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

Summary

Common side effects of Teflaro include: positive direct coombs test. Other side effects include: diarrhea. Continue reading for a comprehensive list of adverse effects.

Applies to ceftaroline: intravenous powder for solution.

Serious side effects of Teflaro

Along with its needed effects, ceftaroline (the active ingredient contained in Teflaro) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ceftaroline:

More common

• Back, leg, or stomach pains
• bleeding gums
• chills
• dark urine
• difficulty with breathing
• fever
• general body swelling
• headache
• loss of appetite
• nausea or vomiting
• nosebleeds
• pale skin
• sore throat
• unusual tiredness or weakness
• yellowing of the eyes or skin

Less common

• Black, tarry stools
• blood in the urine or stools
• bluish color
• changes in skin color
• chest pain, discomfort, or tightness
• confusion
• cough
• decreased frequency or amount of urine
• diarrhea
• difficulty with swallowing
• dizziness
• dry mouth
• fast, irregular, pounding, or racing heartbeat or pulse
• general tiredness and weakness
• increased blood pressure
• increased thirst
• light-colored stools
• lightheadedness, dizziness, or fainting
• lower back or side pain
• mood changes
• muscle pain or cramps
• nervousness
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• skin itching, rash, redness, or hives
• slow or irregular heartbeat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach cramps, pain, or tenderness
• swelling of the face, throat, fingers, or lower legs
• swollen glands
• trouble breathing
• unusual bleeding or bruising
• watery and severe diarrhea, which may also be bloody
• weakness or heaviness of the legs
• weight gain

Incidence not known

• Agitation
• back pain
• blurred vision
• coma
• hallucinations
• irritability
• mood or mental changes
• shaking or jerking of one area or side of the body
• stiff neck

Other side effects of Teflaro

Some side effects of ceftaroline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Difficulty having a bowel movement (stool)
• flushed, dry skin fruit-like breath odor
• increased hunger
• increased urination
• sweating
• unexplained weight loss
• welts

For Healthcare Professionals

Applies to ceftaroline: intravenous powder for injection.

General

The most common side effects reported in adults using this drug were diarrhea, headache, nausea, pruritus, and rash.^[Ref]

Hematologic

In clinical trials, direct antiglobulin test seroconversion was reported in 10.7% of adult patients using this drug every 12 hours (600 mg infused over 1 hour every 12 hours) and in 32.3% of those using this drug every 8 hours (600 mg infused over 2 hours every 8 hours). Seroconversion from negative to positive direct Coombs test result was reported in 17.9% of children using this drug.

Agranulocytosis, eosinophilia, and leukopenia have also been reported during postmarketing experience.^[Ref]

Very common (10% or more): Direct antiglobulin test/Coombs test seroconversion (up to 32.3%), positive direct Coombs test

Uncommon (0.1% to 1%): Anemia, leukopenia, neutropenia, thrombocytopenia, prolonged prothrombin time, prolonged activated partial thromboplastin time, increased INR

Rare (0.01% to 0.1%): Agranulocytosis, eosinophilia^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, constipation, vomiting, abdominal pain

Uncommon (0.1% to 1%): Clostridioides difficile colitis

Frequency not reported: C difficile-associated diarrhea, dyspepsia^[Ref]

Dermatologic

In clinical trials using this drug every 12 hours or every 8 hours, rash was common; however, in a subgroup of Asian patients using this drug every 8 hours, rash was very common (18.5%).^[Ref]

Common (1% to 10%): Rash, pruritus, generalized pruritus

Uncommon (0.1% to 1%): Urticaria

Beta-lactam antibiotics (including cephalosporins):

-Postmarketing reports: Severe cutaneous adverse reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms [DRESS], acute generalized exanthematous pustulosis)^[Ref]

Nervous system

Risk of encephalopathy was higher in patients with renal dysfunction receiving doses of this drug that were not appropriately reduced.^[Ref]

Common (1% to 10%): Headache, dizziness

Frequency not reported: Convulsion

Postmarketing reports: Encephalopathy^[Ref]

Metabolic

Common (1% to 10%): Hypokalemia

Frequency not reported: Decreased appetite, hyperglycemia, hyperkalemia^[Ref]

Cardiovascular

Common (1% to 10%): Phlebitis, hypertension, increased blood pressure

Frequency not reported: Bradycardia, palpitations^[Ref]

Hepatic

Common (1% to 10%): Increased transaminases, increased ALT

Frequency not reported: Abnormal hepatic function, hepatitis, increased AST^[Ref]

Other

Common (1% to 10%): Pyrexia

Frequency not reported: Asthenia^[Ref]

Psychiatric

Common (1% to 10%): Insomnia^[Ref]

Local

Common (1% to 10%): Infusion site reactions (erythema, phlebitis, pain)

Hypersensitivity

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterials.^[Ref]

Uncommon (0.1% to 1%): Hypersensitivity (e.g., urticaria, lip and face swelling), anaphylaxis^[Ref]

Renal

Uncommon (0.1% to 1%): Increased blood creatinine

Frequency not reported: Renal failure^[Ref]

Respiratory

Postmarketing reports: Eosinophilic pneumonia

Genitourinary

Frequency not reported: Urinary tract infection^[Ref]