Cholera is a bacterial infection that can cause severe, life-threatening diarrhea. Cholera is caused by coming into contact with water or food contaminated by feces infected with Vibrio cholerae bacteria.

This vaccine works by exposing you to a small dose of live cholera bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Vaxchora is for use in people ages 2 through 64 years old.

Like any vaccine, the Vaxchora may not provide protection from disease in every person.

For at least 2 weeks after you receive this vaccine, wash your hands often, especially after using the restroom or handling food.

Vaxchora is usually given orally (by mouth) as a single dose. This vaccine is a powder that is mixed with water before you take it. You will receive this mixture in a clinic or other healthcare setting.

Follow your doctor's instructions about receiving a booster dose if needed.

The timing of this vaccination is very important for it to be effective. For best protection against cholera, this vaccine should be given at least 10 days before you travel to a cholera-affected area.

For at least 2 weeks after you receive Vaxchora, wash your hands often, especially after using the restroom or handling food.

While traveling in a cholera-affected area, avoid drinking water or soft drinks that are not from sealed bottles or cans. Avoid ice cubes that were not made from bottled water. Use bottled water while brushing your teeth, and when preparing food or cleaning areas where food is prepared and served.

If bottled water is not available, follow the guidelines of the World Health Organization, or the Centers for Disease Control and Prevention, about disinfecting water from a tap or other source.

You should not receive this vaccine if you have had an allergic reaction to any Vaxchora you received in the past.

Tell your doctor if you have ever had:

• a weak immune system (caused by disease or by using certain medicine); or

• anyone in your household has a weak immune system.

Because the Vaxchora is not absorbed into the bloodstream, it is not expected to be harmful to an unborn baby if you receive the vaccine during pregnancy. However, avoid receiving a this medicine within 7 days before your expected delivery date.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of cholera vaccine on the baby.

Because the Vaxchora is not absorbed into the bloodstream, it is not expected to be harmful to a nursing baby.

Vaxchora is not approved for use by anyone younger than 2 years old or older than 64 years old.

Since Vaxchora is given as a one time vaccine, you are not likely to be on a dosing schedule.

Since Vaxchora is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Avoid eating or drinking anything for at least 1 hour before or 1 hour after taking this vaccine.

For at least 7 days after you receive this vaccine, live cholera bacteria can pass into your feces (bowel movements). During this time, avoid allowing your body fluids to come into contact with your hands or other surfaces. Avoid coming into contact with anyone who has a weak immune system.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects of Vaxchora may include:

• nausea, vomiting, diarrhea;

• stomach pain, loss of appetite;

• headache; or

• feeling tired.

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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Tell your doctor about all the medicines you have used recently, especially:

• an antibiotic; or

• chloroquine.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

• steroids (oral, nasal, inhaled, or injectable);

• medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders; or

• medicines to treat or prevent organ transplant rejection.

If you are using any of these medications, you may not be able to receive Vaxchora, or may need to wait until the other treatments are finished.

This list is not complete. Other drugs may interact with cholera vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.