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Safyral

Last reviewed on RxList: 6/5/2017
Safyral Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/16/2015

Safyral (drospirenone/ethinyl estradiol/levomefolate calcium) is a combination of female hormones and vitamin B used as contraception to prevent pregnancy. Common side effects of Safyral include nausea (especially when you first start taking Safyral), vomiting, headache, bloating, stomach cramps, breast tenderness or swelling, nipple discharge, swelling of the ankles/feet (fluid retention), weight changes, freckles or darkening of facial skin, increased hair growth, loss of scalp hair, problems with contact lenses, or vaginal itching or discharge. Vaginal bleeding between periods (spotting) or missed/irregular menstrual 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.

Safyral Consumer Information

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

Stop using birth control pills and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness, sudden and severe headache, confusion, problems with vision or speech;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • a change in the pattern or severity of migraine headaches;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet;
  • a breast lump; or
  • symptoms of depression (sleep problems, weakness, tired feeling, mood changes).

Less serious side effects may include:

  • mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;
  • breast tenderness or swelling, nipple discharge;
  • freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
  • problems with contact lenses; or
  • vaginal itching or discharge, 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)

Safyral Professional Information

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)

Related Resources for Safyral

Read the Safyral User Reviews »

© Safyral Patient Information is supplied by Cerner Multum, Inc. and Safyral Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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