Home FDA labels 3d83a46b-4eef-64dc-e063-6294a90aa390 Anastrozole openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
Brand name Anastrozole
Generic name ANASTROZOLE
Manufacturer American Health Packaging
Product type HUMAN PRESCRIPTION DRUG
SPL set ID dface914-5135-4136-82f4-75429b496a35
SPL ID 3d83a46b-4eef-64dc-e063-6294a90aa390
Version 8
Effective date 2025-08-29
Source export date 2026-10-12
Source partition 12
Source file https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:54:14 Harmonized routes table Harmonized routes ORAL
Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 14 matching rows.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings and cautions 5. WARNINGS AND PRECAUTIONS In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events occurred with anastrozole use compared to tamoxifen use. Consider risks and benefits. ( 5.1 , 6.1 ) Decreases in bone mineral density may occur. Consider bone mineral density monitoring. ( 5.2 , 6.1 ) Increases in total cholesterol may occur. Consider cholesterol monitoring. ( 5.3 , 6.1 ) Embryo-Fetal Toxicity: anastrozole tablets may cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.4 , 8.1 ) 5.1 Ischemic Cardiovascular Events In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events was observed with anastrozole tablets in the ATAC trial (17% of patients on anastrozole tablets and 10% of patients on tamoxifen). Consider risk and benefits of anastrozole tablets therapy in patients with pre-existing ischemic heart disease [see Adverse Reactions ( 6.1 )]. 5.2 Bone Effects Results from the ATAC trial bone substudy at 12 and 24 months demonstrated that patients receiving anastrozole tablets had a mean decrease in both lumbar spine and total hip bone mineral density (BMD) compared to baseline. Patients receiving tamoxifen had a mean increase in both lumbar spine and total hip BMD compared to baseline. Consider bone mineral density monitoring in patients treated with anastrozole tablets [see Adverse Reactions ( 6.1 )]. 5.3 Cholesterol During the ATAC trial, more patients receiving anastrozole tablets were reported to have elevated serum cholesterol compared to patients receiving tamoxifen (9% versus 3.5%, respectively) [see Adverse Reactions ( 6.1 )]. 5.4 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, anastrozole tablets can cause fetal harm when administered to a pregnant woman. Anastrozole caused embryo-fetal toxicities in rats at maternal exposure that were 9 times the human clinical exposure, based on area under the curve (AUC). In rabbits, anastrozole caused pregnancy failure at doses equal to or greater than 16 times the recommended human dose on a mg/m 2 basis. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during therapy with anastrozole tablets and for at least 3 weeks after the last dose [see Use in Specific Populations ( 8.1 , 8.3 ) and Clinical Pharmacology ( 12.1 )].
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 2 of 2 · 7 matching rows.
adverse reactions table <table width="100%" ID="_RefID0EUYBG"><caption>Table 4 Number of Patients with Pre-specified Adverse Reactions in Trials 0030 and 0027</caption><colgroup><col width="39%"/><col width="30%"/><col width="30%"/></colgroup><thead><tr><th align="left" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Adverse Reaction</content><footnote ID="_RefID48_1">A patient may have had more than 1 adverse reaction.</footnote></th><th align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Number (n) and Percentage of Patients</content></th></tr></thead><tbody><tr><td rowspan="4" styleCode="Rrule Lrule Toprule Botrule " valign="top"/><td align="center" styleCode="Rrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">Anastrozole Tablets</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">NOLVADEX <sup>®*</sup></content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph><content styleCode="bold">1 mg</content></paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph><content styleCode="bold">20 mg</content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph><content styleCode="bold">(N=506)</content></paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph><content styleCode="bold">(N=511)</content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">n (%)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">n (%)</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Depression</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>23 (5)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>32 (6)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Tumor Flare</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>15 (3)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>18 (4)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Thromboembolic Disease <footnote ID="_RefID48_2">Includes pulmonary embolus, thrombophlebitis, retinal vein thrombosis.</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>18 (4)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>33 (6)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Venous <footnoteRef IDREF="_RefID48_2"/></paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>5</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>15</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Coronary and Cerebral <footnote ID="_RefID48_4">Includes myocardial infarction, myocardial ischemia, angina pectoris, cerebrovascular accident, cerebral ischemia and cerebral infarct.</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>13</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>19</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Gastrointestinal Disturbance</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>170 (34)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>196 (38)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Hot Flushes</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>134 (26)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>118 (23)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Vaginal Dryness</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>9 (2)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>3 (1)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Lethargy</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>6 (1)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>15 (3)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Vaginal Bleeding</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>5 (1)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>11 (2)</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Weight Gain</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>11 (2)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>8 (2)</paragraph></td></tr></tbody></table>
adverse reactions table <table width="100%" ID="_RefID0E1DAI"><caption>Table 5 Number (N) and Percentage of Patients with Adverse Reactions in Trials 0004 and 0005</caption><colgroup><col width="24%"/><col width="13%"/><col width="13%"/><col width="13%"/><col width="13%"/><col width="13%"/><col width="13%"/></colgroup><thead><tr><th align="left" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><content styleCode="bold">Adverse Reaction</content><footnote ID="_RefID50_1">A patient may have had more than one adverse reaction.</footnote></th><th align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Anastrozole Tablets</content></th><th align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Anastrozole Tablets</content></th><th align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Megestrol Acetate</content></th></tr></thead><tbody><tr><td rowspan="3" styleCode="Rrule Lrule Toprule Botrule " valign="top"/><td align="center" colspan="2" styleCode="Rrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">1 mg</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">10 mg</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">160 mg</content></paragraph></td></tr><tr><td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">(N=262)</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">(N=246)</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">(N=253)</content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">n</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">%</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">n</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">%</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">n</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">%</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Asthenia</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>42</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(16)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>33</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(13)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>47</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(19)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Nausea</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>41</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(16)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>48</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(20)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>28</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(11)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Headache</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>34</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(13)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>44</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(18)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>24</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(9)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Hot Flashes</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>32</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(12)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>29</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(11)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>21</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(8)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Pain</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>28</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(11)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>38</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(15)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>29</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(11)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Back Pain</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>28</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(11)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>26</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(11)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>19</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(8)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Dyspnea</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>24</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(9)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>27</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(11)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>53</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(21)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Vomiting</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>24</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(9)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>26</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(11)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>16</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(6)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Cough Increased</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>22</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(8)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(7)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>19</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(8)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Diarrhea</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>22</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(8)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(7)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>7</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(3)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Constipation</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(7)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(7)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>21</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(8)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Abdominal Pain</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(7)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>14</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(6)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(7)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Anorexia</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(7)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>19</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(8)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>11</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(4)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Bone Pain</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>17</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(6)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>26</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(12)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>19</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(8)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Pharyngitis</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>16</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(6)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>23</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(9)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>15</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(6)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Dizziness</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>16</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(6)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>12</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(5)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>15</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(6)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Rash</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>15</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(6)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>15</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(6)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>19</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(8)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Dry Mouth</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>15</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(6)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>11</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(4)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>13</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(5)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Peripheral Edema</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>14</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(5)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>21</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(9)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>28</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(11)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Pelvic Pain</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>14</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(5)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>17</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(7)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>13</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(5)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Depression</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>14</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(5)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>6</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(2)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>5</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(2)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Chest Pain</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>13</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(5)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(7)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>13</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(5)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Paresthesia</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>12</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(5)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>15</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(6)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>9</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(4)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Vaginal Hemorrhage</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>6</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(2)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>4</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(2)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>13</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(5)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Weight Gain</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>4</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(2)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>9</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(4)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>30</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(12)</paragraph></td></tr><tr><td styleCode="Rrule Lrule " valign="top"><paragraph>Sweating</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>4</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(2)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>3</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(1)</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>16</paragraph></td><td align="center" styleCode="Rrule Lrule " valign="top"><paragraph>(6)</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Increased Appetite</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>(0)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>1</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>(0)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>13</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>(5)</paragraph></td></tr></tbody></table>
adverse reactions table <table width="100%" ID="_RefID0EXTBI"><caption>Table 6 Number (n) and Percentage of Patients with Pre-specified Adverse Reactions in Trials 0004 and 0005</caption><colgroup><col width="23%"/><col width="13%"/><col width="13%"/><col width="13%"/><col width="13%"/><col width="13%"/><col width="13%"/></colgroup><thead><tr><th align="left" styleCode="Rrule Botrule Lrule Toprule " valign="top"/><th align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><content styleCode="bold">Anastrozole Tablets</content></th><th align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><content styleCode="bold">Anastrozole Tablets</content></th><th align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><content styleCode="bold">Megestrol Acetate</content></th></tr></thead><tbody><tr><td styleCode="Rrule Lrule Toprule " valign="top"/><td align="center" colspan="2" styleCode="Rrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">1 mg</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">10 mg</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">160 mg</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"/><td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph><content styleCode="bold">(N=262)</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph><content styleCode="bold">(N=246)</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph><content styleCode="bold">(N=253)</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Adverse Reaction Group</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">N</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">(%)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">N</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">(%)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">N</content></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">(%)</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Gastrointestinal Disturbance</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>77</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(29)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>81</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(33)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>54</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(21)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Hot Flushes</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>33</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(13)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>29</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(12)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>35</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(14)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Edema</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>19</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(7)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>28</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(11)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>35</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(14)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Thromboembolic Disease</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>9</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(3)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>4</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>12</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Vaginal Dryness</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>5</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>3</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>2</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(1)</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Weight Gain</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>4</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>(2)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>10</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>(4)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>30</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>(12)</paragraph></td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.