Note: This document contains side effect information about norethindrone. Some dosage forms listed on this page may not apply to the brand name Lyza.

Applies to norethindrone: oral tablets.

Side effects include:

Menstrual abnormalities (amenorrhea; frequent, irregular, prolonged, or infrequent bleeding), nausea, weight changes, breast changes (tenderness, enlargement, secretion), headache.

For Healthcare Professionals

Applies to norethindrone: compounding powder, oral tablet.

General

The most commonly reported side effects included cycle irregularity, spotting/breakthrough bleeding, and temporary amenorrhea.^[Ref]

Genitourinary

Common (1% to 10%): Uterine/vaginal bleeding and spotting/breakthrough bleeding, short-lasting amenorrhea

Uncommon (0.1% to 1%): Breast discomfort

Frequency not reported: Irregular/increased/decreased bleeding/delayed menstruation, change in menstrual flow, menorrhagia, vaginal hemorrhage, cervical secretion alteration, cervical erosions, prolonged anovulation, suppressed lactation, galactorrhea, mastodynia, breast tenderness/enlargement, genital discharge, withdrawal bleeding (on treatment discontinuation), premenstrual-type depression, changes in cervical squamocolumnar junction and secretions^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache

Frequency not reported: Drowsiness, somnolence, concentration loss, migraine, tremor, cerebral thrombosis and embolism^[Ref]

Local

Common (1% to 10%): Injection site reaction, local skin reaction^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea

Uncommon (0.1% to 1%): Bloating

Frequency not reported: Vomiting, abdominal pain, gastrointestinal disturbance^[Ref]

Dermatologic

Common (1% to 10%): Skin disorder

Frequency not reported: Angioedema, acne, hirsutism, alopecia, rash, pruritus, pruritic rash, melasma, chloasma, urticaria, exacerbation of existing skin conditions, sweating, allergic rash with and without pruritus^[Ref]

Metabolic

Common (1% to 10%): Increased weight

Frequency not reported: Increased fasting insulin levels, Cushing's syndrome, decreased glucose tolerance, exacerbation of diabetes mellitus, glycosuria, weight gain/change, change in appetite, fluid retention, increased serum calcium and potassium levels, altered serum lipid and lipoprotein levels (e.g., decreased HDL, increased LDL/HDL ratio)^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reaction

Frequency not reported: Anaphylaxis/anaphylactoid reactions^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depressed mood/depression/clinical depression/metal depression

Frequency not reported: Insomnia, nervousness, libido change, mood swings^[Ref]

Respiratory

Frequency not reported: Urge to cough, paroxysmal cough, respiratory distress, dyspnea, pulmonary embolism, voice deepening^[Ref]

Ocular

Frequency not reported: Retinal thrombosis, diabetic cataract, vision disorders, visual disturbance, contact lens intolerance, optic neuritis (may lead to partial or complete vision loss)^[Ref]

Cardiovascular

Frequency not reported: Circulatory irregularity, thromboembolic disorders, thrombophlebitis, increased blood pressure/hypertension, edema^[Ref]

Hepatic

Frequency not reported: Cholestatic liver changes/cholestatic jaundice, hepatitis, disturbed liver function, transient liver test abnormalities (e.g., AST, ALT, bilirubin)^[Ref]

Other

Frequency not reported: Fever, hyperpyrexia, fatigue, extremity pain^[Ref]

Hematologic

Frequency not reported: Increased white cell and platelet counts^[Ref]

Endocrine

Frequency not reported: Masculinization of the female fetus^[Ref]