Femara Side Effects
Generic name: letrozole
Note: This document provides detailed information about Femara Side Effects associated with letrozole. Some dosage forms listed on this page may not apply specifically to the brand name Femara.
Applies to letrozole: oral tablet.
Common side effects of Femara
Some side effects of letrozole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
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:
More common side effects
- back pain
- bone pain
- hot flashes (sudden sweating and feeling of warmth)
- joint pain
- muscle pain
Less common side effects
- anxiety
- confusion
- constipation
- diarrhea
- dry mouth
- headache
- increased thirst
- loss of appetite or weight loss
- metallic taste
- skin rash or itching
- sleepiness
- spinning or whirling sensation causing loss of balance
- stomach pain or upset
- trouble sleeping
- vomiting
- weakness
Incidence not known
- bad, unusual, or unpleasant (after) taste and thirst
- being forgetful
- change in taste
- dryness of the skin
- hair loss
- hives or welts
- increased appetite
- irritability
- nervousness
- red, sore eyes
- redness of the skin
- swelling or inflammation of the mouth
Serious side effects of Femara
Along with its needed effects, letrozole (the active ingredient contained in Femara) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking letrozole:
Less common side effects
- bone fracture
- breast pain
- chest pain
- chills, fever, or flu-like symptoms
- mental depression
- swelling of the feet or lower legs
Rare side effects
- continuing or severe nervousness
- cough
- dizziness or lightheadedness
- fainting
- fast heartbeat
- heart attack
- increased sweating
- nausea
- pain in the chest, groin, or legs, especially the calves
- severe and sudden, unexplained troubled breathing
- severe, sudden headache
- slurred speech
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- swollen glands
- vaginal bleeding
- vision changes
Incidence not known
- black, tarry stools
- blindness
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest discomfort
- dark urine
- decreased vision
- dilated neck veins
- extreme tiredness or weakness
- general tiredness or weakness
- increased need to urinate
- irregular breathing
- irregular heartbeat
- light-colored stools
- painful or difficult urination
- passing urine more often
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- upper right abdominal pain
- weight gain
- white or brownish vaginal discharge
- yellow eyes and skin
For healthcare professionals
Applies to letrozole: oral tablet.
Cardiovascular adverse events
- 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]
Gastrointestinal
- 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]
Other
- 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]
Musculoskeletal
- 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]
Nervous system
- 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
- Frequency not reported: Vertigo[Ref]
Respiratory
- Very common (10% or more): Dyspnea (18%), cough (13%)
- Common (1% to 10%): Chest wall pain
- Frequency not reported: Pleural effusion[Ref]
Dermatologic
- Very common (10% or more): Increased sweating (24%)
- Common (1% to 10%): Alopecia, dry skin, rash (erythematous, maculopapular, psoriasiform, vesicular), pruritus
- Uncommon (0.1% to 1%): Urticaria
- Very rare (less than 0.01%): Angioedema, toxic epidermal necrolysis, erythema multiforme[Ref]
Hepatic
- Uncommon (0.1% to 1%): Increased hepatic enzymes
- Very rare (less than 0.01%): Hepatitis[Ref]
Hematologic
- Uncommon (0.1% to 1%): Leukopenia
- Frequency not reported: Decreased lymphocyte count, thrombocytopenia[Ref]
Ocular
- Common (1% to 10%): Cataract
- Uncommon (0.1% to 1%): Eye irritation, blurred vision[Ref]
Metabolic
- Very common (10% or more): Hypercholesterolemia (53%), increased weight (13%)
- Common (1% to 10%): Decreased weight, anorexia, increased appetite
- Frequency not reported: Hypercalcemia[Ref]
Genitourinary
- 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]
Hypersensitivity
- Very rare (less than 0.01%): Anaphylactic reactions[Ref]
Oncologic
- Common (1% to 10%): Secondary malignancy
- 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]
Psychiatric
- Common (1% to 10%): Depression, insomnia
- Uncommon (0.1% to 1%): Anxiety, nervousness, irritability[Ref]
Renal
- Common (1% to 10%): Renal disorders[Ref]
References
1. (2001) "Product Information. Femara (letrozole)." Novartis Pharmaceuticals
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
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Further information
Femara side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.