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AMOXICILLIN AND CLAVULANATE POTASSIUM

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Amoxicillin And Clavulanate Potassium Adverse Events Reported to the FDA Over Time

How are Amoxicillin And Clavulanate Potassium adverse event reports trending over time?

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

Most Common Amoxicillin And Clavulanate Potassium Adverse Events Reported to the FDA

What are the most common Amoxicillin And Clavulanate Potassium adverse events reported to the FDA?

Pruritus
178 (2.17%)
Diarrhoea
155 (1.89%)
Pyrexia
146 (1.78%)
Rash
142 (1.73%)
Jaundice
127 (1.55%)
Vomiting
115 (1.4%)
Dyspnoea
111 (1.35%)
Renal Failure Acute
96 (1.17%)
Nausea
95 (1.16%)
Malaise
92 (1.12%)
Urticaria
81 (.99%)
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Drug Ineffective
75 (.91%)
Hepatitis Cholestatic
73 (.89%)
Anaphylactic Reaction
72 (.88%)
Erythema
70 (.85%)
Hypotension
66 (.8%)
Abdominal Pain
64 (.78%)
Drug Interaction
57 (.69%)
Hepatitis
57 (.69%)
Cholestasis
56 (.68%)
Alanine Aminotransferase Increased
54 (.66%)
Stevens-johnson Syndrome
54 (.66%)
Liver Function Test Abnormal
49 (.6%)
Asthenia
47 (.57%)
Hepatotoxicity
47 (.57%)
Angioedema
46 (.56%)
Chromaturia
46 (.56%)
Aspartate Aminotransferase Increase...
43 (.52%)
Dizziness
43 (.52%)
Fatigue
43 (.52%)
Blood Alkaline Phosphatase Increase...
42 (.51%)
Gamma-glutamyltransferase Increased
42 (.51%)
Oedema Peripheral
42 (.51%)
Abdominal Pain Upper
40 (.49%)
Jaundice Cholestatic
40 (.49%)
Anaphylactic Shock
39 (.48%)
Hepatic Failure
39 (.48%)
Renal Failure
39 (.48%)
Death
38 (.46%)
Hypersensitivity
38 (.46%)
Drug Hypersensitivity
37 (.45%)
Blood Bilirubin Increased
36 (.44%)
Clostridium Difficile Colitis
36 (.44%)
Tachycardia
35 (.43%)
Headache
34 (.41%)
International Normalised Ratio Incr...
34 (.41%)
Liver Injury
34 (.41%)
Rash Erythematous
34 (.41%)
Acute Generalised Exanthematous Pus...
33 (.4%)
Toxic Epidermal Necrolysis
33 (.4%)
Chest Pain
32 (.39%)
Confusional State
31 (.38%)
Rash Maculo-papular
31 (.38%)
Sepsis
31 (.38%)
Hepatic Enzyme Increased
30 (.37%)
Loss Of Consciousness
30 (.37%)
Weight Decreased
30 (.37%)
Clostridial Infection
29 (.35%)
Condition Aggravated
29 (.35%)
Rash Pruritic
29 (.35%)
Cardiac Arrest
28 (.34%)
Decreased Appetite
28 (.34%)
Dehydration
28 (.34%)
Skin Exfoliation
28 (.34%)
Acute Hepatic Failure
27 (.33%)
Blood Creatinine Increased
27 (.33%)
Erythema Multiforme
27 (.33%)
Drug Rash With Eosinophilia And Sys...
26 (.32%)
Pain
26 (.32%)
Pneumonia
26 (.32%)
Purpura
26 (.32%)
Thrombocytopenia
26 (.32%)
Cough
25 (.3%)
General Physical Health Deteriorati...
25 (.3%)
Medication Error
25 (.3%)
Convulsion
24 (.29%)
Syncope
24 (.29%)
Cytolytic Hepatitis
23 (.28%)
Leukocytoclastic Vasculitis
23 (.28%)
Multi-organ Failure
23 (.28%)
Pancytopenia
23 (.28%)
Fall
22 (.27%)
Neutropenia
22 (.27%)
Toxic Skin Eruption
22 (.27%)
Dysphagia
21 (.26%)
Eosinophilia
21 (.26%)
Hepatomegaly
21 (.26%)
Liver Disorder
21 (.26%)
Product Quality Issue
21 (.26%)
Sinusitis
21 (.26%)
Cardiac Failure
20 (.24%)
Gastroenteritis
20 (.24%)
Intentional Overdose
20 (.24%)
Transaminases Increased
20 (.24%)
Anaemia
19 (.23%)
C-reactive Protein Increased
18 (.22%)
Chills
18 (.22%)
Face Oedema
18 (.22%)
Hallucination
18 (.22%)
Lethargy
18 (.22%)
Leukopenia
18 (.22%)

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This graph shows the top adverse events submitted to the FDA for Amoxicillin And Clavulanate Potassium, 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 Amoxicillin And Clavulanate Potassium 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 Amoxicillin And Clavulanate Potassium

What are the most common Amoxicillin And Clavulanate Potassium adverse events reported to the FDA?

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

Why are people taking Amoxicillin And Clavulanate Potassium, according to those reporting adverse events to the FDA?

Product Used For Unknown Indication
193
Drug Use For Unknown Indication
180
Sinusitis
148
Pneumonia
136
Infection
117
Urinary Tract Infection
105
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Bronchitis
89
Prophylaxis
61
Lower Respiratory Tract Infection
60
Upper Respiratory Tract Infection
59
Pyrexia
52
Cellulitis
46
Ear Infection
45
Respiratory Tract Infection
40
Tooth Abscess
28
Lung Disorder
28
Pharyngitis
27
Acute Sinusitis
25
Tonsillitis
24
Bronchopneumonia
22
Antibiotic Prophylaxis
21
Lung Infection
21
Oropharyngeal Pain
20
Infection Prophylaxis
20
Ill-defined Disorder
20
Erysipelas
18
Skin Infection
17
Wound Infection
15
Chronic Obstructive Pulmonary Disea...
14
Toothache
14
Influenza
14
Cough
13
Antibiotic Therapy
13
Tooth Infection
12
Otitis Media
12
Acute Tonsillitis
12
Nasopharyngitis
11
Skin Ulcer
11
Abscess
11
Bacterial Infection
11
Cholecystitis
10
Respiratory Disorder
9
Pyelonephritis
9
Pneumonia Aspiration
9
Odynophagia
8
Cystitis
8
Sepsis
8
Crohns Disease
8
Localised Infection
8
Pharyngitis Streptococcal
8
Diverticulitis
7

Drug Labels

LabelLabelerEffective
Amoxicillin And Clavulanate PotassiumRebel Distributors Corp.01-JUN-09
Amoxicillin/clavulanate Potassiumbryant ranch prepack12-JUN-09
Amoxicillin And Clavulanate PotassiumPhysicians Total Care, Inc.25-JUN-09
Amoxicillin And Clavulanate PotassiumWest-ward Pharmaceutical Corp28-SEP-09
Amoxicillin And Calvulanate PotassiumAmerican Health Packaging10-DEC-09
Amoxicillin And Clavulanate PotassiumPhysicians Total Care, Inc.15-JAN-10
Amoxicillin And Clavulanate PotassiumLek Pharmaceuticals, Inc.18-FEB-10
Amoxicillin And Clavulanate PotassiumPhysicians Total Care, Inc.21-MAY-10
Amoxicillin And Clavulanate PotassiumState of Florida DOH Central Pharmacy04-JUN-10
Amoxicillin And Clavulanate Potassium State of Florida DOH Central Pharmacy04-JUN-10
Amoxicillin And Clavulanate PotassiumState of Florida DOH Central Pharmacy04-JUN-10
Amoxicillin And Clavulanate PotassiumWest-ward Pharmaceutical Corp10-AUG-10
Amoxicillin And Clavulanate PotassiumRebel Distributors Corp.14-SEP-10
Amoxicillin And Clavulanate PotassiumRebel Distributors Corp.14-SEP-10
Amoxicillin And Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.25-JAN-11
Amoxicillin And Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.25-JAN-11
Amoxicillin And Clavulanate Potassium Preferred Pharmaceuticals, Inc31-MAR-11
Amoxicillin And Clavulanate PotassiumSTAT RX USA LLC18-MAY-11
AugmentinCardinal Health24-MAY-11
Amoxicillin And Clavulanate PotassiumPreferred Pharmaceuticals, Inc24-JUN-11
Amoxicillin And Clavulanate PotassiumPreferred Pharmaceuticals, Inc27-JUN-11
Amoxicillin And Clavulanate PotassiumMorton Grove Pharmaceuticals, Inc.11-JUL-11
Amoxicillin And Clavulanate PotassiumRebel Distributors Corp20-JUL-11
Amoxicillin And Clavulanate PotassiumRedPharm Drug Inc.08-AUG-11
Amoxicillin And Clavulanate Potassium PD-Rx Pharmaceuticals, Inc.12-OCT-11
Amoxicillin And Clavulanate PotassiumUnit Dose Services16-NOV-11
Amoxicillin And Clavulanate PotassiumMedVantx, Inc.16-NOV-11
Amoxicillin And Clavulanate PotassiumUnit Dose Services16-NOV-11
Amoxicillin And Clavulanate PotassiumLake Erie Medical & Surgical Supply DBA Quality Care Products LLC21-DEC-11
Amoxicillin And Clavulanate PotassiumAurobindo Pharma Limited21-DEC-11
Amoxicillin And Clavulanate PotassiumAurobindo Pharma Limited21-DEC-11
Amoxicillin And Clavulanate PotassiumH.J. Harkins Company, Inc.23-DEC-11
Amoxicillin And Clavulanate PotassiumCBSCHEM LIMITD03-JAN-12
Amoxicillin And Clavulanate PotassiumPreferred Pharmaceuticals, Inc09-JAN-12
Amoxicillin And Clavulanate PotassiumNorthStar Rx LLC17-JAN-12
Amoxicillin And Clavulanate PotassiumNorthStar Rx LLC17-JAN-12
Amoxicillin And Clavulanate PotassiumAurobindo Pharma Limited21-JAN-12
Amoxicillin And Clavulanate PotassiumNorthStar Rx LLC23-JAN-12
Amoxicillin And Clavulanate PotassiumPhysicians Total Care, Inc.01-FEB-12
Amoxicillin And Clavulanate PotassiumLake Erie Medical & Surgical Supply DBA Quality Care Products LLC09-MAR-12
AugmentinxrDr Reddys Laboratories Inc12-MAR-12
Amoxicillin And Clavulanate Potassium Extended ReleaseDr Reddys Laboratories Inc12-MAR-12
Amoxicillin And Clavulanate PotassiumDr Reddys Laboratories Inc13-MAR-12
Amoxicillin And Clavulanate PotassiumSandoz Inc13-MAR-12
Amoxicillin And Clavulanate PotassiumSandoz Inc16-MAR-12
Amoxicillin And Clavulanate PotassiumSTAT Rx USA LLC28-MAR-12
Amoxicillin And Clavulanate PotassiumPreferred Pharmaceuticals, Inc30-MAR-12
Amoxicillin And Clavulanate PotassiumSTAT Rx USA LLC12-JUN-12
Amoxicillin And Clavulanate PotassiumSandoz Inc27-JUN-12
Amoxicillin And Clavulanate PotassiumSandoz Inc17-JUL-12
Amoxicillin And Clavulanate Potassium PD-Rx Pharmaceuticals, Inc.31-JUL-12
Amoxicillin And Clavulanate PotassiumRebel Distributors Corp28-AUG-12
Amoxicillin And Clavulanate PotassiumAidarex Pharmaceuticals LLC11-SEP-12
Amoxicillin And Clavulanate PotassiumPreferred Pharmaceuticals, Inc.25-SEP-12
Amoxicillin And Clavulanate PotassiumSandoz Inc24-OCT-12
Amoxicillin And Clavulanate PotassiumPreferred Pharmaceuticals, Inc.19-NOV-12
Augmentin Es-600Dr Reddys Laboratories Inc03-DEC-12
Amoxicillin And Clavulanate Potassium PD-Rx Pharmaceuticals, Inc.06-DEC-12
Amoxicillin And Clavulanate PotassiumTeva Pharmaceuticals USA Inc06-DEC-12
Amoxicillin And Clavulanate PotassiumTeva Pharmaceuticals USA Inc06-DEC-12
Amoxicillin And Clavulanate PotassiumTeva Pharmaceuticals USA Inc07-DEC-12
Amoxicillin And Clavulanate PotassiumTeva Pharmaceuticals USA Inc10-DEC-12
Amoxicillin And Clavulanate PotassiumApotex Corp.01-FEB-13
Amoxicillin And Clavulanate PotassiumPhysicians Total Care, Inc.20-FEB-13
AugmentinDr. Reddy's Laboratories Inc06-MAR-13
Amoxicillin And Clavulanate PotassiumDr. Reddy's Laboratories Inc15-MAR-13
Amoxicillin And Clavulanate PotassiumTeva Pharmaceuticals USA Inc22-APR-13
Amoxicillin And Clavulanate PotassiumPreferred Pharmaceuticals, Inc30-APR-13
Amoxicillin And Clavulanate PotassiumAurobindo Pharma Limited04-MAY-13

Amoxicillin And Clavulanate Potassium Case Reports

What Amoxicillin And Clavulanate Potassium 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 Amoxicillin And Clavulanate Potassium. 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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