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Depo Provera

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Depo Provera

Depo Provera Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Depo-Provera CI (medroxyprogesterone acetate) is used as contraception to prevent pregnancy. It is also used to reduce pain cause by endometriosis, and to ease pain and symptoms in women with metastatic uterine or kidney cancer. It is a form of progesterone, a female hormone. This medication is available in generic form. Common side effects include nausea, stomach cramping/bloating, dizziness, headache, tiredness, breast tenderness, decrease in breast size, acne, hair loss, or irritation/pain at injection site.

The recommended dose of Depo-Provera is 150 mg every 13 weeks administered by deep intramuscular (IM) injection in the gluteal or deltoid muscle. Depo-Provera CI 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 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 breast-feeding.

Our Depo-Provera CI (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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Depo Provera in Detail - Patient Information: Side Effects

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:

  • menstrual periods that are heavier or longer than normal;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • fever;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet; or
  • symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

  • changes in your menstrual periods;
  • weight gain;
  • mild headache, drowsiness;
  • mild stomach pain;
  • hot flashes;
  • joint pain;
  • breast tenderness;
  • feeling tired or irritable;
  • acne;
  • decreased sex drive; or
  • skin changes or a hard lump where the injection was 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.

Read the entire detailed patient monograph for Depo Provera (Medroxyprogesterone) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Depo Provera Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, stomach cramping/bloating, dizziness, headache, tiredness, breast tenderness, decrease in breast size, acne, hair loss, or irritation/pain at injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Your periods may be early or late, shorter or longer, or heavier or lighter than normal. You may also have some spotting between periods, especially during the first several months of use. Your periods may stop completely after you have been receiving this medication for about a year. If this occurs, your periods will normally return after you stop receiving this medication. If you miss a period and have missed an injection, or if more than 13 weeks pass between injections and you think you may be pregnant, see your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., depression), changes in sexual interest/ability, swelling of the ankles/feet, unusual/sudden weight gain, bone pain, unusual breast discharge/lumps in breast, abnormal severe/persistent vaginal bleeding, persistent nausea/vomiting, seizures, severe stomach/abdominal/pelvic pain, unusual weakness/tiredness, dark urine, yellowing skin/eyes.

This drug may rarely cause blood clots. Get medical help right away if you notice any of the following rare but very serious side effects: chest/jaw/left arm pain, sudden shortness of breath, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, sudden/severe headache, slurred speech, vision changes/problems, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Depo Provera (Medroxyprogesterone)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Depo Provera FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE 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 (5):

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> 10 lbs 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.

Read the entire FDA prescribing information for Depo Provera (Medroxyprogesterone) »

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Depo Provera - User Reviews

Depo Provera User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Depo Provera sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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