ADVERSE REACTIONS
Breakthrough bleeding; spotting; change in menstrual flow; amenorrhea; edema; change in weight (increase or decrease); changes in cervical erosion and cervical secretions; cholestatic jaundice; breast tenderness and galactorrhea; pain, irritation, and/or redness at the injection area; skin sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash; acne, alopecia and hirsutism; rash (allergic) with and without pruritus; anaphylactoid reactions; mental depression; pyrexia; insomnia; nausea; and somnolence.
A statistically significant association has been demonstrated between use of estrogen-progestin combination drugs and pulmonary embolism and cerebral thrombosis and embolism. For this reason patients on progestin therapy should be carefully observed. There is also evidence suggestive of an association with neuro-ocular lesions, e.g., 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 individual, premenstrual 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, and dizziness.
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 determinations; thyroid function: increase in PBI and butanol extractable protein bound iodine, and decrease in T3 uptake values.
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REPORTS OF SUSPECTED PROGESTERONE SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Progesterone. The information is not vetted and should not be considered as verified clinical evidence.
Possible Progesterone side effects / adverse reactions in 34 year old female
Reported by a health professional (non-physician/pharmacist) from Belgium on 2011-10-18
Patient: 34 year old female
Reactions: Uterine Hypertonus, Drug Ineffective, Eclampsia, Headache, Premature Delivery
Adverse event resulted in: hospitalization
Suspect drug(s):
Progesterone
Possible Progesterone side effects / adverse reactions in 40 year old female
Reported by a consumer/non-health professional from United States on 2011-10-31
Patient: 40 year old female weighing 61.2 kg (134.7 pounds)
Reactions: Maternal Exposure During Pregnancy, Premature Labour
Adverse event resulted in: death
Suspect drug(s):
Progesterone
Possible Progesterone side effects / adverse reactions in 4 month old female
Reported by a consumer/non-health professional from Brazil on 2011-11-01
Patient: 4 month old female
Reactions: Lactose Intolerance, Maternal Drugs Affecting Foetus, Caesarean Section, Premature Baby, Twin Pregnancy
Suspect drug(s):
Nuvaring
Dosage: trpl
Indication: Foetal Exposure During Pregnancy
Start date: 2010-10-17
Progesterone
Dosage: trpl
Indication: Foetal Exposure During Pregnancy
Start date: 2011-01-01
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