PREMARIN® INTRAVENOUS Full Patient Information

(conjugated estrogens)

Full Patient Information

PATIENT INFORMATION

Premarin Intravenous (conjugated estrogens, USP) for injection

Read this PATIENT INFORMATION which describes the benefit and major risks of your treatment, as well as how and when treatment should be used. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Premarin Intravenous (an estrogen mixture)?

•
Using estrogen-alone increases your chance of getting cancer of the uterus (womb)
Report any unusual vaginal bleeding right away. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
•
Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function)
•
Using estrogen-alone may increase your chances of getting stroke or blood clots
•
Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
•
Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia
•
Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
•
Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
•
You and your healthcare provider should talk regularly about whether you still need treatment with estrogens

What is Premarin Intravenous?

Premarin Intravenous is a medicine that contains a mixture of estrogen hormones.

Premarin Intravenous is used to:

•
Treat certain types of abnormal uterine bleeding due to hormonal imbalance when your doctor has found no other cause of bleeding

Who should not use Premarin Intravenous?

Premarin Intravenous should not be used if you:

•
Have unusual vaginal bleeding that has not been evaluated by your healthcare provider
•
Currently have or have had certain cancers
Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Premarin Intravenous.
•
Had a stroke or heart attack
•
Currently have or have had blood clots
•
Currently have or have had liver problems
•
Have been diagnosed with a bleeding disorder
•
Are allergic to Premarin Intravenous or any of its ingredients
See the list of ingredients in Premarin Intravenous at the end of this leaflet.
•
Think you may be pregnant

Tell your healthcare provider:

•
If you are breast feeding
 
The hormones in Premarin Intravenous can pass into your breast milk.
•
About all of your medical problems
 
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
•
About all the medicines you take
 
This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Premarin Intravenous works.

What are the possible side effects of Premarin Intravenous?

Premarin Intravenous is for short-term use only. However, the risks associated with oral Premarin treatment should be taken into account.

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

•
Heart attack
•
Stroke
•
Blood clots
•
Dementia
•
Breast cancer
•
Cancer of the lining of the uterus (womb)
•
Cancer of the ovary
•
High blood pressure
•
High blood sugar
•
Gallbladder disease
•
Liver problems
•
Enlargement of benign tumors of the uterus ("fibroids")
•
Severe allergic reactions

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

•
New breast lumps
•
Unusual vaginal bleeding
•
Changes in vision or speech
•
Sudden new severe headaches
•
Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
•
Swollen lips, tongue and face

Less serious, but common side effects include:

•
Headache
•
Breast pain
•
Irregular vaginal bleeding or spotting
•
Stomach or abdominal cramps, bloating
•
Nausea and vomiting
•
Hair loss
•
Fluid retention
•
Vaginal yeast infection

These are not all the possible side effects of Premarin. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What can I do to lower my chances of getting a serious side effect with Premarin Intravenous?

•
If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease
Ask your healthcare provider for ways to lower your chances for getting heart disease.

General information about the safe and effective use of Premarin Intravenous

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Premarin Intravenous for conditions for which it was not prescribed. Do not give Premarin Intravenous to other people, even if they have the same symptoms you have. It may harm them. Keep Premarin Intravenous out of the reach of children.

This leaflet provides a summary of the most important information about Premarin Intravenous. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Premarin Intravenous that is written for health professionals. To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What are the ingredients in Premarin IV?

Premarin Intravenous for injection contains a mixture of conjugated estrogens, which are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components including sodium sulfate conjugates: 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin. Premarin Intravenous for injection also contains lactose, sodium citrate, simethicone, and sodium hydroxide or hydrochloric acid in dry form. The reconstituted solution is suitable for intravenous or intramuscular injection.

Each Premarin Intravenous (conjugated estrogens, USP) for injection package provides 25 mg/vial of conjugated estrogens, USP, in dry form for intravenous or intramuscular use.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

Logo

LAB-0505-6.0
Revised 02/2024

PATIENT INFORMATION

Premarin
Intravenous
(conjugated estrogens, USP) for injection

Rx only

Read this PATIENT INFORMATION which describes the benefit and major risks of your treatment, as well as how and when treatment should be used. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Premarin Intravenous (an estrogen mixture)?

•
Using estrogen-alone increases your chance of getting cancer of the uterus (womb)
Report any unusual vaginal bleeding right away. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
•
Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function)
•
Using estrogen-alone may increase your chances of getting stroke or blood clots
•
Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
•
Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia
•
Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
•
Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
•
You and your healthcare provider should talk regularly about whether you still need treatment with estrogens.

What is Premarin Intravenous?

Premarin Intravenous is a medicine that contains a mixture of estrogen hormones.

Premarin Intravenous is used to:

•
Treat certain types of abnormal uterine bleeding due to hormonal imbalance when your doctor has found no other cause of bleeding

Who should not use Premarin Intravenous?

Premarin Intravenous should not be used if you:

•
Have unusual vaginal bleeding that has not been evaluated by your healthcare provider
•
Currently have or have had certain cancers
Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Premarin Intravenous.
•
Had a stroke or heart attack
•
Currently have or have had blood clots
•
Currently have or have had liver problems
•
Have been diagnosed with a bleeding disorder
•
Are allergic to Premarin Intravenous or any of its ingredients
See the list of ingredients in Premarin Intravenous at the end of this leaflet.
•
Think you may be pregnant

Tell your healthcare provider:

•
If you are breast feeding
 
The hormones in Premarin Intravenous can pass into your breast milk.
•
About all of your medical problems
 
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
•
About all the medicines you take
 
This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Premarin Intravenous works.

What are the possible side effects of Premarin Intravenous?

Premarin Intravenous is for short-term use only. However, the risks associated with oral Premarin treatment should be taken into account.

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

•
Heart attack
•
Stroke
•
Blood clots
•
Dementia
•
Breast cancer
•
Cancer of the lining of the uterus (womb)
•
Cancer of the ovary
•
High blood pressure
•
High blood sugar
•
Gallbladder disease
•
Liver problems
•
Enlargement of benign tumors of the uterus ("fibroids")
•
Severe allergic reactions

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

•
New breast lumps
•
Unusual vaginal bleeding
•
Changes in vision or speech
•
Sudden new severe headaches
•
Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
•
Swollen lips, tongue and face

Less serious, but common side effects include:

•
Headache
•
Breast pain
•
Irregular vaginal bleeding or spotting
•
Stomach or abdominal cramps, bloating
•
Nausea and vomiting
•
Hair loss
•
Fluid retention
•
Vaginal yeast infection

These are not all the possible side effects of Premarin. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What can I do to lower my chances of getting a serious side effect with Premarin Intravenous?

•
If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease
Ask your healthcare provider for ways to lower your chances for getting heart disease.

General information about the safe and effective use of Premarin Intravenous

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Premarin Intravenous for conditions for which it was not prescribed. Do not give Premarin Intravenous to other people, even if they have the same symptoms you have. It may harm them. Keep Premarin Intravenous out of the reach of children.

This leaflet provides a summary of the most important information about Premarin Intravenous. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Premarin Intravenous that is written for health professionals. To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What are the ingredients in Premarin IV?

Premarin Intravenous for injection contains a mixture of conjugated estrogens, which are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components including sodium sulfate conjugates: 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin. Premarin Intravenous for injection also contains lactose, sodium citrate, simethicone, and sodium hydroxide or hydrochloric acid in dry form. The reconstituted solution is suitable for intravenous or intramuscular injection.

Each Premarin Intravenous (conjugated estrogens, USP) for injection package provides 25 mg/vial of conjugated estrogens, USP, in dry form for intravenous or intramuscular use.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com

Logo

LAB-0518-4.0
Rev 12/2021

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PATIENT INFORMATION

Premarin Intravenous (conjugated estrogens, USP) for injection

Read this PATIENT INFORMATION which describes the benefit and major risks of your treatment, as well as how and when treatment should be used. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Premarin Intravenous (an estrogen mixture)?

•
Using estrogen-alone increases your chance of getting cancer of the uterus (womb)
Report any unusual vaginal bleeding right away. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
•
Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function)
•
Using estrogen-alone may increase your chances of getting stroke or blood clots
•
Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
•
Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia
•
Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
•
Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
•
You and your healthcare provider should talk regularly about whether you still need treatment with estrogens

What is Premarin Intravenous?

Premarin Intravenous is a medicine that contains a mixture of estrogen hormones.

Premarin Intravenous is used to:

•
Treat certain types of abnormal uterine bleeding due to hormonal imbalance when your doctor has found no other cause of bleeding

Who should not use Premarin Intravenous?

Premarin Intravenous should not be used if you:

•
Have unusual vaginal bleeding that has not been evaluated by your healthcare provider
•
Currently have or have had certain cancers
Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Premarin Intravenous.
•
Had a stroke or heart attack
•
Currently have or have had blood clots
•
Currently have or have had liver problems
•
Have been diagnosed with a bleeding disorder
•
Are allergic to Premarin Intravenous or any of its ingredients
See the list of ingredients in Premarin Intravenous at the end of this leaflet.
•
Think you may be pregnant

Tell your healthcare provider:

•
If you are breast feeding
 
The hormones in Premarin Intravenous can pass into your breast milk.
•
About all of your medical problems
 
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
•
About all the medicines you take
 
This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Premarin Intravenous works.

What are the possible side effects of Premarin Intravenous?

Premarin Intravenous is for short-term use only. However, the risks associated with oral Premarin treatment should be taken into account.

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

•
Heart attack
•
Stroke
•
Blood clots
•
Dementia
•
Breast cancer
•
Cancer of the lining of the uterus (womb)
•
Cancer of the ovary
•
High blood pressure
•
High blood sugar
•
Gallbladder disease
•
Liver problems
•
Enlargement of benign tumors of the uterus ("fibroids")
•
Severe allergic reactions

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

•
New breast lumps
•
Unusual vaginal bleeding
•
Changes in vision or speech
•
Sudden new severe headaches
•
Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
•
Swollen lips, tongue and face

Less serious, but common side effects include:

•
Headache
•
Breast pain
•
Irregular vaginal bleeding or spotting
•
Stomach or abdominal cramps, bloating
•
Nausea and vomiting
•
Hair loss
•
Fluid retention
•
Vaginal yeast infection

These are not all the possible side effects of Premarin. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What can I do to lower my chances of getting a serious side effect with Premarin Intravenous?

•
If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease
Ask your healthcare provider for ways to lower your chances for getting heart disease.

General information about the safe and effective use of Premarin Intravenous

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Premarin Intravenous for conditions for which it was not prescribed. Do not give Premarin Intravenous to other people, even if they have the same symptoms you have. It may harm them. Keep Premarin Intravenous out of the reach of children.

This leaflet provides a summary of the most important information about Premarin Intravenous. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Premarin Intravenous that is written for health professionals. To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What are the ingredients in Premarin IV?

Premarin Intravenous for injection contains a mixture of conjugated estrogens, which are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components including sodium sulfate conjugates: 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin. Premarin Intravenous for injection also contains lactose, sodium citrate, simethicone, and sodium hydroxide or hydrochloric acid in dry form. The reconstituted solution is suitable for intravenous or intramuscular injection.

Each Premarin Intravenous (conjugated estrogens, USP) for injection package provides 25 mg/vial of conjugated estrogens, USP, in dry form for intravenous or intramuscular use.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

Logo

LAB-0505-6.0
Revised 02/2024

PATIENT INFORMATION

Premarin
Intravenous
(conjugated estrogens, USP) for injection

Rx only

Read this PATIENT INFORMATION which describes the benefit and major risks of your treatment, as well as how and when treatment should be used. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Premarin Intravenous (an estrogen mixture)?

•
Using estrogen-alone increases your chance of getting cancer of the uterus (womb)
Report any unusual vaginal bleeding right away. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
•
Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function)
•
Using estrogen-alone may increase your chances of getting stroke or blood clots
•
Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
•
Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia
•
Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
•
Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
•
You and your healthcare provider should talk regularly about whether you still need treatment with estrogens.

What is Premarin Intravenous?

Premarin Intravenous is a medicine that contains a mixture of estrogen hormones.

Premarin Intravenous is used to:

•
Treat certain types of abnormal uterine bleeding due to hormonal imbalance when your doctor has found no other cause of bleeding

Who should not use Premarin Intravenous?

Premarin Intravenous should not be used if you:

•
Have unusual vaginal bleeding that has not been evaluated by your healthcare provider
•
Currently have or have had certain cancers
Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Premarin Intravenous.
•
Had a stroke or heart attack
•
Currently have or have had blood clots
•
Currently have or have had liver problems
•
Have been diagnosed with a bleeding disorder
•
Are allergic to Premarin Intravenous or any of its ingredients
See the list of ingredients in Premarin Intravenous at the end of this leaflet.
•
Think you may be pregnant

Tell your healthcare provider:

•
If you are breast feeding
 
The hormones in Premarin Intravenous can pass into your breast milk.
•
About all of your medical problems
 
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
•
About all the medicines you take
 
This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Premarin Intravenous works.

What are the possible side effects of Premarin Intravenous?

Premarin Intravenous is for short-term use only. However, the risks associated with oral Premarin treatment should be taken into account.

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

•
Heart attack
•
Stroke
•
Blood clots
•
Dementia
•
Breast cancer
•
Cancer of the lining of the uterus (womb)
•
Cancer of the ovary
•
High blood pressure
•
High blood sugar
•
Gallbladder disease
•
Liver problems
•
Enlargement of benign tumors of the uterus ("fibroids")
•
Severe allergic reactions

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

•
New breast lumps
•
Unusual vaginal bleeding
•
Changes in vision or speech
•
Sudden new severe headaches
•
Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
•
Swollen lips, tongue and face

Less serious, but common side effects include:

•
Headache
•
Breast pain
•
Irregular vaginal bleeding or spotting
•
Stomach or abdominal cramps, bloating
•
Nausea and vomiting
•
Hair loss
•
Fluid retention
•
Vaginal yeast infection

These are not all the possible side effects of Premarin. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What can I do to lower my chances of getting a serious side effect with Premarin Intravenous?

•
If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease
Ask your healthcare provider for ways to lower your chances for getting heart disease.

General information about the safe and effective use of Premarin Intravenous

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Premarin Intravenous for conditions for which it was not prescribed. Do not give Premarin Intravenous to other people, even if they have the same symptoms you have. It may harm them. Keep Premarin Intravenous out of the reach of children.

This leaflet provides a summary of the most important information about Premarin Intravenous. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Premarin Intravenous that is written for health professionals. To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What are the ingredients in Premarin IV?

Premarin Intravenous for injection contains a mixture of conjugated estrogens, which are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components including sodium sulfate conjugates: 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin. Premarin Intravenous for injection also contains lactose, sodium citrate, simethicone, and sodium hydroxide or hydrochloric acid in dry form. The reconstituted solution is suitable for intravenous or intramuscular injection.

Each Premarin Intravenous (conjugated estrogens, USP) for injection package provides 25 mg/vial of conjugated estrogens, USP, in dry form for intravenous or intramuscular use.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com

Logo

LAB-0518-4.0
Rev 12/2021
Prescribing Information
Download Prescribing Information

Health Professional Information

Full Patient Information

Full Patient Information

PATIENT INFORMATION

Premarin Intravenous (conjugated estrogens, USP) for injection

Read this PATIENT INFORMATION which describes the benefit and major risks of your treatment, as well as how and when treatment should be used. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Premarin Intravenous (an estrogen mixture)?

•
Using estrogen-alone increases your chance of getting cancer of the uterus (womb)
Report any unusual vaginal bleeding right away. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
•
Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function)
•
Using estrogen-alone may increase your chances of getting stroke or blood clots
•
Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
•
Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia
•
Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
•
Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
•
You and your healthcare provider should talk regularly about whether you still need treatment with estrogens

What is Premarin Intravenous?

Premarin Intravenous is a medicine that contains a mixture of estrogen hormones.

Premarin Intravenous is used to:

•
Treat certain types of abnormal uterine bleeding due to hormonal imbalance when your doctor has found no other cause of bleeding

Who should not use Premarin Intravenous?

Premarin Intravenous should not be used if you:

•
Have unusual vaginal bleeding that has not been evaluated by your healthcare provider
•
Currently have or have had certain cancers
Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Premarin Intravenous.
•
Had a stroke or heart attack
•
Currently have or have had blood clots
•
Currently have or have had liver problems
•
Have been diagnosed with a bleeding disorder
•
Are allergic to Premarin Intravenous or any of its ingredients
See the list of ingredients in Premarin Intravenous at the end of this leaflet.
•
Think you may be pregnant

Tell your healthcare provider:

•
If you are breast feeding
 
The hormones in Premarin Intravenous can pass into your breast milk.
•
About all of your medical problems
 
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
•
About all the medicines you take
 
This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Premarin Intravenous works.

What are the possible side effects of Premarin Intravenous?

Premarin Intravenous is for short-term use only. However, the risks associated with oral Premarin treatment should be taken into account.

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

•
Heart attack
•
Stroke
•
Blood clots
•
Dementia
•
Breast cancer
•
Cancer of the lining of the uterus (womb)
•
Cancer of the ovary
•
High blood pressure
•
High blood sugar
•
Gallbladder disease
•
Liver problems
•
Enlargement of benign tumors of the uterus ("fibroids")
•
Severe allergic reactions

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

•
New breast lumps
•
Unusual vaginal bleeding
•
Changes in vision or speech
•
Sudden new severe headaches
•
Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
•
Swollen lips, tongue and face

Less serious, but common side effects include:

•
Headache
•
Breast pain
•
Irregular vaginal bleeding or spotting
•
Stomach or abdominal cramps, bloating
•
Nausea and vomiting
•
Hair loss
•
Fluid retention
•
Vaginal yeast infection

These are not all the possible side effects of Premarin. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What can I do to lower my chances of getting a serious side effect with Premarin Intravenous?

•
If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease
Ask your healthcare provider for ways to lower your chances for getting heart disease.

General information about the safe and effective use of Premarin Intravenous

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Premarin Intravenous for conditions for which it was not prescribed. Do not give Premarin Intravenous to other people, even if they have the same symptoms you have. It may harm them. Keep Premarin Intravenous out of the reach of children.

This leaflet provides a summary of the most important information about Premarin Intravenous. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Premarin Intravenous that is written for health professionals. To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What are the ingredients in Premarin IV?

Premarin Intravenous for injection contains a mixture of conjugated estrogens, which are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components including sodium sulfate conjugates: 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin. Premarin Intravenous for injection also contains lactose, sodium citrate, simethicone, and sodium hydroxide or hydrochloric acid in dry form. The reconstituted solution is suitable for intravenous or intramuscular injection.

Each Premarin Intravenous (conjugated estrogens, USP) for injection package provides 25 mg/vial of conjugated estrogens, USP, in dry form for intravenous or intramuscular use.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

Logo

LAB-0505-6.0
Revised 02/2024

PATIENT INFORMATION

Premarin
Intravenous
(conjugated estrogens, USP) for injection

Rx only

Read this PATIENT INFORMATION which describes the benefit and major risks of your treatment, as well as how and when treatment should be used. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Premarin Intravenous (an estrogen mixture)?

•
Using estrogen-alone increases your chance of getting cancer of the uterus (womb)
Report any unusual vaginal bleeding right away. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
•
Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function)
•
Using estrogen-alone may increase your chances of getting stroke or blood clots
•
Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
•
Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia
•
Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
•
Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
•
You and your healthcare provider should talk regularly about whether you still need treatment with estrogens.

What is Premarin Intravenous?

Premarin Intravenous is a medicine that contains a mixture of estrogen hormones.

Premarin Intravenous is used to:

•
Treat certain types of abnormal uterine bleeding due to hormonal imbalance when your doctor has found no other cause of bleeding

Who should not use Premarin Intravenous?

Premarin Intravenous should not be used if you:

•
Have unusual vaginal bleeding that has not been evaluated by your healthcare provider
•
Currently have or have had certain cancers
Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Premarin Intravenous.
•
Had a stroke or heart attack
•
Currently have or have had blood clots
•
Currently have or have had liver problems
•
Have been diagnosed with a bleeding disorder
•
Are allergic to Premarin Intravenous or any of its ingredients
See the list of ingredients in Premarin Intravenous at the end of this leaflet.
•
Think you may be pregnant

Tell your healthcare provider:

•
If you are breast feeding
 
The hormones in Premarin Intravenous can pass into your breast milk.
•
About all of your medical problems
 
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
•
About all the medicines you take
 
This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Premarin Intravenous works.

What are the possible side effects of Premarin Intravenous?

Premarin Intravenous is for short-term use only. However, the risks associated with oral Premarin treatment should be taken into account.

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

•
Heart attack
•
Stroke
•
Blood clots
•
Dementia
•
Breast cancer
•
Cancer of the lining of the uterus (womb)
•
Cancer of the ovary
•
High blood pressure
•
High blood sugar
•
Gallbladder disease
•
Liver problems
•
Enlargement of benign tumors of the uterus ("fibroids")
•
Severe allergic reactions

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

•
New breast lumps
•
Unusual vaginal bleeding
•
Changes in vision or speech
•
Sudden new severe headaches
•
Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
•
Swollen lips, tongue and face

Less serious, but common side effects include:

•
Headache
•
Breast pain
•
Irregular vaginal bleeding or spotting
•
Stomach or abdominal cramps, bloating
•
Nausea and vomiting
•
Hair loss
•
Fluid retention
•
Vaginal yeast infection

These are not all the possible side effects of Premarin. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What can I do to lower my chances of getting a serious side effect with Premarin Intravenous?

•
If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease
Ask your healthcare provider for ways to lower your chances for getting heart disease.

General information about the safe and effective use of Premarin Intravenous

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Premarin Intravenous for conditions for which it was not prescribed. Do not give Premarin Intravenous to other people, even if they have the same symptoms you have. It may harm them. Keep Premarin Intravenous out of the reach of children.

This leaflet provides a summary of the most important information about Premarin Intravenous. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Premarin Intravenous that is written for health professionals. To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What are the ingredients in Premarin IV?

Premarin Intravenous for injection contains a mixture of conjugated estrogens, which are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components including sodium sulfate conjugates: 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin. Premarin Intravenous for injection also contains lactose, sodium citrate, simethicone, and sodium hydroxide or hydrochloric acid in dry form. The reconstituted solution is suitable for intravenous or intramuscular injection.

Each Premarin Intravenous (conjugated estrogens, USP) for injection package provides 25 mg/vial of conjugated estrogens, USP, in dry form for intravenous or intramuscular use.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com

Logo

LAB-0518-4.0
Rev 12/2021

Resources

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MI Digital Assistant

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Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.