varicose Vein, Musculoskeletal Chest Pain, Plantar Fasciitis, Anxiety, Rectocele, Osteonecrosis of JAW, Radiculitis, Oral Disorder, Peripheral Arterial Occlusive Disease, Nuclear Magnetic Resonance Imaging Abnormal, Spinal Osteoarthritis, Bronchitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alendronate Sodium
    Indication: Hypercalcaemia

Arimidex

Zometa
    Dosage: 4 mg, qmo
    Indication: Breast Cancer Metastatic
    Start date: 2003-09-01
    End date: 2005-02-03

Other drugs received by patient: Dexamethasone; Glycolax; Simvastatin; Lexapro; Mirtazapine; Avelox; Sulfamethoxazole and Trimethoprim; Cialis; Clotrimazole; Neurontin; Prochlorperazine; Hydrocodone; Hydromorphone Hydrochloride; Effexor XR; Metronidazole; Meloxicam; Methadone Hydrochloride; Wellbutrin XL; Gabapentin; Megestrol Acetate; Prednisone TAB; Ondansetron; Gemcitabine Hydrochloride; Mobic; Methylprednisolone; Xanax; Gemzar; Zebeta; Stool Softener; Morphine Sulfate; Mupirocin; Letrozole; Compro; Lotrel; Tamoxifen Citrate; Fosamax; Lipitor; Ambien; Xeloda; Azithromycin; Oxycodone HCL and Acetaminophen; Omeprazole; Naproxen; Celebrex; Lyrica; Metoclopramide; Raloxifene Hydrochloride; Etodolac; Ciprofloxacin; Folic Acid; Provocholine; Silver Sulfadiazine; Aromasin; Fentanyl; Cephalexin; Betamethasone Dipropionate W / Clotrimazole; Femara; Atenolol; Iron; Taxotere; Calcimate Plus; Miralax; Zofran; Compazine; Alprazolam; Propoxyphene Napsylate W / Acetaminophen; Nystatin; Hydrocortisone with Lidocaine Hydrochloride; Furosemide; Choline Magnesium Trisalicylate; Terconazole; Zocor; Hormones; Kytril; Biafine; Zovirax; Zoloft; Neulasta; Actonel; Potassium Chloride; Citalopram Hydrobromide; Bupropion HCL; Fluconazole; Prozac; Navelbine; Temazepam; Faslodex; Nexium; Protonix; Multi-Vitamins; Levaquin; Iodoquinol; Doxorubicin Hydrochloride



Possible Arimidex side effects in 84 year old female

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

Patient: 84 year old female

Reactions: Myocardial Infarction

Adverse event resulted in: hospitalization

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

Toprol-XL
    Administration route: Oral



Possible Arimidex side effects in 49 year old

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-17

Patient: 49 year old

Reactions: Breast Cancer Metastatic, Metastases To Liver, Metastases To Bone

Drug(s) suspected as cause:
Arimidex



Possible Arimidex side effects in 67 year old female

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

Patient: 67 year old female

Reactions: Neoplasm Malignant

Drug(s) suspected as cause:
Arimidex



Possible Arimidex side effects in 72 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-17

Patient: 72 year old female, weighing 61.2 kg (134.6 pounds)

Reactions: Road Traffic Accident, Dyspnoea, Nasopharyngitis, Neoplasm Malignant, Oropharyngeal Pain, Foreign Body, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Start date: 2010-01-01

Norvasc
    Indication: Blood Pressure Abnormal
    Start date: 2010-01-01

Other drugs received by patient: Calcium



Possible Arimidex side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 54 year old female, weighing 69.4 kg (152.7 pounds)

Reactions: Weight Decreased, Hot Flush, Musculoskeletal Pain, Vulvovaginal Dryness, Blood Cholesterol Increased

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2004-09-01
    End date: 2008-01-01

Faslodex

Other drugs received by patient: Nolvadex



Possible Arimidex side effects in 76 year old female

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

Patient: 76 year old female

Reactions: Skin Wrinkling, Limb Discomfort, Condition Aggravated, Fall

Drug(s) suspected as cause:
Arimidex



Possible Arimidex side effects in 68 year old female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 68 year old female

Reactions: Breast Cancer, Drug Dose Omission, Breast Cancer Female, Discomfort

Drug(s) suspected as cause:
Arimidex

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