Teflaro Side Effects

Generic name: ceftaroline

Note: This document contains side effect information about ceftaroline. Some of the dosage forms listed on this page may not apply to the brand name Teflaro.

Some side effects of Teflaro may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ceftaroline: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking ceftaroline (the active ingredient contained in Teflaro) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• diarrhea that is watery or bloody;

• chest pain;

• fever, chills, body aches, flu symptoms;

• unusual bleeding;

• seizure (convulsions);

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• jaundice (yellowing of the skin or eyes);

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• increased thirst, loss of appetite, swelling, weight gain, feeling short of breath, urinating less than usual or not at all; or

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Less serious side effects of ceftaroline may include:

• nausea, vomiting, constipation, mild diarrhea;

• dizziness; or

• mild itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ceftaroline: intravenous powder for injection

General

The most common side effects reported in patients receiving ceftaroline (the active ingredient contained in Teflaro) were diarrhea, nausea, and rash. During clinical trials, serious side effects were reported in 7.5% of patients receiving ceftaroline and 7.7% of patients receiving comparator drugs. In both treatment groups, the most common serious side effects were in the respiratory and infection system organ classes. Treatment was discontinued due to side effects in 2.7% of patients receiving ceftaroline and 3.7% of patients receiving comparator drugs. Hypersensitivity was the most common side effect leading to discontinuation in both treatment groups.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (5%), nausea (4%), constipation (2%), vomiting (2%), abdominal pain (less than 2%), Clostridium difficile colitis (less than 2%), and C difficile associated diarrhea.

Dermatologic

Dermatologic side effects have included rash (3%) and urticaria (less than 2%).

Metabolic

Metabolic side effects have included hypokalemia (2%), hyperglycemia (less than 2%), and hyperkalemia (less than 2%).

Cardiovascular

Cardiovascular side effects have included phlebitis (2%), bradycardia (less than 2%), and palpitations (less than 2%).

Hepatic

Hepatic side effects have included increased transaminases (2%) and hepatitis (less than 2%).

Hypersensitivity

Hypersensitivity side effects have included hypersensitivity (less than 2%), anaphylaxis (less than 2%), and anaphylactoid reactions. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterials.

Renal

Renal side effects have included renal failure (less than 2%).

Hematologic

Hematologic side effects have included anemia, eosinophilia, neutropenia, and thrombocytopenia in less than 2% of patients.

Nervous system

Nervous system side effects have included dizziness and convulsion in less than 2% of patients.

Other

Other side effects have included pyrexia (less than 2%).

Immunologic

Immunologic side effects have included direct Coombs' test seroconversion.

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