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