Teflaro
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Teflaro
Teflaro Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Teflaro (ceftaroline fosamil) is a cephalosporin antibiotic used to treat skin infections or pneumonia caused by bacteria. Common side effects of Teflaro include nausea, vomiting, constipation, diarrhea, dizziness, and itching.
The recommended dosage of Teflaro is 600 mg every 12 hours. Do not stop taking Teflaro until you have taken the full recommended dose. Other drugs may interact with Teflaro. Tell your doctor all medications you take. Before taking Teflaro tell your doctor if you have kidney disease or a history of intestinal problems. Teflaro will not treat a viral infection such as the common cold or flu. If you are pregnant only take Teflaro if the potential benefit outweighs the potential risk to the fetus. Exercise caution while taking Teflaro if you are breastfeeding.
Our Teflaro (ceftaroline fosamil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Teflaro in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Teflaro (Ceftaroline Fosamil Injection for Intravenous (IV) Use) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Teflaro FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The following serious events are described in greater detail in the Warnings and Precautions section
- Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
- Clostridium difficile-associated diarrhea [see WARNINGS AND PRECAUTIONS]
- Direct Coombs' test seroconversion [see WARNINGS AND PRECAUTIONS]
Adverse Reactions from Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared directly to rates from clinical trials of another drug and may not reflect rates observed in practice.
Teflaro was evaluated in four controlled comparative Phase 3 clinical trials (two in ABSSSI and two in CABP) which included 1300 adult patients treated with Teflaro (600 mg administered by IV over 1 hour every 12h) and 1297 patients treated with comparator (vancomycin plus aztreonam or ceftriaxone) for a treatment period up to 21 days. The median age of patients treated with Teflaro was 54 years, ranging between 18 and 99 years old. Patients treated with Teflaro were predominantly male (63%) and Caucasian (82%).
Serious Adverse Events and Adverse Events Leading to Discontinuation
In the four pooled Phase 3 clinical trials, serious adverse events occurred in 98/1300 (7.5%) of patients receiving Teflaro and 100/1297 (7.7%) of patients receiving comparator drugs. The most common SAEs in both the Teflaro and comparator treatment groups were in the respiratory and infection system organ classes (SOC). Treatment discontinuation due to adverse events occurred in 35/1300 (2.7%) of patients receiving Teflaro and 48/1297 (3.7%) of patients receiving comparator drugs with the most common adverse events leading to discontinuation being hypersensitivity for both treatment groups at a rate of 0.3% in the Teflaro group and 0.5% in comparator group.
Most Common Adverse Reactions
No adverse reactions occurred in greater than 5% of patients receiving Teflaro. The most common adverse reactions occurring in > 2% of patients receiving Teflaro in the pooled phase 3 clinical trials were diarrhea, nausea, and rash.
Table 4 lists adverse reactions occurring in ≥ 2% of patients receiving Teflaro in the pooled Phase 3 clinical trials.
Table 4: Adverse Reactions Occurring in ≥ 2% of Patients Receiving Teflaro in
the Pooled Phase 3 Clinical Trials
| System Organ Class/ Preferred Term | Pooled Phase 3 Clinical Trials (four trials, two in ABSSSI and two in CABP) | |
| Teflaro (N=1300) |
Pooled Comparatorsa (N=1297) |
|
| Gastrointestinal disorders | ||
| Diarrhea | 5 % | 3 % |
| Nausea | 4 % | 4 % |
| Constipation | 2 % | 2 % |
| Vomiting | 2 % | 2 % |
| Investigations | ||
| Increased transaminases | 2% | 3 % |
| Metabolism and nutrition disorders | ||
| Hypokalemia | 2 % | 3 % |
| Skin and subcutaneous tissue disorders | ||
| Rash | 3% | 2% |
| Vascular disorders | ||
| Phlebitis | 2% | 1% |
| a Comparators included vancomycin 1 gram IV every 12h plus aztreonam 1 gram IV every 12h in the Phase 3 ABSSSI trials, and ceftriaxone 1 gram IV every 24h in the Phase 3 CABP trials. | ||
Other Adverse Reactions Observed During Clinical Trials of Teflaro
Following is a list of additional adverse reactions reported by the 1740 patients who received Teflaro in any clinical trial with incidences less than 2%. Events are categorized by System Organ Class.
Blood and lymphatic system disorders - Anemia, Eosinophilia, Neutropenia, Thrombocytopenia
Cardiac disorders - Bradycardia, Palpitations
Gastrointestinal disorders - Abdominal pain
General disorders and administration site conditions - Pyrexia
Hepatobiliary disorders - Hepatitis
Immune system disorders - Hypersensitivity, Anaphylaxis
Infections and infestations - Clostridium difficile colitis
Metabolism and nutrition disorders - Hyperglycemia, Hyperkalemia
Nervous system disorders - Dizziness, Convulsion
Renal and urinary disorders - Renal failure
Skin and subcutaneous tissue disorders - Urticaria
Read the entire FDA prescribing information for Teflaro (Ceftaroline Fosamil Injection for Intravenous (IV) Use) »
Additional Teflaro Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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