Nikki Side Effects Center

Last updated on RxList: 6/30/2021
Nikki Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Nikki?

Nikki (drospirenone and ethinyl estradiol tablets) is a birth control pill that contains two female hormones, a synthetic estrogen and a progestin, used help to lower the chances of becoming pregnant when taken as directed. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases. Nikki is available as a generic.

What Are Side Effects of Nikki?

Common side effects of Nikki include:

  • spotting or bleeding between menstrual periods,
  • nausea,
  • breast tenderness,
  • headache,
  • acne,
  • decreased sex drive,
  • bloating or fluid retention,
  • blotchy darkening of the skin (especially on the face),
  • high blood sugar levels in the blood (especially in women who already have diabetes),
  • high fat (cholesterol, triglycerides),
  • depression,
  • problems with contact lenses, or
  • weight changes

Do not use Nikki if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots, or stroke.

Dosage for Nikki

The dose of Nikki is one pill taken every day at the same time in the order directed on the package.

What Drugs, Substances, or Supplements Interact with Nikki?

Nikki may interact with nonsteroidal anti-inflammatory drugs (NSAIDs), potassium-sparing diuretics, potassium supplementation, ACE inhibitors, angiotensin-II receptor antagonists, heparin, or aldosterone antagonists. Tell your doctor all medications and supplements you use.

Nikki During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Nikki; it is not recommended for use during pregnancy. If you wish to become pregnant, visit your healthcare provider for a pre-pregnancy checkup before you stop taking the pill. Consult your doctor before breastfeeding.

Additional Information

Our Nikki (drospirenone and ethinyl estradiol tablets), 3 mg/0.02 mg 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
Nikki 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 Nikki (Drospirenone and Ethinyl Estradiol Tablets)

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Nikki 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, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Contraception And Acne Clinical Trials

The data provided reflect the experience with the use of Nikki in the adequate and well-controlled studies for contraception (N=1,056) and for moderate acne vulgaris (N=536).

For contraception, a Phase 3, multicenter, multinational, open-label study was conducted to evaluate safety and efficacy up to one year in 1,027 women aged 17 to 36 who took at least one dose of Nikki. A second Phase 3 study was a single center, open-label, active-controlled study to evaluate the effect of 7 28-day cycles of Nikki on carbohydrate metabolism, lipids and hemostasis in 29 women aged 18 to 35. For acne, two multicenter, double-blind, randomized, placebo-controlled studies, in 536 women aged 14 to 45 with moderate acne vulgaris who took at least one dose of Nikki, evaluated the safety and efficacy during up to 6 cycles.

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: headache/migraine (6.7%), menstrual irregularities (including vaginal hemorrhage [primarily spotting] and metrorrhagia (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4%) and mood changes (mood swings, depression, depressed mood and affect lability) (2.2%).

Adverse Reactions (≥1%) Leading To Study Discontinuation

Contraception Clinical Trials

Of 1,056 women, 6.6% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reactions leading to discontinuation were headache/migraine (1.6%) and nausea/vomiting (1.0%).

Acne Clinical Trials

Of 536 women, 5.4% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reaction leading to discontinuation was menstrual irregularities (including menometrorrhagia, menorrhagia, metrorrhagia and vaginal hemorrhage) (2.2%).

Serious Adverse Reactions

Contraception Clinical Trials: migraine and cervical dysplasia

Acne Clinical Trials: none reported in the clinical trials

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Nikki. 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 are grouped into System Organ Classes, and ordered by frequency.

Vascular Disorders

Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, cerebral thrombosis, retinal thrombosis, myocardial infarction and stroke), hypertension (including hypertensive crisis)

Hepatobiliary Disorders

Gallbladder disease, liver function disturbances, liver tumors

Immune System Disorders

Hypersensitivity (including anaphylactic reaction)

Metabolism And Nutrition Disorders

Hyperkalemia, hypertriglyceridemia, changes in glucose tolerance or effect on peripheral insulin resistance (including diabetes mellitus)

Skin and Subcutaneous Tissue Disorders

Chloasma, angioedema, erythema nodosum, erythema multiforme.

Gastrointestinal Disorders

Inflammatory bowel disease

Musculoskeletal And Connective Tissue Disorders

Systemic lupuserythematosus

Read the entire FDA prescribing information for Nikki (Drospirenone and Ethinyl Estradiol Tablets)

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

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