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OTRIVIN

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Otrivin Adverse Events Reported to the FDA Over Time

How are Otrivin adverse event reports trending over time?

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

Most Common Otrivin Adverse Events Reported to the FDA

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

Drug Dependence
115 (13.33%)
Intentional Drug Misuse
54 (6.26%)
Incorrect Drug Administration Durat...
49 (5.68%)
Nasal Congestion
30 (3.48%)
Overdose
24 (2.78%)
Drug Ineffective
16 (1.85%)
Drug Administration Error
14 (1.62%)
Drug Exposure During Pregnancy
14 (1.62%)
Hypertension
14 (1.62%)
Jaundice
14 (1.62%)
Premature Baby
14 (1.62%)
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Small For Dates Baby
14 (1.62%)
Condition Aggravated
13 (1.51%)
Accidental Drug Intake By Child
12 (1.39%)
Wrong Technique In Drug Usage Proce...
11 (1.27%)
Diarrhoea
10 (1.16%)
Rebound Effect
10 (1.16%)
Skin Discolouration
10 (1.16%)
Anal Atresia
9 (1.04%)
Dyspnoea
9 (1.04%)
Anosmia
8 (.93%)
Anxiety
8 (.93%)
Epistaxis
8 (.93%)
Insomnia
8 (.93%)
Pre-eclampsia
8 (.93%)
Premature Labour
8 (.93%)
Dysgeusia
7 (.81%)
Infection
7 (.81%)
Off Label Use
7 (.81%)
Antepartum Haemorrhage
6 (.7%)
Chemical Injury
6 (.7%)
Maternal Drugs Affecting Foetus
6 (.7%)
Palpitations
6 (.7%)
Paraesthesia
6 (.7%)
Drug Abuse
5 (.58%)
Incorrect Route Of Drug Administrat...
5 (.58%)
Therapeutic Response Decreased
5 (.58%)
Therapeutic Response Unexpected
5 (.58%)
Inappropriate Schedule Of Drug Admi...
4 (.46%)
Induced Labour
4 (.46%)
Nasal Discomfort
4 (.46%)
Nasal Septum Deviation
4 (.46%)
Pregnancy
4 (.46%)
Agitation
3 (.35%)
Dizziness
3 (.35%)
Drug Withdrawal Syndrome
3 (.35%)
Gestational Diabetes
3 (.35%)
Headache
3 (.35%)
Heart Rate Increased
3 (.35%)
Hypersensitivity
3 (.35%)
Incorrect Dose Administered
3 (.35%)
Nasal Disorder
3 (.35%)
Panic Attack
3 (.35%)
Product Quality Issue
3 (.35%)
Retained Placenta Or Membranes
3 (.35%)
Sleep Disorder
3 (.35%)
Syncope
3 (.35%)
Tachycardia
3 (.35%)
Urticaria
3 (.35%)
Abasia
2 (.23%)
Abdominal Pain
2 (.23%)
Abnormal Behaviour
2 (.23%)
Abortion Induced
2 (.23%)
Abortion Spontaneous
2 (.23%)
Ageusia
2 (.23%)
Angina Pectoris
2 (.23%)
Application Site Pain
2 (.23%)
Arrhythmia
2 (.23%)
Bradycardia
2 (.23%)
Caesarean Section
2 (.23%)
Convulsion
2 (.23%)
Delirium
2 (.23%)
Disease Recurrence
2 (.23%)
Drug Hypersensitivity
2 (.23%)
Electrocardiogram St Segment Depres...
2 (.23%)
Face Injury
2 (.23%)
Foetal Disorder
2 (.23%)
Haemorrhage
2 (.23%)
Hypotonia
2 (.23%)
Inflammation
2 (.23%)
Intra-uterine Death
2 (.23%)
Loss Of Consciousness
2 (.23%)
Macular Degeneration
2 (.23%)
Mucosal Dryness
2 (.23%)
Muscle Spasms
2 (.23%)
Mydriasis
2 (.23%)
Nasal Dryness
2 (.23%)
Nasal Oedema
2 (.23%)
No Adverse Event
2 (.23%)
Pain
2 (.23%)
Panic Disorder
2 (.23%)
Pericardial Effusion
2 (.23%)
Pharyngeal Oedema
2 (.23%)
Placental Disorder
2 (.23%)
Placental Infarction
2 (.23%)
Psychomotor Hyperactivity
2 (.23%)
Rash
2 (.23%)
Rash Macular
2 (.23%)
Retinal Artery Occlusion
2 (.23%)
Sinus Arrhythmia
2 (.23%)
Sinus Tachycardia
2 (.23%)

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

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

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

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

Nasal Congestion
76
Nasopharyngitis
18
Rhinitis
14
Product Used For Unknown Indication
11
Hypersensitivity
9
Drug Use For Unknown Indication
8
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Sinus Disorder
4
Nasal Decongestion Therapy
4
Sinus Congestion
4
Nasal Septum Deviation
4
Rhinitis Allergic
4
Prophylaxis
3
Sinusitis
3
Nasal Polyps
2
Nasal Mucosal Disorder
2
Otitis Media Acute
2
Seasonal Allergy
1
Influenza
1
Eye Injury
1
Sense Of Oppression
1
Dyspnoea
1
Foetal Exposure During Pregnancy
1
Rhinorrhoea
1
Nasal Obstruction
1
Cautery To Nose
1
Accidental Exposure
1
Cough
1
Ear Infection
1
Upper Respiratory Tract Congestion
1
Suicide Attempt
1
Anaesthesia
1
Insomnia
1
Respiratory Disorder
1

Otrivin Case Reports

What Otrivin 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 Otrivin. 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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