Common Femara Side Effects


The most commonly reported Femara side effects (click to view or check a box to report):

Arthralgia (198)
Fatigue (112)
Dyspnoea (84)
Hot Flush (71)
Headache (69)
Bone Pain (69)
Pain In Extremity (68)
Myalgia (65)
Dizziness (64)
Pain (61)
Asthenia (60)
Malignant Neoplasm Progression (57)
Depression (55)
Death (55)
Nausea (54)
Back Pain (52)
Insomnia (46)
Visual Acuity Reduced (41)
Alopecia (41)
Oedema Peripheral (39)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Femara Side Effects Reported to FDA



Femara Side Effect Report#9992512
Multiple Sclerosis
This is a report of a 68-year-old patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Femara (dosage: Unk Ukn, Unk, start time: NS), combined with:
  • Simvastatin (Unk Ukn, Unk)
  • Clopidogrel (Unk Ukn, Unk)
  • Bezafibrate (Unk Ukn, Unk)
  • Adcal (Unk Ukn, Unk)
and developed a serious reaction and side effect(s): Multiple Sclerosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Femara treatment in patients, resulting in Multiple Sclerosis side effect.
Femara Side Effect Report#9973714
Hepatotoxicity, Liver Function Test Abnormal, Metastases To Lymph Nodes, Breast Cancer, Malignant Neoplasm Progression
This report suggests a potential Femara Hepatotoxicity side effect(s) that can have serious consequences. A female patient (weight: NA) from AT was diagnosed with the following symptoms/conditions: breast cancer and used Femara (dosage: 1 Mg, Unk) starting 201002. After starting Femara the patient began experiencing various side effects, including: Hepatotoxicity, Liver Function Test Abnormal, Metastases To Lymph Nodes, Breast Cancer, Malignant Neoplasm ProgressionAdditional drugs used concurrently:
  • Anastrozol (Unk Ukn, Unk)
  • Fulvestrant (Unk Ukn, Unk)
Although Femara demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatotoxicity, may still occur.
Femara Side Effect Report#9902890
Neuropathy Peripheral
This Neuropathy Peripheral problem was reported by a health professional from FR. A 65-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer. On 2006 this consumer started treatment with Femara (dosage: 2.5 Mg). The following drugs were being taken at the same time:
  • Epirubicin (Unk Ukn, Unk)
  • Taxotere (160 Mg/ 8 Ml)
  • Cyclophosphamide (Unk Ukn, Unk)
When using Femara, the patient experienced the following unwanted symptoms/side effects: Neuropathy PeripheralThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Neuropathy Peripheral, may become evident only after a product is in use by the general population.
Femara Side Effect Report#9893723
Osteoporosis
This Death side effect was reported by a consumer or non-health professional from Country Not Specified. A 94-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer recurrent.The patient was prescribed Femara (drug dosage: 2.5 Mg, Daily), which was initiated on
Feb 11, 2014. Concurrently used drugs:
  • Coversyl Plus /01421201/ (Unk Ukn, Unk)
  • Ferrotabs (Unk Ukn, Unk)
.After starting to take Femara the consumer reported adverse symptoms, such as: OsteoporosisThese side effects may potentially be related to Femara.
Femara Side Effect Report#9886274
Pericarditis
This is a report of a 62-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: breast cancer, who was treated with Femara (dosage: 1 Df, Qd, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Pericarditis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Femara treatment in female patients, resulting in Pericarditis side effect.
Femara Side Effect Report#9869885
Cardiac Failure Chronic, Pulmonary Congestion, Pericardial Effusion, Dyspnoea, Anaemia, Haemoglobin Decreased, Cardiac Disorder, Pyrexia, Weight Increased
This report suggests a potential Femara Cardiac Failure Chronic side effect(s) that can have serious consequences. A 76-year-old female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: breast cancer and used Femara (dosage: 2.5 Mg, Daily) starting
Jun 27, 2013. After starting Femara the patient began experiencing various side effects, including: Cardiac Failure Chronic, Pulmonary Congestion, Pericardial Effusion, Dyspnoea, Anaemia, Haemoglobin Decreased, Cardiac Disorder, Pyrexia, Weight IncreasedAdditional drugs used concurrently:
  • Herceptin (8 Mg/kg, Weekly)
  • Herceptin (Unk)
  • Lansoprazole (15 Mg, Unk)
  • Blopress (4 Mg, Unk)
  • Lasix (40 Mg, Unk)
  • Aldactone A (12.5 Mg, Unk)
  • Aromasin (25 Mg, Unk)
  • Brotizolam
The patient was hospitalized. Although Femara demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Failure Chronic, may still occur.
Femara Side Effect Report#9867649
Fibrin D Dimer Increased, Blood Pressure Increased, Blood Cholesterol Increased, Pain In Extremity, Pain In Extremity, Groin Pain, Electrocardiogram Abnormal, Fear, Amnesia
This Fibrin D Dimer Increased problem was reported by a consumer or non-health professional from US. A 43-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer. On
Nov 01, 2012 this consumer started treatment with Femara (dosage: Stopped 1-28-13?started Again 1-1-14 114). The following drugs were being taken at the same time: NA. When using Femara, the patient experienced the following unwanted symptoms/side effects: Fibrin D Dimer Increased, Blood Pressure Increased, Blood Cholesterol Increased, Pain In Extremity, Pain In Extremity, Groin Pain, Electrocardiogram Abnormal, Fear, AmnesiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Fibrin D Dimer Increased, may become evident only after a product is in use by the general population.
Femara Side Effect Report#9856114
Atrial Fibrillation, Cerebral Infarction
This Atrial Fibrillation side effect was reported by a consumer or non-health professional from JP. A 80-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Femara (drug dosage: Unk Ukn, Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Femara the consumer reported adverse symptoms, such as: Atrial Fibrillation, Cerebral InfarctionThese side effects may potentially be related to Femara. The patient was hospitalized.
Femara Side Effect Report#9848682
Dizziness, Blood Cholesterol Increased, Fatigue
This is a report of a 51-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Femara (dosage: Unk Ukn , Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Dizziness, Blood Cholesterol Increased, Fatigue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Femara treatment in female patients, resulting in Dizziness side effect.
Femara Side Effect Report#9848649
Depression, Musculoskeletal Stiffness, Pain In Extremity, Arthralgia
This report suggests a potential Femara Depression side effect(s) that can have serious consequences. A 74-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: oestrogen receptor positive breast cancer and used Femara (dosage: Unk , Qd) starting NS. After starting Femara the patient began experiencing various side effects, including: Depression, Musculoskeletal Stiffness, Pain In Extremity, ArthralgiaAdditional drugs used concurrently: NA. Although Femara demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Depression, may still occur.
Femara Side Effect Report#9848636
Malignant Neoplasm Progression, Metastases To Bone
This Malignant Neoplasm Progression problem was reported by a physician from US. A 65-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Femara (dosage: Unk Ukn, Unk). The following drugs were being taken at the same time:
  • Caltrate (calcium Carbonate)
  • Glyburide (glibenclamide)
  • Levothyroxine Sodium (levothyroxine Sodium)
  • Multivitamin /00097801/ (ascorbic Acid, Calcium Pantothenate, Ergocaciferol,nicotinamide, Pyridoxine
  • Vitamin B6 (pyridoxine Hydrochloride)
  • Acyclovir (aciclovir) (aciclovir)
  • Exemestane (exemestane)
  • Prochlorpezazine Maleate (prochlorperazine Maleate)
When using Femara, the patient experienced the following unwanted symptoms/side effects: Malignant Neoplasm Progression, Metastases To BoneAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Malignant Neoplasm Progression, may become evident only after a product is in use by the general population.
Femara Side Effect Report#9848316
Fatigue, Dizziness, Alopecia, Insomnia, Blood Cholesterol Increased
This Fatigue side effect was reported by a health professional from US. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Femara (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Femara the consumer reported adverse symptoms, such as: Fatigue, Dizziness, Alopecia, Insomnia, Blood Cholesterol IncreasedThese side effects may potentially be related to Femara.
Femara Side Effect Report#9848311
Decreased Appetite, Fatigue, Dysgeusia, Alopecia, Hot Flush
This is a report of a 55-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Femara (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Decreased Appetite, Fatigue, Dysgeusia, Alopecia, Hot Flush after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Femara treatment in female patients, resulting in Decreased Appetite side effect.
Femara Side Effect Report#9848304
Insomnia
This report suggests a potential Femara Insomnia side effect(s) that can have serious consequences. A 65-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Femara (dosage: NA) starting NS. After starting Femara the patient began experiencing various side effects, including: InsomniaAdditional drugs used concurrently: NA. Although Femara demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Insomnia, may still occur.
Femara Side Effect Report#9848295
Arthralgia
This Arthralgia problem was reported by a health professional from US. A 79-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Femara (dosage: NA). The following drugs were being taken at the same time: NA. When using Femara, the patient experienced the following unwanted symptoms/side effects: ArthralgiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Arthralgia, may become evident only after a product is in use by the general population.
Femara Side Effect Report#9846095
Visual Field Defect, Cataract, Vision Blurred
This Visual Field Defect side effect was reported by a consumer or non-health professional from FR. A 78-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer.The patient was prescribed Femara (drug dosage: Unk Ukn, Qd), which was initiated on 201307. Concurrently used drugs:
  • Letrozole (Unk Ukn, Qd)
.After starting to take Femara the consumer reported adverse symptoms, such as: Visual Field Defect, Cataract, Vision BlurredThese side effects may potentially be related to Femara.
Femara Side Effect Report#9839093
Syncope
This is a report of a 59-year-old female patient (weight: NA) from GR, suffering from the following health symptoms/conditions: breast cancer, who was treated with Femara (dosage: Unk Ukn, Unk, start time: 201309), combined with:
  • Thyroxine (Unk Ukn, Unk)
and developed a serious reaction and side effect(s): Syncope after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Femara treatment in female patients, resulting in Syncope side effect.
Femara Side Effect Report#9830930
Mesenteric Artery Thrombosis, Enterocolitis, Disseminated Intravascular Coagulation, Platelet Count Decreased, Suture Rupture, Abdominal Pain Lower, Diarrhoea
This report suggests a potential Femara Mesenteric Artery Thrombosis side effect(s) that can have serious consequences. A 74-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: breast cancer metastatic and used Femara (dosage: 2.5 Mg, Daily) starting
Dec 16, 2008. After starting Femara the patient began experiencing various side effects, including: Mesenteric Artery Thrombosis, Enterocolitis, Disseminated Intravascular Coagulation, Platelet Count Decreased, Suture Rupture, Abdominal Pain Lower, DiarrhoeaAdditional drugs used concurrently:
  • Flumetholon (Unk Ukn, Unk)
  • Hyalein (Unk Ukn, Unk)
The patient was hospitalized. Although Femara demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Mesenteric Artery Thrombosis, may still occur.
Femara Side Effect Report#9820851
Respiratory Distress, Dyspnoea, Haemoptysis, Cough, Insomnia
This Respiratory Distress problem was reported by a physician from DZ. A 54-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: oestrogen receptor positive breast cancer. On 201306 this consumer started treatment with Femara (dosage: 2.5 Mg, Qd). The following drugs were being taken at the same time: NA. When using Femara, the patient experienced the following unwanted symptoms/side effects: Respiratory Distress, Dyspnoea, Haemoptysis, Cough, InsomniaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Respiratory Distress, may become evident only after a product is in use by the general population.
Femara Side Effect Report#9819479
Palmar-plantar Erythrodysaesthesia Syndrome, Diarrhoea
This Palmar-plantar Erythrodysaesthesia Syndrome side effect was reported by a consumer or non-health professional from JP. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer,colon cancer.The patient was prescribed Femara (drug dosage: 2.5 Mg, Daily), which was initiated on
Aug 23, 2013. Concurrently used drugs:
  • Xeloda (300 Mg, Qd)
  • Alfarol (Unk Ukn, Unk)
  • Aspara-ca (Unk Ukn, Unk)
.After starting to take Femara the consumer reported adverse symptoms, such as: Palmar-plantar Erythrodysaesthesia Syndrome, DiarrhoeaThese side effects may potentially be related to Femara.
Femara Side Effect Report#9784168
Gastritis Erosive, Chest Pain, Syncope
This is a report of a 58-year-old female patient (weight: NA) from RU, suffering from the following health symptoms/conditions: NA, who was treated with Femara (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Gastritis Erosive, Chest Pain, Syncope after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Femara treatment in female patients, resulting in Gastritis Erosive side effect.
Femara Side Effect Report#9782623
Osteoporosis, Hyperparathyroidism
This report suggests a potential Femara Osteoporosis side effect(s) that can have serious consequences. A 53-year-old female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: breast cancer and used Femara (dosage: 2.5 Mg, Daily) starting 201105. After starting Femara the patient began experiencing various side effects, including: Osteoporosis, HyperparathyroidismAdditional drugs used concurrently: NA. Although Femara demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Osteoporosis, may still occur.
Femara Side Effect Report#9749473
Retinal Artery Occlusion
This Retinal Artery Occlusion problem was reported by a health professional from JP. A 59-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 200906 this consumer started treatment with Femara (dosage: 2.5 Mg, Daily). The following drugs were being taken at the same time: NA. When using Femara, the patient experienced the following unwanted symptoms/side effects: Retinal Artery OcclusionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Retinal Artery Occlusion, may become evident only after a product is in use by the general population.
Femara Side Effect Report#9746265
Breast Cancer, Oestrogen Receptor Assay Positive, Nervous System Disorder, Tremor, Fall, Presyncope, Hypoglycaemia, Insulinoma
This Breast Cancer side effect was reported by a consumer or non-health professional from US. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer.The patient was prescribed Femara (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Femara the consumer reported adverse symptoms, such as: Breast Cancer, Oestrogen Receptor Assay Positive, Nervous System Disorder, Tremor, Fall, Presyncope, Hypoglycaemia, InsulinomaThese side effects may potentially be related to Femara. The patient was hospitalized.
Femara Side Effect Report#9745994
Nerve Compression, Pain In Extremity, Pelvic Pain, Back Pain, Pain, Intermittent Claudication
This is a report of a 66-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: breast cancer, who was treated with Femara (dosage: 1 Df, Qd, start time: 2011), combined with: NA. and developed a serious reaction and side effect(s): Nerve Compression, Pain In Extremity, Pelvic Pain, Back Pain, Pain, Intermittent Claudication after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Femara treatment in female patients, resulting in Nerve Compression side effect.


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The appearance of Femara on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Femara Side Effects for Women?

Women Side Effects Reports
Arthralgia 197
Fatigue 109
Dyspnoea 84
Hot Flush 69
Bone Pain 67
Headache 67
Pain In Extremity 66
Myalgia 64
Dizziness 62
Pain 61

What are common Femara Side Effects for Men?

Men Side Effects Reports
Fatigue 3
Hypertension 3
Autonomic Nervous System Imbalance 2
Blood Pressure Increased 2
Death 2
Dizziness 2
Epiphysiolysis 2
Femur Fracture 2
Headache 2
Hot Flush 2

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Femara reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Femara Safety Alerts, Active Ingredients, Usage Information

    NDC 0078-0249
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Femara
    Name letrozole
    Dosage Form TABLET, FILM COATED
    Route ORAL
    On market since 19970731
    Labeler Novartis Pharmaceuticals Corporation
    Active Ingredient(s) LETROZOLE
    Strength(s) 2.5
    Unit(s) mg/1
    Pharma Class Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]

    Femara Dosage, Warnings, Usage.

    Side Effects reported to FDA: 1637

    Femara safety alerts: No

    Reported deaths: 234

    Reported hospitalizations: 508

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