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Depo-SubQ Provera

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Depo-SubQ Provera

Depo-SubQ Provera

Depo-SubQ Provera Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Depo-SubQ Provera (medroxyprogesterone acetate) is used as contraception to prevent pregnancy. It is also used to reduce pain cause by endometriosis, and to ease pain and other symptoms in women with metastatic uterine or kidney cancer. It is a form of progesterone, a female hormone. Common side effects include irregular menstrual bleeding, headache, weight gain, swelling, acne, fatigue, dizziness, nausea, bloating, hot flashes, breast tenderness, changes in appetite, or irritation/pain at injection site.

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.

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-SubQ 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-SubQ Provera (Medroxyprogesterone Acetate) »

What is Patient Information Overview?

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

Depo-SubQ Provera Overview - Patient Information: Side Effects

SIDE EFFECTS: Irregular menstrual bleeding, headache, weight gain, swelling, acne, fatigue, dizziness, nausea, bloating, hot flashes, breast tenderness, changes in appetite, or irritation/pain at injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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, prolonged/complete stopping of menstrual bleeding, bone pain, unusual breast discharge, severe/persistent vaginal bleeding, unusual weakness/tiredness, fainting, persistent nausea/vomiting, severe abdominal pain, yellowing skin/eyes, seizures.

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: sudden/severe headache, chest pain, difficulty breathing, sudden vision changes, numbness in arms/legs, slurred speech, pain in the calf muscles with redness/warmth/swelling.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: 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-SubQ Provera (Medroxyprogesterone Acetate)»

What is Prescribing information?

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

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

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) »

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Depo-SubQ Provera - User Reviews

Depo-SubQ 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-SubQ 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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