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Quick facts
- How it is given
- intramuscular
- Type
- human prescription drug
- RxNorm ID
- 1000153
We do not publish dosing. How much of this medicine to take, how often, and for how long depends on your age, weight, kidney and liver function, other conditions and other medicines. That is a decision for the person who prescribes or dispenses it. Follow the directions on your own pack and ask your pharmacist if anything is unclear.
What it is used to treat
Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)]. Medroxyprogesterone acetate is a progestin indicated for use by females of reproductive potential to prevent pregnancy. (1) Limitations of Use: The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. (1, 5.1)
About this medicine
Medroxyprogesterone acetate injectable suspension, USP, a contraceptive injection, contains medroxyprogesterone acetate, USP a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a white or almost white, crystalline powder that is stable in air and that melts between 205°C and 209°C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α-). The structural formula is as follows: Medroxyprogesterone acetate injectable suspension, USP for IM injection is available in prefilled syringe containing 1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL. For Medroxyprogesterone acetate injectable suspension prefilled syringe, each mL of sterile aqueous suspension contains: Medroxyprogesterone acetate 150 mg Polyethylene glycol 3350 28.90 mg Polysorbate 80 2.41 mg Sodium chloride 8.68 mg Methylparaben 1.37 mg Propylparaben 0.15 mg Water for injection quantity sufficient When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both. spl-medroxy-structure
How it works
12.1 Mechanism of Action Medroxyprogesterone acetate (MPA) injectable suspension, inhibits the secretion of gonadotropins which primarily prevents follicular maturation and ovulation and causes thickening of cervical mucus. These actions contribute to its contraceptive effect.
Who should not take it
The use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: Known or suspected pregnancy or as a diagnostic test for pregnancy. Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [ see Warnings and Precautions ( 5.2 ) ]. Known or suspected malignancy of breast [ see Warnings and Precautions ( 5.3 ) ]. Known hypersensitivity to medroxyprogesterone acetate injectable suspension or any of its other ingredients [ see Warnings and Precautions ( 5.5 ) ]. Significant liver disease [ see Warnings and Precautions ( 5. 7) ]. Undiagnosed vaginal bleeding [ see Warnings and Precautions ( 5. 10) ]. Known or suspected pregnancy or as a diagnostic test for pregnancy. ( 4 ) Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease. ( 4 ) Known or suspected malignancy of breast. ( 4 ) Known hypersensitivity to medroxyprogesterone acetate injectable suspension or any of its other ingredients. ( 4 ) Significant liver disease. ( 4 ) Undiagnosed vaginal bleeding. ( 4 )
Warnings and cautions
Thromboembolic Disorders: Discontinue medroxyprogesterone acetate injectable suspension in patients who develop thrombosis. ( 5.2 ) Cancer Risks: Monitor women with a strong family history of breast cancer carefully. ( 5.3 ) Ectopic Pregnancy: Consider ectopic pregnancy if a woman using medroxyprogesterone acetate injectable suspension becomes pregnant or complains of severe abdominal pain. ( 5.4 ) Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment. ( 5.5 ) Liver Function: Discontinue medroxyprogesterone acetate injectable suspension if jaundice or disturbances of liver function develop. ( 5. 7) Carbohydrate Metabolism: Monitor diabetic patients carefully. ( 5.1 2) 5.1 Loss of Bone Mineral Density Use of medroxyprogesterone acetate injectable suspension reduces serum estrogen levels and is associated with significant loss of bone mineral density (BMD). This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if use of medroxyprogesterone acetate injectable suspension by younger women will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. A study to assess the reversibility of loss of BMD in adolescents was conducted with medroxyprogesterone acetate injectable suspension. After discontinuing medroxyprogesterone acetate injectable suspension in these adolescents, mean BMD loss at the total hip and femoral neck did not fully recover by 5 years (60 months) post-treatment in the sub-group of adolescents who were treated for more than 2 years [see Clinical Studies (14.3)]. Similarly, in adults, there was only partial recovery of mean BMD at the total hip, femoral neck, and lumbar spine towards baseline by 2 years post-treatment [See Clinical Studies (14.2)]. The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. BMD should be evaluated when a woman needs to continue to use medroxyprogesterone acetate injectable suspension long-term. […]
Reported side effects
The following important adverse reactions observed with the use of medroxyprogesterone acetate injectable suspension are discussed in greater detail in the Warnings and Precautions section ( 5 ): Loss of Bone Mineral Density [ see Warnings and Precautions ( 5.1 ) ] Thromboembolic disease [ see Warnings and Precautions ( 5.2 ) ] Breast Cancer [ see Warnings and Precautions ( 5.3 ) ] Anaphylaxis and Anaphylactoid Reactions [ see Warnings and Precautions ( 5.5 ) ] Bleeding Irregularities [ see Warnings and Precautions ( 5. 10) ] Weight Gain [ see Warnings and Precautions ( 5. 11) ] Most common adverse reactions (incidence >5%) are: menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain > 10 lbs at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 medroxyprogesterone acetate injectable suspension, 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 medroxyprogesterone acetate injectable suspension. 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 medroxyprogesterone acetate injectable suspension every 3-months (90 days). The median study duration was 13 months with a range of 1 to 84 months. Fifty eight percent of patients remained in the study after 13 months and 34% after 24 months. […]
Interactions with other medicines
Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of contraceptive drug products. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with medroxyprogesterone acetate injectable suspension. ( 7.1 ) 7.1 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 coadministration 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. 7.2 Laboratory Test Interactions The pathologist should be advised of progestin therapy when relevant specimens are submitted. […]
Use in specific groups
Nursing Mothers : Detectable amounts of drug have been identified in the milk of mothers receiving medroxyprogesterone acetate injectable suspension. ( 8.3 ) Pediatric Patients : Medroxyprogesterone acetate injectable suspension is not indicated before menarche. ( 8.4 ) 8.1 Pregnancy Medroxyprogesterone acetate injectable suspension should not be administered during pregnancy. [ See Contraindications and Warnings and Precautions ( 5.1 7).] 8.3 Nursing Mothers Detectable amounts of drug have been identified in the milk of mothers receiving medroxyprogesterone acetate injectable suspension. [ See Warnings and Precautions ( 5.1 3) .] 8.4 Pediatric Use Medroxyprogesterone acetate injectable suspension is not indicated before menarche. Use of medroxyprogesterone acetate injectable suspension is associated with significant loss of BMD. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity. It is unknown if use of medroxyprogesterone acetate injectable suspension by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life. Other than concerns about loss of BMD, the safety and effectiveness are expected to be the same for postmenarchal adolescents and adult women. 8.5 Geriatric Use This product has not been studied in post-menopausal women and is not indicated in this population. 8.6 Renal Impairment The effect of renal impairment on medroxyprogesterone acetate injectable suspension pharmacokinetics has not been studied. 8.7 Hepatic Impairment The effect of hepatic impairment on medroxyprogesterone acetate injectable suspension pharmacokinetics has not been studied. Medroxyprogesterone acetate injectable suspension should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur. [ See Contraindications ( 4 ) and Warnings and Precautions ( 5. 7) .]
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This page is built from the openFDA record of the U.S. Food and Drug Administration's approved labelling for this product, effective 14 December 2022. Label text has been shortened and reformatted for readability; safety wording has not been altered in meaning. FDA labelling describes products approved in the United States — brand names, strengths, formulations and approved uses may differ in your country. Always read the leaflet that comes with your own pack. PocketsInfo is not affiliated with, and is not endorsed by, the FDA. Retrieved 2026-07-30.