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Depo-SubQ Provera

Last reviewed on RxList: 7/27/2009
Depo-SubQ Provera Side Effects Center

Last reviewed on RxList 8/10/2016

Depo-SubQ Provera (medroxyprogesterone acetate) is a form of progesterone, a female hormone used as contraception to prevent pregnancy. Depo-SubQ Provera is also used to reduce pain cause by endometriosis, and to ease pain and other symptoms in women with metastatic uterine or kidney cancer. Common side effects of Depo-SubQ Provera include:

  • irregular menstrual bleeding
  • headache
  • weight gain
  • swelling
  • acne
  • fatigue
  • dizziness
  • drowsiness
  • nausea
  • stomach pain
  • bloating
  • hot flashes
  • joint pain
  • breast tenderness
  • tiredness
  • irritability
  • changes in appetite
  • decreased sex drive
  • injection site reactions (irritation, pain, skin changes, or a hard lump)

Depo-SubQ Provera 104 is given by subcutaneous injection into the anterior thigh or abdomen, once every 3 months (12 to 14 weeks). Dosage does not need to be adjusted for body weight. Depo-SubQ Provera may interact with aminoglutethimide. Tell your doctor all medications and supplements you use. Depo-SubQ Provera must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor. This drug passes into breast milk. Consult your doctor before breastfeeding.

Our Depo-SubQ 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.

Depo-SubQ Provera Consumer Information

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-SubQ Provera (Medroxyprogesterone Acetate)

Depo-SubQ Provera Professional Information

SIDE EFFECTS

In five clinical studies of depo-subQ provera (medroxyprogesterone acetate) 104 involving 2,325 women (282 treated for up to 6 months, 1,780 treated for up to 1 year and 263 treated for up to 2 years), 9% of women discontinued treatment for adverse reactions. Among these 212 women, the most common reasons for discontinuation were:

  • Uterine bleeding irregularities (35%, n=75)
  • Increased weight (18%, n=39)
  • Decreased libido (11%, n=23)
  • Acne (10%, n=21)
  • Injection site reactions (6%, n=12)

Adverse reactions reported by 5% or more of all women in these clinical trials included:

  • Headache (9%)
  • Intermenstrual bleeding (7%)
  • Increased weight (6%)
  • Amenorrhea (6%)
  • Injection site reactions (5%)

Adverse reactions reported by 1% to < 5% of all women in these clinical trials included:

General disorders: fatigue, injection site pain

Gastrointestinal disorders: abdominal distention, abdominal pain, diarrhea, nausea

Infections: bronchitis, influenza, nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection, urinary tract infection, vaginal candidiasis, vaginitis, vaginitis bacterial

Investigations: abnormal cervix smear

Musculoskeletal, connective tissue, and bone disorders: arthralgia, back pain, limb pain

Nervous system disorders: dizziness, insomnia

Psychiatric disorders: anxiety, depression, irritability, decreased libido

Reproductive system and breast disorders: breast pain, breast tenderness, menometrorrhagia, menorrhagia, menstruation irregular, uterine hemorrhage, vaginal hemorrhage

Skin disorders: acne

Vascular disorders: hot flushes

Postmarketing Experience

There have been rare cases of osteoporosis including osteoporotic fractures reported postmarketing in patients taking DEPO-PROVERA Contraceptive Injection. In addition, infrequent voluntary reports of anaphylaxis and anaphylactoid reaction have been received associated with use of Depo-Provera CI (150 mg).

The following additional reactions have been reported with Depo-Provera Contraceptive Injection and may occur with use of depo-subQ provera 104:

General disorders: asthenia, axillary swelling, chills, chest pain, fever, excessive thirst

Blood and lymphatic system disorders: anemia, blood dyscrasia

Cardiac disorders: tachycardia

Gastrointestinal disorders: gastrointestinal disturbances, rectal bleeding

Hepato-biliary disorders: jaundice

Immune system disorders: allergic reaction

Infections:genitourinary infections

Investigations: decreased glucose tolerance

Musculoskeletal, connective tissue, and bone disorders: loss of bone mineral density, scleroderma

Neoplasms: breast cancer, cervical cancer

Nervous system disorders: convulsions, facial palsy, fainting, paralysis, paresthesia, somnolence

Psychiatric disorders: increased libido, nervousness

Reproductive system and breast disorders: breast lumps, galactorrhea, nipple discharge or bleeding, oligomenorrhea, prevention of lactation, prolonged anovulation, unexpected pregnancy, uterine hyperplasia, vaginal cyst

Respiratory disorders: asthma, dyspnea, hoarseness

Skin disorders: angioedema, dry skin, increased body odor, melasma, pruritus, urticaria

Vascular disorders: deep vein thrombosis, pulmonary embolus, thrombophlebitis

Read the entire FDA prescribing information for Depo-SubQ Provera (Medroxyprogesterone Acetate)

Related Resources for Depo-SubQ Provera

Read the Depo-SubQ Provera User Reviews »

© Depo-SubQ Provera Patient Information is supplied by Cerner Multum, Inc. and Depo-SubQ Provera Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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