(medroxyprogesterone acetate injectable suspension, for intramuscular use)
6 ADVERSE REACTIONS
6 ADVERSE REACTIONS
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):
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- Loss of Bone Mineral Density [see Warnings and Precautions (5.1)]
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- Thromboembolic disease [see Warnings and Precautions (5.2)]
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- Breast Cancer [see Warnings and Precautions (5.3)]
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- Anaphylaxis and Anaphylactoid Reactions [see Warnings and Precautions (5.6)]
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- Bleeding Irregularities [see Warnings and Precautions (5.11)]
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- Weight Gain [see Warnings and Precautions (5.12)]
6.1 Clinical Trials Experience
Clinical trials are conducted under widely varying conditions, therefore, 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.
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Body System* | Adverse Reactions [Incidence (%)] |
Body as a Whole | Headache (16.5%) Abdominal pain/discomfort (11.2%) |
Metabolic/Nutritional | Increased weight >10 lb at 24 months (37.7%) |
Nervous | Nervousness (10.8%) Dizziness (5.6%) Libido decreased (5.5%) |
Reproductive (Urogenital*) | Menstrual irregularities: bleeding (57.3% at 12 months, 32.1% at 24 months) |
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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%) |
Reproductive (Urogenital*) | Leukorrhea (2.9%) Breast pain (2.8%) Vaginitis (1.2%) |
Adverse reactions leading to study discontinuation in ≥2% of subjects: bleeding (8.2%), amenorrhea (2.1%), weight gain (2.0%).
6.2 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
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- * 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 (2.1)].
PATIENT INFORMATION
Patient Information
Depo-Provera® (DEP-po pro-VAIR-ah) CI
(medroxyprogesterone acetate injectable suspension)
Contraceptive Injection
Read this Patient Information carefully before you decide if Depo-Provera CI is right for you. This information does not take the place of talking with your gynecologist or other healthcare professional who specializes in women's health. If you have any questions about Depo-Provera CI, ask your healthcare professional. You should also learn about other birth control methods to choose the one that is best for you.
What is the most important information I should know about Depo-Provera CI?
Depo-Provera CI can cause serious side effects, including:
- •
- Use of Depo-Provera CI may cause you to lose calcium stored in your bone and decrease your bone mass. The longer you use Depo-Provera CI, the greater your loss of calcium from your bones. Your bones may not recover completely when you stop using Depo-Provera CI.
- •
- If you use Depo-Provera CI continuously for a long time (for more than 2 years), it may increase the risk of weak, porous bones (osteoporosis) that could increase the risk of broken bones, especially after menopause.
- •
- You should not use Depo-Provera CI for more than two years unless you cannot use other birth control methods.
- •
- It is not known if your risk of developing osteoporosis is greater if you are a teenager or young adult when you start to use Depo-Provera CI (see "What are the possible side effects of Depo-Provera CI?").
Depo-Provera CI is intended to prevent pregnancy. Depo-Provera CI does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).
What is Depo-Provera CI?
Depo-Provera CI is a progestin hormone birth control method that is given by injection (a shot) to prevent pregnancy.
How well does Depo-Provera CI work?
Your chance of getting pregnant depends on how well you follow the directions for taking your Depo-Provera CI. The more carefully you follow the directions (such as returning every 3 months for your next injection), the less chance you have of getting pregnant.
In clinical studies, about 1 out of 100 women got pregnant during the first year that they used Depo-Provera CI.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
How should I take Depo-Provera CI?
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- Depo-Provera CI is given by your healthcare professional as a shot into your muscle (intramuscular injection). The shot is given in your buttock or upper arm 1 time every 3 months. At the end of the 3 months, you will need to return to your healthcare professional for your next injection in order to continue your protection against pregnancy.
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- To make sure that you are not pregnant before you take Depo-Provera CI, the first injection should be given only:
- o
- during the first 5 days of a normal menstrual period, or
- o
- within the first 5 days after giving birth, if you are not breastfeeding, or
- o
- at the 6th week after giving birth, if you are feeding your baby only breastmilk.
- •
- Depo-Provera CI may be given at other times than those listed above, but you will likely need to have a pregnancy test first to show that you are not pregnant.
- •
- During treatment with Depo-Provera CI, you should see your healthcare professional every year for a blood pressure check and other healthcare needs.
Who Should Not Use Depo-Provera CI?
Do not use Depo-Provera CI if you:
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- have bleeding from your vagina that has not been explained
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- have breast cancer now or in the past, or think you have breast cancer
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- have had a stroke
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- ever had blood clots in your arms, legs or lungs
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- have problems with your liver or liver disease
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- are allergic to medroxyprogesterone acetate or any of the other ingredients in Depo-Provera CI. See the end of this leaflet for a complete list of ingredients in Depo-Provera CI.
What should I tell my healthcare professional before taking Depo-Provera CI?
Before taking Depo-Provera CI, tell your healthcare professional if you have:
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- risk factors for weak bones (osteoporosis) such as bone disease, use alcohol or smoke regularly, anorexia nervosa, or a strong family history of osteoporosis
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- irregular or lighter than usual menstrual periods
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- breast cancer now or in the past, or think you have breast cancer
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- a family history of breast cancer
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- an abnormal mammogram (breast X-ray), lumps in your breasts, or bleeding from your nipples
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- have or have ever had a type of usually benign brain tumor called a meningioma
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- kidney problems
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- high blood pressure
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- had a stroke
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- had blood clots in your arms, legs or lungs
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- migraine headaches
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- asthma
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- epilepsy (convulsions or seizures)
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- diabetes
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- depression or a history of depression
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- any other medical conditions
If you are breastfeeding or plan to breastfeed, Depo-Provera CI can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you take Depo-Provera CI.
Tell your healthcare professional about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Depo-Provera CI and certain other medicines may affect each other, causing serious side effects. Sometimes the doses of other medicines may need to be changed while you are taking Depo-Provera CI.
Some medicines may make Depo-Provera CI less effective at preventing pregnancy, including those listed below.
Especially tell your healthcare professional if you take:
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- medicine to help you sleep
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- bosentan
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- medicine for seizures
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- griseofulvin
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- an antibiotic
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- medicine for HIV (AIDS)
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- St. John's wort
Know the medicines you take. Keep a list of your medicines with you to show your healthcare professional or pharmacist before you first start taking Depo-Provera CI or when you get a new medicine.
Follow your healthcare professional's instructions about using a back-up method of birth control if you are taking medicines that may make Depo-Provera CI less effective.
What are the possible side effects of Depo-Provera CI?
Depo-Provera CI can cause serious side effects, including:
- •
- Effect on the bones: See "What is the most important information I should know about Depo-Provera CI?".
Teenage years are the most important years to gain bone strength. The decrease in calcium in your bones is of most concern if you are a teenager or have the following problems:- •
- bone disease
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- an eating disorder (anorexia nervosa)
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- a strong family history of osteoporosis
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- you take a drug that can lower the amount of calcium in your bones (drugs for epilepsy or steroid drugs)
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- you drink a lot of alcohol (more than 2 drinks a day)
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- you smoke
- If you need a birth control method for more than 2 years, your healthcare professional may switch you to another birth control method instead of using Depo-Provera CI. If you continue using Depo-Provera CI, your healthcare professional may ask you to have a bone test, especially if you have other risks for weak bones.
- When Depo-Provera CI is stopped, your bones may start to regain calcium. However, in a study of teenage girls who used Depo-Provera CI for more than 2 years, their hip bones did not completely recover by 5 years after they stopped using Depo-Provera CI. Taking calcium and Vitamin D and exercising daily may lessen the loss of calcium from your bones.
- •
- possible increased risk of breast cancer. Women who use Depo-Provera CI may have a slightly increased risk of breast cancer compared to non-users.
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- blood clots in your arms, legs, lungs, and eyes
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- stroke
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- a pregnancy outside of your uterus (ectopic pregnancy). Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death.
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- allergic reactions. Severe allergic reactions have been reported in some women using Depo-Provera CI.
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- loss of vision or other eye problems
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- migraine headaches
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- possible increased risk for growth of a meningioma (a usually benign brain tumor), primarily when the product is used for a long time.
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- depression
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- convulsions or seizures
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- liver problems
Call your healthcare professional right away if you have:
- •
- sharp chest pain, coughing up blood, or sudden shortness of breath (indicating a possible clot in the lung)
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- sudden severe headache or vomiting, dizziness or fainting, problems with your eyesight or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)
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- severe pain or swelling in the calf (indicating a possible clot in the leg)
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- sudden blindness, partial or complete (indicating a possible clot in the blood vessels of the eye)
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- unusually heavy vaginal bleeding
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- severe pain or tenderness in the lower abdominal area
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- persistent pain, pus, or bleeding at the injection site
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- yellowing of the eyes or skin
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- hives
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- difficulty breathing
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- swelling of the face, mouth, tongue or neck
The most common side effects of Depo-Provera CI include:
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- irregular vaginal bleeding, such as lighter or heavier menstrual bleeding, or continued spotting
- •
- weight gain. You may experience weight gain while you are using Depo-Provera CI. About two-thirds of the women who used Depo-Provera CI in the clinical trials reported a weight gain of about 5 pounds during the first year of use. You may continue to gain weight after the first year. Women who used Depo-Provera CI for 2 years gained an average of 8 pounds over those 2 years.
- •
- abdominal pain
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- headache
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- weakness
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- tiredness
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- nervousness
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- dizziness
Tell your healthcare professional if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of Depo-Provera CI. For more information, ask your healthcare professional or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1- 800-FDA-1088.
What other information should I know before choosing Depo-Provera CI?
- •
- Pregnancy. When you take Depo-Provera CI every 3 months, your chance of getting pregnant is very low. You could miss a period or have a light period and not be pregnant. If you miss 1 or 2 periods and think you might be pregnant, see your healthcare professional as soon as possible. You should not use Depo-Provera CI if you are pregnant. However, Depo-Provera CI taken by accident during pregnancy does not seem to cause birth defects.
- •
- Nursing Mothers. Although Depo-Provera CI can be passed to the nursing baby in the breast milk, no harmful effects on babies have been found. Depo-Provera CI does not stop the breasts from producing milk, so it can be used by nursing mothers. However, to minimize the amount of Depo-Provera CI that is passed to the baby in the first weeks after birth, you should wait until your baby is 6 weeks old before you start using Depo-Provera CI for birth control.
How will Depo-Provera CI change my periods?
- •
- Change in normal menstrual cycle. The side effect reported most frequently by women who use Depo-Provera CI for birth controls is a change in their normal menstrual cycle. During the first year of using Depo-Provera CI, you might have one or more of the following changes:
- o
- irregular or unpredictable bleeding or spotting
- o
- an increase or decrease in menstrual bleeding
- o
- no bleeding at all. In clinical studies of Depo-Provera CI, 55% of women reported no menstrual bleeding (amenorrhea) after one year of use and 68% of women reported no menstrual bleeding after two years of use.
- •
- Missed period. During the time you are using Depo-Provera CI for birth controls, you may skip a period, or your periods may stop completely. If you have been receiving your shot of Depo-Provera CI regularly every 3 months, then you are probably not pregnant. However, if you think that you may be pregnant, see your healthcare professional.
Unusually heavy or continuous bleeding is not a usual effect of Depo-Provera CI and if this happens you should see your healthcare professional right away.
With continued use of Depo-Provera CI, bleeding usually decreases and many women stop having periods completely. When you stop using Depo-Provera CI your menstrual period will usually, in time, return to its normal cycle.
What if I want to become pregnant?
Because Depo-Provera CI is a long-acting birth control method, it takes some time after your last shot for its effect to wear off. Most women who try to get pregnant after using Depo-Provera CI get pregnant within 18 months after their last shot. The length of time you use Depo-Provera CI has no effect on how long it takes you to become pregnant after you stop using it.
General Information about Depo-Provera CI
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. This leaflet summarizes the most important information about Depo-Provera CI. If you would like more information, talk with your healthcare professional. You can ask your healthcare professional for information about Depo-Provera CI that is written for healthcare professionals.
What are the ingredients in Depo-Provera CI?
Active ingredient: medroxyprogesterone acetate
Inactive ingredients: polyethylene glycol 3350, polysorbate 80, sodium chloride, methylparaben, propylparaben, and water for injection. When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.
This Patient Information has been approved by the U.S. Food and Drug Administration.
This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
LAB-0148-15.0
Revised December 2025
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