DEPO-PROVERA® CI What are the possible side effects of Depo-Provera CI?

(medroxyprogesterone acetate injectable suspension, for intramuscular use)

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
•
an eating disorder (anorexia nervosa)
•
a strong family history of osteoporosis
•
you take a drug that can lower the amount of calcium in your bones (drugs for epilepsy or steroid drugs)
•
you drink a lot of alcohol (more than 2 drinks a day)
•
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.
•
blood clots in your arms, legs, lungs, and eyes
•
stroke
•
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.
•
allergic reactions. Severe allergic reactions have been reported in some women using Depo-Provera CI.
•
loss of vision or other eye problems
•
migraine headaches
•
depression
•
convulsions or seizures
•
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)
•
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)
•
severe pain or swelling in the calf (indicating a possible clot in the leg)
•
sudden blindness, partial or complete (indicating a possible clot in the blood vessels of the eye)
•
unusually heavy vaginal bleeding
•
severe pain or tenderness in the lower abdominal area
•
persistent pain, pus, or bleeding at the injection site
•
yellowing of the eyes or skin
•
hives
•
difficulty breathing
•
swelling of the face, mouth, tongue or neck

The most common side effects of Depo-Provera CI include:

•
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
•
headache
•
weakness
•
tiredness
•
nervousness
•
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.

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What are the possible side effects of Depo-Provera CI?

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
•
an eating disorder (anorexia nervosa)
•
a strong family history of osteoporosis
•
you take a drug that can lower the amount of calcium in your bones (drugs for epilepsy or steroid drugs)
•
you drink a lot of alcohol (more than 2 drinks a day)
•
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.
•
blood clots in your arms, legs, lungs, and eyes
•
stroke
•
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.
•
allergic reactions. Severe allergic reactions have been reported in some women using Depo-Provera CI.
•
loss of vision or other eye problems
•
migraine headaches
•
depression
•
convulsions or seizures
•
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)
•
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)
•
severe pain or swelling in the calf (indicating a possible clot in the leg)
•
sudden blindness, partial or complete (indicating a possible clot in the blood vessels of the eye)
•
unusually heavy vaginal bleeding
•
severe pain or tenderness in the lower abdominal area
•
persistent pain, pus, or bleeding at the injection site
•
yellowing of the eyes or skin
•
hives
•
difficulty breathing
•
swelling of the face, mouth, tongue or neck

The most common side effects of Depo-Provera CI include:

•
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
•
headache
•
weakness
•
tiredness
•
nervousness
•
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.
Prescribing Information
Download Prescribing Information

Health Professional Information

What are the possible side effects of Depo-Provera CI?

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
•
an eating disorder (anorexia nervosa)
•
a strong family history of osteoporosis
•
you take a drug that can lower the amount of calcium in your bones (drugs for epilepsy or steroid drugs)
•
you drink a lot of alcohol (more than 2 drinks a day)
•
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.
•
blood clots in your arms, legs, lungs, and eyes
•
stroke
•
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.
•
allergic reactions. Severe allergic reactions have been reported in some women using Depo-Provera CI.
•
loss of vision or other eye problems
•
migraine headaches
•
depression
•
convulsions or seizures
•
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)
•
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)
•
severe pain or swelling in the calf (indicating a possible clot in the leg)
•
sudden blindness, partial or complete (indicating a possible clot in the blood vessels of the eye)
•
unusually heavy vaginal bleeding
•
severe pain or tenderness in the lower abdominal area
•
persistent pain, pus, or bleeding at the injection site
•
yellowing of the eyes or skin
•
hives
•
difficulty breathing
•
swelling of the face, mouth, tongue or neck

The most common side effects of Depo-Provera CI include:

•
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
•
headache
•
weakness
•
tiredness
•
nervousness
•
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.

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