Uses of BCG Vaccine:

• It is used to prevent TB (tuberculosis).

What do I need to tell my doctor BEFORE I take BCG Vaccine?

• If you have an allergy to BCG or any other part of BCG vaccine (immunization).
• If you are allergic to BCG vaccine (immunization); any part of BCG vaccine (immunization); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Active TB (tuberculosis), cancer, a fever, HIV infection, or a weak immune system.
• If a family member has had immune system problems.
• If you have recently had a live vaccine
• If you are taking any drugs to suppress your immune system. This may be certain doses of steroids like prednisone. There are many drugs that can suppress your immune system. Ask your doctor or pharmacist if you are not sure.
• If you have bone marrow problems from a drug or radiation.
• If you are pregnant or may be pregnant. Do not use BCG vaccine (immunization) if you are pregnant.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with BCG vaccine (immunization).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take BCG vaccine (immunization) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take BCG Vaccine?

• Tell all of your health care providers that you take BCG vaccine (immunization). This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take BCG vaccine (immunization).
• Very bad bone problems have happened with BCG vaccine (immunization). This can happen from 4 months to 2 years after the vaccine is received. Rarely, this has been deadly. Talk with the doctor.

How is this medicine (BCG Vaccine) best taken?

Use BCG vaccine (immunization) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the skin.
• Keep the site where the shot was given dry and loosely covered for 24 hours.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Flu-like signs lasting for more than 2 days.
• Bone pain.
• High fever.
• Very bad irritation where the shot was given.
• Redness, pain, or swelling where the shot was given that lasts more than 2 to 3 days.
• Skin ulcers.

What are some other side effects of BCG Vaccine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flu-like signs. These include headache, weakness, fever, shakes, aches, pains, and sweating. Mild pain drugs may help.
• Feeling tired or weak.
• Swollen gland.
• Irritation where the shot is given.
• Small red bumps may appear where the shot was given within 10 to 14 days. Most of the time, these may grow to be the biggest after 4 to 6 weeks. By 6 months, there usually is not a sign that a shot was given. Call your doctor right away if you have a reaction other than this or one that is not normal.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out BCG Vaccine?

• If you need to store BCG vaccine (immunization) at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about BCG vaccine (immunization), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

• Does the BCG vaccine for TB help with COVID-19 (coronavirus)?