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Tulana Side Effects

Generic name: norethindrone

Medically reviewed by Drugs.com. Last updated on Mar 22, 2022.

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

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]

References

1. "Product Information. Micronor (norethindrone)." Ortho McNeil Pharmaceutical (2001):

2. "Product Information. Nor-QD (norethindrone)." Watson Laboratories Inc (2001):

3. "Product Information. Aygestin (norethindrone)." Lederle Laboratories (2001):

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.