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Nikki Side Effects

Generic Name: drospirenone / ethinyl estradiol

Note: This page contains side effects data for the generic drug drospirenone / ethinyl estradiol. It is possible that some of the dosage forms included below may not apply to the brand name Nikki.

In Summary

Common side effects of Nikki include: headache and migraine. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to drospirenone / ethinyl estradiol: oral tablet

As well as its needed effects, drospirenone / ethinyl estradiol may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking drospirenone / ethinyl estradiol, check with your doctor immediately:

More common:
  • Breast pain or tenderness
  • headache, severe and throbbing
  • heavy non-menstrual vaginal bleeding
  • irregular menstrual periods
  • nausea
  • normal menstrual bleeding occurring earlier, possibly lasting longer than expected
Less common:
  • Longer or heavier menstrual periods
  • unusual tiredness or weakness
  • vomiting
Incidence not known:
  • Abdominal or stomach pain
  • chills
  • clay-colored stools
  • dark urine
  • difficulty with breathing
  • dizziness
  • fever
  • headache
  • itching
  • loss of appetite
  • pain in the chest, groin, or legs, especially the calves
  • rash
  • slurred speech
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • sudden, unexplained shortness of breath
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vision changes
  • vomiting of blood
  • yellow eyes or skin

Minor Side Effects

Some drospirenone / ethinyl estradiol side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common:
  • Crying
  • decreased interest in sexual intercourse
  • delusions of persecution, mistrust, suspiciousness, and/or combativeness
  • false or unusual sense of well-being
  • inability to have or keep an erection
  • irritability
  • loss in sexual ability, desire, drive, or performance
  • mental depression
  • quick to react or overreact emotionally
  • rapidly changing moods
  • weight gain

For Healthcare Professionals

Applies to drospirenone / ethinyl estradiol: oral tablet

General

The most common adverse events were irregular uterine bleeding, nausea, breast tenderness, and headache.[Ref]

Genitourinary

Very common (10% or more): Breast pain or discomfort (17.9%), menstrual disorders (17%), female genital tract bleeding (14%), premenstrual syndrome (13.2%)
Common (1% to 10%): Vaginal candidiasis, leukorrhea, intermenstrual bleeding, cystitis, unscheduled uterine bleeding/genital tract bleeding NOS, metrorrhagia, amenorrhea, breast tenderness, vaginal discharge, cervical polyp
Uncommon (0.1% to 1%): Vaginitis, pelvic pain, breast enlargement, fibrocystic breast, genital discharge, dysmenorrhea, hypomenorrhea, menorrhagia, vaginal dryness, Pap smear suspicious, breast hypertrophy
Rare (less than 0.1%): Dyspareunia, vulvovaginitis, postcoital bleeding, withdrawal bleeding, breast cyst, breast hyperplasia, endometrial atrophy, ovarian cyst, uterine enlargement, breast discharge
Frequency not reported: Cervical dysplasia[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, which occurs in approximately 10% of treated women and may be more frequent during the first cycles of therapy. Some early reports suggested an association between oral contraceptive use and gallbladder disease. Abdominal pain and gastroenteritis have been reported in postmarketing experience.[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hypertension, hypotension, varicose vein
Rare (less than 0.1%): Venous and arterial thromboembolic events, tachycardia, vascular disorder, phlebitis[Ref]

Venous and arterial thromboembolic events includes peripheral deep vein occlusion, thrombosis and embolism/pulmonary vascular occlusion, thrombosis, embolism, infarction, intracardiac thrombosis, retinal vein occlusion, myocardial infarction, cerebral infarction, and stroke.[Ref]

Nervous system

Very common (10% or more): Headache (20%)
Common (1% to 10%): Dizziness, migraine
Uncommon (0.1% to 1%): Somnolence, dizziness, paresthesia, asthenia
Rare (less than 0.1%): Vertigo, tremor, syncope[Ref]

Psychiatric

Common (1% to 10%): Depression/depressive mood, nervousness, emotional lability, decrease and loss of libido, libido increased, affect lability
Rare (less than 0.1%): Anorgasmia, insomnia[Ref]

Other

Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Weight gain, weight loss, hot flushes, edema (generalized)
Rare (less than 0.1%): Candidiasis, malaise, hypoacusis[Ref]

Dermatologic

Common (1% to 10%): Acne
Uncommon (0.1% to 1%): Pruritus, rash, increased sweating, eczema, alopecia
Rare (less than 0.1%): Chloasma, dermatitis acneiform, dry skin, erythema nodosum, erythema multiforme, hypertrichosis, skin disorder, skin striae, contact dermatitis, photosensitive dermatitis, skin nodule
Postmarketing reports: Angioedema[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, sinusitis
Rare (less than 0.1%): Epistaxis, asthma[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity, allergic reaction[Ref]

Oncologic

Rare (less than 0.1%): Breast neoplasm, breast cancer, focal nodular hyperplasia
Frequency not reported: Uterine leiomyoma
Postmarketing reports: Liver tumors[Ref]

Hepatic

Rare (less than 0.1%): Biliary pain, cholecystitis acute
Postmarketing reports: Gallbladder disease, liver function disturbances[Ref]

Metabolic

Uncommon (0.1% to 1%): Fluid retention
Rare (less than 0.1%): Increased appetite, anorexia, hyperkalemia, hyponatremia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain, pain in extremity, muscle cramps
Postmarketing reports: Systemic lupus erythematosus[Ref]

Ocular

Rare (less than 0.1%): Conjunctivitis, dry eye, eye disorder, contact lens intolerance[Ref]

Hematologic

Rare (less than 0.1%): Anemia, thrombocythemia[Ref]

Endocrine

Rare (less than 0.1%): Endocrine disorder[Ref]

References

1. "Product Information. Yasmin (drospirenone-ethinyl estradiol)" Berlex Laboratories, Richmond, CA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Gianvi (drospirenone-ethinyl estradiol)." Teva Pharmaceuticals USA, North Wales, PA.

4. Cerner Multum, Inc. "Australian Product Information." O 0

It is possible that some side effects of Nikki may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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