A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Provera Side Effects, and Drug Interactions - Medroxyprogesterone Acetate
Provera Side Effects, and Drug Interactions - Medroxyprogesterone Acetate
SIDE EFFECTS
Oral Tablets
Pregnancy: See BOXED WARNING
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: Thromboembolic phenomena
including thrombophlebitis and pulmonary embolism
have been reported.
The following adverse reactions have been observed in women taking
progestins including medroxyprogesterone acetate
tablets: 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, e.g., retinal
thrombosis and optic neuritis.
Sterile Aqueous Suspension
See WARNINGS for possible
adverse effects on the fetus.
- Breakthrough bleeding.
- Spotting.
- Change in menstrual flow.
- Amenorrhea.
- Headache.
- Nervousness.
- Dizziness.
- Edema.
- Change in weight
(increase or decrease).
- Changes in cervial erosion
and cervial secretions.
- Cholestatic jaundice, including neonatal
jaundice.
- Breast tenderness
and galactorrhea.
- Skin sensitivity reactions consisting of urticaria, pruritus,
edema and generalized rash.
- Acne, alopecia
and hirsutism.
- Rash (allergic) with and without pruritis.
- Anaphylactoid reactions and anaphylaxis.
- Mental depression.
- Pyrexia.
- Fatigue.
- Insomnia.
- Nausea.
- Somnolence.
In a few instances there have been undesirable sequelae at the
first site of injection, such as residual
lump, change in color
of skin, or sterile abscess.
A statistically significant
association has
been demonstrated between use of estrogen-progestin combination
durgs 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 associatin with neuro-ocular lesions, e.g.,
retinal thrombosis and
optic neuritis.
Oral Tablets and Sterile Aqueous Suspension
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 uptake
values.
Contraceptive Injection
In the largest clinical
trial with medroxyprogesterone acetate
contraceptive injection, over 3900 women, who were treated for up
to 7 years, reported the following adverse reactions, which may
or may not be related to the use of medroxyprogesterone acetate
contraceptive
injection.
The Following Adverse Reactions Reported By More Than 5%
of Subjects:
- Menstrual irregularities (bleeding or amenorrhea, or both).
- Abdominal pain or discomfort.
- Weight changes.
- Dizziness.
- Headache.
- Asthenia (weakness or fatigue).
- Nervousness.
Adverse Reactions Reported By 1% To 5% of Subjects:
- Decreased libido
or anorgasmia.
- Pelvic Pain.
- Backache.
- Breast Pain.
- Leg Cramps.
- No hair growth
or alopecia.
- Depression.
- Bloating.
- Nausea.
- Rash.
- Insomnia.
- Edema.
- Leukorrhea.
- Hot flashes.
- Acne.
- Arthralgia.
- Vaginitis.
Events reported by fewer than 1% of subjects included: galactorrhea,
melasma, chloasma, convulsions, changes in appetite, gastrointestinal
disturbances, jaundice, genitourinary infections, vaginal
cysts, dyspareunia, paresthesia, chest pain, pulmonary embolus,
allergic reactions,
anemia, drowsiness, syncope, dyspnea
and asthma, tachycardia, fever, excessive sweating
and body odor, dry skin, chills, increased libido, excessive thirst,
hoarseness, pain at injection
site, blood dyscrasia,
rectal bleeding, changes
in breast size, breast
lumps or nipple bleeding,
axillary swelling, breast
cancer, prevention of lactation, sensation
of pregnancy, lack of return to fertility, paralysis, facial
palsy, scleroderma, osteoporosis, uterine
hyperplasia, cervical cancer, varicose
veins, dysmenorrhea, hirsutism, unexpected pregnancy, thrombophlebitis,
deep vein
thrombosis.
In addition, voluntary reports have been received of anaphylaxis
and anaphylactoid reaction
with use of medroxyprogesterone acetate
contraceptive injection.
DRUG INTERACTIONS
Sterile Aqueous Suspension and Contraceptive Injection:
Aminoglutethimide administered concomitantly with the medroxyprogesterone
acetate sterile aqueous
suspension or contraceptive
injection may significantly
depress the serum concentrations
of medroxyprogesterone acetate.16 Users of medroxyprogesterone
acetate should be warned
of the possibility of decreased efficacy with the use of this or
any related drugs.
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