DEPO-PROVERA

(medroxyprogesterone acetate) Injectable Suspension, for Intramuscular Use

WARNING: LOSS OF BONE MINERAL DENSITY

Women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible.
It is unknown if use of Depo-Provera Contraceptive Injection during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.
Depo-Provera Contraceptive Injection should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate. (See WARNINGS AND PRECAUTIONS

What are the possible side effects of medroxyprogesterone (Depo-Provera, Depo-Provera Contraceptive, Depo-SubQ Provera 104)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• fever;
• jaundice (yellowing of...

Read All Potential Side Effects and See Pictures of Depo Provera »

SIDE EFFECTS

The following important adverse reactions observed with the use of Depo-Provera CI are discussed in greater detail in the WARNINGS AND PRECAUTIONSsection:

• Loss of Bone Mineral Density [see WARNINGS AND PRECAUTIONS]
• Thromboembolic disease [see WARNINGS AND PRECAUTIONS]
• Breast Cancer [see WARNINGS AND PRECAUTIONS]
• Anaphylaxis and Anaphylactoid Reactions [see WARNINGS AND PRECAUTIONS]
• Bleeding Irregularities [see WARNINGS AND PRECAUTIONS]
• Weight Gain [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In the two pivotal clinical trials with Depo-Provera CI, over 3,900 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 Depo-Provera CI. The population studied ranges in age from 15 to 51 years, of which 46% were White, 50% Non-White, and 4.9% Unknown race. The patients received 150 mg Depo-Provera CI every 3-months (90 days). The median study duration was 13 months with a range of 1-84 months. Fifty eight percent of patients remained in the study after 13 months and 34% after 24 months.

Table 1: Adverse Reactions that Were Reported by More than 5% of Subjects

Body System*	Adverse Reactions (Incidence (%))
Body as a Whole	Headache (16.5%) Abdominal pain/discomfort (11 .2%)
Metabolic/Nutritional	Increased weight > 10 Ibs at 24 months (37.7%)
Nervous	Nervousness (10.8%) Dizziness (5.6%) Libido decreased (5.5%)
Urogenital	Menstrual irregularities: bleeding (57.3% at 12 months, 32.1% at 24 months) amenorrhea (55% at 12 months, 68% at 24 months)
* Body System represented from COSTART medical dictionary.

Table 2: Adverse Reactions that Were Reported by between 1 and 5% of Subjects

Body System*	Adverse Reactions (Incidence (%)
Body as a Whole	Asthenia/fatigue (4.2%) Backache (2.2%) Dysmenorrhea (1 .7%) Hot flashes (1.0%)
Digestive	Nausea (3.3%) Bloating (2.3%)
Metabolic/Nutritional	Edema (2.2%)
Musculoskeletal	Leg cramps (3.7%) Arthralgia(1.0%)
Nervous	Depression (1 .5%) Insomnia (1.0%)
Skin and Appendages	Acne (1.2%), No hair growth/alopecia (1.1%) Rash (1.1%)
Urogenital	Leukorrhea (2.9%) Breast pain (2.8%) Vaginitis (1.2%)
Body System represented from COSTART medical dictionary.

Adverse reactions leading to study discontinuation in ≥ 2% of subjects: bleeding (8.2%), amenorrhea (2.1%), weight gain (2.0%)

Post-marketing Experience

The following adverse reactions have been identified during post approval use of Depo-Provera CI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
There have been cases of osteoporosis including osteoporotic fractures reported post-marketing in patients taking Depo-Provera CI.

Table 3: Adverse Reactions Reported during Post-Marketing Experience

Body System	Adverse Reactions
Body as a Whole	Chest pain, Allergic reactions, Fever, Pain at injection site, Chills, Axillary swelling
Cardiovascular	Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins
Digestive	Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding
Hematologic and Lymphatic	Anemia, Blood dyscrasia
Musculoskeletal	Osteoporosis
Nervous	Paralysis, Facial palsy, Paresthesia, Drowsiness
Respiratory	Dyspnea and asthma, Hoarseness
Skin and Appendages	Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma
Urogenital	Cervical cancer, Breast cancer, Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia
* Body System represented from COSTART medical dictionary.