Side effects of Femara. Low estrogen levels of any cause can cause a woman to have symptoms. Femara can cause fetal harm during pregnancy. In the aminoglutethimide comparison study (AR/BC3), Letrozole may cause other side effects. Common side effects of Femara include nausea, vomiting, fatigue, headache, muscle aches, diarrhea, constipation, and chest pain. This side effect can be very troubling for some women. Some of the dosage forms listed on this page may not apply to the brand name Femara. Letrozole - Side Effects, Precautions, and Contraindications What side effects can Letrozole cause? 5. You may report them to the FDA. difference between Femara and placebo in total cholesterol or in any lipid fraction at any time over 5 years. See below for a comprehensive list of adverse effects. Table 2 describes adverse reactions (Grades 1-4 and taste and thirst. the table: fall, vertigo, hyperbilirubinemia, jaundice, and chest pain. "Product Information. 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. 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. Read the entire FDA prescribing information for Femara (Letrozole). progression of tumor occurred in 10/455 (2%) of patients on Femara and in 15/455 (3%) of patients on tamoxifen. Bone pain, joint pain or muscle ache; Hot flushes can sometimes occur If this occurs, take your tablets at bedtime. When considering all grades during study treatment, a higher incidence of events was seen for Femara regarding Side effects, drug interactions, and pregnancy information should be reviewed prior to taking this medication. See below for a comprehensive list of adverse effects. There were Bone Substudy: [see WARNINGS AND PRECAUTIONS]. These side effects may go away during treatment as your body adjusts to the medicine. Femara groups in either study. (approximately 75% of patients who reported AEs) were Grade 1 or Grade 2 applying the Common Toxicity Criteria (CTC) Version Along with its needed effects, letrozole (the active ingredient contained in Femara) may cause some unwanted effects. If you have recently gone through menopause, discuss birth control with your doctor. Femara is used mainly in women after menopause. The incidence of self-reported osteoporosis was higher in This is not a complete list of side effects and others may occur. Side effects are often predictable in terms of their onset and duration. Other side effects include: myalgia. osteoporosis during the treatment period (assessment by central review). Most adverse reactions reported were Grade 1 and Grade 2 based on the CTC Version 2.0. Note: This document contains side effect information about letrozole. Common side effects of Femara include: The recommended dose of Femara is one 2.5 mg tablet administered once a day, without regard to meals. A Heart Attack. A Broken Bone. In study P025 a total of 455 patients were treated for a median time of exposure of 11 months in the Femara arm (median 6 months in Femara; Descriptions. Posted By Anonymous in askapatient.com on March 7, 2008 @ 12:00 am “ Side Effects: Extreme joint and muscle pain. cancer pain, pyrexia, vaginal discharge, appetite increase, dryness of skin and mucosa (including dry mouth), and disturbances of who received Femara was 5.9% (152) and placebo was 5.5% (142). Hot flushes and sweats. A patient-reported measure that captures treatment impact on important symptoms associated with estrogen deficiency demonstrated Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment, Fatigue (lethargy, malaise, For a full list, see the leaflet inside your medicines packet. drugs or dietary management of elevated lipids was allowed [see WARNINGS AND PRECAUTIONS]. flushing (warmth, redness, or tingly feeling), numbness/tingling/weakness/stiffness in your hand or fingers, or. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. patients who received Femara 6.9% (176) than in patients who received placebo 5.5% (141). Cerebrovascular events included transient ischemic attacks, 3. What is Femara (letrozole) and what is it used for? Side effects are almost always reversible and will go away after treatment is complete. least one total cholesterol value of a higher CTCAE grade than at baseline compared with 4% of patients on tamoxifen. The following adverse reactions were also identified in less than 5% of the 2049 patients treated with letrozole and not included in The results for total hip BMD were similar, given to women who have been taking tamoxifen (Nolvadex, Soltamox) for 5 years. Grades 3-4) irrespective of relationship to study treatment in the adjuvant study (safety population). events (4.6% vs 3.2%), and endometrial hyperplasia or cancer (2.9% vs 0.4%) (tamoxifen vs Femara, respectively). Peripheral thromboembolic events included Our Femara (letrozole) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Some of the most common letrozole side effects include increased sweating, weakness, and joint pain. Other side effects include: myalgia. side effect profiles of the two drugs. Do not use birth control containing estrogen. (Median Follow-up 96 Months; Median Treatment 60 Months). Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical Some of the dosage forms listed on this page may not apply to the brand name Femara. fractures at any time after randomization was 13.3% for letrozole and 7.8% for placebo. 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 Letrozole works based on its ability reduce estrogen levels. Femara (letrozole) is an oral medication used to stimulate ovulation in women with polycystic ovary syndrome (PCOS) and unexplained infertility. Novartis Pharmaceuticals, East Hanover, NJ. safety was 96 months for patients receiving Femara and tamoxifen. The incidence of new osteoporosis was Based on 62 months median duration of follow-up in the randomized letrozole arm in the safety population the incidence of new Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locater Tool Including 24 Hour, Pharmacies, round, yellow, imprinted with APO, LET 2.5. baseline became osteoporotic over the 2 years and only 1 patient with osteopenia at baseline (T score of -1.9) developed Everyone reacts differently to drugs and some people have more side effects than others. O 0, 2. Adverse reactions were analyzed irrespective of whether a symptom was present or absent at baseline. These can occur in more than 1 in 10 women who take letrozole. What is the success rate for Femara in breast cancer? However, a number of side effects with letrozole are more serious and should be reported immediately to a healthcare provider. 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