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Letrozole Side Effects

In Summary

Commonly reported side effects of letrozole include: bone fracture, edema, arthralgia, dizziness, fatigue, hypercholesterolemia, osteoporosis, and flushing. Other side effects include: myalgia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to letrozole: oral tablet

In addition to its needed effects, some unwanted effects may be caused by letrozole. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking letrozole:

Less common:
  • Bone fracture
  • breast pain
  • chest pain
  • chills, fever, or flu-like symptoms
  • mental depression
  • shortness of breath
  • swelling of the feet or lower legs
Rare
  • 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 shortness of breath
  • severe, sudden headache
  • slurred speech
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • 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
  • decreased vision
  • dilated neck veins
  • extreme fatigue
  • increased need to urinate
  • irregular breathing
  • irregular heartbeat
  • painful or difficult urination
  • passing urine more often
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weight gain
  • wheezing
  • white or brownish vaginal discharge

Minor Side Effects

Some of the side effects that can occur with letrozole may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Back pain
  • bone pain
  • hot flashes (sudden sweating and feeling of warmth)
  • joint pain
  • muscle pain
Less common:
  • 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

For Healthcare Professionals

Applies to letrozole: oral tablet

Cardiovascular

Very common (10% or more): Hot flash/flushing (49.7%), cardiovascular disease (14.4%), other cardiovascular event (12.7%)
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 (11.3%)
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 (33.6%), edema (18.4%), night sweats (14.6%)
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 (25.2%), bone fracture (22%), musculoskeletal pain/back pain/arm pain/leg pain (22%), osteoporosis (14.5%), 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 (20.1%), dizziness/lightheadedness (14.2%)
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 (24.2%)
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 (52.5%), increased weight (12.9%)
Common (1% to 10%): Decreased weight, anorexia, increased appetite
Frequency not reported: Hypercalcemia[Ref]

Genitourinary

Very common (10% or more): Vaginal bleeding (12.7%)
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. "Product Information. Femara (letrozole)." Novartis Pharmaceuticals, East Hanover, NJ.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Not all side effects for letrozole may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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