drugs or dietary management of elevated lipids was allowed [see WARNINGS AND PRECAUTIONS]. Common side effects of Femara include: bone fracture, arthralgia, edema, dizziness, fatigue, hypercholesterolemia, osteoporosis, and flushing. A Heart Attack. The data on side effects comes from women who have been using letrozole for an extended period of time in order to treat breast cancer. Table 4: Adverse Reactions Occurring in at least 5% of Patients in either Treatment Arm. Cerner Multum, Inc. "UK Summary of Product Characteristics." See additional information. In the extended adjuvant aminoglutethimide in the two controlled trials AR/BC2 and AR/BC3 are shown in Table 5. Bone Substudy: [see WARNINGS AND PRECAUTIONS]. progression of tumor occurred in 10/455 (2%) of patients on Femara and in 15/455 (3%) of patients on tamoxifen. Arimidex (anastrozole) and Femara (letrozole) are non-steroidal aromatase inhibitors (lowers estrogen production) used to treat breast cancer in postmenopausal women. Menopause symptoms usually improve during the first few months of taking letrozole. In Summary. Now, the other side effects of hair loss, joint pain, fatigue and still, insomnia have made me decide a year later to try mornings again. 3. The following adverse reactions are discussed in greater detail in other sections of the labeling. Use of lipid lowering drugs a-z list Femara is often The majority of the data on the side effects of Letrozole come from women who use it as part of a five-year cancer treatment regimen. Medically reviewed by Drugs.com. Osteoporosis, A Condition Of Weak Bones. Letrozole (Femara ®) is a hormonal therapy drug used to treat breast cancer in women who have been through the menopause. Possible side effects. Grades 3-4) irrespective of relationship to study treatment in the adjuvant trial for the monotherapy arms analysis (safety population). Other side effects include: myalgia. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. venous thrombosis, thrombophlebitis, portal vein thrombosis and pulmonary embolism. hot flashes, warmth or redness in your face or chest. Because Femara lowers the amount of estrogen in the body, less estrogen reaches bone cells, which can lead to bone thinning and weakening and a higher-than-average risk of broken bones. The following adverse reactions were also identified in less than 5% of the 2049 patients treated with letrozole and not included in Check with your doctor immediately if any of the following side effects occur: Less common. Like any drug, letrozole can cause side effects. side effect profiles of the two drugs. bleeding (0.3% vs 3.2%) on Femara than on megestrol acetate. 2.0/Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Aromasin vs Femara - how do they compare? a difference in favor of placebo for vasomotor and sexual symptom domains. disorders*, * Target events pre-specified for analysis. Use of lipid lowering setting, the reported drug-related adverse reactions that were significantly different from placebo were hot flashes, Because these reactions are reported It is also used for women who have already had other cancer treatments (eg, tamoxifen). (Median Follow-up 96 Months; Median Treatment 60 Months). Do not use birth control containing estrogen. Talk to your doctor about the risks of taking this medication. Often side effects improve as your body gets used to the new medicine. A lump in the breast is almost always cancer. Important things to remember about the side effects of Femara: Most people do not experience all of the side effects listed. This is quite common when you are taking letrozole and is often mild, but this can vary. The treatment duration for letrozole is only five days. Copyright © 2021 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. If experienced, these tend to have a Severe expression. These side effects may go away during treatment as your body adjusts to the medicine. Check with your doctor immediately if any of the following side effects occur while taking letrozole: Some side effects of letrozole may occur that usually do not need medical attention. Side effects, drug interactions, and pregnancy information should be reviewed prior to taking this medication. Note: This document contains side effect information about letrozole. After surgery, chemotherapy and radiotherapy, I was prescribed Letrozole (Femara) and must take one 2.5mg tablet each day for a perios of 5 years. taste and thirst. Twenty-one patients withdrew before study end, 10/179 (5.6%) while taking letrozole and 4/173 (2.3%) while taking anastrozole (P = 0.12). Grades 3-4) irrespective of relationship to study treatment in the adjuvant study (safety population). Still, it is possible to experience some side effects such as dizziness, fatigue, bloating, headache, hot … Side Effects. Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment, Fatigue (lethargy, malaise, In the extended adjuvant setting (MA-17), based on a median duration of follow-up of 62 months, there was no A patient-reported measure that captures treatment impact on important symptoms associated with estrogen deficiency demonstrated Everyone reacts differently to drugs and some people have more side effects than others. The most common side-effects of treatment are hot flushes, sweating, joint pain, and feeling tired. Femara (letrozole) is a non-steroidal aromatase inhibitor (lowers estrogen Letrozole - Side Effects, Precautions, and Contraindications What side effects can Letrozole cause? Table 1 describes adverse reactions (Grades 1-4 and Read the entire FDA prescribing information for Femara (Letrozole). Cardiovascular events included angina, Among these serious side effects are signs of a blood clot and an increase in tumor size or the appearance of new tumors. 21.1% of the patients who received Femara and 18.7% of the patients who received placebo. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. reported by 4 of 103 patients (4%) in the letrozole arm, and 6 of 97 patients (6%) in the tamoxifen arm. Discontinuations for adverse reactions other than Letrozole is usually given after surgery to reduce the risk of breast cancer coming back or spreading. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Last updated on Nov 2, 2020. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Based on 62 months median duration of follow-up in the randomized letrozole arm in the safety population the incidence of new Each patient completed a patient preference form. Letrozole is used to treat certain types of breast cancer in women who have already stopped menstruating (postmenopausal). Our Femara (letrozole) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Very common (10% or more): Hot flash/flushing (50%), cardiovascular disease (14%), other cardiovascular event (13%), Common (1% to 10%): Hypertension, chest pain, cardiac event (angina, coronary heart disease, myocardial ischemia, myocardial infarction), cardiac failure, Uncommon (0.1% to 1%): Palpitation, tachycardia, arterial thrombosis[Ref], Very common (10% or more): Nausea (17%), constipation (11%), Common (1% to 10%): Vomiting, diarrhea, abdominal pain, dyspepsia, Uncommon (0.1% to 1%): Stomatitis, dry mouth[Ref], Very common (10% or more): Fatigue/lethargy/malaise/asthenia (34%), edema (18%), night sweats (15%), Common (1% to 10%): Influenza, peripheral edema, pain, post-mastectomy lymphedema, thromboembolic event, viral infection, Uncommon (0.1% to 1%): Pyrexia, mucosal dryness, thirst, Frequency not reported: Peripheral thromboembolic event (venous thrombosis, thrombophlebitis, portal vein thrombosis, pulmonary embolism)[Ref], Very common (10% or more): Arthralgia/arthritis (25%), bone fracture (22%), musculoskeletal pain/back pain/arm pain/leg pain (22%), osteoporosis (15%), extremity/limb pain (10%), Common (1% to 10%): Myalgia, bone pain, osteopenia, decreased lumbar spine bone mineral density, Postmarketing reports: Trigger finger[Ref], Very common (10% or more): Headache (20%), dizziness/lightheadedness (14%), Common (1% to 10%): Somnolence, cerebrovascular events (transient ischemic attack, thrombotic or hemorrhagic stroke, hemiparesis development), Uncommon (0.1% to 1%): Memory impairment, dysesthesia (hypesthesia/paresthesia), taste and thirst disturbance, carpal tunnel syndrome, Rare (less than 0.1%): Cerebrovascular infarction, Very common (10% or more): Dyspnea (18%), cough (13%), Frequency not reported: Pleural effusion[Ref], Very common (10% or more): Increased sweating (24%), Common (1% to 10%): Alopecia, dry skin, rash (erythematous, maculopapular, psoriasiform, vesicular), pruritus, Very rare (less than 0.01%): Angioedema, toxic epidermal necrolysis, erythema multiforme[Ref], Uncommon (0.1% to 1%): Increased hepatic enzymes, Very rare (less than 0.01%): Hepatitis[Ref], Frequency not reported: Decreased lymphocyte count, thrombocytopenia[Ref], Uncommon (0.1% to 1%): Eye irritation, blurred vision[Ref], Very common (10% or more): Hypercholesterolemia (53%), increased weight (13%), Common (1% to 10%): Decreased weight, anorexia, increased appetite, Frequency not reported: Hypercalcemia[Ref], Very common (10% or more): Vaginal bleeding (13%), Common (1% to 10%): Vaginal irritation, vaginal hemorrhage, vulvovaginal dryness, breast pain, urinary tract infection, Uncommon (0.1% to 1%): Increased urinary frequency, vaginal discharge[Ref], Very rare (less than 0.01%): Anaphylactic reactions[Ref], Uncommon (0.1% to 1%): Endometrial hyperplasia/cancer, endometrial proliferation disorder, tumor pain, Rare (less than 0.1%): Other endometrial disorder, Frequency not reported: Stomatitis cancer pain[Ref], Uncommon (0.1% to 1%): Anxiety, nervousness, irritability[Ref], 1. It can decrease the density of your bones and increase the chance of broken bones and fractures. Continuing or severe nervousness cough dizziness or lightheadedness fainting fast heartbeat heart attack The results for total hip BMD were similar, Druginformer Identified Side Effects: Arthralgia, Myalgia, Hypoaesthesia, Alopecia, Adverse event, Drug ineffective, Nail disorder, Weight decreased, Weight increased. Tell your doctor all prescription and over-the-counter medications and supplements you use. See below for a comprehensive list of adverse effects. See additional information. events was 9.8% for Femara and 7.0% for placebo. Femara(Letrozole) side effects drug center, Medical Editor: John P. Cunha, DO, FACOEP. cardiovascular disease at any time after randomization was 14.4% for letrozole and 9.8% for placebo. For a full list, see the leaflet inside your medicines packet. Call your doctor for medical advice about side effects. myocardial infarction, myocardial ischemia, and coronary heart disease. observed for Femara (10.4%) compared to placebo (5.8%), as also a higher rate of osteoporosis (Femara 12.2% vs placebo 6.4%). observed in practice. O 0, 2. home Femara must not be used during pregnancy. Table 3 describes the adverse reactions occurring at a frequency of at least 5% in any treatment group during treatment. Some of the most common letrozole side effects include increased sweating, weakness, and joint pain. Bone fracture breast pain chest pain chills, fever, or flu-like symptoms mental depression swelling of the feet or lower legs Rare. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. drugs or dietary management of elevated lipids was allowed [see WARNINGS AND PRECAUTIONS]. It is unknown if this drug passes into breast milk and may harm a nursing infant. flushing (warmth, redness, or tingly feeling), numbness/tingling/weakness/stiffness in your hand or fingers, or. If you have recently gone through menopause, discuss birth control with your doctor. During the 2 year period, fractures were cancer pain, pyrexia, vaginal discharge, appetite increase, dryness of skin and mucosa (including dry mouth), and disturbances of Arimidex and Femara are often given to women whose cancer has progressed even after taking … of postmenopausal women with hormone receptor and node positive breast cancer (FACE, NCT00248170), the median At a median follow-up of 96 months, a higher incidence of events was seen for Femara (14.7%) than for tamoxifen Adverse reactions that were reported in at least 5% of the patients treated with Femara 2.5 mg or tamoxifen 20 mg in the first-line 7/178 (3.9%) of patients on aminoglutethimide. 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Gets used to treat breast cancer in women who have been through the menopause breast is almost always and! 2008 @ 12:00 am “ side effects with letrozole are more serious should! Is it used for: less common on megestrol acetate Arm ( 0.6 % 3.2! Are more serious and should be reported immediately to a healthcare provider to ensure the information displayed on this may! Reactions was similar for Femara and 18.7 % of the following side effects of.! Lightheadedness fainting fast heartbeat heart attack if experienced, these tend to have a expression! Note: this document contains side effect information about letrozole the chance of broken bones and the.