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AMPICILLIN AND SULBACTAM

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Ampicillin And Sulbactam Adverse Events Reported to the FDA Over Time

How are Ampicillin And Sulbactam adverse event reports trending over time?

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

Most Common Ampicillin And Sulbactam Adverse Events Reported to the FDA

What are the most common Ampicillin And Sulbactam adverse events reported to the FDA?

Pneumonia
28 (1.69%)
Enterocolitis Haemorrhagic
24 (1.45%)
Anaphylactic Reaction
23 (1.39%)
Drug Interaction
23 (1.39%)
Jaundice
21 (1.27%)
Diarrhoea
19 (1.14%)
Rash
19 (1.14%)
Hypersensitivity
17 (1.02%)
Septic Shock
17 (1.02%)
Toxic Epidermal Necrolysis
17 (1.02%)
Renal Failure Acute
16 (.96%)
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Stevens-johnson Syndrome
16 (.96%)
Acute Respiratory Distress Syndrome
15 (.9%)
Alanine Aminotransferase Increased
15 (.9%)
Pyrexia
15 (.9%)
Tachycardia
14 (.84%)
Culture Stool Positive
13 (.78%)
Liver Injury
13 (.78%)
Pruritus
13 (.78%)
Vomiting
13 (.78%)
Acute Generalised Exanthematous Pus...
12 (.72%)
Clostridial Infection
12 (.72%)
Hepatitis Toxic
12 (.72%)
Hepatitis Acute
11 (.66%)
Liver Disorder
11 (.66%)
Angioedema
10 (.6%)
Blood Pressure Increased
10 (.6%)
Clostridium Difficile Colitis
10 (.6%)
Condition Aggravated
10 (.6%)
Drug Ineffective
10 (.6%)
Pseudomembranous Colitis
10 (.6%)
Rash Maculo-papular
10 (.6%)
Sepsis
10 (.6%)
Drug Hypersensitivity
9 (.54%)
General Physical Condition Abnormal
9 (.54%)
Haemorrhage Intracranial
9 (.54%)
Hypoglycaemia
9 (.54%)
International Normalised Ratio Incr...
9 (.54%)
Nausea
9 (.54%)
Rash Generalised
9 (.54%)
Anaphylactic Shock
8 (.48%)
Cholecystitis
8 (.48%)
Dehydration
8 (.48%)
Erythema
8 (.48%)
Hypotension
8 (.48%)
Infusion Related Reaction
8 (.48%)
Klebsiella Infection
8 (.48%)
Liver Function Test Abnormal
8 (.48%)
Malaise
8 (.48%)
Rash Macular
8 (.48%)
Acute Respiratory Failure
7 (.42%)
Aspartate Aminotransferase Increase...
7 (.42%)
Bacteraemia
7 (.42%)
Cardiac Arrest
7 (.42%)
Hepatitis
7 (.42%)
Multi-organ Failure
7 (.42%)
Quadriparesis
7 (.42%)
Renal Impairment
7 (.42%)
Respiratory Failure
7 (.42%)
Thrombocytopenia
7 (.42%)
Thyrotoxic Crisis
7 (.42%)
Urinary Tract Infection
7 (.42%)
Urticaria
7 (.42%)
Acute Hepatic Failure
6 (.36%)
Autoimmune Thyroiditis
6 (.36%)
Bacterial Infection
6 (.36%)
Benign Prostatic Hyperplasia
6 (.36%)
Bronchospasm
6 (.36%)
Cardiogenic Shock
6 (.36%)
Cholestasis
6 (.36%)
Drug Exposure During Pregnancy
6 (.36%)
Drug Level Decreased
6 (.36%)
Enterocolitis Infectious
6 (.36%)
Gamma-glutamyltransferase Increased
6 (.36%)
Hepatic Failure
6 (.36%)
Inflammation
6 (.36%)
Palpitations
6 (.36%)
Panic Attack
6 (.36%)
Platelet Count Decreased
6 (.36%)
Pulmonary Embolism
6 (.36%)
Rash Erythematous
6 (.36%)
Rash Morbilliform
6 (.36%)
Restlessness
6 (.36%)
Staphylococcal Infection
6 (.36%)
Ventricular Fibrillation
6 (.36%)
Anaemia
5 (.3%)
Blister
5 (.3%)
Blood Bilirubin Increased
5 (.3%)
Brain Oedema
5 (.3%)
C-reactive Protein Increased
5 (.3%)
Cardiac Failure
5 (.3%)
Convulsion
5 (.3%)
Delirium
5 (.3%)
Drug Eruption
5 (.3%)
Dyspnoea
5 (.3%)
Gait Disturbance
5 (.3%)
Hepatic Steatosis
5 (.3%)
Hepatocellular Injury
5 (.3%)
Hyperglycaemia
5 (.3%)
Jaundice Cholestatic
5 (.3%)
Medication Error
5 (.3%)

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This graph shows the top adverse events submitted to the FDA for Ampicillin And Sulbactam, 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 Ampicillin And Sulbactam 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 Ampicillin And Sulbactam

What are the most common Ampicillin And Sulbactam adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Ampicillin And Sulbactam, 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 Ampicillin And Sulbactam 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 Ampicillin And Sulbactam According to Those Reporting Adverse Events

Why are people taking Ampicillin And Sulbactam, according to those reporting adverse events to the FDA?

Pneumonia
125
Product Used For Unknown Indication
45
Urinary Tract Infection
36
Drug Use For Unknown Indication
33
Infection
28
Lower Respiratory Tract Infection
20
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Infection Prophylaxis
19
Prophylaxis
17
Cellulitis
15
Bronchitis
15
Sinusitis
13
Ill-defined Disorder
12
Pneumonia Aspiration
11
Pyrexia
10
Bacteraemia
9
Pleurisy
9
Wound Infection
7
Skin Infection
7
Staphylococcal Sepsis
7
Acute Sinusitis
7
Antibiotic Prophylaxis
6
Osteomyelitis
6
Respiratory Tract Infection
6
Endocarditis
5
Anti-infective Therapy
5
Endocarditis Prophylaxis
5
Pyelonephritis
5
Tonsillitis
5
Cystitis
5
Acinetobacter Infection
4
Appendicitis
4
Erysipelas
4
Myocarditis
4
Surgery
4
Bacterial Infection
4
Cough
4
Pneumonia Bacterial
4
Empyema
4
Skin Ulcer
3
Tooth Abscess
3
Upper Respiratory Tract Infection
3
Diabetic Gangrene
3
Pharyngitis
3
Ear Infection
3
Sepsis
3
Lower Respiratory Tract Inflammatio...
3
Chronic Obstructive Pulmonary Disea...
3
Pyothorax
3
Osteonecrosis
2
Pharyngolaryngeal Pain
2
Pelvic Infection
2

Drug Labels

LabelLabelerEffective
Ampicillin And SulbactamAPP Pharmaceuticals, LLC15-NOV-07
Ampicillin And SulbactamAPP Pharmaceuticals, LLC15-NOV-07
Ampicillin And SulbactamGeneraMedix Inc.05-AUG-09
Ampicillin And SulbactamBaxter Healthcare Corporation19-FEB-10
Ampicillin And SulbactamBaxter Healthcare Corporation19-FEB-10
Ampicillin And SulbactamBaxter Healthcare Corporation23-FEB-10
Ampicillin And SulbactamBaxter Healthcare Corporation26-MAR-10
Ampicillin And SulbactamBaxter Healthcare Corporation08-APR-10
Ampicillin And SulbactamBaxter Healthcare Corporation08-APR-10
Ampicillin And SulbactamCardinal Health20-MAY-11
Ampicillin And SulbactamAuroMedics Pharma LLC10-FEB-12
Ampicillin And SulbactamWest-ward Pharmaceutical Corp.01-MAR-12
Ampicillin And SulbactamWest-ward Pharmaceutical Corp.01-MAR-12
Ampicillin And SulbactamHospira, Inc22-MAR-12
Ampicillin And SulbactamHospira, Inc04-APR-12
Ampicillin And SulbactamHospira, Inc05-APR-12
Ampicillin And SulbactamWest-ward Pharmaceutical Corp.21-MAY-12
Ampicillin And SulbactamWest-ward Pharmaceutical Corp.22-MAY-12
Ampicillin And SulbactamWest-ward Pharmaceutical Corp.22-MAY-12
Ampicillin And SulbactamSandoz Inc06-AUG-12
Ampicillin And SulbactamAuroMedics Pharma LLC22-AUG-12
UnasynRoerig24-AUG-12
Ampicillin And SulbactamSagent Pharmaceuticals, Inc.31-AUG-12
Ampicillin And SulbactamMylan Institutional LLC31-AUG-12
Ampicillin And SulbactamSagent Pharmaceuticals, Inc.31-AUG-12
Ampicillin And SulbactamAuroMedics Pharma LLC10-SEP-12
Ampicillin And SulbactamHospira, Inc.31-JAN-13
Ampicillin And SulbactamHospira, Inc.31-JAN-13
Ampicillin And SulbactamWG Critical Care, LLC20-FEB-13
Ampicillin And SulbactamWG Critical Care, LLC20-FEB-13
Ampicillin And SulbactamHospira, Inc.25-FEB-13
Ampicillin And SulbactamSandoz Inc15-MAR-13
UnasynRoerig29-MAR-13
Ampicillin And SulbactamSandoz Inc02-APR-13

Ampicillin And Sulbactam Case Reports

What Ampicillin And Sulbactam 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 Ampicillin And Sulbactam. 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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