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LEVOFLOXACIN

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Levofloxacin Adverse Events Reported to the FDA Over Time

How are Levofloxacin adverse event reports trending over time?

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

Most Common Levofloxacin Adverse Events Reported to the FDA

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

Drug Interaction
204 (1.39%)
Pyrexia
185 (1.26%)
Tendon Rupture
174 (1.18%)
Arthralgia
172 (1.17%)
Tendonitis
158 (1.07%)
Dyspnoea
156 (1.06%)
Diarrhoea
150 (1.02%)
Renal Failure Acute
147 (1%)
Nausea
141 (.96%)
Pneumonia
126 (.86%)
Pain In Extremity
121 (.82%)
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Vomiting
115 (.78%)
Rash
111 (.75%)
Hypoglycaemia
105 (.71%)
Toxic Epidermal Necrolysis
104 (.71%)
Dizziness
100 (.68%)
Interstitial Lung Disease
97 (.66%)
Myalgia
97 (.66%)
Asthenia
96 (.65%)
Confusional State
92 (.62%)
Pain
91 (.62%)
Tendon Disorder
89 (.6%)
Convulsion
87 (.59%)
Oedema Peripheral
86 (.58%)
Pruritus
83 (.56%)
Tendon Pain
82 (.56%)
Rhabdomyolysis
80 (.54%)
Metabolic Acidosis
79 (.54%)
Hypotension
76 (.52%)
Urticaria
73 (.5%)
Death
71 (.48%)
International Normalised Ratio Incr...
71 (.48%)
Drug Ineffective
69 (.47%)
Thrombocytopenia
69 (.47%)
Electrocardiogram Qt Prolonged
66 (.45%)
Gait Disturbance
66 (.45%)
Liver Disorder
66 (.45%)
Delirium
65 (.44%)
Malaise
65 (.44%)
Renal Failure
64 (.43%)
Back Pain
63 (.43%)
Erythema
63 (.43%)
Loss Of Consciousness
62 (.42%)
Alanine Aminotransferase Increased
61 (.41%)
Anaemia
61 (.41%)
Drug Rash With Eosinophilia And Sys...
61 (.41%)
Fatigue
60 (.41%)
Hepatic Function Abnormal
58 (.39%)
Respiratory Failure
58 (.39%)
Blood Creatinine Increased
57 (.39%)
Condition Aggravated
57 (.39%)
Drug Eruption
57 (.39%)
Insomnia
57 (.39%)
Sepsis
57 (.39%)
Aspartate Aminotransferase Increase...
55 (.37%)
Disorientation
54 (.37%)
Platelet Count Decreased
53 (.36%)
Headache
52 (.35%)
Decreased Appetite
51 (.35%)
Muscular Weakness
51 (.35%)
Rotator Cuff Syndrome
51 (.35%)
Acute Respiratory Distress Syndrome
50 (.34%)
Cough
49 (.33%)
Dehydration
49 (.33%)
Anaphylactic Shock
48 (.33%)
Paraesthesia
48 (.33%)
Tremor
48 (.33%)
Clostridium Difficile Colitis
47 (.32%)
Tachycardia
47 (.32%)
Musculoskeletal Pain
46 (.31%)
Myocardial Infarction
45 (.31%)
Multi-organ Failure
44 (.3%)
Stevens-johnson Syndrome
43 (.29%)
Clostridial Infection
42 (.29%)
Haemoglobin Decreased
42 (.29%)
Septic Shock
42 (.29%)
Abdominal Pain
41 (.28%)
Blood Pressure Decreased
41 (.28%)
Shock
41 (.28%)
Cardiac Arrest
40 (.27%)
Chills
40 (.27%)
Drug Hypersensitivity
40 (.27%)
Hepatotoxicity
40 (.27%)
Joint Swelling
40 (.27%)
Pancytopenia
40 (.27%)
Fall
39 (.26%)
Hypersensitivity
39 (.26%)
Renal Impairment
39 (.26%)
White Blood Cell Count Decreased
39 (.26%)
Abasia
38 (.26%)
Altered State Of Consciousness
38 (.26%)
Blood Bilirubin Increased
38 (.26%)
Cholestasis
37 (.25%)
Urinary Tract Infection
37 (.25%)
Coma
36 (.24%)
Hypoaesthesia
36 (.24%)
Rash Generalised
36 (.24%)
Depressed Level Of Consciousness
35 (.24%)
Respiratory Distress
35 (.24%)
Torsade De Pointes
35 (.24%)
Disseminated Intravascular Coagulat...
34 (.23%)

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

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

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

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

Product Used For Unknown Indication
570
Drug Use For Unknown Indication
553
Pneumonia
534
Urinary Tract Infection
324
Infection Prophylaxis
225
Prophylaxis
209
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Bronchitis
209
Infection
192
Antibiotic Prophylaxis
161
Pyrexia
152
Sinusitis
144
Cystitis
106
Respiratory Tract Infection
86
Upper Respiratory Tract Infection
66
Nasopharyngitis
63
Antibiotic Therapy
61
Bacterial Infection
58
Lung Infection
54
Bronchopneumonia
52
Upper Respiratory Tract Inflammatio...
50
Prostatitis
47
Pulmonary Tuberculosis
46
Pyelonephritis
45
Lower Respiratory Tract Infection
41
Pharyngitis
40
Cough
39
Cellulitis
36
Ill-defined Disorder
36
Mycobacterium Avium Complex Infecti...
35
Diverticulitis
32
Lung Disorder
32
Sepsis
31
Bacteraemia
31
Chronic Obstructive Pulmonary Disea...
31
Pneumonia Legionella
24
Bronchitis Acute
18
Diarrhoea
17
Influenza
17
Tuberculosis
17
Acute Sinusitis
15
Staphylococcal Infection
15
Crohns Disease
15
Conjunctivitis
15
Gastroenteritis
15
Febrile Neutropenia
14
Asthma
14
Inflammation
14
Enterocolitis
13
Pneumonitis
13
Otitis Media
13
Nosocomial Infection
13

Drug Labels

LabelLabelerEffective
IquixVistakon Pharmaceuticals LLC18-MAR-10
LevaquinPD-Rx Pharmaceuticals, Inc.26-APR-10
LevaquinPD-Rx Pharmaceuticals, Inc.26-APR-10
LevaquinRebel Distributors Corp28-DEC-10
LevofloxacinAkorn Inc.31-DEC-10
LevofloxacinPACK Pharmaceuticals, LLC04-MAY-11
LevaquinCardinal Health26-MAY-11
LevofloxacinAkorn, Inc.08-JUN-11
LevofloxacinPD-Rx Pharmaceuticals, Inc.20-JUN-11
LevofloxacinPD-Rx Pharmaceuticals, Inc.20-JUN-11
LevofloxacinTorrent Pharmaceuticals Limited23-JUN-11
LevaquinPhysicians Total Care, Inc.23-JUN-11
LevofloxacinAmerican Health Packaging30-JUN-11
LevofloxacinMajor Pharmaceuticals14-JUL-11
LevofloxacinRebel Distributors Corp19-JUL-11
LevaquinRedPharm Drug Inc.27-JUL-11
LevaquinRedPharm Drug Inc.27-JUL-11
LevaquinRedPharm Drug Inc.27-JUL-11
LevofloxacinUnit Dose Services04-AUG-11
QuixinVistakon Pharmaceuticals LLC17-AUG-11
LevofloxacinSTAT RX USA LLC31-AUG-11
LevaquinPD-Rx Pharmaceuticals, Inc.24-OCT-11
LevofloxacinMylan Institutional Inc.16-DEC-11
LevofloxacinMylan Pharmaceuticals Inc.12-JAN-12
LevofloxacinWest-ward Pharmaceutical Corp31-JAN-12
LevofloxacinNorthstar Rx LLC10-FEB-12
LevofloxacinHi-Tech Pharmacal Co., Inc.13-APR-12
LevofloxacinH.J. Harkins Company, Inc.16-APR-12
LevofloxacinPhysicians Total Care, Inc.24-APR-12
LevaquinJanssen Pharmaceuticals, Inc.30-APR-12
LevofloxacinMacleods Pharmaceuticals Limited15-MAY-12
LevofloxacinSagent Pharmaceuticals22-MAY-12
LevofloxacinSagent Pharmaceuticals24-MAY-12
LevofloxacinDr. Reddy's Laboratories Limited 08-JUN-12
LevofloxacinSandoz Inc20-JUN-12
LevofloxacinBoca Pharmacal Inc.25-JUN-12
LevofloxacinSagent Pharmaceuticals29-JUN-12
LevofloxacinSandoz Inc22-JUL-12
LevofloxacinHi-Tech Pharmacal Co., Inc.06-SEP-12
LevofloxacinAurobindo Pharma Limited25-SEP-12
LevofloxacinTeva Pharmaceuticals USA Inc25-SEP-12
LevaquinBryant Ranch Prepack12-OCT-12
Levaquin Lake Erie Medical DBA Quality Care Products LLC15-OCT-12
LevofloxacinWockhardt USA LLC.17-OCT-12
LevofloxacinWockhardt Limited17-OCT-12
LevofloxacinBryant Ranch Prepack23-OCT-12
LevofloxacinGreenstone LLC05-NOV-12
LevofloxacinZydus Pharmaceuticals (USA) Inc.07-NOV-12
LevofloxacinCadila Healthcare Limited07-NOV-12
LevofloxacinLake Erie Medical DBA Quality Care Products LLC21-NOV-12
LevofloxacinLupin Pharmaceuticals, Inc.03-JAN-13
LevofloxacinBryant Ranch Prepack17-JAN-13
LevofloxacinHeritage Pharmaceuticals Inc.28-JAN-13
LevofloxacinPreferred Pharmaceuticals, Inc.29-JAN-13
LevofloxacinAuroMedics Pharma LLC02-FEB-13
LevofloxacinPreferred Pharmaceuticals, Inc.04-FEB-13
LevofloxacinLake Erie Medical DBA Quality Care Products LLC14-FEB-13
LevofloxacinREMEDYREPACK INC. 08-MAR-13
LevofloxacinPreferred Pharmaceuticals, Inc13-MAR-13
LevofloxacinPreferred Pharmaceuticals, Inc15-MAR-13
LevofloxacinPreferred Pharmaceuticals, Inc.27-MAR-13
LevaquinREMEDYREPACK INC. 10-APR-13
LevaquinREMEDYREPACK INC. 11-APR-13
LevofloxacinCardinal Health29-APR-13

Levofloxacin Case Reports

What Levofloxacin 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 Levofloxacin. 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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