This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Teflaro (Ceftaroline Fosamil) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (21)
Life Threatening Events (3)
Reports by Reaction Type
Off Label Use (3),
Medication Error (3),
Dyspnoea (3),
Pancytopenia (3),
Rash (3),
Product Label Issue (3),
Neutropenia (3),
Leukopenia (3),
Stridor (2),
Adverse Drug Reaction (2),
Blood Glucose Fluctuation (2),
Apnoea (2)
Possible Teflaro side effects in 73 year old male
Reported by a pharmacist from United States on 2012-08-15
Patient: 73 year old male
Reactions: Dyspnoea, Stridor, Adverse Drug Reaction, Apnoea
Drug(s) suspected as cause:
Teflaro
Indication: Wound Infection Pseudomonas
Teflaro
Indication: Wound Infection Staphylococcal
Teflaro
Dosage: 600 mg every 12 hours
Indication: Decubitus Ulcer
Start date: 2012-07-31
End date: 2012-07-31
Teflaro
Indication: Enterococcal Bacteraemia
Teflaro
Indication: Enterococcal Infection
Other drugs received by patient: Combivent; Magnesium Oxide; Solu-Medrol; Ascorbic Acid; Docusate; Coreg; Furosemide
Possible Teflaro side effects in 73 year old male
Reported by a pharmacist from United States on 2012-08-08
Patient: 73 year old male
Reactions: Off Label Use, Dyspnoea, Stridor, Adverse Drug Reaction, Apnoea
Drug(s) suspected as cause:
Teflaro
Other drugs received by patient: Combivent; Docusate; Furosemide; Solu-Medrol; Magnesium Oxide; Ascorbic Acid; Coreg
Possible Teflaro side effects in 67 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-10
Patient: 67 year old female, weighing 120.0 kg (264.0 pounds)
Reactions: Leukopenia
Drug(s) suspected as cause:
Teflaro
Indication: Osteomyelitis
Teflaro
Dosage: 600 mg
Indication: Skin Ulcer
Start date: 2012-02-01
End date: 2012-03-30
Possible Teflaro side effects in 74 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-10
Patient: 74 year old male, weighing 120.0 kg (264.0 pounds)
Reactions: Leukopenia
Drug(s) suspected as cause:
Teflaro
Dosage: 1200 mg
Indication: Staphylococcal Infection
Start date: 2012-02-17
End date: 2012-03-30
Teflaro
Indication: Knee Arthroplasty
Possible Teflaro side effects in
Reported by a individual with unspecified qualification from United States on 2012-07-06
Patient:
Reactions: Circumstance or Information Capable of Leading To Medication Error, Product Label Issue, Medication Error
Drug(s) suspected as cause:
Teflaro
Possible Teflaro side effects in 55 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-25
Patient: 55 year old female, weighing 90.7 kg (199.6 pounds)
Reactions: Anaphylactic Reaction, Drug Hypersensitivity
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Teflaro
Possible Teflaro side effects in 66 year old male
Reported by a pharmacist from United States on 2012-06-13
Patient: 66 year old male, weighing 54.6 kg (120.1 pounds)
Reactions: Neutropenia, Rash, Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Teflaro
Possible Teflaro side effects in 83 year old female
Reported by a physician from United States on 2012-05-29
Patient: 83 year old female, weighing 45.3 kg (99.7 pounds)
Reactions: Haemolytic Anaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Teflaro
Possible Teflaro side effects in 56 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-02
Patient: 56 year old male, weighing 1434.2 kg (3155.2 pounds)
Reactions: Neutropenia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Teflaro
Possible Teflaro side effects in female
Reported by a pharmacist from United States on 2012-04-26
Patient: female, weighing 35.5 kg (78.1 pounds)
Reactions: Pruritus, Rash, Blood Pressure Decreased
Drug(s) suspected as cause:
Teflaro
Other drugs received by patient: Ferrous Sulfate TAB; Nephro-Vite; Mirtazapine; Flagyl; Fluconazole; Clorpactin Topical; Norethindrone; Magnesium Oxide; Epogen; Nystatin; Cefepime; Lansoprazole
Possible Teflaro side effects in 85 year old female
Reported by a physician from United States on 2012-03-26
Patient: 85 year old female
Reactions: Pancytopenia
Drug(s) suspected as cause:
Teflaro
Possible Teflaro side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-02
Patient: female, weighing 79.3 kg (174.5 pounds)
Reactions: Blood Glucose Fluctuation
Drug(s) suspected as cause:
Teflaro
Other drugs received by patient: Glyburide
Possible Teflaro side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-01
Patient: female, weighing 79.3 kg (174.5 pounds)
Reactions: Blood Glucose Fluctuation
Drug(s) suspected as cause:
Teflaro
Other drugs received by patient: Glyburide
Possible Teflaro side effects in 46 year old male
Reported by a physician from United States on 2012-02-21
Patient: 46 year old male
Reactions: Off Label Use, Pancytopenia
Drug(s) suspected as cause:
Teflaro
Dosage: 600 mg every 12 hours (600 mg,every 12 hours),intravenous (not otherwise specified)
Indication: Osteomyelitis
Start date: 2011-03-19
End date: 2011-04-22
Teflaro
Dosage: 600 mg every 12 hours (600 mg,every 12 hours),intravenous (not otherwise specified)
Indication: Staphylococcal Infection
Start date: 2011-03-19
End date: 2011-04-22
Other drugs received by patient: Iron (Iron) (Iron); Gabapentin; Insulin (Insulin) (Insulin); Omeprazole; Propranolol; Baclofen (Baclofenq)(baclofen); MVI (Mvi) (Mvi); Rifampin (Rifampicin)(rifampicin); Fluoxetine; Lisinopril; Dalteparin (Dalteparin)(dalteparin); Morphine; Senna (Senna) ( Senna)
Possible Teflaro side effects in male
Reported by a physician from United States on 2012-02-09
Patient: male
Reactions: Tachycardia, Rash
Drug(s) suspected as cause:
Teflaro
Teflaro
Possible Teflaro side effects in 55 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-03
Patient: 55 year old female, weighing 105.4 kg (231.9 pounds)
Reactions: Dyspnoea, Oedema Peripheral, Neutropenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Teflaro
Dosage: ceftaroline 600mg every 12 hrs intravenous
Indication: Cellulitis
Start date: 2011-12-20
End date: 2012-01-05
Clindamycin
Dosage: clindamycin 900mg every 12 hrs intravenous
Indication: Cellulitis
Start date: 2011-12-20
End date: 2012-01-05
Possible Teflaro side effects in
Reported by a individual with unspecified qualification from United States on 2012-01-25
Patient:
Reactions: Product Packaging Issue, Medication Error, Product Label Issue, Circumstance or Information Capable of Leading To Medication Error
Drug(s) suspected as cause:
Teflaro
Dosage: oral
Administration route: Oral
Teflaro
Possible Teflaro side effects in male
Reported by a physician from United States on 2011-12-16
Patient: male
Reactions: Off Label Use, Pancytopenia
Drug(s) suspected as cause:
Teflaro
Possible Teflaro side effects in 36 year old male
Reported by a pharmacist from United States on 2011-12-14
Patient: 36 year old male
Reactions: Leukopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Teflaro
Other drugs received by patient: Septra (Bactrim)(bactrim); Fluconazole
Possible Teflaro side effects in 22 year old male
Reported by a physician from United States on 2011-11-25
Patient: 22 year old male, weighing 93.4 kg (205.6 pounds)
Reactions: Blood Iron Decreased, Cellulitis, Anaemia, Condition Aggravated, Culture Wound Positive, Purulent Discharge, Staphylococcus Test Positive
Drug(s) suspected as cause:
Teflaro
Other drugs received by patient: Tylenol (Aceaminophen) (500 Milligram, Tablets) (Acetaminophen); Nicotine Patch (Nicotine) (21 Milligram, Poultice OR Patch) (Nicotine); Lortab (Acetaminophen and Hydrocodone) (7.5 Milligram, Tablets) (Aceta
Possible Teflaro side effects in
Reported by a individual with unspecified qualification from United States on 2011-11-10
Patient:
Reactions: Product Label Issue, Medication Error
Drug(s) suspected as cause:
Teflaro
Dosage: injectable vial
Teflaro
Dosage: injectable vial
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