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Loryna Side Effects

Generic Name: drospirenone / ethinyl estradiol

Note: This page contains information about the side effects of drospirenone / ethinyl estradiol. Some of the dosage forms included on this document may not apply to the brand name Loryna.

In Summary

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

For the Consumer

Applies to drospirenone / ethinyl estradiol: oral tablet

In addition to its needed effects, some unwanted effects may be caused by drospirenone / ethinyl estradiol. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking drospirenone / ethinyl estradiol:

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 of the side effects that can occur with drospirenone / ethinyl estradiol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Not all side effects for Loryna may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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