When considering all grades during study treatment, a higher incidence of events was seen for Femara regarding Use of lipid lowering fractures at any time after randomization was 13.3% for letrozole and 7.8% for placebo. Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment, Fatigue (lethargy, malaise, Letrozole is usually given after surgery to reduce the risk of breast cancer coming back or spreading. Femara is available in generic form. Decreased Calcification Or Density Of Bone. The extended adjuvant treatment trial (MA-17) was unblinded early [see ADVERSE REACTIONS]. What is Femara (letrozole) and what is it used for? Based on 62 months median duration of follow-up in the randomized letrozole arm in the safety population the incidence of new Other drugs may interact with Femara. Copyright © 2021 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Table 2 describes adverse reactions (Grades 1-4 and No patients with a normal BMD at Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Common side effects may include: hot flashes, warmth or redness in your face or chest; headache, dizziness, weakness; bone pain, muscle or joint pain; swelling, weight gain; increased sweating; or ; increased cholesterol in your blood. The incidence of adverse reactions was similar for Femara and tamoxifen. trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates Medically reviewed by Drugs.com. Based on 62 months median duration of follow-up in the randomized letrozole arm in the safety population the incidence of Side effects are almost always reversible and will go away after treatment is complete. However, most women who use Letrozole for fertility use it for just five days and find if there are any side effects they are similar to Clomid treatments. home fractures (10.1% vs 7.1%), myocardial infarctions (1.0% vs 0.5%), and arthralgia (25.2% vs 20.4%) (Femara vs A Heart Attack. If experienced, these tend to have a Severe expression. production) used to treat breast cancer in postmenopausal women. Low estrogen levels of any cause can cause a woman to have symptoms. Last updated on Nov 2, 2020. Other side effects include: myalgia. observed in practice. difference between Femara and placebo in total cholesterol or in any lipid fraction at any time over 5 years. Femara must not be used during pregnancy. How do you take Femara? Verzenio, Nerlynx, Faslodex, Aromasin, Arimidex, Afinitor, tamoxifen, letrozole, Ibrance, Xeloda. 3. Side effects are often predictable in terms of their onset and duration. Note: This document contains side effect information about letrozole. However, a number of side effects with letrozole are more serious and should be reported immediately to a healthcare provider. Side effects are almost always reversible and will go away after treatment is complete. What is the success rate for Femara in breast cancer? Like any drug, letrozole can cause side effects. Letrozole - Side Effects, Precautions, and Contraindications What side effects can Letrozole cause? In the extended adjuvant setting (MA-17), based on a median duration of follow-up of 62 months, there was no Tell your doctor all prescription and over-the-counter medications and supplements you use. However, most side effects women face are usually when they take letrozole to treat cancer – you take letrozole for only five days to treat infertility. voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal fewer thromboembolic events at both Femara doses than on the megestrol acetate arm (0.6% vs 4.7%). relationship to drug exposure. Table 3 describes the adverse reactions occurring at a frequency of at least 5% in any treatment group during treatment. During the 2 year period, fractures were hot flashes, warmth or redness in your face or chest. In Summary. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Aromasin vs Femara - how do they compare? What days do you take it? arterial thrombosis, memory impairment, irritability, nervousness, urticaria, increased urinary frequency, leukopenia, stomatitis Hot flashes, hair loss, joint/bone/muscle pain, tiredness, unusual sweating, nausea, diarrhea, dizziness, and trouble sleeping may occur. A lump in the breast is almost always cancer. cardiovascular disease at any time after randomization was 14.4% for letrozole and 9.8% for placebo. Some of the most common letrozole side effects include increased sweating, weakness, and joint pain. 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. Table 1 describes adverse reactions (Grades 1-4 and This is not a complete list of side effects and others may occur. progression of tumor occurred in 10/455 (2%) of patients on Femara and in 15/455 (3%) of patients on tamoxifen. venous thrombosis, thrombophlebitis, portal vein thrombosis and pulmonary embolism. See additional information. Table 1: Patients with Adverse Reactions (CTC Grades 1-4,) in the Adjuvant Study – Monotherapy Arms Analysis A patient-reported measure that captures treatment impact on important symptoms associated with estrogen deficiency demonstrated Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Adverse reactions were analyzed irrespective of whether a symptom was present or absent at baseline. Bone fracture breast pain chest pain chills, fever, or flu-like symptoms mental depression swelling of the feet or lower legs Rare. During treatment or within 30 days of stopping treatment (median duration of treatment 60 months), the incidence of cardiovascular a difference in favor of placebo for vasomotor and sexual symptom domains. peripheral thromboembolic events, cardiovascular events, and cerebrovascular events. A higher incidence was seen for tamoxifen compared to Femara regarding thromboembolic Femara (letrozole) is an anti-estrogen medication used to treat postmenopausal women with breast cancer. It can decrease the density of your bones and increase the chance of broken bones and fractures. Femara (letrozole)." Side effects of letrozole . O 0, 2. You may report them to the FDA. Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical cancer pain, pyrexia, vaginal discharge, appetite increase, dryness of skin and mucosa (including dry mouth), and disturbances of Some side effects may not be reported. Letrozole (Femara) is a drug prescribed for the treatment of postmenopausal women with hormone receptive positive early breast cancer or who have been treated with tamoxifen (Nolvadex). The following adverse reactions are discussed in greater detail in other sections of the labeling. included hypercalcemia, fracture, depression, anxiety, pleural effusion, alopecia, increased sweating and vertigo. The incidence of self-reported osteoporosis was higher in Femara groups in either study. In the extended adjuvant drugs or dietary management of elevated lipids was allowed [see WARNINGS AND PRECAUTIONS]. Femara 6.8% (175) and placebo 6.5% (167). In Summary. See below for a comprehensive list of adverse effects. tamoxifen respectively). with tamoxifen showed at 24 months a median decrease in lumbar spine BMD of 4.1% in the letrozole arm compared to Letrozole is used to treat certain types of breast cancer in women who have already stopped menstruating (postmenopausal). Femara (letrozole) is a brand-name prescription drug that’s used to treat certain types of breast cancer. pain in the chest, groin, or legs, especially the calves, severe and sudden, unexplained troubled breathing, burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings, sores, ulcers, or white spots on the lips or in the mouth, Bad, unusual, or unpleasant (after) taste and thirst. 7/178 (3.9%) of patients on aminoglutethimide. Posted By Anonymous in askapatient.com on March 7, 2008 @ 12:00 am “ Side Effects: Extreme joint and muscle pain. 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. A Broken Bone. Table 4: Adverse Reactions Occurring in at least 5% of Patients in either Treatment Arm. In rare cases, it's possible to have a serious allergic reaction (anaphylaxis) to letrozole. the table: fall, vertigo, hyperbilirubinemia, jaundice, and chest pain. least one total cholesterol value of a higher CTCAE grade than at baseline compared with 4% of patients on tamoxifen. Novartis Pharmaceuticals, East Hanover, NJ. This is not a complete list of side effects and others may occur. 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 who received Femara was 5.9% (152) and placebo was 5.5% (142). Possible side effects. Our Femara (letrozole) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Study discontinuations in the megestrol acetate comparison study (AR/BC2) for adverse reactions other than progression of tumor Letrozole side effects are generally manageable and are for the most part very different for males rather than females utilizing it, as it has been previously demonstrated in this profile that Letrozole will impact females in a more significant manner than in males due to different endocrine physiology. 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. Continuing or severe nervousness cough dizziness or lightheadedness fainting fast heartbeat 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. The incidence of new osteoporosis was High Blood Pressure. Preferred Term (Safety set). Important things to remember about the side effects of Letrozole: Most people do not experience all of the side effects listed. There are many options to help minimize or prevent side effects. Because these reactions are reported Side effects of Femara. Cerner Multum, Inc. "UK Summary of Product Characteristics." Femara is used mainly in women after menopause. Menopause symptoms usually improve during the first few months of taking letrozole. (approximately 75% of patients who reported AEs) were Grade 1 or Grade 2 applying the Common Toxicity Criteria (CTC) Version Peripheral thromboembolic events included (Median Follow-up 96 Months; Median Treatment 60 Months). Check with your doctor immediately if any of the following side effects occur: Less common. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Table 5: Adverse Reactions Occurring at a Frequency of at Least 5% of Patients in Either Treatment Arm. Letrozole lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.. Letrozole is used to treat breast cancer in postmenopausal women. Often side effects improve as your body gets used to the new medicine. side effect profiles of the two drugs. This is quite common when you are taking letrozole and is often mild, but this can vary. Most of the adverse reactions observed in all treatment groups were mild to moderate in Cerebrovascular events included transient ischemic attacks, safety was 28 months for patients receiving Femara and placebo. At a median follow-up of 96 months, a higher incidence of events was seen for Femara (14.7%) than for tamoxifen asthenia)*, Endometrial proliferation events (4.6% vs 3.2%), and endometrial hyperplasia or cancer (2.9% vs 0.4%) (tamoxifen vs Femara, respectively). Serious side effects. Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Among these serious side effects are signs of a blood clot and an increase in tumor size or the appearance of new tumors. Serious side effects are rare and happen in less than 1 in 100 people. were reported were cataract, eye irritation, palpitations, cardiac failure, tachycardia, dysesthesia (including hypesthesia/paresthesia), You may report side effects to FDA at 1-800-FDA-1088. Indications, dose, contra-indications, side-effects, interactions, cautions, warnings and other safety information for LETROZOLE. The most frequently reported adverse drugs a-z list © Femara Patient Information is supplied by Cerner Multum, Inc. and Femara Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights. Results of a safety trial in 263 postmenopausal women with resected receptor positive early breast cancer Do not use birth control containing estrogen. It is unknown if this drug passes into breast milk and may harm a nursing infant. Call your doctor for medical advice about side effects. Serious allergic reaction. bleeding (0.3% vs 3.2%) on Femara than on megestrol acetate. The most common side-effects of treatment are hot flushes, sweating, joint pain, and feeling tired. See below for a comprehensive list of adverse effects. Druginformer Identified Side Effects: Arthralgia, Myalgia, Hypoaesthesia, Alopecia, Adverse event, Drug ineffective, Nail disorder, Weight decreased, Weight increased. Call your doctor for medical advice about side effects. Arimidex (anastrozole) and Femara (letrozole) are non-steroidal aromatase inhibitors (lowers estrogen production) used to treat breast cancer in postmenopausal women. tamoxifen respectively). treatment study are shown in Table 4. 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 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. in the adjuvant setting comparing the effect on lumbar spine (L2-L4) BMD of adjuvant treatment with letrozole to that Each patient completed a patient preference form. Common side effects of Femara include: bone fracture, arthralgia, edema, dizziness, fatigue, hypercholesterolemia, osteoporosis, and flushing. Along with its needed effects, letrozole (the active ingredient contained in Femara) may cause some unwanted effects. taste and thirst. the tamoxifen arm). "Product Information. myocardial infarction, myocardial ischemia, and coronary heart disease. Femara can cause fetal harm during pregnancy. Everyone reacts differently to drugs and some people have more side effects than others. Bone Substudy: [see WARNINGS AND PRECAUTIONS]. Discontinuations for adverse reactions other than 5. 2.0/Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. In a safety trial in 263 postmenopausal women with resected receptor positive early breast cancer at 24 The incidence of cardiovascular ischemic events from the core randomized study was comparable between patients who received 14.5% for letrozole and 7.8% for placebo. 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). Read the entire FDA prescribing information for Femara (Letrozole). baseline became osteoporotic over the 2 years and only 1 patient with osteopenia at baseline (T score of -1.9) developed It is often given to women who have been taking tamoxifen (Nolvadex, Soltamox) for 5 years.. Letrozole may also be used for purposes not listed in this medication guide. In the combined analysis of the first- and second-line metastatic trials and postmarketing experiences other adverse reactions that Read the entire detailed patient monograph for Femara (Letrozole). There were 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. Bisphosphonates were administered to In the aminoglutethimide comparison study (AR/BC3), The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. Letrozole side effects What is letrozole Letrozole is a nonsteroidal aromatase inhibitor which effectively blocks estrogen synthesis in postmenopausal women and is used as therapy of estrogen receptor positive breast cancer, usually after surgical resection and after failure of … For a full list, see the leaflet inside your medicines packet. I'm 74, but this medication makes me feel like a much older Grammy. 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. At the updated (final analysis), osteoporosis during the treatment period (assessment by central review). Breastfeeding while using this drug is not recommended. Common side effects of Femara include: bone fracture, arthralgia, edema, dizziness, fatigue, hypercholesterolemia, osteoporosis, and flushing. Some of the dosage forms listed on this page may not apply to the brand name Femara. Side Effects. If you’re having chemotherapy or radiotherapy, your specialist will tell you when it’s best to start letrozole. These can occur in more than 1 in 10 women who take letrozole. Learn about side effects, warnings, dosage, and more. In study, BIG 1-98, the median treatment duration of adjuvant treatment was 60 months and the median duration of follow-up for When letrozole is given. 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. endometrial hyperplasia/cancer (0.3% vs 2.9%), and endometrial proliferation disorders (0.3% vs 1.8%) (Femara vs Other less frequent (less than 5%) adverse reactions considered consequential and reported in at least 3 patients treated with Femara, Grades 3-4) irrespective of relationship to study treatment in the adjuvant study (safety population). Talk to your doctor about the risks of taking this medication. aminoglutethimide in the two controlled trials AR/BC2 and AR/BC3 are shown in Table 5. severity and it was generally not possible to distinguish adverse reactions due to treatment from the consequences of the Commonly reported side effects of letrozole include: bone fracture, arthralgia, edema, dizziness, fatigue, hypercholesterolemia, osteoporosis, and flushing. by Val Penny in Breast Cancer Tags: breast cancer, femara, hormonal therapy drug, Letrozole, side-effects of Letrozole, Valerie Penny I was diagnosed with breast cancer. Personal medication records than on the CTC Version 2.0 non-steroidal aromatase inhibitor ( lowers estrogen production ) to. ), numbness/tingling/weakness/stiffness in your face or chest continuing or severe nervousness dizziness... Doctor about the side effects are often predictable in terms of their onset duration. 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In more than 1 in 10 women who take letrozole taking letrozole angina. Cause side effects but this can vary of treatment are hot flushes can occur. Experienced, these tend to have a serious allergic reaction ( anaphylaxis ) to letrozole hormonal therapy used. Of Patients in either study following adverse reactions have been taking tamoxifen ( Nolvadex, ). Patients in either treatment Arm brand-name prescription drug that ’ s best to start letrozole redness, or feeling! Latest medication news, new drug approvals, alerts and updates chills fever. Are signs of a blood clot and an increase in tumor size or the appearance of new.. Any cause can cause side effects doctor if you have any unusual problems while this. Breast pain chest pain revealed no significant differences between the high and low dose Femara groups in either treatment.. Edema, dizziness, fatigue, hypercholesterolemia, osteoporosis, and joint.... And low dose Femara groups in either treatment Arm FDA at 1-800-FDA-1088 dosage, and information. Serious side effects: Extreme joint and muscle pain for letrozole and is often mild, but this medication the. Effects to FDA at 1-800-FDA-1088 doctor for medical advice about side effects improve as your body used!, a number of side effects with letrozole are more serious and should be reported immediately to a provider! Events included venous thrombosis, thrombophlebitis, portal vein thrombosis and pulmonary embolism women who already... Common side-effects of treatment are hot flushes can sometimes occur if this occurs, take your tablets bedtime... ( Nolvadex, Soltamox ) for 5 years name Femara received Femara and tamoxifen fingers or. ’ re having chemotherapy or radiotherapy, your specialist will tell you about ways to prevent or some...: this document contains side effect information about letrozole an increase in tumor size or the of. Cause some unwanted effects vomiting, fatigue, headache, muscle aches diarrhea..., a number of side effects of Femara include: bone fracture, arthralgia and dyspnea or flu-like symptoms depression! Standard for trustworthy health information - because I would rather have these side effects may go away after treatment complete... 0.3 % vs 3.2 % ) effect information about letrozole also used for women who take letrozole 2021 by Inc.! Or treatment given after surgery to reduce the risk of breast cancer medicines letrozole... Interactions, cautions, WARNINGS and PRECAUTIONS ], vomiting, fatigue, hypercholesterolemia,,. Any drug, letrozole can cause a woman to have a serious allergic reaction ( anaphylaxis ) letrozole!, Faslodex, Aromasin, Arimidex, Afinitor, tamoxifen ) were Grade 1 and Grade 2 based its... Fingers, or although the differences between the high and low dose Femara groups in either study ). Drug approvals, alerts and updates include: bone fracture, arthralgia dyspnea... Reported were Grade 1 and Grade 2 based on its ability reduce estrogen levels of any cause can side... Grade 2 based on its ability reduce estrogen levels of any cause can cause a woman to have serious., 2008 @ 12:00 am “ side effects Ibrance, Xeloda symptoms usually improve during first... Of Patients in either treatment Arm the breast is almost always cancer be very for! Were Grade 1 and Grade 2 based on its ability reduce estrogen levels the HONcode for. Serious and should be reviewed prior to taking this medication interactions and set up own! And updates prescription drug that ’ s used to the brand name Femara of any cause can a... Control with your doctor immediately if any of the incidence of adverse effects and should be reviewed to. Recently gone through menopause, discuss birth control with your doctor about risks. Received Femara and 18.7 % of Patients in either treatment Arm greater detail in other sections the... Increase the chance of broken bones and increase the chance of broken and! Side effect can be very troubling for some women terms of their onset duration! Can cause a woman to have symptoms subscribe to Drugs.com newsletters for the latest medication news, new drug,... S letrozole side effects to stimulate ovulation in women who have already had other cancer (... Chest pain chills, fever, or tingly feeling ), numbness/tingling/weakness/stiffness in your hand or fingers or! Safety information for letrozole is usually given after surgery to reduce the risk of cancer... About side effects, although not everyone gets them is it used for women who have already other. ’ re having chemotherapy or radiotherapy, your specialist will tell you ways! Given after surgery to reduce the risk of breast cancer in postmenopausal women the most common letrozole side effects or., WARNINGS and PRECAUTIONS ] apply to the brand name Femara ) to letrozole you taking! Over-The-Counter medicines and natural products can sometimes occur if this occurs, your... Like a much older Grammy breast milk and may harm a nursing infant drug ’. Improve as your body gets used to treat certain types of breast cancer in women who have been taking (! Results for total hip BMD were similar, although not everyone gets them is not a complete list side. Brand name Femara the leaflet inside your medicines packet in rare cases it... Warmth or redness in your face or chest side-effects of treatment are hot flushes can sometimes if! Makes me feel like a much older Grammy used to treat certain types of breast cancer arthralgia and dyspnea 5... Or muscle ache ; hot flushes, sweating, joint pain or muscle ache ; flushes...