Safyral Oral Tablet 3-0.451-0.03-0.451Mg Drug Medication Dosage Information
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SAFYRAL: Oral tablet (3-0.451-0.03-0.451mg)

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SAFYRAL Tablet

What is this Medicine?

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE (dro SPY re nown; ETH in il es tra DYE ole; lee voe ME FOE late) is an oral contraceptive (birth control pill). This medicine combines two types of female hormones, an estrogen and a progestin. This medicine also has levomefolate, a B vitamin. It is used to prevent ovulation and pregnancy. It is also used to treat the symptoms of premenstrual dysphoric disorder (PMDD), to treat acne, and to raise folate levels in women who want to use birth control.

CVS Pharmacy Patient Statistics for SAFYRAL: Oral tablet(3-0.451-0.03-0.451mg)
Generic vs. Brand Name Usage*
*Brand contains same active ingredient but may not represent FDA-approved generic equivalent
Usage By Strength
In-Depth Information

SAFYRAL Tablet

NDC: 504190403
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Acne Vulgaris, Nutritional Supplementation, Premenstrual Dysphoric Disorder (PMDD), Contraception

Sometimes used for but not FDA approved for the following conditions:
Endometriosis

Storage Information
Store at 77 degrees F; excursions permitted to 59-86 degrees F
SAFYRAL Tablet

Reported Side Effects for SAFYRAL Tablet

Liver Infection Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
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
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 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
Increased Sexual Desire Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Vaginal Discharge Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Vaginal Irritation Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Pelvic Pain Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Heavy Menstrual Period Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Menstrual Cramps Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Increase In Breast Size Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Yeast Infection Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Nervousness Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Weakness Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Causing To Be Hungry Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Acne Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Vaginal Discharge Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Irregular Periods Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Stomach Pain Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Vaginal Infection Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Depression Incidence:
1.4-2.2%*
Severity: MODERATE
Onset: DELAYED
Emotional Lability Incidence:
2.1%*
Severity: MILD
Onset: EARLY
Weight Gain Incidence:
2.5%*
Severity: MILD
Onset: DELAYED
Decreased Sexual Desire Incidence:
2.8%*
Severity: MILD
Onset: DELAYED
Irritability Incidence:
2.8%*
Severity: MILD
Onset: DELAYED
Breast Pain Incidence:
3.2-10.5%*
Severity: MILD
Onset: DELAYED
Upset Stomach Incidence:
3.5-15.8%*
Severity: MILD
Onset: EARLY
Vomiting Incidence:
3.5%*
Severity: MILD
Onset: EARLY
Tired Incidence:
4.2%*
Severity: MILD
Onset: EARLY
Headache Incidence:
5.9-13.0%*
Severity: MILD
Onset: EARLY
Migraine Incidence:
5.9%*
Severity: MODERATE
Onset: EARLY
No Menstrual Periods Incidence:
6.0-10.0%*
Severity: MILD
Onset: DELAYED
Breakthrough Bleeding Incidence:
>10.0%*
Severity: MILD
Onset: DELAYED
*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 SAFYRAL Tablet

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 SAFYRAL Tablet(Ethinyl Estradiol)
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 SAFYRAL Tablet(Ethinyl Estradiol)
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 SAFYRAL Tablet(Drospirenone)
Grapefruit juice and Drospirenone(Drospirenone)
Grapefruit juice and grapefruit-containing foods may increase the side effects of Estrogens 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. Drospirenone can increase the level of potassium in the blood. Your health care provider may need to monitor your potassium level in the first month of treatment, and as needed thereafter.
Minor Lifestyle Interaction
Grapefruit juice and SAFYRAL Tablet(Ethinyl Estradiol)
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 SAFYRAL Tablet(Ethinyl Estradiol)
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.
Minor Lifestyle Interaction
Alcohol and SAFYRAL Tablet(Levomefolate Calcium)
Alcohol and Levomefolate(Levomefolate Calcium)
If you regularly drink alcohol-containing drinks, you may have a lack of certain B-vitamins including folate. Discuss which supplements would be most appropriate for you with your health care provider. If you experience weakness, fatigue, numbness, tingling in fingers and toes, decreased appetite, diarrhea, hair loss, or depression, contact your health care prescriber.
Minor Lifestyle Interaction
Tobacco and SAFYRAL Tablet(Levomefolate Calcium)
Tobacco and Levomefolate(Levomefolate Calcium)
Although an interaction is possible, people who smoke may take Levomefolate. Smoking may decrease Levomefolate levels in the body. Additional Levomefolate may be recommended if you smoke. Ask your prescriber if you have questions regarding your Levomefolate intake.
Pregnancy & Lactation Information
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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