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BIAXIN XL

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Biaxin Xl Adverse Events Reported to the FDA Over Time

How are Biaxin Xl adverse event reports trending over time?

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

Most Common Biaxin Xl Adverse Events Reported to the FDA

What are the most common Biaxin Xl adverse events reported to the FDA?

Nausea
34 (2.33%)
Dyspnoea
26 (1.78%)
Dysgeusia
25 (1.71%)
Pain
23 (1.58%)
Psychotic Disorder
22 (1.51%)
Pyrexia
22 (1.51%)
Anxiety
21 (1.44%)
Drug Interaction
21 (1.44%)
Vomiting
18 (1.23%)
Abdominal Pain
15 (1.03%)
Asthenia
15 (1.03%)
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Fatigue
15 (1.03%)
Feeling Abnormal
15 (1.03%)
Hepatitis
15 (1.03%)
Insomnia
15 (1.03%)
Muscle Spasms
15 (1.03%)
Blood Pressure Increased
13 (.89%)
Hallucination
13 (.89%)
Cough
12 (.82%)
Headache
12 (.82%)
Abdominal Pain Upper
11 (.75%)
Haematochezia
11 (.75%)
Malaise
11 (.75%)
Chromaturia
10 (.68%)
Dry Mouth
10 (.68%)
Mania
10 (.68%)
Rash
10 (.68%)
Anorexia
9 (.62%)
Dizziness
9 (.62%)
Haematocrit Decreased
9 (.62%)
Haemoglobin Decreased
9 (.62%)
Hiccups
9 (.62%)
Joint Swelling
9 (.62%)
Medication Residue
9 (.62%)
Myalgia
9 (.62%)
Renal Failure Acute
9 (.62%)
Skin Laceration
9 (.62%)
Adverse Drug Reaction
8 (.55%)
Alanine Aminotransferase Increased
8 (.55%)
Anaemia
8 (.55%)
Appetite Disorder
8 (.55%)
Arthralgia
8 (.55%)
Aspartate Aminotransferase Increase...
8 (.55%)
Bronchitis Chronic
8 (.55%)
Chest Discomfort
8 (.55%)
Chills
8 (.55%)
Chronic Hepatic Failure
8 (.55%)
Diarrhoea
8 (.55%)
Flatulence
8 (.55%)
Food Intolerance
8 (.55%)
Heart Rate Increased
8 (.55%)
Hepatic Pain
8 (.55%)
Hyperbilirubinaemia
8 (.55%)
Hyperhidrosis
8 (.55%)
Intentional Self-injury
8 (.55%)
Jaundice
8 (.55%)
Liver Disorder
8 (.55%)
Nasopharyngitis
8 (.55%)
Pain In Extremity
8 (.55%)
Pharyngitis
8 (.55%)
Sputum Discoloured
8 (.55%)
Thinking Abnormal
8 (.55%)
Tongue Coated
8 (.55%)
Wheezing
8 (.55%)
Abasia
7 (.48%)
Activities Of Daily Living Impaired
7 (.48%)
Agitation
7 (.48%)
Dehydration
7 (.48%)
Erythema
7 (.48%)
Hepatic Enzyme Increased
7 (.48%)
Hypotension
7 (.48%)
Joint Stiffness
7 (.48%)
Pruritus
7 (.48%)
Small Intestinal Obstruction
7 (.48%)
Suicide Attempt
7 (.48%)
Tinnitus
7 (.48%)
Weight Bearing Difficulty
7 (.48%)
Asthma
6 (.41%)
Blood Alkaline Phosphatase Increase...
6 (.41%)
Constipation
6 (.41%)
Decreased Appetite
6 (.41%)
Fall
6 (.41%)
Frustration
6 (.41%)
Gamma-glutamyltransferase Increased
6 (.41%)
Gastric Ulcer
6 (.41%)
Haemorrhage
6 (.41%)
Hypersensitivity
6 (.41%)
Hypertension
6 (.41%)
Injury
6 (.41%)
Joint Injury
6 (.41%)
Liver Transplant
6 (.41%)
Nasal Congestion
6 (.41%)
Paralysis
6 (.41%)
Paranoia
6 (.41%)
Rash Macular
6 (.41%)
Stress
6 (.41%)
Suicidal Ideation
6 (.41%)
Unevaluable Event
6 (.41%)
Blood Creatinine Increased
5 (.34%)
Chest Pain
5 (.34%)
Confusional State
5 (.34%)

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

What are the most common Biaxin Xl adverse events reported to the FDA?

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

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

Drug Use For Unknown Indication
65
Sinusitis
57
Bronchitis
28
Product Used For Unknown Indication
26
Pneumonia
21
Upper Respiratory Tract Infection
18
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Cough
8
Infection
7
Respiratory Tract Infection
6
Pharyngolaryngeal Pain
6
Lobar Pneumonia
5
Ear Infection
5
Lyme Disease
4
Chronic Obstructive Airways Disease
3
Pyrexia
3
Respiratory Disorder
3
Asthma
3
Helicobacter Infection
3
Nasopharyngitis
3
Chronic Obstructive Pulmonary Disea...
2
Acute Sinusitis
2
Lower Respiratory Tract Infection
2
Urinary Tract Infection
2
Epstein-barr Virus Infection
1
Influenza Like Illness
1
Hypersensitivity
1
Staphylococcal Infection
1
Monocytosis
1
Pharyngitis
1
Bronchitis Acute
1
Lymphadenopathy
1
Skin Disorder
1
Sinus Disorder
1
Bacterial Infection
1
Dermal Cyst
1
Chronic Sinusitis
1
Pharyngitis Streptococcal
1
Lung Infection
1
Bronchitis Chronic
1
Cellulitis
1

Drug Labels

LabelLabelerEffective
BiaxinPhysicians Total Care, Inc.22-FEB-12
BiaxinAbbVie Inc.13-FEB-13
BiaxinREMEDYREPACK INC. 25-FEB-13
BiaxinREMEDYREPACK INC. 13-MAR-13
BiaxinCardinal Health10-APR-13

Biaxin Xl Case Reports

What Biaxin Xl 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 Biaxin Xl. 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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