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Biaxin Adverse Events Reported to the FDA Over Time

How are Biaxin adverse event reports trending over time?

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

Most Common Biaxin Adverse Events Reported to the FDA

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

Nausea
132 (2.34%)
Dysgeusia
104 (1.84%)
Dyspnoea
98 (1.73%)
Drug Interaction
97 (1.72%)
Vomiting
84 (1.49%)
Diarrhoea
65 (1.15%)
Insomnia
61 (1.08%)
Asthenia
59 (1.04%)
Anxiety
57 (1.01%)
Pyrexia
56 (.99%)
Rash
56 (.99%)
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Dizziness
54 (.96%)
Urticaria
53 (.94%)
Fatigue
52 (.92%)
Confusional State
50 (.89%)
Psychotic Disorder
49 (.87%)
Malaise
45 (.8%)
Abdominal Pain Upper
44 (.78%)
Headache
42 (.74%)
Feeling Abnormal
41 (.73%)
Pruritus
41 (.73%)
Hypersensitivity
40 (.71%)
Depression
39 (.69%)
Dehydration
37 (.65%)
Oedema Peripheral
37 (.65%)
Palpitations
36 (.64%)
Cough
35 (.62%)
Hallucination
35 (.62%)
Pain
34 (.6%)
Paraesthesia
33 (.58%)
Abdominal Pain
32 (.57%)
Drug Ineffective
32 (.57%)
Heart Rate Increased
31 (.55%)
Tremor
30 (.53%)
Arthralgia
29 (.51%)
Pneumonia
29 (.51%)
Renal Failure
29 (.51%)
Renal Failure Acute
29 (.51%)
Anaemia
28 (.5%)
Chest Pain
27 (.48%)
Blood Pressure Increased
26 (.46%)
Drug Hypersensitivity
26 (.46%)
Muscle Spasms
25 (.44%)
Myalgia
25 (.44%)
Agitation
24 (.42%)
Anorexia
23 (.41%)
Convulsion
23 (.41%)
Hyperhidrosis
23 (.41%)
Pancytopenia
23 (.41%)
Rhabdomyolysis
23 (.41%)
Suicide Attempt
23 (.41%)
Ageusia
22 (.39%)
Erythema
22 (.39%)
Chest Discomfort
21 (.37%)
Decreased Appetite
21 (.37%)
Pain In Extremity
21 (.37%)
Rash Generalised
21 (.37%)
Weight Decreased
21 (.37%)
Chills
20 (.35%)
Fall
20 (.35%)
Hypotension
20 (.35%)
Mania
20 (.35%)
Abdominal Discomfort
19 (.34%)
Aggression
19 (.34%)
Hepatic Enzyme Increased
19 (.34%)
Hepatitis
19 (.34%)
Sinusitis
19 (.34%)
Swollen Tongue
19 (.34%)
Deafness
18 (.32%)
Muscular Weakness
18 (.32%)
Paranoia
18 (.32%)
Dry Mouth
17 (.3%)
Flatulence
17 (.3%)
Joint Swelling
17 (.3%)
Loss Of Consciousness
17 (.3%)
Suicidal Ideation
17 (.3%)
Thinking Abnormal
17 (.3%)
Tinnitus
17 (.3%)
White Blood Cell Count Decreased
17 (.3%)
Anosmia
16 (.28%)
Condition Aggravated
16 (.28%)
Disorientation
16 (.28%)
Hypoaesthesia
16 (.28%)
Unevaluable Event
16 (.28%)
Abasia
15 (.27%)
Medication Residue
15 (.27%)
Activities Of Daily Living Impaired
14 (.25%)
Atrial Fibrillation
14 (.25%)
Bronchitis
14 (.25%)
Burning Sensation
14 (.25%)
Chromaturia
14 (.25%)
Crying
14 (.25%)
Fear
14 (.25%)
Hepatic Failure
14 (.25%)
Hypertension
14 (.25%)
Abnormal Behaviour
13 (.23%)
Aspartate Aminotransferase Increase...
13 (.23%)
Constipation
13 (.23%)
Feeling Hot
13 (.23%)
Liver Disorder
13 (.23%)
Mood Swings
13 (.23%)

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

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

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

Drug Use For Unknown Indication
364
Sinusitis
194
Product Used For Unknown Indication
185
Bronchitis
119
Pneumonia
107
Helicobacter Infection
89
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Upper Respiratory Tract Infection
61
Infection
57
Multiple Myeloma
56
Mycobacterium Avium Complex Infecti...
34
Respiratory Tract Infection
32
Bacterial Infection
26
Cough
24
Pyrexia
20
Ear Infection
20
Tonsillitis
20
Lower Respiratory Tract Infection
19
Asthma
18
Nasopharyngitis
18
Pharyngitis
16
Otitis Media
14
Acid Fast Bacilli Infection
13
Pharyngolaryngeal Pain
13
Lyme Disease
13
Gastritis Erosive
12
Prophylaxis
11
Lung Infection
11
Staphylococcal Infection
10
Hypersensitivity
9
Urinary Tract Infection
9
Suicide Attempt
8
Influenza
8
Pharyngitis Streptococcal
8
Antibiotic Prophylaxis
7
Helicobacter Gastritis
7
Bronchopneumonia
7
Bronchitis Acute
7
Ill-defined Disorder
6
Cellulitis
6
Gastric Ulcer
5
Lobar Pneumonia
5
Respiratory Disorder
5
Viral Infection
5
Bronchitis Chronic
5
Waldenstroms Macroglobulinaemia
4
Influenza Like Illness
4
Acute Sinusitis
4
Antibiotic Therapy
4
Chronic Obstructive Airways Disease
4
Sinus Disorder
4
Pneumonia Primary Atypical
4

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 Case Reports

What Biaxin 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. 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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