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Norethindrone Side Effects

In Summary

Commonly reported side effects of norethindrone include: ectopic pregnancy. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to norethindrone: oral tablet

Along with its needed effects, norethindrone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking norethindrone:

More Common

  • Frequent and irregular bleeding
  • menstrual changes

Incidence Not Known

  • Abdominal or stomach pain
  • blindness
  • blue-yellow color blindness
  • blurred vision
  • breast pain
  • changes in menstrual period
  • changes in vision
  • chills
  • clay-colored stools
  • confusion
  • cough
  • dark urine
  • decreased vision
  • diarrhea
  • difficulty with swallowing
  • discouragement
  • dizziness
  • double vision
  • eye pain
  • fast heartbeat
  • feeling sad or empty
  • fever
  • general tiredness and weakness
  • headache
  • heavy non-menstrual vaginal bleeding
  • hives, itching, or rash
  • irritability
  • lack of appetite
  • light-colored stools
  • light vaginal bleeding between regular menstrual periods
  • loss of interest or pleasure
  • migraine headache
  • nausea and vomiting
  • numbness of the hands
  • pain, redness, or swelling in the arm or leg
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • swelling
  • tightness in the chest
  • trouble concentrating
  • trouble sleeping
  • unpleasant breath odor
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • vomiting of blood
  • yellow eyes and skin

Some side effects of norethindrone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Breast tenderness
  • increased hair growth, especially on the face
  • pimples
  • weight gain

Incidence Not Known

  • Brown, blotchy spots on exposed skin
  • enlarged breasts
  • hair loss or thinning of the hair
  • mood swings
  • nervousness
  • weight changes

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. Nor-QD (norethindrone)" Watson Laboratories Inc, Corona, CA.

2. "Product Information. Aygestin (norethindrone)" Lederle Laboratories, Philadelphia, PA.

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

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

5. "Product Information. Micronor (norethindrone)" Ortho McNeil Pharmaceutical, Raritan, NJ.

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.

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