Depo-SubQ Provera Side Effects Center

Last updated on RxList: 4/21/2022
Depo-SubQ Provera Side Effects Center

What Is Depo-SubQ Provera?

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.

What Are Side Effects of Depo-SubQ Provera?

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)

Dosage for Depo-SubQ Provera

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.

What Drugs, Substances, or Supplements Interact with Depo-SubQ Provera?

Depo-SubQ Provera may interact with aminoglutethimide. Tell your doctor all medications and supplements you use.

Depo-SubQ Provera During Pregnancy and Breastfeeding

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.

Additional Information

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.

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Depo-SubQ Provera Consumer Information

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.

Read the entire detailed patient monograph for Depo-SubQ Provera (Medroxyprogesterone Acetate)

QUESTION

Which of the following are methods for contraception? See Answer
Depo-SubQ Provera Professional Information

SIDE EFFECTS

The following important adverse reactions are described in more detail in other sections of the prescribing information:

  • Loss of bone mineral density [see WARNINGS AND PRECAUTIONS]
  • Arterial and venous thromboembolic disorders [see WARNINGS AND PRECAUTIONS]
  • Anaphylaxis [see WARNINGS AND PRECAUTIONS]
  • Fluid retention [see WARNINGS AND PRECAUTIONS]
  • Delayed return of ovulation or fertility [see WARNINGS AND PRECAUTIONS]
  • Depression [see WARNINGS AND PRECAUTIONS]
  • Injection site reactions [see WARNINGS AND PRECAUTIONS]
  • Bleeding irregularities [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials 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.

The data described below reflect exposure to depo-subQ provera 104 in five clinical trials involving 2325 women including 2043 women who received treatment for contraception (1780 treated up to 1 year and 263 treated for up to 2 years) and 282 women for endometriosis for up to 6 months. In these pooled trials, 9% of women discontinued treatment due to an adverse reaction and the most common reason for discontinuation was dysfunctional uterine bleeding (3%).

Adverse Reactions In The Contraception Adult Studies

Table 1 presents frequently reported adverse reactions (>1%) in the contraception pooled studies. In these studies, the most frequently reported adverse reactions (>5%) were dysfunctional uterine bleeding (e.g., irregular, increased, decreased, or spotting), headache, increased weight, amenorrhea, and injection site reactions (e.g., pain/tenderness, nodule/lump, persistent atrophy/indentation/dimpling or lipodystrophy).

The frequency reported is based on the all-causality incidence in the pooled results of the three contraception studies. Closely related “Adverse Reaction” terms were grouped but individual patients reporting two or more grouped events were only counted once.

Table 1: Frequently Reported Adverse Reactions in the Contraception Studies (>1%)

Adverse Reaction Frequency
Dysfunctional uterine bleeding (irregular, increase, decrease, spotting) 18%
Headache 9%
Increased weight (see below) 7%
Amenorrhea 6%
Injection site reactions (such as pain/tenderness, nodule/lump, persistent atrophy /indentation/ dimpling, lipodystrophy) 6%
Vaginitis, including candidiasis and bacterial 5%
Abdominal pain 4%
Urinary tract infections 4%
Acne 4%
Depression 3%
Decreased libido 3%
Nausea 3%
Back pain 3%
Breast pain/tenderness 2%
Fatigue 2%
Anxiety 1%
Irritability 1%
Dizziness 1%

Dysfunctional Uterine Bleeding

The extent of bleeding and spotting in the three contraception trials is presented in Figure N; data from the endometriosis trials are presented in Figure O [see WARNINGS AND PRECAUTIONS].

Figure N: Mean Number of Bleeding or Spotting Days in the Subgroup of Women with Bleeding or Spotting Among Women Treated with deposubQ provera 104 in Contraception Studies

 Mean Number of Bleeding or Spotting Days in
the Subgroup of Women with Bleeding or Spotting Among Women Treated with
deposubQ provera 104 in Contraception Studies - Illustration

N=Number of subjects with bleeding or spotting during indicated month.

Figure O: Mean Number of Bleeding or Spotting Days in the Subgroup of Women with Bleeding or Spotting Among Women Treated with deposubQ provera 104 in Endometriosis Studies

Mean Number of Bleeding or Spotting Days in
the Subgroup of Women with Bleeding or Spotting Among Women Treated with
deposubQ provera 104 in Endometriosis Studies - Illustration

N=Number of subjects with bleeding or spotting during indicated month.

Weight Gain

In three large clinical trials, the mean weight gain in depo-subQ provera 104 treated patients was 3.5 lb (1.6 kg) in the first year of use. Half (50%) of women remained within 4.9 lb (2.2 kg) of their initial body weight; 12% of women lost more than 4.9 lb (2.2 kg), and 38% of women gained more than 5.1 lb (2.3 kg). In a small, 2-year study comparing depo-subQ provera 104 to DMPA-IM, the mean weight gain observed for women using depo-subQ provera 104 [7.5 lb (3.4 kg)] was similar to the mean weight gain for women using DMPA-IM [7.7 lb (3.5 kg)].

Other Adverse Reactions Observed In Contraception Clinical Trials With depo-subQ provera 104

Other adverse reactions occurring at an incidence of <1% in women who received depo-subQ provera 104 were as follows:

  • Neoplasms benign, malignant and unspecified (including cysts and polyps): breast lump
  • Blood and lymphatic system disorders: anemia
  • Immune system disorders: drug hypersensitivity
  • Metabolism and nutrition disorders: weight decreased, fluid retention
  • Nervous system disorders: facial palsy, syncope, paresthesia, somnolence
  • Cardiac disorders: tachycardia
  • Vascular disorders: hot flushes
  • Respiratory, thoracic and mediastinal disorders: asthma, dyspnea
  • Gastrointestinal disorders: diarrhea, abdominal distension
  • Skin and subcutaneous tissue disorders: urticaria, pruritus, dry skin
  • Reproductive system and breast disorders: dysmenorrhea, galactorrhea, dyspareunia
  • General disorders and administration site conditions: chest pain
Adverse Reactions In The Endometriosis Adult Studies

The safety profile of depo-subQ provera 104 in endometriosis clinical trials was similar to the safety profile of depo-subQ provera 104 in the contraception studies with the exception of the following adverse reactions which were more frequently reported in patients with endometriosis: abdominal pain, diarrhea, nausea, and back pain.

In endometriosis studies, subjects recorded daily the occurrence and severity of hot flushes. Of the depo-subQ provera 104 users, 29% reported experiencing moderate or severe hot flushes at baseline, 36% at Month 3, and 27% at Month 6. Of the leuprolide users, 33% reported experiencing moderate or severe hot flushes at baseline, 74% at Month 3, and 69% at Month 6.

Adverse Reactions In The Adolescent Contraception Study

Depo-sub-Q provera 104 and DMPA-IM clinical trials reported similar safety profiles in adult study populations (see Table 1 above). Accordingly, a similar safety profile is expected for adolescents receiving depo-subQ provera 104 as for adolescents receiving DMPA-IM.

The safety profile of DMPA-IM for prevention of pregnancy in adolescents was observed to be generally similar to the safety profile of adult women using DMPA-IM for prevention of pregnancy, with the exception of the following adverse reactions which were reported more frequently by adolescents: abdominal pain, diarrhea, back pain, weight increased, depression, headache, and dysmenorrhea.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of DMPA-IM. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

  • Immune system disorders: anaphylactic reaction, anaphylactoid reaction, angioedema
  • Vascular disorders: pulmonary embolism, deep vein thrombosis, thrombophlebitis
  • Musculoskeletal and connective tissue disorders: osteoporosis (including osteoporotic fractures)
  • Reproductive system and breast disorders: prolonged anovulation, unexpected pregnancy, uterine hyperplasia
  • Respiratory, thoracic and mediastinal disorders: hoarseness
  • Skin and subcutaneous tissue disorders: increased body odor
  • Gastrointestinal disorders: gastrointestinal disturbances
  • General disorders and administration site conditions: axillary swelling, chills, thirst

DRUG INTERACTIONS

Effect Of Other Drugs On Depo-subQ provera 104

Moderate Or Strong CYP3A Inducers

Concomitant use with moderate or strong CYP3A inducers may decrease concentrations of medroxyprogesterone acetate which may reduce depo-subQ provera 104 efficacy. This effect is based upon the primary metabolism of medroxyprogesterone acetate by CYP3A and was not confirmed by a clinical study.

Avoid coadministration of depo-subQ provera 104 with moderate or strong CYP3A inducers. Some examples of moderate CYP3A inducers are bosentan, efavirenz, etravirine, and modafinil. Some examples of strong CYP3A inducers are rifampin, carbamazepine, phenytoin, phenobarbital, mitotane, and St. John's wort (the CYP3A4 induction effect of St. John's wort varies widely and is preparation dependent). These examples are a guide and do not represent a comprehensive list of all possible drugs that may fit these categories.

The use of CYP3A inducers may require using a back-up or alternate contraceptive method.

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

© 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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