Fyavolv Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Fyavolv?

Fyavolv (norethindrone acetate and ethinyl estradiol tablet, film coated) is a combination of female hormones used to treat moderate to severe vasomotor symptoms due to menopause and to prevent postmenopausal osteoporosis.

What Are Side Effects of Fyavolv?

Side effects of Fyavolv include:

headache,
abdominal pain,
breast pain, and
fluid retention (edema)

Seek medical care or call 911 at once if you have the following serious side effects:

Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Fyavolv

The dose of Fyavolv is one tablet taken orally once daily.

Fyavolv In Children

Fyavolv is not indicated in children. Clinical studies have not been conducted in the pediatric population.

What Drugs, Substances, or Supplements Interact with Fyavolv?

Fyavolv may interact with other medicines such as:

inducers of CYP3A4 (such as St. John's wort, phenobarbital, carbamazepine, and rifampin),
inhibitors of CYP3A4 (such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice),
atorvastatin,
ascorbic acid (vitamin C),
acetaminophen, and
lamotrigine

Tell your doctor all medications and supplements you use.

Fyavolv During Pregnancy and Breastfeeding

Fyavolv should not be used during pregnancy. Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk. Fyavolv should not be used while breastfeeding.

Additional Information

Our Fyavolv (norethindrone acetate and ethinyl estradiol tablet, film coated) 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.

SLIDESHOW

What Is Osteoporosis? Treatment, Symptoms, Medication See Slideshow

Fyavolv 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 this medicine and call your doctor at once if you have:

heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;
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;
swelling or tenderness in your stomach;
jaundice (yellowing of the skin or eyes);
unusual vaginal bleeding, pelvic pain;
a breast lump;
memory problems, confusion, unusual behavior; or
high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

stomach pain;
bloating, swelling, weight gain;
breast pain;
light vaginal bleeding or spotting;
thinning scalp hair; or
headache.

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

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer

Fyavolv Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

Cardiovascular Disorders[see BOXED WARNING, WARNINGS AND PRECAUTIONS] .
Malignant Neoplasms[see BOXED WARNING, WARNINGS AND PRECAUTIONS ] .

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.

Adverse reactions reported by ≥5 percent of subjects in controlled clinical studies of norethindrone acetate and ethinyl estradiol are shown in Table 1.

Table 1: Associated Adverse Reactions Reported by ≥5 Percent of Subjects by Body System*

	Placebo N = 247	Number (Percent) of Subjects
	Placebo N = 247	Norethindrone Acetate and Ethinyl Estradiol 0.5/2.5 N = 244	Norethindrone Acetate and Ethinyl Estradiol 1/5 N = 258
BODY AS A WHOLE	23 (12.8)	30(16.9)	30(15.7)
Edema - Generalized	10 (4.0)	12 (4.9)	11(4.3)
Headache	12 (4.9)	14 (5.7)	16 (6.2)
DIGESTIVE SYSTEM	8 (4.4)	17(9.6)	25 (13.1)
Abdominal Pain	3(1.2)	13 (5.3)	14 (6.8)
UROGENITAL SYSTEM	20(11.1)	34(19.2)	45 (23.6)
Breast Pain	9 (3.6)	22 (9.0)	20 (7.8)
*The total number of subjects for each body system may be less than the number of subjects with AEs in that body system because a subject may have had more than one AE per body system

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of norethindrone acetate 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.

Genitourinary System

Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; increase in size of uterine leiomyomata, vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer; uterine cancer; vaginal hemorrhage; ovarian cyst; irregular menstruation; metrorrhagia; menorrhagia; dysmenorrhea; uterine enlargement.

Breasts

Tenderness, enlargement, breast pain, nipple pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer; breast disorder; breast mass; breast enlargement.

Cardiovascular

Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; thrombosis; chest pain; myocardial infarction; cerebrovascular accident (stroke); transient ischemic attack; hemiparesis; increase in blood pressure; irregular heart rate; palpitations; dyspnea.

Gastrointestinal

Nausea, vomiting; cholestatic jaundice; pancreatitis, enlargement of hepatic hemangiomas; bloating, abdominal cramps; abdominal pain; increased incidence of gallbladder disease; cholecystitis; cholelithiasis.

Skin

Chloasma or melasma that may persist when drug is discontinued; generalized erythema; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; rash, pruritus.

Eyes

Retinal vascular thrombosis; visual impairment; intolerance to contact lenses.

Central Nervous System (CNS)

Headache; migraine; dizziness; depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia; paresthesia; insomnia.

Miscellaneous

Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; back pain; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides; blood glucose abnormal; fatigue; myalgia; hypersensitivity.

DRUG INTERACTIONS

No drug-drug interaction studies have been conducted for norethindrone acetate and ethinyl estradiol.

Effect Of Other Drugs On Combined Hormonal Products

Substances Decreasing Or Increasing The Plasma Concentration Of Estrogen

In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John's wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine and rifampin may decrease the plasma concentration of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase the plasma concentration of estrogens and may result in side effects. Co-administration of atorvastatin and certain hormonal products containing ethinyl estradiol increase AUC values for ethinyl estradiol approximately 20 percent. Ascorbic acid and acetaminophen may increase the plasma ethinyl estradiol concentration, possibly by inhibition of conjugation.

Effect Of Combined Hormonal Products On Other Drugs

Combination hormonal products containing some synthetic estrogens (for example, ethinyl estradiol) may inhibit the metabolism of other compounds. Combination hormonal products have been shown to significantly decrease the plasma concentration of lamotrigine likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

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