Demulen 1/50 Oral Tablet 1-0.05Mg Drug Medication Dosage Information
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Demulen 1/50: Oral tablet (1-0.05mg)

Detailed Information
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What is this Medicine?

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE (ETH in il es tra DYE ole; e thye noe DYE ole dye AS e tate) is an oral contraceptive. The products combine two types of female hormones, an estrogen and a progestin. They are used to prevent ovulation and pregnancy.

In-Depth Information

Demulen 1/50 28-Day Tablet

NDC: 000250081
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Contraception

Sometimes used for but not FDA approved for the following conditions:
Acne Vulgaris, Dysfunctional Uterine Bleeding, Endometriosis, Amenorrhea, Polycystic Ovary Syndrome, Hirsutism

Demulen 1/50 28-Day Tablet
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Reported Side Effects for Demulen 1/50 28-Day Tablet

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Cataracts Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Liver Infection Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Bleeding In The Brain Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Yellow Skin Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Heart Attack Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Inflamed Pancreas Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Optic Disc Swelling Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Porphyria Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Brain Attack Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Liver Infection Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Fluid From Breast Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Double Vision Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Elevated Hepatic Enzymes Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Galactorrhea Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Liver Cancer Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Visual Impairment Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Blood Clot Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Blood Clot In Lung Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Inflamed Optic Nerve Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Blood Clot In Eye Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Blood Clot Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Pelvic Pain Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Increased Sexual Desire Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Heavy Menstrual Period Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Weight Gain Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Vaginal Irritation Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Decreased Sexual Desire Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Vaginal Discharge Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Acne Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
No Menstrual Periods Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Nervousness Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Yeast Infection Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Depression Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Menstrual Cramps Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Tired Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Breast Pain Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Vaginal Infection Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Stomach Pain Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Irregular Periods Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Vaginal Discharge Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Vomiting Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Causing To Be Hungry Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Weakness Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Increase In Breast Size Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Emotional Lability Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Irritability Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Headache Incidence:
>10.0%*
Severity: MILD
Onset: EARLY
Breakthrough Bleeding Incidence:
>10.0%*
Severity: MILD
Onset: DELAYED
Upset Stomach Incidence:
>10.0%*
Severity: MILD
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Daily Life Interactions for Demulen 1/50 28-Day Tablet
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Elements of your daily lifestyle may have an effect on the medications you are taking. Drug interactions can result in unwanted side effects, reduce the effectiveness of your medicine or possibly increase the action of a particular medicine.

Major Lifestyle Interaction
Tobacco and Demulen 1/50 28-Day Tablet(Ethinyl Estradiol)
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Tobacco and Estrogens in Hormonal Contraceptives(Ethinyl Estradiol)
You are strongly advised not to smoke while taking this medication. Tobacco smoking can increase the risk of a blood clot, stroke, heart attack or other serious problem while taking this medication. This is especially true if you are a female over 35 years of age or if you smoke > 15 cigarettes per day. While taking this medication, you should report any of the following "ACHES" to your prescriber immediately: Abdominal pain, Chest pain, severe or frequent Headaches or migraines; Eye pain or Severe leg pain in the calves or the thighs.
Moderate Lifestyle Interaction
Marijuana and Demulen 1/50 28-Day Tablet(Ethinyl Estradiol)
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Marijuana and Ethinyl Estradiol(Ethinyl Estradiol)
Ethinyl Estradiol can theoretically decrease the elimination of Marijuana, Medical from the body. Side effects from Marijuana, Medical may worsen if you take Ethinyl Estradiol. You may feel drowsy or more tired. Do not drive or operate machinery until you know how these drugs affect you. Contact your health care provider immediately if you notice slurred speech, confusion, increases heart rate, or palpitations while taking Marijuana, Medical.
Minor Lifestyle Interaction
Grapefruit juice and Demulen 1/50 28-Day Tablet(Ethinyl Estradiol)
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Grapefruit juice and Estrogens(Ethinyl Estradiol)
Grapefruit juice and grapefruit-containing foods may increase the side effects of estrogen in some females, such as nausea, breast tenderness, headache or fluid retention. There may be no interaction. Do not significantly change your grapefruit intake while taking estrogens for hormone replacement therapy or as part of hormonal birth control products. Report any unusual side effects, like unusual non-menstrual vaginal bleeding, promptly for evaluation.
Minor Lifestyle Interaction
Caffeine-containing Foods/Beverages and Demulen 1/50 28-Day Tablet(Ethinyl Estradiol)
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Caffeine-containing Foods/Beverages and Ethinyl Estradiol(Ethinyl Estradiol)
Side effects from Caffeine may get worse if you take Ethinyl Estradiol (an estrogen hormone commonly found in birth control pills). Too much Caffeine can cause effects like nausea, nervousness, or sleeplessness. Although an interaction is possible, these drugs are often used together without problems.
Pregnancy & Lactation Information
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FIRST Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

SECOND Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

THIRD Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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Patient Experiences with Demulen 1/50

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