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AMOXICILLIN TRIHYDRATE

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Amoxicillin Trihydrate Adverse Events Reported to the FDA Over Time

How are Amoxicillin Trihydrate adverse event reports trending over time?

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

Most Common Amoxicillin Trihydrate Adverse Events Reported to the FDA

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

Pruritus
759 (2.1%)
Diarrhoea
677 (1.87%)
Pyrexia
657 (1.82%)
Rash
594 (1.64%)
Vomiting
478 (1.32%)
Erythema
430 (1.19%)
Jaundice
408 (1.13%)
Urticaria
397 (1.1%)
Dyspnoea
388 (1.07%)
Renal Failure Acute
377 (1.04%)
Nausea
330 (.91%)
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Hypotension
329 (.91%)
Alanine Aminotransferase Increased
328 (.91%)
Anaphylactic Shock
313 (.87%)
Rash Maculo-papular
280 (.77%)
Malaise
278 (.77%)
Toxic Skin Eruption
271 (.75%)
Aspartate Aminotransferase Increase...
270 (.75%)
Blood Alkaline Phosphatase Increase...
269 (.74%)
Gamma-glutamyltransferase Increased
269 (.74%)
Cholestasis
268 (.74%)
Hypersensitivity
253 (.7%)
Hepatitis Cholestatic
248 (.69%)
Abdominal Pain
240 (.66%)
Drug Interaction
237 (.66%)
Thrombocytopenia
209 (.58%)
Face Oedema
196 (.54%)
Asthenia
190 (.53%)
Blood Bilirubin Increased
187 (.52%)
Eosinophilia
184 (.51%)
Hepatitis
180 (.5%)
Oedema Peripheral
179 (.5%)
Drug Ineffective
174 (.48%)
Rash Erythematous
170 (.47%)
Skin Exfoliation
170 (.47%)
General Physical Health Deteriorati...
169 (.47%)
Renal Failure
167 (.46%)
International Normalised Ratio Incr...
166 (.46%)
Purpura
166 (.46%)
Dehydration
164 (.45%)
Drug Hypersensitivity
164 (.45%)
Anaphylactic Reaction
161 (.45%)
Abdominal Pain Upper
160 (.44%)
Weight Decreased
156 (.43%)
Bronchospasm
154 (.43%)
Tachycardia
154 (.43%)
Stevens-johnson Syndrome
149 (.41%)
Angioedema
148 (.41%)
Cytolytic Hepatitis
148 (.41%)
Fatigue
148 (.41%)
Acute Generalised Exanthematous Pus...
147 (.41%)
Loss Of Consciousness
146 (.4%)
Dizziness
145 (.4%)
Rash Generalised
144 (.4%)
Anaemia
140 (.39%)
Hepatic Enzyme Increased
140 (.39%)
Drug Rash With Eosinophilia And Sys...
139 (.38%)
Toxic Epidermal Necrolysis
138 (.38%)
Generalised Erythema
136 (.38%)
Inflammation
136 (.38%)
Dermatitis Exfoliative
133 (.37%)
Headache
133 (.37%)
Chromaturia
130 (.36%)
Agranulocytosis
129 (.36%)
Leukocytosis
128 (.35%)
Pain
126 (.35%)
Condition Aggravated
125 (.35%)
Chills
121 (.33%)
Confusional State
119 (.33%)
Rash Pustular
118 (.33%)
Transaminases Increased
118 (.33%)
Overdose
115 (.32%)
Blood Creatinine Increased
114 (.32%)
Pancytopenia
114 (.32%)
Drug Exposure During Pregnancy
113 (.31%)
Haematuria
113 (.31%)
Skin Lesion
110 (.3%)
Liver Function Test Abnormal
109 (.3%)
Neutropenia
108 (.3%)
Pneumonia
108 (.3%)
Oedema
105 (.29%)
Blister
102 (.28%)
Death
100 (.28%)
Anorexia
99 (.27%)
Cardiac Arrest
96 (.27%)
Dermatitis Bullous
96 (.27%)
Product Quality Issue
96 (.27%)
Rash Macular
94 (.26%)
Convulsion
93 (.26%)
Haemoglobin Decreased
92 (.25%)
Leukopenia
92 (.25%)
Lung Disorder
92 (.25%)
Liver Disorder
91 (.25%)
Rash Pruritic
89 (.25%)
C-reactive Protein Increased
88 (.24%)
Hepatic Failure
87 (.24%)
Lymphadenopathy
86 (.24%)
Hyperhidrosis
85 (.24%)
Medication Error
85 (.24%)
Blood Pressure Decreased
84 (.23%)
Pruritus Generalised
83 (.23%)

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

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

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

Drug Use For Unknown Indication
1191
Sinusitis
413
Bronchitis
365
Product Used For Unknown Indication
330
Infection
299
Urinary Tract Infection
263
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Prophylaxis
262
Pneumonia
240
Ill-defined Disorder
205
Ear Infection
167
Lung Disorder
163
Upper Respiratory Tract Infection
143
Erysipelas
131
Antibiotic Prophylaxis
121
Helicobacter Infection
119
Pyrexia
119
Tonsillitis
112
Cough
109
Pharyngitis
106
Lower Respiratory Tract Infection
105
Infection Prophylaxis
101
Acute Sinusitis
98
Otitis Media
89
Cellulitis
89
Tooth Abscess
77
Respiratory Tract Infection
74
Bronchopneumonia
73
Bacterial Infection
73
Lung Infection
73
Skin Infection
52
Antibiotic Therapy
45
Toothache
44
Acute Tonsillitis
41
Tooth Infection
40
Sepsis
37
Respiratory Disorder
37
Oropharyngeal Pain
36
Bronchopneumopathy
36
Pharyngolaryngeal Pain
34
Nasopharyngitis
33
Abscess
33
Chronic Sinusitis
32
Influenza
29
Pharyngitis Streptococcal
28
Otitis Media Acute
28
Pneumonia Bacterial
26
Pneumonia Aspiration
25
Helicobacter Gastritis
24
Cystitis
23
Superinfection Lung
22
Wound Infection
22

Amoxicillin Trihydrate Case Reports

What Amoxicillin Trihydrate 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 Trihydrate. 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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