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Femara (Letrozole) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Femara (Letrozole) 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 (503)
Death (72)
Life Threatening Events (6)
Disability (30)

Reports by Reaction Type

Arthralgia (52)Death (41)Neoplasm Malignant (39)Myalgia (26)Fatigue (26)Pain (25)Bone Pain (23)Headache (21)Dizziness (21)Neoplasm Progression (20)Hot Flush (20)Dysphagia (20)

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

Possible Femara side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: female

Reactions: Dyspnoea, Sense of Oppression

Drug(s) suspected as cause:
Femara

Other drugs received by patient: Avastin



Possible Femara side effects in female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-08-26

Patient: female

Reactions: Rheumatoid Arthritis, Pain

Drug(s) suspected as cause:
Femara
    Indication: Breast Cancer

Herceptin
    Indication: Breast Cancer



Possible Femara side effects in female

Reported by a physician from Germany on 2012-08-23

Patient: female, weighing 62.0 kg (136.4 pounds)

Reactions: Night Sweats, Mouth Ulceration, Mucosal Haemorrhage, Herpes Zoster, Klebsiella Infection, Metastases To Skin, Oedema Peripheral, Pleural Effusion, Skin Haemorrhage, Proteus Test Positive, Bacillus Infection, Thrombocytopenia, Staphylococcal Skin Infection, Urinary Tract Infection, Acute Myeloid Leukaemia, General Physical Health Deterioration, Mucosal Inflammation, Bone Neoplasm Malignant, Neoplasm Malignant, Skin Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Femara
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Start date: 2010-11-10
    End date: 2011-09-01

Zoledronoc Acid
    Dosage: 4 mg, every 4 week
    Indication: Bone Disorder
    Start date: 2010-11-19

Other drugs received by patient: Pentasa; Omeprazole; Faslodex; Fentanyl; Lyrica; Sumatriptan; Hydroxyurea



Possible Femara side effects in 61 year old female

Reported by a physician from France on 2012-08-23

Patient: 61 year old female

Reactions: Jaundice, Hepatitis Cholestatic

Adverse event resulted in: hospitalization

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

Herceptin
    Indication: Breast Cancer Metastatic

Lapatinib
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    End date: 2011-08-06



Possible Femara side effects in female

Reported by a lawyer from United States on 2012-08-23

Patient: female

Reactions: Weight Decreased, Primary Sequestrum, Lymph Node Calcification, Metastases To Liver, Headache, Pyrexia, Breast Cancer Recurrent, Cerebral Ischaemia, Lumbar Spinal Stenosis, Pulmonary Oedema, Pneumothorax, Tendonitis, Muscle Spasms, Cough, Stomatitis, Anaemia, Oral Infection, Aortic Calcification, General Physical Health Deterioration, Mastoiditis, Abscess JAW, Decreased Interest, Diverticulum, Metastases To Spine, Compression Fracture, Lymphadenopathy Mediastinal, Neutropenia, Metastases To Central Nervous System, Atelectasis, Breast Cancer Stage IV, Exposed Bone in JAW, Wheezing, Central Nervous System Lesion, Mouth Ulceration, Pain, Fatigue, Aortic Arteriosclerosis, Splenic Granuloma, Chest Pain, Intervertebral Disc Degeneration, Abdominal Distension, Pleural Effusion, Toothache, Depression, Sinusitis, Decreased Appetite, Dyspnoea, Vomiting, Nausea, Urinary Tract Infection, Ileus Paralytic, Anxiety, Osteoarthritis, Arthralgia, Neoplasm Malignant, Osteonecrosis of JAW, Dysuria, Pollakiuria, Bronchitis, Metastases To Bone, Leukopenia, Deep Vein Thrombosis

Drug(s) suspected as cause:
Aredia

Femara

Zometa
    Dosage: 4 mg, qmo
    Start date: 2003-09-16

Zometa
    Dosage: 4 mg, qmo
    Start date: 2003-01-01

Other drugs received by patient: Celexa; Decadron; Celebrex; MS Contin



Possible Femara side effects in female

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

Patient: female

Reactions: Erythema of Eyelid, Pruritus, Skin Exfoliation, DRY Skin, Headache, Generalised Erythema, Eye Swelling, Dizziness, Vision Blurred, Eye Disorder

Drug(s) suspected as cause:
Femara
    Dosage: unk ukn, unk
    Start date: 2011-06-01

Femara
    Dosage: unk ukn, unk



Possible Femara side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female

Reactions: Fatigue, Dyspnoea, Arthralgia, Oedema Peripheral, Swelling, Swollen Tongue, Sjogren's Syndrome

Drug(s) suspected as cause:
Femara

Other drugs received by patient: Synthroid; Bisoprolol Fumarate



Possible Femara side effects in 60 year old female

Reported by a physician from Switzerland on 2012-08-22

Patient: 60 year old female

Reactions: Toxoplasma Serology Positive, Visual Impairment, Optic Neuritis, Blindness, Papilloedema, Eye Pain, Amblyopia

Drug(s) suspected as cause:
Femara

Other drugs received by patient: Calcimagon-D3; Crestor



Possible Femara side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female, weighing 137.0 kg (301.4 pounds)

Reactions: Nerve Injury, Deafness

Drug(s) suspected as cause:
Cancer Treatment
    Indication: Neoplasm Malignant

Femara
    Dosage: 2.5 mg, daily
    Administration route: Oral
    Indication: Breast Cancer

Other drugs received by patient: Lovastatin; Lexapro; Metformin; Actonel



Possible Femara side effects in 75 year old female

Reported by a health professional (non-physician/pharmacist) from India on 2012-08-18

Patient: 75 year old female

Reactions: Death, General Physical Health Deterioration

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Femara



Possible Femara side effects in female

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

Patient: female

Reactions: Rheumatoid Arthritis, Pain

Drug(s) suspected as cause:
Femara
    Indication: Breast Cancer

Herceptin
    Indication: Breast Cancer



Possible Femara side effects in female

Reported by a physician from France on 2012-08-15

Patient: female, weighing 80.0 kg (176.0 pounds)

Reactions: Dyspnoea, Hypokinesia, Restrictive Pulmonary Disease, Discomfort

Drug(s) suspected as cause:
Femara

Other drugs received by patient: Procoralan; Plavix; Atorvastatin; Lasix; Fluticasone Propionate / Salmeterol; Spiriva; Aspirin



Possible Femara side effects in female

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

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Femara

Other drugs received by patient: Vicodin; Prochlorperazine; Lisinopril; Klor-CON



Possible Femara side effects in female

Reported by a physician from Australia on 2012-08-14

Patient: female

Reactions: Arthralgia, Pain in Extremity, Musculoskeletal Pain, Abasia, Musculoskeletal Stiffness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Femara



Possible Femara side effects in female

Reported by a physician from Japan on 2012-08-14

Patient: female, weighing 47.0 kg (103.4 pounds)

Reactions: Jaundice, Abdominal Pain, Visual Acuity Reduced, Tricuspid Valve Incompetence, Pyrexia, Erythema, Myalgia, Malaise, Neck Pain, C-Reactive Protein Increased, Oedema, Endocarditis, Urinary Retention, Tenderness, Cardiothoracic Ratio Increased, Musculoskeletal Pain, Streptococcal Infection, Endophthalmitis, Mitral Valve Incompetence, Swelling, Dysuria, Sepsis, Vision Blurred, Immune System Disorder, Blood Pressure Fluctuation, Blood Pressure Decreased, Inflammation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Femara
    Dosage: 2.5 mg, qd
    Administration route: Oral
    Indication: Breast Cancer Metastatic

Femara
    Dosage: 2.5 mg, daily
    Administration route: Oral
    Start date: 2011-12-29

Zometa
    Dosage: 4 mg per administration, unk
    End date: 2011-10-01

Other drugs received by patient: Herceptin; Anastrozole



Possible Femara side effects in female

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

Patient: female, weighing 76.0 kg (167.2 pounds)

Reactions: Primary Sequestrum, Gingivitis, Respiratory Disorder, Exposed Bone in JAW, Bone Pain, Neoplasm Progression, Osteomyelitis, Bone Fistula, Periodontal Infection, Pleural Effusion, Pneumonia Staphylococcal, Metastases To Chest Wall, Bone Lesion, General Physical Health Deterioration, Bone Swelling, Mediastinal Shift, Neoplasm Malignant, Osteonecrosis of JAW, Bone Neoplasm, Gingival Infection, Metastases To Bone

Adverse event resulted in: death

Drug(s) suspected as cause:
Aredia
    Dosage: 90 mg, daily
    Indication: Metastases To Bone
    Start date: 2006-02-01
    End date: 2006-05-01

Fareston
    Dosage: 40 mg, daily
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2009-07-27
    End date: 2010-11-22

Femara
    Dosage: 2.5 mg, daily
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2010-11-22
    End date: 2011-04-25

Medroxyprogesterone Acetate
    Dosage: 1200 mg, daily
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2008-06-02
    End date: 2009-07-27

Tamoxifen Citrate
    Dosage: 20 mg, daily
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-04-25
    End date: 2011-09-13

Zometa
    Dosage: 4 mg, daily
    Indication: Metastases To Bone
    Start date: 2006-05-01
    End date: 2008-05-01

Other drugs received by patient: Capecitabine; Paclitaxel; Medroxyprogesterone Acetate



Possible Femara side effects in 72 year old female

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

Patient: 72 year old female

Reactions: Abdominal Discomfort, Hypotension, Incorrect Dose Administered, Dizziness

Drug(s) suspected as cause:
Femara
    Dosage: 2.5mg per day
    Indication: Breast Cancer
    Start date: 2012-06-01

Femara
    Dosage: 1.25 mg/day
    Start date: 2012-07-25
    End date: 2012-07-30

Femara
    Dosage: 2.5mg per day
    Start date: 2012-07-31



Possible Femara side effects in female

Reported by a physician from United States on 2012-08-07

Patient: female, weighing 65.0 kg (143.0 pounds)

Reactions: General Physical Health Deterioration, Cerebrovascular Accident

Adverse event resulted in: death

Drug(s) suspected as cause:
Femara



Possible Femara side effects in 69 year old female

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

Patient: 69 year old female

Reactions: Hypokinesia, Dyspnoea, Discomfort

Drug(s) suspected as cause:
Femara

Other drugs received by patient: Lasix; Aspirin; Procoralan; Plavix; Atorvastatin



Possible Femara side effects in 62 year old female

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

Patient: 62 year old female

Reactions: Abdominal Pain, Fatigue, Arthralgia, Nausea, Pain in Extremity, Restlessness, Insomnia, Crying

Drug(s) suspected as cause:
Femara



Possible Femara side effects in 58 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-03

Patient: 58 year old female

Reactions: Congestive Cardiomyopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epirubicin Hydrochloride
    Dosage: unk
    Indication: Breast Cancer
    Start date: 2002-01-01
    End date: 2003-03-20

Femara
    Dosage: unk
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2009-01-01

Other drugs received by patient: Effexor; Zolpidem Tartrate; Levothyroxine Sodium; Lexomil



Possible Femara side effects in female

Reported by a pharmacist from Japan on 2012-08-02

Patient: female

Reactions: Uterine Leiomyoma, Condition Aggravated

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

Toremifene
    Administration route: Oral



Possible Femara side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: female

Reactions: Breast Cancer, Lymphadenopathy, Neoplasm Malignant

Drug(s) suspected as cause:
Femara



Possible Femara side effects in female

Reported by a consumer/non-health professional from Denmark on 2012-08-02

Patient: female

Reactions: Rheumatoid Arthritis

Drug(s) suspected as cause:
Femara
    Indication: Breast Cancer

Herceptin
    Indication: Breast Cancer



Possible Femara side effects in female

Reported by a physician from India on 2012-08-01

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Femara



Possible Femara side effects in 58 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-01

Patient: 58 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Glaucoma, Toothache

Drug(s) suspected as cause:
Femara

Other drugs received by patient: Xalatan; Zopiclone; Famotidine; Synthroid



Possible Femara side effects in 66 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-01

Patient: 66 year old female

Reactions: Asthma, Breast Cancer, Osteoporosis, Hypothyroidism, Hypertension

Drug(s) suspected as cause:
Femara

Other drugs received by patient: Advair Diskus 100 / 50; Synthroid; Nasonex; Singulair; Diovan HCT



Possible Femara side effects in female

Reported by a pharmacist from Germany on 2012-07-30

Patient: female, weighing 75.0 kg (165.0 pounds)

Reactions: Confusional State, Tremor, Speech Disorder, Dizziness, Nervous System Disorder, Gait Disturbance, Memory Impairment, Coordination Abnormal, Myocardial Infarction, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bisoprolol Fumarate
    Dosage: 2.5mg twice per day

Femara
    Dosage: 2.5mg unknown

Herceptin

Ibandronate Sodium

Lapatinib
    Dosage: 1000mg per day
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2012-01-23
    End date: 2012-06-19



Possible Femara side effects in female

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

Patient: female, weighing 55.0 kg (121.0 pounds)

Reactions: Atelectasis, Chest Pain

Drug(s) suspected as cause:
Femara

Other drugs received by patient: Taxol; Avastin



Possible Femara side effects in female

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

Patient: female

Reactions: Ovarian Haemorrhage, Ovarian Cyst

Drug(s) suspected as cause:
Femara

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