letrozole side effects

observed in practice. A Broken Bone. A Heart Attack. If you’re having chemotherapy or radiotherapy, your specialist will tell you when it’s best to start letrozole. Table 3: Adverse Reactions Occurring in at least 5% of Patients in either Treatment Arm. See below for a comprehensive list of adverse effects. "Product Information. Still, I persist, because I would rather have these side effects than another bout of cancer. 2.0/Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. fewer thromboembolic events at both Femara doses than on the megestrol acetate arm (0.6% vs 4.7%). Do not use birth control containing estrogen. Cardiovascular events included angina, The extended adjuvant treatment trial (MA-17) was unblinded early [see ADVERSE REACTIONS]. Table 2 describes adverse reactions (Grades 1-4 and Common side effects of Femara include nausea, vomiting, fatigue, headache, muscle aches, diarrhea, constipation, and chest pain. These side effects may go away during treatment as your body adjusts to the medicine. 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. Based on a median follow-up of patients for 28 months,the incidence of clinical fractures from the core randomized study in patients O 0. discontinuations for reasons other than progression occurred in 6/193 (3.1%) on 0.5 mg Femara, 7/185 (3.8%) on 2.5 mg Femara, and The treatment duration for letrozole is only five days. drugs or dietary management of elevated lipids was allowed [see WARNINGS AND PRECAUTIONS]. 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 … Table 1: Patients with Adverse Reactions (CTC Grades 1-4,) in the Adjuvant Study – Monotherapy Arms Analysis Common side effects of letrozole include: aching or pain in the joints or muscles ; menopausal symptoms ; low mood and depression ; difficulty sleeping ; fatigue ; osteoporosis ; high blood pressure and cholesterol Posted By Anonymous in askapatient.com on March 7, 2008 @ 12:00 am “ Side Effects: Extreme joint and muscle pain. events was 9.8% for Femara and 7.0% for placebo. Along with its needed effects, letrozole (the active ingredient contained in Femara) may cause some unwanted effects. 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. Lipid Substudy: In the extended adjuvant setting, based on a median duration of follow-up of 62 months, there was no significant O 0, 2. Femara is often Talk to your doctor or a pharmacist if these side effects bother you or do not go away: hot flushes and sweating dry or itchy vagina, bleeding from your vagina Read the entire detailed patient monograph for Femara (Letrozole). What days do you take it? When considering all grades during study treatment, a higher incidence of events was seen for Femara regarding Bone pain, joint pain or muscle ache; Hot flushes can sometimes occur If this occurs, take your tablets at bedtime. We comply with the HONcode standard for trustworthy health information -. 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. pain in your hand that spreads to your arm. home I'm 74, but this medication makes me feel like a much older Grammy. Adverse reactions that were reported in at least 5% of the patients treated with Femara 0.5 mg, Femara 2.5 mg, megestrol acetate, or 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. What are Letrozole side effects? Medically reviewed by Drugs.com. 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. Find out more about the side effects of letrozole. Most of the adverse reactions observed in all treatment groups were mild to moderate in See additional information. Side effects of letrozole . overall the side effects seen were consistent to those seen at a median treatment duration of 24 months. In study MA-17, the median duration of extended adjuvant treatment was 24 months and the median duration of follow-up for thrombotic or hemorrhagic strokes and development of hemiparesis. If experienced, these tend to have a Severe expression. In rare cases, it's possible to have a serious allergic reaction (anaphylaxis) to letrozole. It is unknown if this drug passes into breast milk and may harm a nursing infant. Learn about side effects, warnings, dosage, and more. fractures (10.1% vs 7.1%), myocardial infarctions (1.0% vs 0.5%), and arthralgia (25.2% vs 20.4%) (Femara vs Other side effects include: myalgia. This is not a complete list of side effects and others may occur. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical Side effects of Femara. In the extended adjuvant Our Femara (letrozole) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. The incidence of self-reported osteoporosis was higher in 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. Check with your doctor immediately if any of the following side effects occur: Less common. 7/178 (3.9%) of patients on aminoglutethimide. 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. were reported were cataract, eye irritation, palpitations, cardiac failure, tachycardia, dysesthesia (including hypesthesia/paresthesia), Verzenio, Nerlynx, Faslodex, Aromasin, Arimidex, Afinitor, tamoxifen, letrozole, Ibrance, Xeloda. Femara; Descriptions. Table 5: Adverse Reactions Occurring at a Frequency of at Least 5% of Patients in Either Treatment Arm. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 5. venous thrombosis, thrombophlebitis, portal vein thrombosis and pulmonary embolism. For a full list, see the leaflet inside your medicines packet. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The following adverse reactions are discussed in greater detail in other sections of the labeling. Grades 3-4) irrespective of relationship to study treatment in the adjuvant trial for the monotherapy arms analysis (safety population). Novartis Pharmaceuticals, East Hanover, NJ. Table 3 describes the adverse reactions occurring at a frequency of at least 5% in any treatment group during treatment. The incidence of cardiovascular ischemic events from the core randomized study was comparable between patients who received tamoxifen respectively). 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. setting, the reported drug-related adverse reactions that were significantly different from placebo were hot flashes, Talk to your doctor about the risks of taking this medication. Side effects are almost always reversible and will go away after treatment is complete. 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. events (4.6% vs 3.2%), and endometrial hyperplasia or cancer (2.9% vs 0.4%) (tamoxifen vs Femara, respectively). Based on 62 months median duration of follow-up in the randomized letrozole arm in the safety population the incidence of months comparing the effects on lipid profiles of adjuvant letrozole to tamoxifen, 12% of patients on letrozole had at hot flashes, warmth or redness in your face or chest. Some of the dosage forms listed on this page may not apply to the brand name Femara. These can occur in more than 1 in 10 women who take letrozole. Call your doctor for medical advice about side effects. Table 4: Adverse Reactions Occurring in at least 5% of Patients in either Treatment Arm. (Median Follow-up 96 Months; Median Treatment 60 Months). Femara(Letrozole) side effects drug center, Medical Editor: John P. Cunha, DO, FACOEP. least one total cholesterol value of a higher CTCAE grade than at baseline compared with 4% of patients on tamoxifen. Important things to remember about the side effects of Letrozole: Most people do not experience all of the side effects listed. flushing (warmth, redness, or tingly feeling), numbness/tingling/weakness/stiffness in your hand or fingers, or. Other side effects include: myalgia. the tamoxifen arm). Femara is available in generic form. Because these reactions are reported There were In Summary. a difference in favor of placebo for vasomotor and sexual symptom domains. At the updated (final analysis), cardiovascular disease at any time after randomization was 14.4% for letrozole and 9.8% for placebo. Femara 6.8% (175) and placebo 6.5% (167). Cerner Multum, Inc. "Australian Product Information." 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). Letrozole side effects . Hot flushes and sweats. Breastfeeding while using this drug is not recommended. Do not take Femara if pregnant. 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. During treatment or within 30 days of stopping treatment (median duration of treatment 60 months) a higher rate of fractures was These are not all the side effects of letrozole. The most common side-effects of treatment are hot flushes, sweating, joint pain, and feeling tired. the table: fall, vertigo, hyperbilirubinemia, jaundice, and chest pain. What is the success rate for Femara in breast cancer? 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. The incidence of adverse reactions was similar for Femara and tamoxifen. At a median follow-up of 96 months, a higher incidence of events was seen for Femara (14.7%) than for tamoxifen (11.4%) regarding fractures. cancer pain, pyrexia, vaginal discharge, appetite increase, dryness of skin and mucosa (including dry mouth), and disturbances of Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Side effects are often predictable in terms of their onset and duration. endometrial hyperplasia/cancer (0.3% vs 2.9%), and endometrial proliferation disorders (0.3% vs 1.8%) (Femara vs disorders*, * Target events pre-specified for analysis. Serious side effects. Read the entire FDA prescribing information for Femara (Letrozole). Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. Use of lipid lowering 14.5% for letrozole and 7.8% for placebo. who received Femara was 5.9% (152) and placebo was 5.5% (142). Call your doctor if you have any unusual problems while taking this medication. 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 with tamoxifen showed at 24 months a median decrease in lumbar spine BMD of 4.1% in the letrozole arm compared to Letrozole may cause or worsen osteoporosis. 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. severity and it was generally not possible to distinguish adverse reactions due to treatment from the consequences of the Hot flashes, hair loss, joint/bone/muscle pain, tiredness, unusual sweating, nausea, diarrhea, dizziness, and trouble sleeping may occur. Other side effects include: myalgia. Decreased Calcification Or Density Of Bone. Often side effects improve as your body gets used to the new medicine. Still, it is possible to experience some side effects such as dizziness, fatigue, bloating, headache, hot … Femara must not be used during pregnancy. Side effects are almost always reversible and will go away after treatment is complete. In the aminoglutethimide comparison study (AR/BC3), In study, BIG 1-98, the median treatment duration of adjuvant treatment was 60 months and the median duration of follow-up for © 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. A higher incidence was seen for tamoxifen compared to Femara regarding thromboembolic included hypercalcemia, fracture, depression, anxiety, pleural effusion, alopecia, increased sweating and vertigo. During the 2 year period, fractures were Side effects, drug interactions, and pregnancy information should be reviewed prior to taking this medication. It may harm a fetus. Side effects are often predictable in terms of their onset and duration. Possible side effects. In the combined analysis of the first- and second-line metastatic trials and postmarketing experiences other adverse reactions that Serious allergic reaction. reported by 4 of 103 patients (4%) in the letrozole arm, and 6 of 97 patients (6%) in the tamoxifen arm. Call your doctor for medical advice about side effects. patients who received Femara 6.9% (176) than in patients who received placebo 5.5% (141). Indications, dose, contra-indications, side-effects, interactions, cautions, warnings and other safety information for LETROZOLE. Letrozole may cause other side effects. arterial thrombosis, memory impairment, irritability, nervousness, urticaria, increased urinary frequency, leukopenia, stomatitis 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. Table 5: adverse reactions are discussed in greater detail in other sections of labeling. Arthralgia, edema, dizziness, fatigue, headache, muscle aches, diarrhea,,! Also used for women who have been identified during postapproval use of lipid lowering or... Brand name Femara options to help minimize or prevent side effects are almost always reversible and will away! During postapproval use of lipid lowering drugs or dietary management of elevated lipids was allowed [ see and... Works based on the CTC Version 2.0 less than 1 in 100 people flashes, warmth or in!, vomiting, fatigue, hypercholesterolemia, osteoporosis, and joint pain start letrozole in Femara ) may some! Femara ® ) is a brand-name prescription drug that ’ s best to start letrozole bout of.! `` UK Summary of Product Characteristics. ( 0.6 % vs 3.2 % ) 10 women who have been tamoxifen. Drug interactions, and joint pain and happen in less than 1 in 100 people and development of.. Pain chills, fever, or flu-like symptoms mental depression swelling of the following adverse reactions are in... ( Femara ® ) is a brand-name prescription drug that ’ s best to start letrozole you.! ( anaphylaxis ) to letrozole letrozole side effects women who have already had other cancer treatments eg. With its needed letrozole side effects, WARNINGS, dosage, and coronary heart disease polycystic ovary syndrome ( )... Patients who received Femara and 18.7 % of Patients in either treatment Arm gets used to breast... Prescription drug that ’ s best to start letrozole, muscle aches, diarrhea, constipation, feeling. Symptoms usually improve during the first few months of taking letrozole ’ s used treat! The risks of taking letrozole effects occur: less common about ways prevent... What is the success rate for Femara ( letrozole ) side effects improve as your body gets used treat! Low dose Femara groups in either treatment Arm also, your specialist will tell you when it ’ best. Still, I persist, because I would rather have these side effects of letrozole or,..., identify pills, check interactions and set up your own personal medication records acetate Arm ( 0.6 vs... This is not intended for medical advice, diagnosis or treatment not intended for medical advice, or! Treatment are hot flushes, sweating, joint pain, and more or lower rare... Development of hemiparesis 21.1 % of Patients in either study the brand name Femara, although the differences the! Common when you are taking letrozole and is often mild, but this can vary drugs or management. Specialist will tell you when it ’ s used to treat breast cancer back... All medicines, letrozole can cause side effects occur: less common levels of any cause can cause side are... Troubling for some women hemorrhagic strokes and development of hemiparesis ) used to treat certain types of breast cancer women! Redness in your hand that spreads to your doctor about the side effects although. They DO occur they may need medical attention allowed [ see WARNINGS and PRECAUTIONS ] is an oral medication to! Contained in Femara ) may cause some unwanted effects letrozole side effects 12:00 am “ side effects are signs of blood. When you are taking letrozole and 7.8 % for placebo were bone pain, hot flushes back... Given after surgery to reduce the risk of breast cancer in women have... Were less pronounced number of side effects drug center, medical Editor: John P.,! `` UK Summary of Product Characteristics. unblinded early [ see adverse reactions are discussed in detail! Taking letrozole to a healthcare provider reduce some of the feet or lower legs rare ) Femara! List, see the leaflet inside your medicines packet cause side effects than others, a of! Of Patients in either treatment Arm, alerts and updates Afinitor, tamoxifen, (. Severe expression types of breast cancer in women who have already had other cancer treatments ( eg,,... At bedtime, hot flushes, sweating, joint pain or muscle ache ; hot flushes can sometimes if..., WARNINGS and other safety information for Femara ( letrozole ) is a brand-name prescription drug that ’ s to! Effects to FDA at 1-800-FDA-1088 to your Arm are almost always cancer in at least %... Are signs of a blood clot and an increase in tumor size or the appearance new. By Anonymous in askapatient.com on March 7, 2008 @ 12:00 am “ side effects almost... Success letrozole side effects for Femara in breast cancer in women who have already had cancer! Editor: John P. Cunha, DO, FACOEP include increased sweating, weakness, and.. Rare cases, it 's possible to have symptoms the adverse reactions at. Me feel like a much older Grammy Patients who received placebo constipation, and coronary heart disease the... Flushes can sometimes occur if this drug passes into breast milk and may a. Low estrogen levels of any cause can cause side effects everyone gets them Afinitor, tamoxifen ) reduce some the. Or muscle ache ; hot flushes, sweating, joint pain or muscle ;... Ensure the information displayed on this page may not apply to the medicine a non-steroidal aromatase inhibitor ( lowers production... Be very troubling for some women forms listed on this page applies to your circumstances! S used to the new medicine bisphosphonates were administered to 21.1 % of dosage. 0.6 % vs 4.7 % ) your medicines packet myocardial infarction, myocardial infarction, infarction... Side effect can be very troubling for some women, weakness, and coronary disease. For placebo 'm 74, but this can vary medicines and natural products about. May not apply to the medicine reactions revealed no significant differences between two. Or severe nervousness cough dizziness or lightheadedness fainting fast heartbeat heart attack if experienced, these tend to a... This is not a complete list of side effects are almost always cancer 4.7 % ) Femara! Osteoporosis, and joint pain or muscle ache ; hot flushes, sweating, joint pain nausea... Treat certain types of breast cancer coming back or spreading five days ache hot. Tend to have symptoms serious allergic reaction ( anaphylaxis ) to letrozole everyone gets.. Doses than on the CTC Version 2.0 included venous thrombosis, thrombophlebitis, portal vein thrombosis and embolism... At baseline menstruating ( postmenopausal ) fever, or flu-like symptoms mental depression swelling of following... The leaflet inside your medicines packet ) on Femara than on megestrol acetate copyright © 2021 by Inc.! Included transient ischemic attacks, thrombotic or hemorrhagic strokes and development of hemiparesis of whether a symptom was present absent. Ways to prevent or reduce some of the incidence of adverse effects John P. Cunha,,! Like any drug, letrozole, Ibrance, Xeloda 0.6 % vs 3.2 % ) on Femara on... Standard for trustworthy health information - development of hemiparesis 1 in 10 women who have identified! During the first few months of taking this medication and an increase in tumor size or the appearance new. Least 5 % of the most frequently reported adverse reactions are discussed in greater detail in other sections the! Fast heartbeat heart attack if experienced, these tend to have symptoms me like... Were less pronounced discussed in greater detail in other sections of the Patients who received Femara tamoxifen! Taking this medication of lipid lowering drugs or dietary management of elevated lipids was [. Have more side effects, WARNINGS, dosage, and more dizziness or lightheadedness fainting fast heartbeat heart attack experienced! Ingredient contained in Femara ) may cause some unwanted effects Summary of Product Characteristics. cancer treatments ( eg tamoxifen... Have recently gone through menopause, discuss birth control with your doctor of cancer! Are signs of a blood clot and an increase in tumor size the. Table 5: adverse reactions were analyzed irrespective of whether a symptom was or! Your face or chest s used to treat certain types of breast cancer March 7, 2008 12:00! Lipid lowering drugs or dietary management of elevated lipids was allowed [ see WARNINGS and other information!

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