Syeda

Last updated on RxList: 7/19/2021
Syeda Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Syeda?

Syeda (drospirenone and ethinyl estradiol) is an estrogen/progestin combined oral contraceptive (COC) indicated for use by women to prevent pregnancy. Syeda is available as a generic.

What Are Side Effects of Syeda?

Common side effects of Syeda include:

  • headache / migraine,
  • breast pain / tenderness/ discomfort,
  • nausea,
  • vomiting,
  • abdominal pain / tenderness / discomfort, and
  • mood changes

Cigarette smoking increases the risk of serious cardiovascular side effects from use of oral contraceptives such as Syeda. Women who use oral contraceptives including Syeda are strongly advised not to smoke.

Dosage for Syeda

The dose of Syeda is one tablet daily by mouth at the same time every day. Syeda tablets must be taken in the order directed on the blister pack.

What Drugs, Substances, or Supplements Interact with Syeda?

Syeda may interact with phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate, St. John's wort, azole antifungals, ascorbic acid (vitamin C), acetaminophen, verapamil, macrolides antibiotics, diltiazem, grapefruit juice, HIV/HCV protease inhibitors, non-nucleoside reverse transcriptase inhibitors, lamotrigine, omeprazole, voriconazole, theophylline, tizanidine, thyroid hormone replacement therapy, and other drugs that may increase serum potassium concentration. Tell your doctor all medications and supplements you use.

Syeda During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Syeda; it is not intended for use during pregnancy. Syeda is not recommended for use during breastfeeding; it can decrease milk production.

Additional Information

Our Syeda (drospirenone and ethinyl estradiol) Tablets, For Oral Use 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.

QUESTION

Which of the following are methods for contraception? See Answer
Syeda Consumer Information

Get emergency medical help if you have 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:

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • liver problems--loss of appetite, upper stomach pain, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;
  • swelling in your hands, ankles, or feet;
  • a change in the pattern or severity of migraine headaches; or
  • symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

  • nausea, vomiting;
  • breast tenderness;
  • headache, mood changes, feeling tired or irritable;
  • weight gain; or
  • changes in your menstrual periods, decreased sex drive.

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 Syeda (Drospirenone and Ethinyl Estradiol Tablets)

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Syeda 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:

  • Irregular uterine bleeding
  • Nausea
  • Breast tenderness
  • Headache

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.

The data provided reflect the experience with the use of drospirenone and ethinyl estradiol (3 mg DRSP/0.03 mg EE) in the adequate and wellcontrolled studies for contraception (N=2,837). The US pivotal clinical study (N=326) was a multicenter, open-label trial in healthy women aged 18 to 35 who were treated for up to 13 cycles. The second pivotal study (N=442)was a multicenter, randomized, open-label comparative European study of drospirenone and ethinyl estradiol vs. 0.150 mg desogestrel/0.03 mg EE conducted in healthy women aged 17 to 40 who were treated for up to 26 cycles.

The most common adverse reactions (≥ 2% of users) were: premenstrual syndrome (13.2%), headache/migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%) abdominal pain/discomfort/tenderness (2.3%) and mood changes (depression, depressed mood, irritability, mood swings, mood altered and affect lability (2.3%).

Adverse Reactions (≥ 1%) Leading To Study Discontinuation

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%).

Serious Adverse Reactions

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

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of drospirenone and ethinyl estradiol. 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 Syeda (Drospirenone and Ethinyl Estradiol Tablets)

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

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