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UNASYN

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Unasyn Adverse Events Reported to the FDA Over Time

How are Unasyn adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Unasyn, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Unasyn is flagged as the suspect drug causing the adverse event.

Most Common Unasyn Adverse Events Reported to the FDA

What are the most common Unasyn adverse events reported to the FDA?

Pneumonia
116 (1.92%)
Anaphylactic Shock
108 (1.79%)
Pyrexia
99 (1.64%)
Renal Failure Acute
78 (1.29%)
Toxic Epidermal Necrolysis
75 (1.24%)
Rash
69 (1.14%)
Hepatic Function Abnormal
60 (.99%)
Platelet Count Decreased
59 (.98%)
Pruritus
59 (.98%)
Sepsis
57 (.94%)
Alanine Aminotransferase Increased
55 (.91%)
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Aspartate Aminotransferase Increase...
52 (.86%)
Drug Ineffective
52 (.86%)
Interstitial Lung Disease
52 (.86%)
Dyspnoea
51 (.84%)
Erythema
51 (.84%)
Jaundice
51 (.84%)
Vomiting
49 (.81%)
Shock
48 (.79%)
Drug Eruption
44 (.73%)
Stevens-johnson Syndrome
44 (.73%)
Condition Aggravated
43 (.71%)
Liver Disorder
43 (.71%)
Enterocolitis Haemorrhagic
42 (.69%)
Hypersensitivity
42 (.69%)
Hypotension
40 (.66%)
Rhabdomyolysis
40 (.66%)
Anaphylactic Reaction
39 (.64%)
Convulsion
38 (.63%)
Blood Pressure Decreased
36 (.6%)
Diarrhoea
36 (.6%)
Loss Of Consciousness
36 (.6%)
Acute Respiratory Distress Syndrome
35 (.58%)
Cardiac Arrest
35 (.58%)
Drug Interaction
32 (.53%)
Respiratory Failure
31 (.51%)
Renal Impairment
29 (.48%)
Multi-organ Failure
28 (.46%)
Drug Hypersensitivity
27 (.45%)
Nausea
27 (.45%)
Septic Shock
27 (.45%)
Staphylococcal Infection
26 (.43%)
Acute Generalised Exanthematous Pus...
25 (.41%)
Cardio-respiratory Arrest
25 (.41%)
Blood Bilirubin Increased
24 (.4%)
Cardiac Failure
24 (.4%)
Pneumonia Aspiration
24 (.4%)
Respiratory Arrest
24 (.4%)
White Blood Cell Count Decreased
24 (.4%)
Depressed Level Of Consciousness
23 (.38%)
Prothrombin Time Prolonged
23 (.38%)
Rash Generalised
23 (.38%)
International Normalised Ratio Incr...
22 (.36%)
Thrombocytopenia
22 (.36%)
Urticaria
22 (.36%)
Blood Lactate Dehydrogenase Increas...
21 (.35%)
Cyanosis
21 (.35%)
Death
21 (.35%)
Hepatitis Fulminant
21 (.35%)
White Blood Cell Count Increased
21 (.35%)
Chills
20 (.33%)
Haemorrhage
20 (.33%)
Lymphocyte Stimulation Test Positiv...
20 (.33%)
Tachycardia
20 (.33%)
C-reactive Protein Increased
19 (.31%)
Clostridium Colitis
19 (.31%)
Liver Function Test Abnormal
19 (.31%)
Bradycardia
18 (.3%)
Brain Oedema
18 (.3%)
Disseminated Intravascular Coagulat...
18 (.3%)
Generalised Erythema
18 (.3%)
Haemoglobin Decreased
18 (.3%)
Malaise
18 (.3%)
Clostridium Difficile Colitis
17 (.28%)
Eosinophil Count Increased
17 (.28%)
Gamma-glutamyltransferase Increased
17 (.28%)
Haemolytic Anaemia
17 (.28%)
Haemorrhagic Diathesis
17 (.28%)
Medication Error
17 (.28%)
Toxic Skin Eruption
17 (.28%)
Urinary Tract Infection
17 (.28%)
Urine Colour Abnormal
17 (.28%)
Blood Alkaline Phosphatase Increase...
16 (.26%)
Clostridial Infection
16 (.26%)
Erythema Multiforme
16 (.26%)
General Physical Health Deteriorati...
16 (.26%)
Hepatitis Acute
16 (.26%)
Hyperhidrosis
16 (.26%)
Liver Injury
16 (.26%)
Melaena
16 (.26%)
Oxygen Saturation Decreased
16 (.26%)
Pseudomembranous Colitis
16 (.26%)
Blood Pressure Increased
15 (.25%)
Cholestasis
15 (.25%)
Dehydration
15 (.25%)
Inflammation
15 (.25%)
Pancytopenia
15 (.25%)
Post Procedural Complication
15 (.25%)
Flushing
14 (.23%)
Hepatitis
14 (.23%)
Hypoglycaemia
14 (.23%)

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This graph shows the top adverse events submitted to the FDA for Unasyn, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Unasyn is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Unasyn

What are the most common Unasyn adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Unasyn, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Unasyn is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Unasyn According to Those Reporting Adverse Events

Why are people taking Unasyn, according to those reporting adverse events to the FDA?

Pneumonia
451
Drug Use For Unknown Indication
127
Ill-defined Disorder
123
Infection
116
Infection Prophylaxis
108
Product Used For Unknown Indication
91
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Pyrexia
85
Urinary Tract Infection
83
Pneumonia Aspiration
77
Prophylaxis
62
Bronchitis
48
Antibiotic Prophylaxis
46
Sepsis
43
Cellulitis
43
Bacterial Infection
42
Lower Respiratory Tract Infection
31
Cholecystitis
24
Lung Infection
22
Sinusitis
18
Bacteraemia
16
Postoperative Care
15
Biliary Tract Infection
14
Respiratory Tract Infection
13
Pneumonia Bacterial
13
Cholangitis
12
Upper Respiratory Tract Infection
12
Anti-infective Therapy
12
Pyelonephritis
11
Bronchopneumonia
11
Peritonitis
10
Pharyngitis
10
Febrile Neutropenia
10
Skin Infection
10
Staphylococcal Infection
10
Tonsillitis
9
Osteomyelitis
9
Appendicitis
9
Pleurisy
9
Antibiotic Therapy
9
Inflammation
9
Endocarditis
9
Acinetobacter Infection
8
Wound Infection
8
Staphylococcal Sepsis
8
Post Procedural Infection
8
Acute Sinusitis
7
Intestinal Obstruction
7
Cystitis
7
Abscess
7
Surgery
7
Tracheal Oedema
7

Drug Labels

LabelLabelerEffective
UnasynRoerig24-AUG-12
UnasynRoerig29-MAR-13

Unasyn Case Reports

What Unasyn safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Unasyn. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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