Pregnancy (see Warnings for possible adverse effects on the fetus).
Breast: Breast tenderness or galactorrhea has been reported rarely.
Skin: Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred in an occasional patient. Acne, alopecia and hirsutism have been reported in a few cases.
Thromboembolic Phenomena: Thrombophlebitis and pulmonary embolism have been reported.
The following adverse reactions have been observed in women taking progestins including Provera: Breakthrough bleeding, spotting, change in menstrual flow, amenorrhea, edema, change in weight (increase or decrease), changes in cervical erosion and cervical secretions, cholestatic jaundice, anaphylactoid reactions and anaphylaxis, rash (allergic) with and without pruritus, mental depression, pyrexia, insomnia, nausea, somnolence.
A statistically significant association has been demonstrated between use of estrogen-progestin combination drugs and the following serious adverse reactions: Thrombophlebitis; pulmonary embolism and cerebral thrombosis and embolism. For this reason, patients on progestin therapy should be carefully observed.
Although available evidence is suggestive of an association, such a relationship has been neither confirmed nor refuted for the following serious adverse reactions: Neuro-ocular lesions eg, retinal thrombosis and optic neuritis.
The following adverse reactions have been observed in patients receiving estrogen-progestin combination drugs: Rise in blood pressure in susceptible individuals, premenstrual-like syndrome, changes in libido, changes in appetite, cystitis-like syndrome, headache, nervousness, fatigue, backache, hirsutism, loss of scalp hair, erythema multiforme, erythema nodosum, hemorrhagic eruption, itching, dizziness.
In view of these observations, patients on progestin therapy should be carefully observed.
The following laboratory results may be altered by the use of estrogen-progestin combination drugs: Increased sulfobromophthalein retention and other hepatic function tests.
Coagulation Tests: Increase in prothrombin factors VII, VIII, IX and X.
Metyrapone Test. Pregnanediol determination.
Thyroid Function: Increase in PBI and butanol extractable protein bound iodine and decrease in T3