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Clarithromycin Adverse Events Reported to the FDA Over Time

How are Clarithromycin adverse event reports trending over time?

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

Most Common Clarithromycin Adverse Events Reported to the FDA

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

Drug Interaction
1040 (4.14%)
Pyrexia
439 (1.75%)
Diarrhoea
348 (1.39%)
Dyspnoea
311 (1.24%)
Vomiting
274 (1.09%)
Renal Failure Acute
264 (1.05%)
Nausea
260 (1.04%)
Rhabdomyolysis
227 (.9%)
Rash
210 (.84%)
Confusional State
206 (.82%)
Pneumonia
188 (.75%)
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Pruritus
173 (.69%)
Hypotension
169 (.67%)
Myalgia
169 (.67%)
Asthenia
164 (.65%)
Dizziness
163 (.65%)
Malaise
162 (.65%)
Headache
161 (.64%)
Alanine Aminotransferase Increased
151 (.6%)
Blood Creatine Phosphokinase Increa...
147 (.59%)
Abdominal Pain
145 (.58%)
Erythema
143 (.57%)
Liver Function Test Abnormal
142 (.57%)
Oedema Peripheral
137 (.55%)
Dehydration
136 (.54%)
Cough
128 (.51%)
Respiratory Failure
125 (.5%)
Hepatic Function Abnormal
124 (.49%)
Liver Disorder
124 (.49%)
Pancytopenia
123 (.49%)
Dysgeusia
122 (.49%)
Stevens-johnson Syndrome
120 (.48%)
Convulsion
119 (.47%)
Tachycardia
116 (.46%)
Depressed Level Of Consciousness
115 (.46%)
Drug Toxicity
115 (.46%)
Drug Eruption
114 (.45%)
Drug Ineffective
114 (.45%)
Pleural Effusion
111 (.44%)
Aspartate Aminotransferase Increase...
106 (.42%)
Blood Creatinine Increased
105 (.42%)
Agitation
103 (.41%)
Insomnia
102 (.41%)
International Normalised Ratio Incr...
102 (.41%)
Condition Aggravated
101 (.4%)
Renal Impairment
96 (.38%)
Myositis
93 (.37%)
Agranulocytosis
91 (.36%)
Erythema Multiforme
91 (.36%)
Pseudomembranous Colitis
91 (.36%)
Thrombocytopenia
90 (.36%)
Hypoglycaemia
89 (.35%)
Sepsis
89 (.35%)
Hypersensitivity
88 (.35%)
Weight Decreased
88 (.35%)
Jaundice
86 (.34%)
Pericardial Effusion
86 (.34%)
Atrial Fibrillation
85 (.34%)
Myopathy
85 (.34%)
Urticaria
85 (.34%)
Haemoglobin Decreased
83 (.33%)
Lower Respiratory Tract Infection
83 (.33%)
Interstitial Lung Disease
82 (.33%)
Delirium
81 (.32%)
Arthralgia
80 (.32%)
Somnolence
79 (.31%)
Muscular Weakness
78 (.31%)
Decreased Appetite
75 (.3%)
Anxiety
72 (.29%)
C-reactive Protein Increased
72 (.29%)
Tubulointerstitial Nephritis
72 (.29%)
Pulmonary Embolism
71 (.28%)
Electrocardiogram Qt Prolonged
70 (.28%)
Pain
70 (.28%)
Renal Failure
70 (.28%)
Drug Hypersensitivity
69 (.27%)
Loss Of Consciousness
69 (.27%)
Abdominal Pain Upper
66 (.26%)
Anorexia
65 (.26%)
Multi-organ Failure
65 (.26%)
Anaemia
64 (.26%)
Heart Rate Increased
64 (.26%)
Hyponatraemia
64 (.26%)
Fatigue
63 (.25%)
Hyperhidrosis
63 (.25%)
Rash Maculo-papular
63 (.25%)
Swollen Tongue
63 (.25%)
Cardiac Arrest
62 (.25%)
Drug Level Increased
62 (.25%)
Torsade De Pointes
62 (.25%)
Toxic Epidermal Necrolysis
62 (.25%)
Neutropenia
60 (.24%)
Angioedema
59 (.24%)
Hallucination
59 (.24%)
Rash Generalised
59 (.24%)
Paraesthesia
58 (.23%)
Infection
56 (.22%)
Blood Alkaline Phosphatase Increase...
54 (.22%)
Bradycardia
54 (.22%)
Mouth Ulceration
54 (.22%)
Gamma-glutamyltransferase Increased
53 (.21%)

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

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

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

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

Helicobacter Infection
694
Product Used For Unknown Indication
623
Pneumonia
572
Lower Respiratory Tract Infection
544
Drug Use For Unknown Indication
446
Bronchitis
391
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Mycobacterium Avium Complex Infecti...
207
Respiratory Tract Infection
199
Sinusitis
165
Infection
142
Upper Respiratory Tract Infection
136
Prophylaxis
129
Atypical Mycobacterial Infection
128
Nasopharyngitis
115
Upper Respiratory Tract Inflammatio...
103
Pyrexia
100
Helicobacter Gastritis
88
Pharyngitis
82
Cough
80
Gastric Ulcer
68
Bronchitis Chronic
67
Asthma
57
Mycobacterial Infection
49
Ear Infection
47
Ill-defined Disorder
40
Chest Discomfort
40
Acute Sinusitis
38
Bronchopneumonia
37
Lung Infection
35
Mycobacterium Abscessus Infection
33
Duodenal Ulcer
32
Tonsillitis
32
Gastritis
32
Opportunistic Infection Prophylaxis
31
Influenza
30
Urinary Tract Infection
29
Antibiotic Prophylaxis
28
Cellulitis
28
Infection Prophylaxis
28
Chronic Obstructive Pulmonary Disea...
27
Bacterial Infection
27
Chronic Sinusitis
25
Tooth Abscess
24
Pneumonia Mycoplasmal
24
Bronchiolitis
24
Mycoplasma Infection
23
Pseudomonas Infection
23
Bronchiectasis
23
Pneumonia Bacterial
20
Antibiotic Therapy
19
Osteomyelitis
19

Drug Labels

LabelLabelerEffective
ClarithromycinKAISER FOUNDATION HOSPITALS28-OCT-09
ClarithromycinSandoz Inc30-NOV-09
PrevpacTakeda Pharmaceuticals America, Inc.15-MAR-10
PrevpacPhysicians Total Care, Inc.15-MAR-10
ClarithromycinRebel Distributors Corp.15-SEP-10
ClarithromycinKAISER FOUNDATION HOSPITALS02-NOV-10
ClarithromycinPhysicians Total Care, Inc.15-DEC-10
ClarithromycinREMEDYREPACK INC. 20-APR-11
ClarithromycinREMEDYREPACK INC. 04-MAY-11
ClarithromycinREMEDYREPACK INC. 12-MAY-11
ClarithromycinREMEDYREPACK INC. 01-JUN-11
ClarithromycinUDL Laboratories, Inc.10-JUN-11
ClarithromycinREMEDYREPACK INC. 27-JUN-11
ClarithromycinPreferred Pharmaceuticals, Inc05-JUL-11
ClarithromycinREMEDYREPACK INC. 08-JUL-11
Clarithromycinextended ReleaseEon Labs, Inc.28-SEP-11
ClarithromycinLake Erie Medical DBA Quality Care Products LLC09-DEC-11
ClarithromycinPhysicians Total Care, Inc.01-FEB-12
ClarithromycinDispensing Solutions, Inc.02-FEB-12
Clarithromycin Life Line Home Care Services, Inc.07-FEB-12
ClarithromycinWockhardt Limited08-FEB-12
ClarithromycinPD-Rx Pharmaceuticals, Inc.08-FEB-12
ClarithromycinWockhardt USA LLC.08-FEB-12
BiaxinPhysicians Total Care, Inc.22-FEB-12
ClarithromycinRebel Distributors Corp20-MAR-12
ClarithromycinAmerican Health Packaging09-APR-12
ClarithromycinRoxane Laboratories, Inc01-JUN-12
ClarithromycinSandoz Inc09-JUL-12
ClarithromycinZydus Pharmaceuticals USA Inc26-JUL-12
ClarithromycinAurobindo Pharma Limited26-JUL-12
ClarithromycinTeva Pharmaceuticals USA Inc10-AUG-12
ClarithromycinTeva Pharmaceuticals USA Inc13-AUG-12
ClarithromycinWatson Pharma, Inc.25-SEP-12
Clarithromycinbryant ranch prepack12-OCT-12
ClarithromycinBryant Ranch Prepack12-OCT-12
Clarithromycin Apotex Corp17-OCT-12
ClarithromycinBryant Ranch Prepack18-JAN-13
BiaxinAbbVie Inc.13-FEB-13
BiaxinREMEDYREPACK INC. 25-FEB-13
ClarithromycinMylan Pharmaceuticals Inc.01-MAR-13
BiaxinREMEDYREPACK INC. 13-MAR-13
ClarithromycinSandoz Inc19-MAR-13
BiaxinCardinal Health10-APR-13

Clarithromycin Case Reports

What Clarithromycin 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 Clarithromycin. 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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