April 29, 2017
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Side Effects


The following serious adverse reactions 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]

Clinical Trials Experience

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 Reactions and Adverse Reactions Leading to Discontinuation

In the four pooled Phase 3 clinical trials, serious adverse reactions (SARs) occurred in 98/1300 (7.5%) of patients receiving Teflaro and 100/1297 (7.7%) of patients receiving comparator drugs. Treatment discontinuation due to adverse reactions 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 reactions 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

Adverse Reactions Pooled Phase 3 Clinical Trials (four trials, two in ABSSSI and two in CABP)
Pooled Comparatorsa
Gastrointestinal Disorders
  Diarrhea 5 % 3 %
  Nausea 4 % 4 %
  Constipation 2 % 2 %
  Vomiting 2 % 2 %
Laboratory 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%.

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

Postmarketing Experience

The following adverse reaction has been identified during postapproval use of Teflaro. Because this adverse reaction was reported voluntarily from a population of uncertain size, it is not possible to estimate its frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: Agranulocytosis.

Read the Teflaro (ceftaroline fosamil injection for intravenous (iv) use) Side Effects Center for a complete guide to possible side effects


No information provided.

Read the Teflaro Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 9/15/2015

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