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AMIKACIN SULFATE

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Amikacin Sulfate Adverse Events Reported to the FDA Over Time

How are Amikacin Sulfate adverse event reports trending over time?

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

Most Common Amikacin Sulfate Adverse Events Reported to the FDA

What are the most common Amikacin Sulfate adverse events reported to the FDA?

Drug Rash With Eosinophilia And Sys...
60 (1.64%)
Renal Failure Acute
57 (1.56%)
Pyrexia
55 (1.51%)
Renal Failure
50 (1.37%)
Acute Respiratory Distress Syndrome
49 (1.34%)
Thrombocytopenia
49 (1.34%)
Diarrhoea
37 (1.01%)
Pancytopenia
37 (1.01%)
Toxic Epidermal Necrolysis
37 (1.01%)
Neutropenia
36 (.99%)
Sepsis
34 (.93%)
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Hypoglycaemia
32 (.88%)
Rash
32 (.88%)
Erythema
30 (.82%)
Haemorrhage Intracranial
30 (.82%)
Hypotension
28 (.77%)
Renal Impairment
27 (.74%)
Deafness
25 (.69%)
Dermatitis Exfoliative
25 (.69%)
Dyspnoea
25 (.69%)
Lymphadenopathy
25 (.69%)
Drug Interaction
24 (.66%)
Pneumonia
24 (.66%)
Septic Shock
24 (.66%)
Toxic Skin Eruption
24 (.66%)
Acute Generalised Exanthematous Pus...
23 (.63%)
Death
23 (.63%)
Cytolytic Hepatitis
22 (.6%)
Rash Maculo-papular
22 (.6%)
Anaemia
21 (.58%)
Blood Creatinine Increased
21 (.58%)
Bronchopulmonary Aspergillosis
21 (.58%)
Condition Aggravated
21 (.58%)
Convulsion
21 (.58%)
Leukopenia
21 (.58%)
General Physical Health Deteriorati...
20 (.55%)
Pruritus
20 (.55%)
Stevens-johnson Syndrome
20 (.55%)
Agranulocytosis
19 (.52%)
Eosinophilia
19 (.52%)
Hepatotoxicity
19 (.52%)
Purpura
19 (.52%)
Alanine Aminotransferase Increased
18 (.49%)
Face Oedema
18 (.49%)
Oedema Peripheral
18 (.49%)
Coma
17 (.47%)
Febrile Neutropenia
17 (.47%)
Gamma-glutamyltransferase Increased
17 (.47%)
Respiratory Failure
17 (.47%)
Pseudomonas Infection
16 (.44%)
Vomiting
16 (.44%)
Bacterial Infection
15 (.41%)
Cheilitis
15 (.41%)
Cholestasis
15 (.41%)
Haemoglobin Decreased
15 (.41%)
Multi-organ Failure
15 (.41%)
Skin Exfoliation
15 (.41%)
Aspartate Aminotransferase Increase...
14 (.38%)
Drug Ineffective
14 (.38%)
Premature Baby
14 (.38%)
Respiratory Distress
14 (.38%)
Bacteraemia
13 (.36%)
Cardiac Arrest
13 (.36%)
Dermatitis Bullous
13 (.36%)
Hypokalaemia
13 (.36%)
Immune Reconstitution Syndrome
13 (.36%)
Anuria
12 (.33%)
Eyelid Oedema
12 (.33%)
Haematuria
12 (.33%)
Platelet Count Decreased
12 (.33%)
Tachycardia
12 (.33%)
Blood Bilirubin Increased
11 (.3%)
Candidiasis
11 (.3%)
Cyanosis
11 (.3%)
Dehydration
11 (.3%)
Hepatic Failure
11 (.3%)
Hyperkalaemia
11 (.3%)
Liver Disorder
11 (.3%)
Abdominal Pain
10 (.27%)
C-reactive Protein Increased
10 (.27%)
Chills
10 (.27%)
Confusional State
10 (.27%)
Drug Eruption
10 (.27%)
Drug Exposure During Pregnancy
10 (.27%)
Haemorrhage
10 (.27%)
Malaise
10 (.27%)
Nephropathy Toxic
10 (.27%)
Staphylococcal Infection
10 (.27%)
Tinnitus
10 (.27%)
White Blood Cell Count Decreased
10 (.27%)
Blood Alkaline Phosphatase Increase...
9 (.25%)
Coagulopathy
9 (.25%)
Grand Mal Convulsion
9 (.25%)
Hepatitis
9 (.25%)
Infection
9 (.25%)
Lung Disorder
9 (.25%)
Nausea
9 (.25%)
Periventricular Leukomalacia
9 (.25%)
Renal Tubular Disorder
9 (.25%)
Disseminated Intravascular Coagulat...
8 (.22%)
Dizziness
8 (.22%)

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

What are the most common Amikacin Sulfate adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Amikacin Sulfate, 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 Amikacin Sulfate 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 Amikacin Sulfate According to Those Reporting Adverse Events

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

Drug Use For Unknown Indication
125
Pyrexia
96
Pneumonia
90
Product Used For Unknown Indication
84
Infection
75
Sepsis
71
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Tuberculosis
57
Febrile Neutropenia
49
Urinary Tract Infection
36
Bacteraemia
33
Antibiotic Prophylaxis
29
Mycobacterium Avium Complex Infecti...
28
Bacterial Infection
24
Lung Infection
19
Antibiotic Therapy
19
Prophylaxis
18
Infection Prophylaxis
17
Pseudomonas Infection
15
Mycobacterial Infection
13
Respiratory Tract Infection
12
Mycobacterium Abscessus Infection
11
Atypical Mycobacterial Infection
10
Septic Shock
10
Anti-infective Therapy
9
Peritonitis
9
Neutropenia
9
Lung Disorder
9
Staphylococcal Infection
8
Device Related Infection
8
Endophthalmitis
7
Bronchopneumonia
7
Mycobacterium Chelonei Infection
7
Ill-defined Disorder
7
Pulmonary Tuberculosis
7
Lung Abscess
6
Enterobacter Infection
6
Bronchitis
6
Lower Respiratory Tract Infection
6
Pneumonia Bacterial
5
Evidence Based Treatment
5
Abdominal Sepsis
5
Osteomyelitis
4
Staphylococcal Sepsis
4
Premedication
4
Nocardiosis
4
Appendicitis
4
Upper Respiratory Tract Infection
4
Cellulitis
4
Encephalitis
4
Respiratory Failure
3
Bronchopulmonary Aspergillosis
3

Drug Labels

LabelLabelerEffective
Amikacin SulfateBedford Laboratories21-DEC-09
Amikacin SulfateBedford Laboratories21-DEC-09
Amikacin SulfateHospira, Inc.11-JUL-11
Amikacin SulfateTeva Parenteral Medicines, Inc.27-MAR-13

Amikacin Sulfate Case Reports

What Amikacin Sulfate 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 Amikacin Sulfate. 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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