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See “WARNINGS” for further information on Retinal vascular thrombosis, Thrombotic and thromboembolism events, and Use in pregnancy. The following adverse reactions have been observed in women taking progestins:

Breakthrough bleeding.
Change in menstrual flow.
Changes in weight (decreases, increases).
Changes in cervical erosion and cervical secretions.
Cholestatic jaundice.
Rash (allergic) with and without pruritus.
Melasma or chloasma.
Mental depression.
Breast enlargement/tenderness.
Abnormalities of liver tests (i.e., AST, ALT, Bilirubin).
Mood swings.
Anaphylactic/anaphylactoid reactions.
Thrombotic and thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, cerebral thrombosis and embolism).
Optic neuritis (which may lead to partial or complete loss of vision).
Progestins may alter the result of pregnanediol determinations. The following laboratory results may be altered by the concomitant use of estrogens with progestins:
Hepatic function.
Coagulation tests - increase in prothrombin, factors VII, VIII, IX, and X.
Increase in PBI, BEI, and a decrease in T3 uptake.
Reduced response to metyrapone test.

The following adverse reactions have been observed in patients receiving estrogen-progestogen combination drugs:

  1. Rise in blood pressure in susceptible individuals.
  2. Premenstrual-like syndrome.
  3. Changes in libido.
  4. Changes in appetite.
  5. Cystitis-like syndrome.
  6. Headache.
  7. Nervousness.
  8. Dizziness.
  9. Fatigue.
  10. Backache.
  11. Hirsutism.
  12. Loss of scalp hair.
  13. Erythema multiforme.
  14. Erythema nodosum.
  15. Hemorrhagic eruption.
  16. Itching.

In view of these observations, patients on progestogen therapy should be carefully observed.