NUZYRA® (omadacycline) is a prescription antibiotic medicine used to treat adults 18 years and older with:
- An infection of the lung caused by certain kinds of germs called bacteria (community-acquired bacterial pneumonia)
- Skin infections caused by certain bacteria (acute bacterial skin and skin structure infections)
Some infections are caused by viruses and not by bacteria. Examples include viral infections such as the common cold or flu. Antibacterial medicines, including NUZYRA, do not treat viral infections. NUZYRA should only be used to treat bacterial infections. Call your healthcare provider if you think your condition is not getting better while you are taking NUZYRA.
Do not take NUZYRA if you are allergic to tetracycline-class drugs. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
In the community-acquired bacterial pneumonia clinical trial, death occurred in 2% of NUZYRA-treated patients (8 out of 382) compared to 1% of patients (4 out of 388) who received another antibiotic. All deaths in both treatment groups occurred in patients older than 65 years of age.
Before taking NUZYRA, tell your healthcare provider:
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About all of your medical conditions, including if you:
- are pregnant or plan to become pregnant, as NUZYRA may harm an unborn baby. Taking NUZYRA during tooth development (during the last half of pregnancy, infancy, and during childhood up to the age of 8 years) may cause serious side effects including permanent discoloration of teeth and slow bone growth of your baby. Talk to your healthcare provider before taking NUZYRA if you plan to become pregnant, or if you are already taking NUZYRA and plan to become pregnant.
- are breastfeeding or plan to breastfeed. NUZYRA passes into your milk and may harm your baby. You and your healthcare provider should decide if you will take NUZYRA or breastfeed. You should not do both.
- have diarrhea or have had diarrhea while taking antibiotics, as you can develop an infection of the intestines
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About all the medicines you take, including prescription drugs (such as oral contraceptives) and over-the-counter medicines, vitamins, and herbal supplements. NUZYRA and certain other medicines may affect each other or may cause side effects. It is especially important to mention if you are taking any of the following:
- blood thinners (anticoagulants) such as warfarin
- antacids that contain aluminum, calcium, or magnesium or iron-containing products.
NUZYRA may cause serious side effects, including:
- Serious allergic reactions have occurred in patients taking NUZYRA and life-threatening allergic reactions have occurred with other tetracyclines. Stop taking NUZYRA and get emergency medical help if a serious allergic reaction occurs.
- Clostridioides difficile-associated diarrhea (CDAD) – CDAD is an infection of your intestines (bowels) that can happen with many antibacterial medicines like NUZYRA and may cause mild diarrhea to life-threatening swelling of your intestines (colitis). Call your healthcare provider right away if you get stomach cramps, fever, watery diarrhea, diarrhea that does not go away, or bloody stools.
- NUZYRA is similar to other tetracycline-class antibacterial drugs and may cause similar side effects. NUZYRA can make your skin sensitive to the sun and the light from sunlamps and tanning beds. Protect your skin while out in sunlight. Stop taking NUZYRA and tell your healthcare provider right away if you have blurred vision, vision loss, or unusual headaches or if you get stomach pain, yellowing of your skin or eyes, unexplained bleeding, confusion, loss of appetite, or a flat red skin patch that recurs at the same site or sites each time the medication is restarted.
The most common side effects of NUZYRA include: nausea, vomiting, increased liver function tests, elevated blood pressure (hypertension), headache, diarrhea, difficulty sleeping (insomnia), and constipation. Reactions at the infusion site (pain, swelling, redness, and irritation) were also common in patients who received NUZYRA intravenously (IV).
These are not all of the possible side effects of NUZYRA. Call your healthcare provider if you have these or any other side effects while taking NUZYRA.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
Please see full Prescribing Information.
