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AMOXICILLIN

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Amoxicillin Adverse Events Reported to the FDA Over Time

How are Amoxicillin adverse event reports trending over time?

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

Most Common Amoxicillin Adverse Events Reported to the FDA

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

Pruritus
1200 (1.81%)
Diarrhoea
1153 (1.74%)
Pyrexia
1130 (1.7%)
Rash
1099 (1.65%)
Vomiting
845 (1.27%)
Renal Failure Acute
726 (1.09%)
Dyspnoea
718 (1.08%)
Urticaria
710 (1.07%)
Erythema
685 (1.03%)
Jaundice
633 (.95%)
Nausea
608 (.92%)
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Malaise
521 (.78%)
Drug Interaction
499 (.75%)
Hypotension
498 (.75%)
Alanine Aminotransferase Increased
494 (.74%)
Abdominal Pain
459 (.69%)
Anaphylactic Shock
449 (.68%)
Hypersensitivity
438 (.66%)
Rash Maculo-papular
418 (.63%)
Drug Hypersensitivity
416 (.63%)
Aspartate Aminotransferase Increase...
389 (.59%)
Cholestasis
384 (.58%)
Drug Ineffective
382 (.58%)
Gamma-glutamyltransferase Increased
381 (.57%)
Blood Alkaline Phosphatase Increase...
370 (.56%)
Hepatitis Cholestatic
352 (.53%)
Anaphylactic Reaction
347 (.52%)
Toxic Skin Eruption
342 (.51%)
Asthenia
328 (.49%)
Stevens-johnson Syndrome
323 (.49%)
Oedema Peripheral
321 (.48%)
Drug Rash With Eosinophilia And Sys...
320 (.48%)
Abdominal Pain Upper
307 (.46%)
Angioedema
303 (.46%)
Dizziness
303 (.46%)
Toxic Epidermal Necrolysis
299 (.45%)
Thrombocytopenia
298 (.45%)
Rash Erythematous
297 (.45%)
Rash Generalised
286 (.43%)
Hepatitis
285 (.43%)
International Normalised Ratio Incr...
281 (.42%)
Renal Failure
280 (.42%)
Face Oedema
279 (.42%)
Blood Bilirubin Increased
278 (.42%)
Weight Decreased
278 (.42%)
Eosinophilia
273 (.41%)
Fatigue
268 (.4%)
Drug Exposure During Pregnancy
264 (.4%)
Headache
263 (.4%)
General Physical Health Deteriorati...
261 (.39%)
Dehydration
260 (.39%)
Condition Aggravated
254 (.38%)
Loss Of Consciousness
250 (.38%)
Liver Function Test Abnormal
248 (.37%)
Acute Generalised Exanthematous Pus...
244 (.37%)
Anaemia
244 (.37%)
Tachycardia
244 (.37%)
Pain
243 (.37%)
Skin Exfoliation
239 (.36%)
Confusional State
233 (.35%)
Cytolytic Hepatitis
229 (.34%)
Purpura
221 (.33%)
Pneumonia
220 (.33%)
Chromaturia
199 (.3%)
Medication Error
199 (.3%)
Hepatic Enzyme Increased
195 (.29%)
Bronchospasm
191 (.29%)
Generalised Erythema
191 (.29%)
Blood Creatinine Increased
189 (.28%)
Overdose
188 (.28%)
Convulsion
186 (.28%)
Neutropenia
184 (.28%)
Chills
183 (.28%)
Leukocytosis
181 (.27%)
Dermatitis Exfoliative
178 (.27%)
Inflammation
178 (.27%)
Rash Pruritic
178 (.27%)
Transaminases Increased
178 (.27%)
Swelling Face
177 (.27%)
Rash Pustular
176 (.26%)
Product Quality Issue
175 (.26%)
Pancytopenia
174 (.26%)
Agranulocytosis
172 (.26%)
Hyperhidrosis
168 (.25%)
Erythema Multiforme
167 (.25%)
Arthralgia
166 (.25%)
Sepsis
166 (.25%)
Death
164 (.25%)
Haematuria
164 (.25%)
Skin Lesion
164 (.25%)
Hepatic Failure
163 (.25%)
Blister
160 (.24%)
Haemoglobin Decreased
160 (.24%)
Oedema
159 (.24%)
Liver Disorder
157 (.24%)
Jaundice Cholestatic
155 (.23%)
Rash Macular
155 (.23%)
C-reactive Protein Increased
153 (.23%)
Drug Eruption
152 (.23%)
Somnolence
150 (.23%)
Cardiac Arrest
149 (.22%)

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

What are the most common Amoxicillin 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, 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 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 According to Those Reporting Adverse Events

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

Drug Use For Unknown Indication
1915
Product Used For Unknown Indication
1083
Sinusitis
786
Helicobacter Infection
708
Infection
652
Bronchitis
631
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Urinary Tract Infection
556
Prophylaxis
517
Pneumonia
494
Lower Respiratory Tract Infection
421
Ear Infection
402
Upper Respiratory Tract Infection
364
Pyrexia
262
Ill-defined Disorder
254
Pharyngitis
237
Tonsillitis
222
Respiratory Tract Infection
209
Lung Disorder
206
Tooth Abscess
206
Antibiotic Prophylaxis
200
Cough
199
Otitis Media
188
Infection Prophylaxis
186
Erysipelas
175
Cellulitis
166
Tooth Infection
152
Acute Sinusitis
138
Bacterial Infection
121
Antibiotic Therapy
121
Nasopharyngitis
120
Bronchopneumonia
118
Oropharyngeal Pain
118
Lung Infection
109
Toothache
106
Pharyngitis Streptococcal
104
Helicobacter Gastritis
99
Skin Infection
78
Streptococcal Infection
74
Gastric Ulcer
68
Influenza
67
Sepsis
65
Acute Tonsillitis
65
Respiratory Disorder
64
Tooth Disorder
58
Dental Disorder Prophylaxis
57
Tooth Extraction
57
Abscess
55
Chronic Sinusitis
54
Pharyngolaryngeal Pain
54
Otitis Media Acute
51
Cystitis
48

Drug Labels

LabelLabelerEffective
AmoxicillinDAVA International, Inc.19-JAN-09
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
AmoxicillinPD-Rx Pharmaceuticals, Inc.30-SEP-09
AmoxicillinPD-Rx Pharmaceuticals, Inc.30-SEP-09
AmoxicillinDispensing Solutions Inc.30-OCT-09
Amoxicillin Rebel Distributors Corp.01-DEC-09
Amoxicillin And Calvulanate PotassiumAmerican Health Packaging10-DEC-09
AmoxicillinBlenheim Pharmacal, Inc.06-JAN-10
Amoxicillin And Clavulanate PotassiumPhysicians Total Care, Inc.15-JAN-10
AmoxicillinPhysicians Total Care, Inc.19-JAN-10
AmoxicillinPD-Rx Pharmaceuticals, Inc.28-JAN-10
AmoxicillinRebel Distributors Corp.01-FEB-10
Amoxicillin And Clavulanate PotassiumLek Pharmaceuticals, Inc.18-FEB-10
AmoxicillinPD-Rx Pharmaceuticals, Inc.04-MAR-10
AmoxicillinWest-ward Pharmaceutical Corp04-MAR-10
PrevpacPhysicians Total Care, Inc.15-MAR-10
PrevpacTakeda Pharmaceuticals America, Inc.15-MAR-10
AmoxicillinSTAT RX USA LLC22-MAR-10
AmoxicillinApotheca Inc.30-MAR-10
AmoxicillinAltura Pharmaceuticals, Inc.28-APR-10
Amoxicillin And Clavulanate PotassiumPhysicians Total Care, Inc.21-MAY-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 PotassiumState of Florida DOH Central Pharmacy04-JUN-10
Amoxicillin And Clavulanate PotassiumWest-ward Pharmaceutical Corp10-AUG-10
AmoxicillinBlenheim Pharmacal, Inc.24-AUG-10
AmoxicillinRebel Distributors Corp.08-SEP-10
AmoxicillinRebel Distributors Corp.08-SEP-10
AmoxicillinRebel Distributors Corp.08-SEP-10
AmoxicillinAurobindo Pharma Limited10-SEP-10
Amoxicillin And Clavulanate PotassiumRebel Distributors Corp.14-SEP-10
Amoxicillin And Clavulanate PotassiumRebel Distributors Corp.14-SEP-10
AmoxicillinBlenheim Pharmacal, Inc.18-OCT-10
MoxatagVictory Pharma, Inc. 07-JAN-11
Amoxicillin And Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.25-JAN-11
Amoxicillin And Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.25-JAN-11
AmoxicillinSTAT RX USA LLC04-FEB-11
Amoxicillin And Clavulanate Potassium Preferred Pharmaceuticals, Inc31-MAR-11
AmoxicillinCardinal Health12-MAY-11
Amoxicillin And Clavulanate PotassiumSTAT RX USA LLC18-MAY-11
AugmentinCardinal Health24-MAY-11
AmoxicillinPreferred Pharmaceuticals, Inc15-JUN-11
Amoxicillin And Clavulanate PotassiumPreferred Pharmaceuticals, Inc24-JUN-11
Amoxicillin Preferred Pharmaceuticals, Inc27-JUN-11
Amoxicillin And Clavulanate PotassiumPreferred Pharmaceuticals, Inc27-JUN-11
AmoxicillinAmerican Antibiotics,Inc28-JUN-11
AmoxicillinRedPharm Drug Inc.01-JUL-11
AmoxicillinRedPharm Drug Inc.01-JUL-11
AmoxicillinRedPharm Drug Inc.01-JUL-11
AmoxicillinRedPharm Drug Inc.01-JUL-11
AmoxicillinRedPharm Drug Inc.08-JUL-11
Amoxicillin And Clavulanate PotassiumMorton Grove Pharmaceuticals, Inc.11-JUL-11
Amoxicillin And Clavulanate PotassiumRebel Distributors Corp20-JUL-11
MoxatagShionogi Inc.01-AUG-11
Amoxicillin And Clavulanate PotassiumRedPharm Drug Inc.08-AUG-11
Amoxicillin AvKARE, Inc.09-AUG-11
AmoxicillinH.J. Harkins Company, Inc.10-OCT-11
Amoxicillin And Clavulanate Potassium PD-Rx Pharmaceuticals, Inc.12-OCT-11
AmoxicillinWest-ward Pharmaceutical Corp14-OCT-11
AmoxicillinUnit Dose Services14-OCT-11
AmoxicillinSTAT RX USA LLC21-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
AmoxicillinPD-Rx Pharmaceuticals, Inc.27-NOV-11
AmoxicillinPD-Rx Pharmaceuticals, Inc.27-NOV-11
AmoxicillinLake Erie Medical & Surgical Supply DBA Quality Care Products LLC20-DEC-11
AmoxicillinLake Erie Medical & Surgical Supply DBA Quality Care Products LLC20-DEC-11
Amoxicillin And Clavulanate PotassiumAurobindo Pharma Limited21-DEC-11
Amoxicillin And Clavulanate PotassiumAurobindo Pharma Limited21-DEC-11
Amoxicillin And Clavulanate PotassiumLake Erie Medical & Surgical Supply DBA Quality Care Products LLC21-DEC-11
Amoxicillin And Clavulanate PotassiumH.J. Harkins Company, Inc.23-DEC-11
Amoxicillin H.J. Harkins Company, Inc.03-JAN-12
AmoxicillinGolden State Medical Supply, Inc.03-JAN-12
Amoxicillin And Clavulanate PotassiumCBSCHEM LIMITD03-JAN-12
Amoxicillin And Clavulanate PotassiumPreferred Pharmaceuticals, Inc09-JAN-12
AmoxicillinPreferred Pharmaceuticals, Inc12-JAN-12
Amoxicillin And Clavulanate PotassiumNorthStar Rx LLC17-JAN-12
Amoxicillin And Clavulanate PotassiumNorthStar Rx LLC17-JAN-12
AmoxicillinSandoz Inc21-JAN-12
Amoxicillin And Clavulanate PotassiumAurobindo Pharma Limited21-JAN-12
Amoxicillin And Clavulanate PotassiumNorthStar Rx LLC23-JAN-12
AmoxicillinRebel Distributors Corp24-JAN-12
Amoxicillin And Clavulanate PotassiumPhysicians Total Care, Inc.01-FEB-12
Amoxicillin H.J. Harkins Company, Inc.02-FEB-12
AmoxicillinVirtus Pharmaceuticals, LLC08-FEB-12
AmoxicillinPhysicians Total Care, Inc.08-FEB-12
Amoxicillin And Clavulanate PotassiumLake Erie Medical & Surgical Supply DBA Quality Care Products LLC09-MAR-12
Amoxicillin And Clavulanate Potassium Extended ReleaseDr Reddys Laboratories Inc12-MAR-12
AugmentinxrDr 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
AmoxicillinPutney Inc21-MAR-12
Amoxicillin And Clavulanate PotassiumSTAT Rx USA LLC28-MAR-12
Amoxicillin And Clavulanate PotassiumPreferred Pharmaceuticals, Inc30-MAR-12
AmoxicillinDAVA Pharmaceuticals, Inc.07-MAY-12
AmoxicillinUnit Dose Services07-MAY-12
AmoxicillinAurobindo Pharma Limited22-MAY-12
AmoxicillinAurobindo Pharma Limited22-MAY-12
AmoxicillinMedVantx, Inc.22-MAY-12
AmoxicillinPreferred Pharmaceuticals, Inc.22-MAY-12
AmoxicillinNorthStar Rx LLC31-MAY-12
AmoxicillinSTAT Rx USA LLC05-JUN-12
AmoxicillinSTAT Rx USA LLC07-JUN-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
AmoxicillinAidarex Pharmaceuticals LLC11-SEP-12
AmoxicillinGreenstone LLC12-SEP-12
AmoxicillinDr Reddys Laboratories Inc21-SEP-12
AmoxicillinDr Reddys Laboratories Inc21-SEP-12
Amoxicillin And Clavulanate PotassiumPreferred Pharmaceuticals, Inc.25-SEP-12
AmoxicillinDispensing Solutions, Inc.03-OCT-12
AmoxicillinPreferred Pharmaceuticals, Inc15-OCT-12
AmoxicillinPreferred Pharmaceuticals, Inc16-OCT-12
Amoxicillin And Clavulanate PotassiumSandoz Inc24-OCT-12
Amoxicillin And Clavulanate PotassiumPreferred Pharmaceuticals, Inc.19-NOV-12
AmoxicillinGreenstone LLC22-NOV-12
Augmentin Es-600Dr Reddys Laboratories Inc03-DEC-12
Amoxicillin And Clavulanate PotassiumTeva Pharmaceuticals USA Inc06-DEC-12
AmoxicillinTeva Pharmaceuticals USA Inc06-DEC-12
Amoxicillin And Clavulanate PotassiumTeva Pharmaceuticals USA Inc06-DEC-12
Amoxicillin And Clavulanate Potassium PD-Rx Pharmaceuticals, Inc.06-DEC-12
Amoxicillin And Clavulanate PotassiumTeva Pharmaceuticals USA Inc07-DEC-12
Amoxicillin And Clavulanate PotassiumTeva Pharmaceuticals USA Inc10-DEC-12
AmoxicillinAurobindo Pharma Limited13-DEC-12
AmoxicillinPD-Rx Pharmaceuticals, Inc.01-FEB-13
AmoxicillinTeva Pharmaceuticals USA Inc01-FEB-13
Amoxicillin And Clavulanate PotassiumApotex Corp.01-FEB-13
Amoxicillin PD-Rx Pharmaceuticals, Inc.01-FEB-13
Amoxicillin And Clavulanate PotassiumPhysicians Total Care, Inc.20-FEB-13
AmoxicillinPreferred Pharmaceuticals, Inc.27-FEB-13
AmoxicillinTeva Pharmaceuticals USA Inc01-MAR-13
AugmentinDr. Reddy's Laboratories Inc06-MAR-13
AmoxicillinCardinal Health08-MAR-13
Amoxicillin And Clavulanate PotassiumDr. Reddy's Laboratories Inc15-MAR-13
AmoxicillinGreenstone LLC15-MAR-13
AmoxicillinPreferred Pharmaceuticals, Inc20-MAR-13
AmoxicillinWest-Ward Pharmaceutical Corp15-APR-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 Case Reports

What Amoxicillin 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. 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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