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Oseltamivir Adverse Events Reported to the FDA Over Time

How are Oseltamivir adverse event reports trending over time?

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

Most Common Oseltamivir Adverse Events Reported to the FDA

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

Abnormal Behaviour
1136 (4.96%)
No Adverse Event
889 (3.88%)
Drug Exposure During Pregnancy
792 (3.46%)
Hallucination
511 (2.23%)
Pregnancy
413 (1.8%)
Vomiting
387 (1.69%)
Normal Newborn
361 (1.58%)
Delirium
344 (1.5%)
Convulsion
332 (1.45%)
Pneumonia
304 (1.33%)
Overdose
260 (1.14%)
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Drug Ineffective
239 (1.04%)
Diarrhoea
238 (1.04%)
Depressed Level Of Consciousness
220 (.96%)
Death
215 (.94%)
Nausea
197 (.86%)
Confusional State
192 (.84%)
Pyrexia
191 (.83%)
Loss Of Consciousness
187 (.82%)
Pathogen Resistance
185 (.81%)
Influenza
178 (.78%)
Rash
158 (.69%)
Respiratory Failure
158 (.69%)
Acute Respiratory Distress Syndrome
156 (.68%)
Fall
151 (.66%)
Renal Failure Acute
137 (.6%)
Agitation
128 (.56%)
Headache
125 (.55%)
Incorrect Dose Administered
118 (.52%)
Dizziness
116 (.51%)
Cardio-respiratory Arrest
115 (.5%)
Abdominal Pain
114 (.5%)
Dyspnoea
113 (.49%)
Accidental Overdose
110 (.48%)
Insomnia
110 (.48%)
Hepatic Function Abnormal
106 (.46%)
Anxiety
104 (.45%)
White Blood Cell Count Decreased
101 (.44%)
Malaise
97 (.42%)
Liver Disorder
96 (.42%)
Encephalopathy
94 (.41%)
Multi-organ Failure
94 (.41%)
Urticaria
94 (.41%)
Dehydration
93 (.41%)
Hypothermia
91 (.4%)
Nightmare
90 (.39%)
Platelet Count Decreased
88 (.38%)
Aggression
86 (.38%)
Depression
86 (.38%)
Tremor
84 (.37%)
Restlessness
83 (.36%)
Rhabdomyolysis
82 (.36%)
Thrombocytopenia
82 (.36%)
Amnesia
79 (.35%)
Hallucination, Visual
79 (.35%)
Renal Failure
79 (.35%)
International Normalised Ratio Incr...
77 (.34%)
Blood Creatine Phosphokinase Increa...
76 (.33%)
Altered State Of Consciousness
74 (.32%)
Enterocolitis Haemorrhagic
73 (.32%)
Melaena
73 (.32%)
Hallucination, Auditory
72 (.31%)
Shock
72 (.31%)
Crying
70 (.31%)
Delusion
70 (.31%)
Caesarean Section
69 (.3%)
Feeling Abnormal
66 (.29%)
Suicidal Ideation
66 (.29%)
Medication Error
65 (.28%)
Drug Administration Error
64 (.28%)
Decreased Appetite
63 (.28%)
Disorientation
63 (.28%)
Somnolence
63 (.28%)
Fear
60 (.26%)
Leukopenia
60 (.26%)
Sepsis
60 (.26%)
Fatigue
59 (.26%)
Jaundice
59 (.26%)
Mental Disorder
59 (.26%)
Renal Impairment
58 (.25%)
Disseminated Intravascular Coagulat...
57 (.25%)
Stevens-johnson Syndrome
57 (.25%)
Sudden Death
57 (.25%)
Arthralgia
55 (.24%)
Aspartate Aminotransferase Increase...
53 (.23%)
Drug Interaction
53 (.23%)
Screaming
53 (.23%)
Asthenia
52 (.23%)
Disease Progression
52 (.23%)
Psychiatric Symptom
52 (.23%)
Abortion Spontaneous
51 (.22%)
Septic Shock
50 (.22%)
Alanine Aminotransferase Increased
49 (.21%)
Cardiac Failure
49 (.21%)
Speech Disorder
49 (.21%)
Cough
47 (.21%)
Cardiac Failure Acute
46 (.2%)
Hypersensitivity
46 (.2%)
Hypoaesthesia
46 (.2%)
Neutropenia
46 (.2%)
Pruritus
45 (.2%)

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

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

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

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

Influenza
3014
Drug Use For Unknown Indication
970
H1n1 Influenza
565
Product Used For Unknown Indication
234
Antiviral Prophylaxis
212
Avian Influenza
150
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Prophylaxis
117
Influenza Like Illness
50
Influenza Immunisation
45
Viral Infection
26
Pyrexia
16
Pneumonia
13
Ill-defined Disorder
13
Influenza Serology Positive
11
Cough
9
Nasopharyngitis
7
Infection Prophylaxis
7
Upper Respiratory Tract Infection
7
Respiratory Disorder
6
Bronchitis
5
Dyspnoea
5
Drug Therapy
5
Influenza Serology
5
Evidence Based Treatment
4
Infection
4
Streptococcal Infection
4
Exposure To Communicable Disease
4
Pain
3
Pharyngitis
3
Upper Respiratory Tract Inflammatio...
3
Sepsis
3
Adverse Event
3
Pneumonia Influenzal
3
Back Pain
2
Pregnancy
2
Febrile Infection
2
Asthma
2
Myalgia
2
Acute Respiratory Distress Syndrome
2
Schizophrenia, Paranoid Type
2
Respiratory Tract Infection
2
Therapeutic Procedure
2
Viral Test Positive
2
Influenza B Virus Test Positive
2
Headache
2
Encephalopathy
2
Neuropathy Peripheral
2
Neck Pain
2
Antiviral Treatment
2
Prophylactic Chemotherapy
2
Drug Level
1

Drug Labels

LabelLabelerEffective
TamifluDispensing Solutions, Inc.05-OCT-11
TamifluRebel Distributors Corp02-NOV-11
TamifluPhysicians Total Care, Inc.22-DEC-11
TamifluRebel Distributors Corp27-DEC-11
TamifluGenentech, Inc.01-DEC-12

Oseltamivir Case Reports

What Oseltamivir 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 Oseltamivir. 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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