Home FDA labels 456ed484-059b-2ee9-e063-6294a90a3f83 LETROZOLE openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name LETROZOLE
Generic name LETROZOLE
Manufacturer Chartwell RX, LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID fa2d40a5-3504-44ef-8f5c-aa4c06308074
SPL ID 456ed484-059b-2ee9-e063-6294a90a3f83
Version 5
Effective date 2025-12-08
Source export date 2026-09-28
Source partition 13
Source file https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
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Import run 20260929T050834Z
Imported at 2026-09-29 06:38:24 Harmonized routes table Harmonized routes ORAL
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warnings and cautions 5 WARNINGS AND PRECAUTIONS Decreases in bone mineral density may occur. Consider bone mineral density monitoring ( 5.1 ) Increases in total cholesterol may occur. Consider cholesterol monitoring. ( 5.2 ) Fatigue, dizziness and somnolence may occur. Exercise caution when operating machinery ( 5.4 ) Embryo-Fetal toxicity: Can cause fetal harm when administered to pregnant women. Obtain a pregnancy test in females of reproductive potential. Advise females of reproductive potential to use effective contraception ( 5.6 , 8.1 , 8.3 ) 5.1 Bone Effects Use of letrozole may cause decreases in bone mineral density (BMD). Consideration should be given to monitoring BMD. Results of a safety study to evaluate safety in the adjuvant setting comparing the effect on lumbar spine (L2 to L4) BMD of adjuvant treatment with letrozole to that with tamoxifen showed at 24 months a median decrease in lumbar spine BMD of 4.1% in the letrozole arm compared to a median increase of 0.3% in the tamoxifen arm (difference = 4.4%) ( P <0.0001) [ see Adverse Reactions (6) ]. Updated results from the BMD substudy (MA-17B) in the extended adjuvant setting demonstrated that at 2 years patients receiving letrozole had a median decrease from baseline of 3.8% in hip BMD compared to a median decrease of 2.0% in the placebo group. The changes from baseline in lumbar spine BMD in letrozole and placebo treated groups were not significantly different [ see Adverse Reactions (6) ]. In the adjuvant trial (BIG 1-98) the incidence of bone fractures at any time after randomization was 14.7% for letrozole and 11.4% for tamoxifen at a median follow-up of 96 months. The incidence of osteoporosis was 5.1% for letrozole and 2.7% for tamoxifen [ see Adverse Reactions (6) ]. In the extended adjuvant trial (MA-17), the incidence of bone fractures at any time after randomization was 13.3% for letrozole and 7.8% for placebo at a median follow-up of 62 months. The incidence of new osteoporosis was 14.5% for letrozole and 7.8% for placebo [ see Adverse Reactions (6) ]. 5.2 Cholesterol Consideration should be given to monitoring serum cholesterol. In the adjuvant trial (BIG 1-98), hypercholesterolemia was reported in 52.3% of letrozole patients and 28.6% of tamoxifen patients. Grade 3 to 4 hypercholesterolemia was reported in 0.4% of letrozole patients and 0.1% of tamoxifen patients. Also in the adjuvant setting, an increase of greater than or equal to 1.5 x upper limit of normal (ULN) in total cholesterol (generally non-fasting) was observed in patients on monotherapy who had baseline total serum cholesterol within the normal range (i.e., less than =1.5 x ULN) in 155/1843 (8.4%) patients on letrozole vs 71/1840 (3.9%) patients on tamoxifen Lipid lowering medications were required for 29% of patients on letrozole and 20% on tamoxifen [see Adverse Reactions (6) ]. 5.3 Hepatic Impairment Subjects with cirrhosis and severe hepatic impairment who were dosed with 2.5 mg of letrozole experienced approximately twice the exposure to letrozole as healthy volunteers with normal liver function [ see Clinical Pharmacology (12.3) ]. Therefore, a dose reduction is recommended for this patient population. The effect of hepatic impairment on letrozole exposure in cancer patients with elevated bilirubin levels has not been determined [ see Dosage and Administration (2.5) ]. 5.4 Fatigue and Dizziness Because fatigue, dizziness, and somnolence have been reported with the use of letrozole, caution is advised when driving or using machinery until it is known how the patient reacts to letrozole use. 5.5 Laboratory Test Abnormalities No dose-related effect of letrozole on any hematologic or clinical chemistry parameter was evident. Moderate decreases in lymphocyte counts, of uncertain clinical significance, were observed in some patients receiving letrozole tablets 2.5 mg. This depression was transient in about half of those affected. Two patients on letrozole developed thrombocytopenia; relationship to the study drug was unclear. Patient withdrawal due to laboratory abnormalities, whether related to study treatment or not was infrequent. 5.6 Embryo-Fetal Toxicity Based on post-marketing reports, findings from animal studies and the mechanism of action, letrozole can cause fetal harm and is contraindicated for use in pregnant women. In post-marketing reports, use of letrozole during pregnancy resulted in cases of spontaneous abortions and congenital birth defects. Letrozole caused embryo-fetal toxicities in rats and rabbits at maternal exposures that were below the maximum recommended human dose (MHRD) on a mg/m 2 basis. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during therapy with letrozole and for at least 3 weeks after the last dose [ see Adverse Reactions (6.2) , Use in Specific Populations ( 8.1 , 8.3 ) and Clinical Pharmacology (12.1) ]. 5.7 Warning statement This product contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No.5 (tartrazine) sensitive in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
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adverse reactions table <table width="60%" cellspacing="0" cellpadding="0"><tbody><tr><td colspan="3"/></tr><tr><td valign="bottom"><paragraph><content styleCode="bold">Adverse</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">Letrozole</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">Tamoxifen</content></paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold">Reactions</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">2.5 mg</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">20 mg</content></paragraph></td></tr><tr><td align="center"/><td align="center"><paragraph><content styleCode="bold">(N = 455)</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">(N = 455)</content></paragraph></td></tr><tr><td align="center"/><td align="center"><paragraph><content styleCode="bold">%</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">%</content></paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold">General Disorders</content></paragraph></td><td valign="bottom"/><td valign="bottom"/></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Fatigue</paragraph></td><td valign="bottom"><paragraph>13</paragraph></td><td valign="bottom"><paragraph>13</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Chest Pain</paragraph></td><td valign="bottom"><paragraph>8</paragraph></td><td valign="bottom"><paragraph>9</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Edema Peripheral</paragraph></td><td valign="bottom"><paragraph>5</paragraph></td><td valign="bottom"><paragraph>6</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Pain NOS</paragraph></td><td valign="bottom"><paragraph>5</paragraph></td><td valign="bottom"><paragraph>7</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Weakness</paragraph></td><td valign="bottom"><paragraph>6</paragraph></td><td valign="bottom"><paragraph>4</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph><content styleCode="bold">Investigations</content></paragraph></td><td valign="bottom"/><td valign="bottom"/></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Weight Decreased</paragraph></td><td valign="bottom"><paragraph>7</paragraph></td><td valign="bottom"><paragraph>5</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph><content styleCode="bold">Vascular Disorders</content></paragraph></td><td valign="bottom"/><td valign="bottom"/></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Hot Flushes</paragraph></td><td valign="bottom"><paragraph>19</paragraph></td><td valign="bottom"><paragraph>16</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Hypertension</paragraph></td><td valign="bottom"><paragraph>8</paragraph></td><td valign="bottom"><paragraph>4</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph><content styleCode="bold">Gastrointestinal Disorders</content></paragraph></td><td valign="bottom"/><td valign="bottom"/></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Nausea</paragraph></td><td valign="bottom"><paragraph>17</paragraph></td><td valign="bottom"><paragraph>17</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Constipation</paragraph></td><td valign="bottom"><paragraph>10</paragraph></td><td valign="bottom"><paragraph>11</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Diarrhea</paragraph></td><td valign="bottom"><paragraph>8</paragraph></td><td valign="bottom"><paragraph>4</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Vomiting</paragraph></td><td valign="bottom"><paragraph>7</paragraph></td><td valign="bottom"><paragraph>8</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph><content styleCode="bold">Infections/Infestations</content></paragraph></td><td valign="bottom"/><td valign="bottom"/></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Influenza</paragraph></td><td valign="bottom"><paragraph>6</paragraph></td><td valign="bottom"><paragraph>4</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Urinary Tract Infection NOS</paragraph></td><td valign="bottom"><paragraph>6</paragraph></td><td valign="bottom"><paragraph>3</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph><content styleCode="bold">Injury, Poisoning and Procedural Complications</content></paragraph></td><td valign="bottom"/><td valign="bottom"/></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Post-Mastectomy Lymphedema</paragraph></td><td valign="bottom"><paragraph>7</paragraph></td><td valign="bottom"><paragraph>7</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph><content styleCode="bold">Metabolism and Nutrition Disorders</content></paragraph></td><td valign="bottom"/><td valign="bottom"/></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Anorexia</paragraph></td><td valign="bottom"><paragraph>4</paragraph></td><td valign="bottom"><paragraph>6</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph><content styleCode="bold">Musculoskeletal and Connective Tissue Disorders</content></paragraph></td><td valign="bottom"/><td valign="bottom"/></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Bone Pain</paragraph></td><td valign="bottom"><paragraph>22</paragraph></td><td valign="bottom"><paragraph>21</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Back Pain</paragraph></td><td valign="bottom"><paragraph>18</paragraph></td><td valign="bottom"><paragraph>19</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Arthralgia</paragraph></td><td valign="bottom"><paragraph>16</paragraph></td><td valign="bottom"><paragraph>15</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Pain in Limb</paragraph></td><td valign="bottom"><paragraph>10</paragraph></td><td valign="bottom"><paragraph>8</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph><content styleCode="bold">Nervous System Disorders</content></paragraph></td><td valign="bottom"/><td valign="bottom"/></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Headache NOS</paragraph></td><td valign="bottom"><paragraph>8</paragraph></td><td valign="bottom"><paragraph>7</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph><content styleCode="bold">Psychiatric Disorders</content></paragraph></td><td valign="bottom"/><td valign="bottom"/></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Insomnia</paragraph></td><td valign="bottom"><paragraph>7</paragraph></td><td valign="bottom"><paragraph>4</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph><content styleCode="bold">Reproductive System and Breast Disorders</content></paragraph></td><td valign="bottom"/><td valign="bottom"/></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Breast Pain</paragraph></td><td valign="bottom"><paragraph>7</paragraph></td><td valign="bottom"><paragraph>7</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph><content styleCode="bold">Respiratory, Thoracic and Mediastinal Disorders</content></paragraph></td><td valign="bottom"/><td valign="bottom"/></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Dyspnea</paragraph></td><td valign="bottom"><paragraph>18</paragraph></td><td valign="bottom"><paragraph>17</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Cough</paragraph></td><td valign="bottom"><paragraph>13</paragraph></td><td valign="bottom"><paragraph>13</paragraph></td></tr><tr align="center"><td align="left" valign="bottom"><paragraph> Chest Wall Pain</paragraph></td><td valign="bottom"><paragraph>6</paragraph></td><td valign="bottom"><paragraph>6</paragraph></td></tr></tbody></table>
adverse reactions table <table width="70%" cellspacing="0" cellpadding="0"><tbody><tr><td colspan="5"/></tr><tr><td colspan="5"/></tr><tr><td valign="bottom"><paragraph><content styleCode="bold">Adverse</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">Pooled</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">Pooled</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">Megestrol</content></paragraph></td><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph><content styleCode="bold">Reactions</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">Letrozole</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">Letrozole</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">Acetate</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">Aminoglutethimide</content></paragraph></td></tr><tr><td align="center"/><td align="center"><paragraph><content styleCode="bold">2.5 mg</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">0.5 mg</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">160 mg</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">500 mg</content></paragraph></td></tr><tr><td align="center"/><td align="center"><paragraph><content styleCode="bold">(N = 359)</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">(N = 380)</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">(N = 189)</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">(N = 178)</content></paragraph></td></tr><tr><td align="center"/><td align="center"><paragraph><content styleCode="bold">%</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">%</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">%</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">%</content></paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold">Body as a Whole</content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td/><td/><td/><td/><td/></tr><tr><td valign="bottom"><paragraph> Chest Pain</paragraph></td><td align="center"><paragraph>6</paragraph></td><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>7</paragraph></td><td align="center"><paragraph>3</paragraph></td></tr><tr><td valign="bottom"><paragraph> Peripheral Edema <sup>1</sup></paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>8</paragraph></td><td align="center"><paragraph>3</paragraph></td></tr><tr><td valign="bottom"><paragraph> Asthenia</paragraph></td><td align="center"><paragraph>4</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>4</paragraph></td><td align="center"><paragraph>5</paragraph></td></tr><tr><td valign="bottom"><paragraph> Weight Increase</paragraph></td><td align="center"><paragraph>2</paragraph></td><td align="center"><paragraph>2</paragraph></td><td align="center"><paragraph>9</paragraph></td><td align="center"><paragraph>3</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold">Cardiovascular</content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph> Hypertension</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>7</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>6</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold">Digestive System</content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph> Nausea</paragraph></td><td align="center"><paragraph>13</paragraph></td><td align="center"><paragraph>15</paragraph></td><td align="center"><paragraph>9</paragraph></td><td align="center"><paragraph>14</paragraph></td></tr><tr><td valign="bottom"><paragraph> Vomiting</paragraph></td><td align="center"><paragraph>7</paragraph></td><td align="center"><paragraph>7</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>9</paragraph></td></tr><tr><td valign="bottom"><paragraph> Constipation</paragraph></td><td align="center"><paragraph>6</paragraph></td><td align="center"><paragraph>7</paragraph></td><td align="center"><paragraph>9</paragraph></td><td align="center"><paragraph>7</paragraph></td></tr><tr><td valign="bottom"><paragraph> Diarrhea</paragraph></td><td align="center"><paragraph>6</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>4</paragraph></td></tr><tr><td valign="bottom"><paragraph> Pain-Abdominal</paragraph></td><td align="center"><paragraph>6</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>9</paragraph></td><td align="center"><paragraph>8</paragraph></td></tr><tr><td valign="bottom"><paragraph> Anorexia</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>5</paragraph></td></tr><tr><td valign="bottom"><paragraph> Dyspepsia</paragraph></td><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>4</paragraph></td><td align="center"><paragraph>6</paragraph></td><td align="center"><paragraph>5</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold">Infections/Infestations</content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph> Viral Infection</paragraph></td><td align="center"><paragraph>6</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>6</paragraph></td><td align="center"><paragraph>3</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold">Lab Abnormality</content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph> Hypercholesterolemia</paragraph></td><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>0</paragraph></td><td align="center"><paragraph>6</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold">Musculoskeletal System</content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph> Musculoskeletal <sup>2</sup></paragraph></td><td align="center"><paragraph>21</paragraph></td><td align="center"><paragraph>22</paragraph></td><td align="center"><paragraph>30</paragraph></td><td align="center"><paragraph>14</paragraph></td></tr><tr><td valign="bottom"><paragraph> Arthralgia</paragraph></td><td align="center"><paragraph>8</paragraph></td><td align="center"><paragraph>8</paragraph></td><td align="center"><paragraph>8</paragraph></td><td align="center"><paragraph>3</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold">Nervous System</content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph> Headache</paragraph></td><td align="center"><paragraph>9</paragraph></td><td align="center"><paragraph>12</paragraph></td><td align="center"><paragraph>9</paragraph></td><td align="center"><paragraph>7</paragraph></td></tr><tr><td valign="bottom"><paragraph> Somnolence</paragraph></td><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>2</paragraph></td><td align="center"><paragraph>2</paragraph></td><td align="center"><paragraph>9</paragraph></td></tr><tr><td valign="bottom"><paragraph> Dizziness</paragraph></td><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>7</paragraph></td><td align="center"><paragraph>3</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold">Respiratory System</content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph> Dyspnea</paragraph></td><td align="center"><paragraph>7</paragraph></td><td align="center"><paragraph>9</paragraph></td><td align="center"><paragraph>16</paragraph></td><td align="center"><paragraph>5</paragraph></td></tr><tr><td valign="bottom"><paragraph> Coughing</paragraph></td><td align="center"><paragraph>6</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>7</paragraph></td><td align="center"><paragraph>5</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold">Skin and Appendages</content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph> Hot Flushes</paragraph></td><td align="center"><paragraph>6</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>4</paragraph></td><td align="center"><paragraph>3</paragraph></td></tr><tr><td valign="bottom"><paragraph> Rash <sup>3</sup></paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>4</paragraph></td><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>12</paragraph></td></tr><tr><td valign="bottom"><paragraph> Pruritus</paragraph></td><td align="center"><paragraph>1</paragraph></td><td align="center"><paragraph>2</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>3</paragraph></td></tr></tbody></table>
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