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DEPO-PROVERA® 400 (medroxyprogesterone acetate - DEPO-PROVERA 400) Adverse Reactions

ADVERSE REACTIONS

See PRECAUTIONS for possible adverse effects on the fetus

Reproductive System and Breast Disorders

breakthrough bleeding
spotting
change in menstrual flow
amenorrhea
changes in cervical erosion and cervical secretions
breast tenderness and galactorrhea
erectile dysfunction

Nervous System Disorders

headache
dizziness
somnolence
convulsions

Psychiatric Disorders

nervousness
euphoria
mental depression
insomnia

General Disorders and Administration Site Conditions

edema
pyrexia
fatigue
malaise
injection site reaction, injection site pain/tenderness, injection site persistent atrophy/indentation/dimpling, lipodystrophy acquired, injection site nodule/lump

In a few instances there have been undesirable sequelae at the site of injection, such as residual lump, change in color of skin, or sterile abscess.

Investigations

change in weight (increase or decrease)

Hepatobiliary Disorders

cholestatic jaundice, including neonatal jaundice

Skin and Subcutaneous Tissue Disorders

skin sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash
acne, alopecia and hirsutism
rash (allergic) with and without pruritis

Immune System Disorders

anaphylactoid reactions and anaphylaxis
angioedema

Gastrointestinal Disorders

nausea

Endocrine Disorders

corticoid-like effects (e.g., Cushingoid syndrome)

Metabolism and Nutrition Disorders

hypercalcemia

A statistically significant association has been demonstrated between use of estrogen-pro-gestin 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 individuals
premenstrual syndrome
changes in libido
changes in appetite
cystitis-like syndrome
headache
nervousness
fatigue
backache
hirsutism
loss of scalp hair
erythema multiforma
erythema nodosum
hemorrhagic eruption
itching
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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