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The following important adverse reactions observed with the use of Depo-Provera CI are discussed in greater detail in the WARNINGS AND PRECAUTIONS section (5):

• 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 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

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

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

Changes in Contraceptive Effectiveness Associated with Co-Administration of Other Products

If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include:

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's wort
• topiramate

HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors.

Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

Laboratory Test Interactions

The pathologist should be advised of progestin therapy when relevant specimens are submitted.

The following laboratory tests may be affected by progestins including Depo-Provera CI:

1. Plasma and urinary steroid levels are decreased (e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol).
2. Gonadotropin levels are decreased.
3. Sex-hormone-binding-globulin concentrations are decreased.
4. Protein-bound iodine and butanol extractable protein-bound iodine may increase. T3-uptake values may decrease.
5. Coagulation test values for prothrombin (Factor II), and Factors VII, VIII, IX, and X may increase.
6. Sulfobromophthalein and other liver function test values may be increased.
7. The effects of medroxyprogesterone acetate on lipid metabolism are inconsistent. Both increases and decreases in total cholesterol, triglycerides, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol have been observed in studies.

Last reviewed on RxList: 8/31/2011
This monograph has been modified to include the generic and brand name in many instances.