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Safyral

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Safyral

Safyral

Safyral Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Safyral (drospirenone/ethinyl estradiol/levomefolate calcium) is a combination of female hormones and vitamin B used as contraception to prevent pregnancy. Common side effects include nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use.

Take one orange Safyral daily for 21 consecutive days, followed by one light orange tablet, containing levomefolate alone, daily on Days 22 through 28. Safyral should be taken in the order directed on the package at the same time each day. Safyral may interact with bosentan, folic acid or potassium supplements, heparin, St. John's wort, antibiotics, rifampin, heart or blood pressure medication, diuretics, HIV or AIDS medications, antifungals, NSAIDs (nonsteroidal anti-inflammatory drugs), phenobarbital and other barbiturates, or seizure medications. Tell your doctor all medications and supplements you use. Safyral must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about birth control, and find out when it is safe to use birth control containing estrogen, such as this medication. This medication passes into breast milk. It may affect milk production and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Our Safyral (drospirenone/ethinyl estradiol/levomefolate calcium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Safyral in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness, confusion, pain behind the eyes, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • a change in the pattern or severity of migraine headaches;
  • jaundice (yellowing of the skin or eyes); or
  • symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

  • breast pain, tenderness, or swelling;
  • mild headache, feeling tired or irritable;
  • bloating, stomach pain, mild nausea;
  • weight gain, swelling of your hands or feet;
  • problems with contact lenses;
  • loss of interest in sex; or
  • changes in your menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Safyral (Drospirenone/Ethinyl Estradiol/Levomefolate Calcium Tablets and Levomefolate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Safyral Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Precautions section.

Nausea, vomiting, headache, abdominal cramps, bloating, breast tenderness, swelling of the ankles/feet (retaining fluid), or weight change may occur. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: lumps in the breast, mental/mood changes (such as new/worsening depression), unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding), severe stomach/abdominal pain, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), dark urine, yellowing eyes/skin.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Talk to your doctor about the risks and benefits of this birth control pill. Get medical help right away if you have: pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, sudden shortness of breath/rapid breathing, coughing up blood, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, confusion, slurred speech, weakness on one side of the body, sudden vision changes (such as partial/complete blindness), unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Safyral (Drospirenone/Ethinyl Estradiol/Levomefolate Calcium Tablets and Levomefolate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Safyral FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

Adverse reactions commonly reported by COC users are:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.

Contraception and Folate Supplementation Clinical Trials

The data provided reflect the experience with the use of Yasmin (3 mg DRSP/0.03 mg EE) in the adequate and well-controlled studies for contraception (N=2,837) and folate supplementation (N=172). For contraception, the US pivotal clinical study (N=326) for the oral contraception indication for Yasmin was a multicenter, open-label trial in healthy women aged 18 -35 who were treated with Yasmin for up to 13 cycles. The second contraceptive pivotal study (N=442) was a multicenter, randomized, open-label comparative European study of Yasmin vs. 0.150 mg desogestrel/0.03 mg EE conducted in healthy women aged 17-40 who were treated for up to 26 cycles. The primary efficacy study using Safyral for folate supplementation was a randomized, single-center European trial in 172 healthy, female subjects aged 18-40 years comparing the pharmacodynamic effects of Yasmin + 0.451 mg levomefolate calcium to Yasmin co-administered with folic acid during 24 weeks of treatment followed by 20 weeks of open-label Yasmin.

The adverse reactions seen across the 2 indications overlapped and are reported using the frequencies from the pooled dataset. The most common adverse reactions (≥ 2% of users) were: premenstrual syndrome (12.4%), headache/migraine (10.3%), breast pain/tenderness/discomfort (8.1%), nausea/vomiting (4.4%), mood changes (depression, depressed mood, irritability, mood swings, mood altered and affect lability (2.3%), and abdominal pain/discomfort/tenderness (2.2%).

Adverse Reactions (≥ 1%) Leading to Study Discontinuation

Contraception Clinical Trials

Of 2,837 women, 6.7% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reaction leading to discontinuation was headache/migraine (1.5%).

Folate Clinical Trial

There were no subjects who discontinued due to an adverse reaction.

Serious Adverse Reactions

Contraception Clinical Trials

depression, pulmonary embolism, toxic skin eruption, and uterine leiomyoma.

Folate Supplementation Clinical Trial

none reported in the clinical trial

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Yasmin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions, including fatalities, are grouped into System Organ Classes and ordered by frequency.

Vascular disorders: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, intracardiac thrombosis, intracranial venous sinus thrombosis, sagittal sinus thrombosis, retinal vein occlusion, myocardial infarction and stroke), hypertension

Hepatobiliary disorders: Gallbladder disease

Immune system disorders: Hypersensitivity

Metabolism and nutrition disorders: Hyperkalemia

Skin and subcutaneous tissue disorders: Chloasma

Read the entire FDA prescribing information for Safyral (Drospirenone/Ethinyl Estradiol/Levomefolate Calcium Tablets and Levomefolate) »

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Safyral - User Reviews

Safyral User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Safyral sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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