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),
Dyspnoea (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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-30
Patient: female
Reactions: Back Pain, Pain, Aggression, Myalgia, Thinking Abnormal, Arthralgia, Mental Disorder, Musculoskeletal Stiffness, Gait Disturbance, Anuria
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Femara
Dosage: 2.5 mg, daily
Administration route: Oral
Indication: Breast Cancer
Letrozole
Dosage: 2.5 mg, unk
Indication: Breast Cancer
Possible Femara side effects in female
Reported by a consumer/non-health professional from Australia on 2012-07-30
Patient: female
Reactions: Pneumonia
Drug(s) suspected as cause:
Femara
Dosage: unk ukn, unk
Femara
Dosage: unk ukn, unk
Administration route: Oral
Indication: Breast Cancer
Start date: 2009-01-01
End date: 2012-06-01
Letrozole
Dosage: unk ukn, unk
Indication: Breast Cancer
Start date: 2012-06-01
Possible Femara side effects in female
Reported by a consumer/non-health professional from Canada on 2012-07-30
Patient: female
Reactions: Night Sweats, Neoplasm, Lacrimal Duct Neoplasm, Breast Infection, Weight Increased, Arthralgia, Alopecia, Gait Disturbance, Depression, Depressed Mood
Drug(s) suspected as cause:
Femara
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