Medical Editor: John P. Cunha, DO, FACOEP
What Is Depo-Provera?
Depo-Provera (medroxyprogesterone acetate) is a form of progesterone, a female hormone used as contraception to prevent pregnancy. Depo-Provera is also used to reduce pain cause by endometriosis, and to ease pain and symptoms in women with metastatic uterine or kidney cancer. Depo-Provera is available in generic form.
What Are Side Effects of Depo-Provera?
Common side effects of Depo-Provera include:
- changes in menstrual periods,
- weight gain,
- nausea,
- stomach cramping or pain,
- bloating,
- dizziness,
- headache,
- tiredness,
- drowsiness,
- irritability,
- breast tenderness,
- decrease in breast size,
- acne,
- hair loss,
- decreased sex drive,
- hot flashes,
- joint pain, or
- injection site reactions (irritation, pain, skin changes, or a hard lump).
Tell your doctor if you have serious side effects of Depo-Provera including:
- mental/mood changes (such as new or worsening depression),
- changes in sexual interest or ability,
- swelling of the ankles or feet,
- bone pain,
- unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding),
- persistent nausea or vomiting,
- severe stomach/abdominal/pelvic pain,
- unusual weakness or tiredness,
- dark urine,
- yellowing eyes or skin, or
- seizures.
Dosage for Depo-Provera
The recommended dose of Depo-Provera is 150 mg every 13 weeks administered by deep intramuscular (IM) injection in the gluteal or deltoid muscle.
What Drugs, Substances, or Supplements Interact with Depo-Provera?
Depo-Provera should not be used as a long-term birth control method (longer than 2 years). Depo-Provera may interact with aminoglutethimide (Cytadren). Other drugs may interact with Depo-Provera. Tell your doctor all prescription and over-the-counter medications and supplements you use.
Depo-Provera During Pregnancy and Breastfeeding
Depo-Provera must not be used during pregnancy. It may take longer for you to get pregnant after you stop using this medication. This drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Depo-Provera (medroxyprogesterone acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- menstrual periods that are heavier or longer than normal;
- severe pain in your lower stomach;
- swelling in your face, or your hands, ankles, and feet;
- pain, bleeding, oozing (pus), or skin changes where the injection was given;
- symptoms of depression (sleep problems, weakness, mood changes);
- liver problems--upper stomach pain, itching, tiredness, dark urine, jaundice (yellowing of the skin or eyes); or
- signs of a blood clot--sudden numbness or weakness, severe headache, chest pain, sudden cough, coughing up blood; problems with vision or speech, swelling or pain in an arm or leg.
Common side effects may include:
- changes in your menstrual periods;
- weakness, feeling tired;
- stomach pain;
- feeling nervous;
- decreased sexual drive;
- weight gain;
- headache, dizziness; or
- lumps or dimpling in your skin where injections were given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
Which of the following are methods for contraception? See AnswerSIDE EFFECTS
The following important adverse reactions observed with the use of Depo-Provera CI are discussed in greater detail in the WARNINGS AND PRECAUTIONS section:
- 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
| Body System* | Adverse Reactions [Incidence (%)] |
| Body as a Whole | Headache (16.5%) Abdominal pain/discomfort (11.2%) |
| Metabolic/Nutritional | Increased weight> 10lbs 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 including angioedema, Fever, Injection site abscess†, Injection site infection† , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, 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 | |
| Neoplasms | Cervical cancer, Breast cancer | |
| Nervous | Paralysis, Facial palsy, Paresthesia, Drowsiness | |
| Respiratory | Dyspnea and asthma, Hoarseness | |
| Skin and Appendages | Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma | |
| Urogenital | 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. † Injection site abscess and injection site infections have been reported; therefore strict aseptic injection technique should be followed when administering Depo Provera CI in order to avoid injection site infections [see DOSAGE AND ADMINISTRATION]. | ||
Read the entire FDA prescribing information for Depo-Provera (Medroxyprogesterone)
© Depo-Provera Patient Information is supplied by Cerner Multum, Inc. and Depo-Provera Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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