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This document outlines key safety concerns and warnings associated with the use of Nuzyra (omadacycline). Carefully consider these points and discuss any uncertainties with your healthcare provider before use.

• Increased Mortality in Pneumonia Treatment: Clinical studies have shown a higher number of deaths among patients aged over 65 with multiple health issues who were treated with Nuzyra (omadacycline) for pneumonia, compared to those treated with moxifloxacin (Avelox). The exact cause of this increased mortality is unclear, highlighting the importance of consulting your doctor if you have concerns about using this medication.

• Dental Discoloration: Nuzyra (omadacycline), a tetracycline antibiotic, may lead to permanent yellow, gray, or brown discoloration of teeth in young children or an unborn baby if used during the second or third trimester of pregnancy. It can also weaken the teeth's enamel. Therefore, it is not recommended for children under 8 or pregnant individuals unless no other options are available.

• Impaired Bone Growth in Children: The medication can slow bone growth in young children, an effect that typically reverses once treatment is stopped. Pregnant individuals should also avoid this antibiotic during the second and third trimesters unless absolutely necessary.

• Allergic Reactions: Discontinue use immediately and seek medical help if you experience symptoms such as tingling, facial swelling, breathing difficulties, itching, or a rash. Anaphylaxis, a severe allergic reaction, requires urgent emergency care. Inform your healthcare team about any past reactions to tetracycline antibiotics before starting treatment.

• Severe Diarrhea (C. diff-associated diarrhea): Nuzyra (omadacycline) may increase the risk of severe diarrhea caused by Clostridioides difficile (C. diff), especially in individuals with a history of C. diff infection, recent hospitalizations, weakened immune systems, or those aged 65 and older.

• Side Effects of Tetracycline Antibiotics: As a tetracycline antibiotic, Nuzyra (omadacycline) may cause similar side effects to others in its class.

• Risk of Drug-Resistant Infections: Usage may promote the growth of drug-resistant bacteria or fungi, resulting in challenging infections to treat.

Contraindications:

• Do not use Nuzyra (omadacycline) if you have a known allergy to any tetracycline antibiotic. Always consult your healthcare provider if any contraindications apply to you.

When taking this medication, some individuals may experience common side effects such as nausea, vomiting, or diarrhea. These effects are typically mild and often resolve on their own. However, if they persist or worsen, it is important to seek advice from a healthcare provider. Other mild side effects that may occur include stomach pain, constipation, trouble sleeping, headache, tiredness, a faster heart rate, and elevated liver enzyme levels. Additionally, some people might experience reactions at the infusion site, such as pain, swelling, redness, or irritation.

In rare cases, more serious side effects may occur, requiring immediate medical attention. These include signs of liver problems, such as loss of appetite, abdominal pain, yellowing of the eyes or skin, and dark urine. Kidney issues might present as changes in urine output or pink urine. Omadacycline can also cause increased pressure around the brain, known as intracranial hypertension, which is particularly concerning for women of childbearing age who are overweight or have a history of this condition. Symptoms to watch for include severe headaches, vision changes, or persistent nausea and vomiting.

Severe intestinal conditions caused by C. difficile infection are serious side effects that demand quick medical intervention. Symptoms include persistent diarrhea, stomach cramping, and blood or mucus in stools. Avoid using anti-diarrhea or opioid products in such cases, as they can worsen the condition. Rarely, an allergic reaction may occur, which can be severe. Symptoms such as fever, swelling of the lymph nodes, rash, itching, swelling of the face or throat, severe dizziness, or breathing difficulties require emergency medical help. Additionally, prolonged use of the medication might lead to oral thrush or a yeast infection, indicated by white patches in the mouth or changes in vaginal discharge. Always consult your healthcare provider if you notice any unusual symptoms or side effects not listed here.