Home FDA labels 34df04e6-9f4f-4b77-85fa-dfc6646cf904 FDA label 34df04e6-9f4f-4b77-85fa-dfc6646cf904 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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SPL set ID a9b01bc6-95ac-46f9-befa-d845a74d53c1
SPL ID 34df04e6-9f4f-4b77-85fa-dfc6646cf904
Version 16
Effective date 2024-02-22
Source export date 2026-09-28
Source partition 5
Source file https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
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warnings WARNINGS It has been shown that there is an increased risk of thrombosis, including fatal and nonfatal myocardial infarction, in men receiving estrogens for prostatic cancer. EMCYT Capsules should be used with caution in patients with a history of thrombophlebitis, thrombosis, or thromboembolic disorders, especially if they were associated with estrogen therapy. Caution should also be used in patients with cerebral vascular or coronary artery disease. Glucose Tolerance—Because glucose tolerance may be decreased, diabetic patients should be carefully observed while receiving EMCYT. Elevated Blood Pressure—Because hypertension may occur, blood pressure should be monitored periodically.
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adverse reactions ADVERSE REACTIONS In a randomized, double-blind trial comparing therapy with EMCYT Capsules in 93 patients (11.5 to 15.9 mg/kg/day) or diethylstilbestrol (DES) in 93 patients (3.0 mg/day), the following adverse effects were reported: EMCYT n=93 DES n=93 CARDIOVASCULAR-RESPIRATORY Cardiac Arrest 0 2 Cerebrovascular Accident 2 0 Myocardial Infarction 3 1 Thrombophlebitis 3 7 Pulmonary Emboli 2 5 Congestive Heart Failure 3 2 Edema 19 17 Dyspnea 11 3 Leg Cramps 8 11 Upper Respiratory Discharge 1 1 Hoarseness 1 0 GASTROINTESTINAL Nausea 15 8 Diarrhea 12 11 Minor Gastrointestinal Upset 11 6 Anorexia 4 3 Flatulence 2 0 Vomiting 1 1 Gastrointestinal Bleeding 1 0 Burning Throat 1 0 Thirst 1 0 INTEGUMENTARY Rash 1 4 Pruritus 2 2 Dry Skin 2 0 Pigment Changes 0 3 Easy Bruising 3 0 Flushing 1 0 Night Sweats 0 1 Fingertip—Peeling Skin 1 0 Thinning Hair 1 1 BREAST CHANGES Tenderness 66 64 Enlargement Mild 60 54 Moderate 10 16 Marked 0 5 MISCELLANEOUS Lethargy Alone 4 3 Depression 0 2 Emotional Lability 2 0 Insomnia 3 0 Headache 1 1 Anxiety 1 0 Chest Pain 1 1 Hot Flashes 0 1 Pain in Eyes 0 1 Tearing of Eyes 1 1 Tinnitus 0 1 LABORATORY ABNORMALITIES Hematologic Leukopenia 4 2 Thrombopenia 1 2 Hepatic Bilirubin Alone 1 5 Bilirubin and LDH 0 1 Bilirubin and SGOT 2 1 Bilirubin, LDH and SGOT 2 0 LDH and/or SGOT 31 28 Miscellaneous Hypercalcemia—Transient 0 1
adverse reactions table <table width="80%"><col width="41%"/><col width="20%"/><col width="18%"/><thead><tr><th align="left" styleCode="Botrule Toprule " valign="middle"/><th align="center" styleCode="Botrule Toprule " valign="middle"><content styleCode="bold">EMCYT</content> <content styleCode="bold">n=93</content></th><th align="center" styleCode="Botrule Toprule " valign="middle"><content styleCode="bold">DES</content> <content styleCode="bold">n=93</content></th></tr></thead><tbody><tr><td styleCode="Toprule " valign="middle"><paragraph>CARDIOVASCULAR-RESPIRATORY</paragraph></td><td styleCode="Toprule " valign="middle"/><td styleCode="Toprule " valign="middle"/></tr><tr><td valign="middle"><paragraph> Cardiac Arrest</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td><td align="center" valign="middle"><paragraph>2</paragraph></td></tr><tr><td valign="middle"><paragraph> Cerebrovascular Accident</paragraph></td><td align="center" valign="middle"><paragraph>2</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td></tr><tr><td valign="middle"><paragraph> Myocardial Infarction</paragraph></td><td align="center" valign="middle"><paragraph>3</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td></tr><tr><td valign="middle"><paragraph> Thrombophlebitis</paragraph></td><td align="center" valign="middle"><paragraph>3</paragraph></td><td align="center" valign="middle"><paragraph>7</paragraph></td></tr><tr><td valign="middle"><paragraph> Pulmonary Emboli</paragraph></td><td align="center" valign="middle"><paragraph>2</paragraph></td><td align="center" valign="middle"><paragraph>5</paragraph></td></tr><tr><td valign="middle"><paragraph> Congestive Heart Failure</paragraph></td><td align="center" valign="middle"><paragraph>3</paragraph></td><td align="center" valign="middle"><paragraph>2</paragraph></td></tr><tr><td valign="middle"><paragraph> Edema</paragraph></td><td align="center" valign="middle"><paragraph>19</paragraph></td><td align="center" valign="middle"><paragraph>17</paragraph></td></tr><tr><td valign="middle"><paragraph> Dyspnea</paragraph></td><td align="center" valign="middle"><paragraph>11</paragraph></td><td align="center" valign="middle"><paragraph>3</paragraph></td></tr><tr><td valign="middle"><paragraph> Leg Cramps</paragraph></td><td align="center" valign="middle"><paragraph>8</paragraph></td><td align="center" valign="middle"><paragraph>11</paragraph></td></tr><tr><td valign="middle"><paragraph> Upper Respiratory Discharge</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td></tr><tr><td valign="middle"><paragraph> Hoarseness</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td></tr><tr><td valign="middle"><paragraph>GASTROINTESTINAL</paragraph></td><td valign="middle"/><td valign="middle"/></tr><tr><td valign="middle"><paragraph> Nausea</paragraph></td><td align="center" valign="middle"><paragraph>15</paragraph></td><td align="center" valign="middle"><paragraph>8</paragraph></td></tr><tr><td valign="middle"><paragraph> Diarrhea</paragraph></td><td align="center" valign="middle"><paragraph>12</paragraph></td><td align="center" valign="middle"><paragraph>11</paragraph></td></tr><tr><td valign="middle"><paragraph> Minor Gastrointestinal Upset</paragraph></td><td align="center" valign="middle"><paragraph>11</paragraph></td><td align="center" valign="middle"><paragraph>6</paragraph></td></tr><tr><td valign="middle"><paragraph> Anorexia</paragraph></td><td align="center" valign="middle"><paragraph>4</paragraph></td><td align="center" valign="middle"><paragraph>3</paragraph></td></tr><tr><td valign="middle"><paragraph> Flatulence</paragraph></td><td align="center" valign="middle"><paragraph>2</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td></tr><tr><td valign="middle"><paragraph> Vomiting</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td></tr><tr><td valign="middle"><paragraph> Gastrointestinal Bleeding</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td></tr><tr><td valign="middle"><paragraph> Burning Throat</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td></tr><tr><td valign="middle"><paragraph> Thirst</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td></tr><tr><td valign="middle"><paragraph>INTEGUMENTARY</paragraph></td><td valign="middle"/><td valign="middle"/></tr><tr><td valign="middle"><paragraph> Rash</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>4</paragraph></td></tr><tr><td valign="middle"><paragraph> Pruritus</paragraph></td><td align="center" valign="middle"><paragraph>2</paragraph></td><td align="center" valign="middle"><paragraph>2</paragraph></td></tr><tr><td valign="middle"><paragraph> Dry Skin</paragraph></td><td align="center" valign="middle"><paragraph>2</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td></tr><tr><td valign="middle"><paragraph> Pigment Changes</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td><td align="center" valign="middle"><paragraph>3</paragraph></td></tr><tr><td valign="middle"><paragraph> Easy Bruising</paragraph></td><td align="center" valign="middle"><paragraph>3</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td></tr><tr><td valign="middle"><paragraph> Flushing</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td></tr><tr><td valign="middle"><paragraph> Night Sweats</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td></tr><tr><td valign="middle"><paragraph> Fingertip—Peeling Skin</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td></tr><tr><td valign="middle"><paragraph> Thinning Hair</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td></tr><tr><td valign="middle"><paragraph>BREAST CHANGES</paragraph></td><td valign="middle"/><td valign="middle"/></tr><tr><td valign="middle"><paragraph> Tenderness</paragraph></td><td align="center" valign="middle"><paragraph>66</paragraph></td><td align="center" valign="middle"><paragraph>64</paragraph></td></tr><tr><td valign="middle"><paragraph> Enlargement</paragraph></td><td valign="middle"/><td valign="middle"/></tr><tr><td valign="middle"><paragraph> Mild</paragraph></td><td align="center" valign="middle"><paragraph>60</paragraph></td><td align="center" valign="middle"><paragraph>54</paragraph></td></tr><tr><td valign="middle"><paragraph> Moderate</paragraph></td><td align="center" valign="middle"><paragraph>10</paragraph></td><td align="center" valign="middle"><paragraph>16</paragraph></td></tr><tr><td valign="middle"><paragraph> Marked</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td><td align="center" valign="middle"><paragraph>5</paragraph></td></tr><tr><td valign="middle"><paragraph>MISCELLANEOUS</paragraph></td><td valign="middle"/><td valign="middle"/></tr><tr><td valign="middle"><paragraph> Lethargy Alone</paragraph></td><td align="center" valign="middle"><paragraph>4</paragraph></td><td align="center" valign="middle"><paragraph>3</paragraph></td></tr><tr><td valign="middle"><paragraph> Depression</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td><td align="center" valign="middle"><paragraph>2</paragraph></td></tr><tr><td valign="middle"><paragraph> Emotional Lability</paragraph></td><td align="center" valign="middle"><paragraph>2</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td></tr><tr><td valign="middle"><paragraph> Insomnia</paragraph></td><td align="center" valign="middle"><paragraph>3</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td></tr><tr><td valign="middle"><paragraph> Headache</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td></tr><tr><td valign="middle"><paragraph> Anxiety</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td></tr><tr><td valign="middle"><paragraph> Chest Pain</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td></tr><tr><td valign="middle"><paragraph> Hot Flashes</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td></tr><tr><td valign="middle"><paragraph> Pain in Eyes</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td></tr><tr><td valign="middle"><paragraph> Tearing of Eyes</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td></tr><tr><td valign="middle"><paragraph> Tinnitus</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td></tr><tr><td valign="middle"><paragraph>LABORATORY ABNORMALITIES</paragraph></td><td valign="middle"/><td valign="middle"/></tr><tr><td valign="middle"><paragraph> Hematologic</paragraph></td><td valign="middle"/><td valign="middle"/></tr><tr><td valign="middle"><paragraph> Leukopenia</paragraph></td><td align="center" valign="middle"><paragraph>4</paragraph></td><td align="center" valign="middle"><paragraph>2</paragraph></td></tr><tr><td valign="middle"><paragraph> Thrombopenia</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>2</paragraph></td></tr><tr><td valign="middle"><paragraph> Hepatic</paragraph></td><td valign="middle"/><td valign="middle"/></tr><tr><td valign="middle"><paragraph> Bilirubin Alone</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td><td align="center" valign="middle"><paragraph>5</paragraph></td></tr><tr><td valign="middle"><paragraph> Bilirubin and LDH</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td></tr><tr><td valign="middle"><paragraph> Bilirubin and SGOT</paragraph></td><td align="center" valign="middle"><paragraph>2</paragraph></td><td align="center" valign="middle"><paragraph>1</paragraph></td></tr><tr><td valign="middle"><paragraph> Bilirubin, LDH and SGOT</paragraph></td><td align="center" valign="middle"><paragraph>2</paragraph></td><td align="center" valign="middle"><paragraph>0</paragraph></td></tr><tr><td valign="middle"><paragraph> LDH and/or SGOT</paragraph></td><td align="center" valign="middle"><paragraph>31</paragraph></td><td align="center" valign="middle"><paragraph>28</paragraph></td></tr><tr><td valign="middle"><paragraph> Miscellaneous</paragraph></td><td valign="middle"/><td valign="middle"/></tr><tr><td styleCode="Botrule " valign="middle"><paragraph> Hypercalcemia—Transient</paragraph></td><td align="center" styleCode="Botrule " valign="middle"><paragraph>0</paragraph></td><td align="center" styleCode="Botrule " valign="middle"><paragraph>1</paragraph></td></tr></tbody></table>
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