EMCYT® Adverse Reactions

(estramustine sodium phosphate)

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

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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

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FDA Medwatch

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