Uses of Omadacycline Tablets:

• It is used to treat bacterial infections.

What do I need to tell my doctor BEFORE I take Omadacycline Tablets?

• If you are allergic to this medicine (omadacycline tablets); any part of this medicine (omadacycline tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking any of these drugs: Acitretin, isotretinoin, or a penicillin.
• If you are breast-feeding. Do not breast-feed for at least 4 days after using this medicine (omadacycline tablets).

This is not a list of all drugs or health problems that interact with this medicine (omadacycline tablets).

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 this medicine (omadacycline tablets) 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 Omadacycline Tablets?

For all patients taking this medicine (omadacycline tablets):

• Tell all of your health care providers that you take this medicine (omadacycline tablets). This includes your doctors, nurses, pharmacists, and dentists.
• In one study, a slightly higher number of deaths happened in people taking this medicine (omadacycline tablets) compared to people taking another drug used to treat pneumonia. All people who died were older than 65 years of age and most had other health problems, as well. The cause of these deaths is not known. If you have questions, talk with your doctor.
• Do not use longer than you have been told. A second infection may happen.
• This medicine may make you sunburn more easily. Use care if you will be in the sun. Tell your doctor if you sunburn easily while taking this drug.
• If you are 65 or older, use this medicine (omadacycline tablets) with care. You could have more side effects.
• This medicine may cause harm to an unborn baby. Women must use birth control while taking this medicine (omadacycline tablets). If you get pregnant, call your doctor right away.

Children:

• This medicine is not approved for use in children younger than 18 years of age. Talk with the doctor.
• This medicine may cause a change in tooth color to yellow-gray-brown in children younger than 8 years old. If this change of tooth color happens, it will not go away. Talk with the doctor.

How is this medicine (Omadacycline Tablets) best taken?

Use this medicine (omadacycline tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take this medicine (omadacycline tablets) on an empty stomach. Take at least 2 hours before food or 4 hours after food.
• Take with water only; do not take with other drinks.
• Keep taking this medicine (omadacycline tablets) as you have been told by your doctor or other health care provider, even if you feel well.
• Do not eat or drink dairy products or take antacids, bismuth, multivitamins, or other products that contain aluminum, calcium, iron, or magnesium within 4 hours after taking this medicine (omadacycline tablets).

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

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.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of too much acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
• Not able to pass urine or change in how much urine is passed.
• Diarrhea is common with antibiotics. Rarely, a severe form called C diff–associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen during or a few months after taking antibiotics. Call your doctor right away if you have stomach pain, cramps, or very loose, watery, or bloody stools. Check with your doctor before treating diarrhea.
• Raised pressure in the brain has happened with drugs like this one. Most of the time, this went back to normal after the drug was stopped. Sometimes, loss of eyesight happened and did not go away even after the drug was stopped. Call your doctor right away if you have a headache or eyesight problems like blurred eyesight, seeing double, or loss of eyesight.

What are some other side effects of Omadacycline Tablets?

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:

• Upset stomach or throwing up.
• Diarrhea.

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 Omadacycline Tablets?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• 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.

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.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (omadacycline tablets), 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

• What type of drug is Nuzyra (omadacycline)?