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Relenza Adverse Events Reported to the FDA Over Time

How are Relenza adverse event reports trending over time?

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

Most Common Relenza Adverse Events Reported to the FDA

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

Abnormal Behaviour
745 (10.04%)
Overdose
462 (6.23%)
Drug Exposure During Pregnancy
411 (5.54%)
Hallucination
285 (3.84%)
Delirium
217 (2.92%)
Drug Exposure Via Breast Milk
146 (1.97%)
Loss Of Consciousness
139 (1.87%)
No Adverse Event
131 (1.77%)
Aggression
122 (1.64%)
Pyrexia
122 (1.64%)
Depressed Level Of Consciousness
105 (1.41%)
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Restlessness
97 (1.31%)
Altered State Of Consciousness
82 (1.1%)
Vomiting
77 (1.04%)
Agitation
76 (1.02%)
Amnesia
72 (.97%)
Convulsion
72 (.97%)
Hallucination, Auditory
71 (.96%)
Dyspnoea
64 (.86%)
Fall
62 (.84%)
Feeling Abnormal
59 (.8%)
Speech Disorder
59 (.8%)
Crying
55 (.74%)
Dizziness
54 (.73%)
Nausea
53 (.71%)
Memory Impairment
50 (.67%)
Headache
48 (.65%)
Hallucination, Visual
47 (.63%)
Delivery
46 (.62%)
Nightmare
43 (.58%)
Rash
43 (.58%)
Asthma
42 (.57%)
Cough
42 (.57%)
Screaming
42 (.57%)
Fear
41 (.55%)
Tremor
39 (.53%)
Malaise
38 (.51%)
Diarrhoea
37 (.5%)
Somnolence
36 (.49%)
Death
35 (.47%)
Incoherent
32 (.43%)
Urticaria
32 (.43%)
Abdominal Pain
31 (.42%)
Body Temperature Increased
31 (.42%)
Pallor
31 (.42%)
Vision Blurred
31 (.42%)
Syncope
30 (.4%)
Anaphylactic Shock
27 (.36%)
Product Quality Issue
27 (.36%)
Dyskinesia
26 (.35%)
Disorientation
24 (.32%)
Drug Ineffective
24 (.32%)
Hyperthermia
24 (.32%)
Accidental Overdose
22 (.3%)
Decreased Appetite
22 (.3%)
Hyperhidrosis
22 (.3%)
Ill-defined Disorder
22 (.3%)
Delirium Febrile
20 (.27%)
Encephalopathy
20 (.27%)
Wheezing
20 (.27%)
Aspartate Aminotransferase Increase...
19 (.26%)
Incorrect Route Of Drug Administrat...
19 (.26%)
Respiratory Disorder
19 (.26%)
Shock
19 (.26%)
Stevens-johnson Syndrome
19 (.26%)
Asthenia
18 (.24%)
Blood Pressure Decreased
18 (.24%)
Epistaxis
18 (.24%)
Erythema
18 (.24%)
Erythema Multiforme
18 (.24%)
Hypoaesthesia
18 (.24%)
Bronchospasm
17 (.23%)
Logorrhoea
17 (.23%)
Musculoskeletal Stiffness
17 (.23%)
Underdose
17 (.23%)
Confusional State
16 (.22%)
Drug Eruption
16 (.22%)
Dysgeusia
16 (.22%)
Visual Impairment
16 (.22%)
Contusion
15 (.2%)
Fatigue
15 (.2%)
Insomnia
15 (.2%)
Sleep Disorder
15 (.2%)
Visual Acuity Reduced
15 (.2%)
Acute Respiratory Distress Syndrome
14 (.19%)
Body Temperature Decreased
14 (.19%)
Epilepsy
14 (.19%)
Pain
14 (.19%)
Alanine Aminotransferase Increased
13 (.18%)
Anxiety
13 (.18%)
Blood Creatine Phosphokinase Increa...
13 (.18%)
Hypersensitivity
13 (.18%)
Liver Function Test Abnormal
13 (.18%)
Pneumonia
13 (.18%)
Tinnitus
13 (.18%)
Wrong Technique In Drug Usage Proce...
13 (.18%)
Anorexia
12 (.16%)
Chest Discomfort
12 (.16%)
Drug Administration Error
12 (.16%)
Electroencephalogram Abnormal
12 (.16%)
Encephalitis
12 (.16%)

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

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

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

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

Influenza
1886
Drug Use For Unknown Indication
560
Antiviral Prophylaxis
103
H1n1 Influenza
38
Product Used For Unknown Indication
32
Prophylaxis
16
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Influenza Like Illness
9
Drug Exposure Via Breast Milk
7
Viral Infection
4
Ill-defined Disorder
2
Drug Exposure During Pregnancy
2
Exposure To Communicable Disease
1
Asthma
1
Hyperthermia
1

Drug Labels

LabelLabelerEffective
RelenzaDispensing Solutions Inc.02-MAR-10
RelenzaPhysicians Total Care, Inc.02-MAR-10
RelenzaGlaxoSmithKline LLC03-JAN-12

Relenza Case Reports

What Relenza 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 Relenza. 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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