Taytulla

Last updated on RxList: 8/2/2021
Taytulla Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Taytulla?

Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) is an estrogen/progestin combined oral contraceptive (COC) indicated for use by women to prevent pregnancy.

What Are Side Effects of Taytulla?

Common side effects of Taytulla include:

Dosage for Taytulla

Take a dose of one Taytulla capsule by mouth at the same time every day. Take Taytulla capsules in the order directed on the blister pack.

What Drugs, Substances, or Supplements Interact with Taytulla?

Taytulla may interact with phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, St. John's wort, atorvastatin, ascorbic acid, acetaminophen, itraconazole or ketoconazole, HIV/HCV protease inhibitors, non-nucleoside reverse transcriptase inhibitors, lamotrigine, and thyroid hormone replacement therapy. Tell your doctor all medications and supplements you use.

Taytulla During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Taytulla; it is not recommended for use during pregnancy. Taytulla is not recommended for use while breastfeeding because it may decrease milk production. Small amounts of Taytulla pass into breast milk. Other forms of contraception are recommended until the child is weaned.

Additional Information

Our Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 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.

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Taytulla Consumer Information

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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 this medicine 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;
  • a breast lump; or
  • symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

  • nausea, vomiting;
  • breast tenderness;
  • breakthrough bleeding;
  • headache; or
  • problems with contact lenses.

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 Taytulla (Norethindrone Acetate and Ethinyl Estradiol)

QUESTION

Which of the following are methods for contraception? See Answer
Taytulla 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 Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data presented in Section 6.1 are from a clinical trial conducted with a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets. TAYTULLA is bioequivalent to these norethindrone acetate/ethinyl estradiol tablets.

Common Adverse Reactions (≥ 2% of all Treated Subjects)

The most common adverse reactions reported by at least 2% of the 743 women using norethindrone acetate/ethinyl estradiol tablets were the following, in order of decreasing incidence: headache (6.3%), vaginal candidiasis (6.1%), nausea (4.6%), menstrual cramps (4.4%), breast tenderness (3.4%), bacterial vaginitis (3.1%), abnormal cervical smear (3.1%), acne (2.7%), mood swings (2.2%), and weight gain (2.0%).

Adverse Reactions Leading to Study Discontinuation

Among the 743 women using norethindrone acetate/ethinyl estradiol tablets, 46 women (6.2%) withdrew because of an adverse event. Adverse events occurring in 3 or more subjects leading to discontinuation of treatment were, in decreasing order: abnormal or irregular bleeding (1.3%), nausea (0.8%), menstrual cramps (0.5%), and increased blood pressure (0.4%).

Postmarketing Experience

The following adverse reactions have been identified during post approval use of a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or evaluate a causal relationship to drug exposure.

Vascular disorders: thrombosis/embolism (coronary artery, pulmonary, cerebral, deep vein).

Hepatobiliary disorders: cholelithiasis, cholecystitis, hepatic adenoma, hemangioma of liver.

Immune system disorders: hypersensitivity reaction.

Skin and subcutaneous disorders: alopecia, rash (generalized and allergic), pruritus, skin discoloration.

GI disorders: nausea, vomiting, abdominal pain.

Musculoskeletal and connective tissue disorders: myalgia.

Eye disorders: blurred vision, visual impairment, corneal thinning, change in corneal curvature (steepening).

Infections and infestations: fungal infection, vaginal infection.

Investigations: change in weight or appetite (increase or decrease), fatigue, malaise, peripheral edema, blood pressure increased.

Nervous system disorders: headache, dizziness, migraine, loss of consciousness.

Psychiatric disorders: mood swings, depression, insomnia, anxiety, suicidal ideation, panic attack, changes in libido.

Renal and urinary disorders: cystitis-like syndrome.

Reproductive system and breast disorders: breast changes (tenderness, pain, enlargement, and secretion), premenstrual syndrome, dysmenorrhea.

Cardiovascular: chest pain, palpitations, tachycardia, myocardial infarction.

Read the entire FDA prescribing information for Taytulla (Norethindrone Acetate and Ethinyl Estradiol)

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

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