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ADVIL COLD AND SINUS

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Advil Cold And Sinus Adverse Events Reported to the FDA Over Time

How are Advil Cold And Sinus adverse event reports trending over time?

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

Most Common Advil Cold And Sinus Adverse Events Reported to the FDA

What are the most common Advil Cold And Sinus adverse events reported to the FDA?

Drug Ineffective
219 (3.51%)
Completed Suicide
141 (2.26%)
Drug Toxicity
139 (2.23%)
Death
86 (1.38%)
Insomnia
86 (1.38%)
Dyspnoea
83 (1.33%)
Dizziness
76 (1.22%)
Vomiting
76 (1.22%)
Loss Of Consciousness
75 (1.2%)
Headache
74 (1.18%)
Overdose
70 (1.12%)
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Nausea
61 (.98%)
Somnolence
60 (.96%)
Cardiac Arrest
57 (.91%)
Convulsion
55 (.88%)
Hypersensitivity
54 (.86%)
Heart Rate Increased
53 (.85%)
Fatigue
46 (.74%)
Tremor
46 (.74%)
Cardio-respiratory Arrest
44 (.7%)
Feeling Abnormal
43 (.69%)
Malaise
42 (.67%)
Chest Pain
41 (.66%)
Palpitations
40 (.64%)
Multiple Drug Overdose
38 (.61%)
Hypertension
37 (.59%)
Rash
37 (.59%)
Sudden Infant Death Syndrome
37 (.59%)
Tachycardia
36 (.58%)
Anxiety
35 (.56%)
Drug Interaction
35 (.56%)
Urticaria
35 (.56%)
Respiratory Arrest
34 (.54%)
Asthenia
33 (.53%)
Pruritus
33 (.53%)
Intentional Overdose
32 (.51%)
Abdominal Pain Upper
30 (.48%)
Blood Pressure Increased
30 (.48%)
Diarrhoea
29 (.46%)
Medication Error
28 (.45%)
Pyrexia
27 (.43%)
Accidental Drug Intake By Child
26 (.42%)
Drug Hypersensitivity
26 (.42%)
Hallucination
26 (.42%)
Incorrect Dose Administered
26 (.42%)
Nasal Congestion
26 (.42%)
Condition Aggravated
24 (.38%)
Drug Screen Positive
24 (.38%)
Dysphagia
24 (.38%)
Intentional Drug Misuse
24 (.38%)
Muscle Spasms
24 (.38%)
Pain
24 (.38%)
Anoxic Encephalopathy
23 (.37%)
Eye Swelling
23 (.37%)
Feeling Jittery
23 (.37%)
Hyperhidrosis
23 (.37%)
Renal Impairment
23 (.37%)
Restlessness
23 (.37%)
Swelling Face
23 (.37%)
Drug Effect Decreased
22 (.35%)
Dry Mouth
22 (.35%)
Unresponsive To Stimuli
22 (.35%)
Accidental Overdose
21 (.34%)
Dysgeusia
21 (.34%)
Fall
21 (.34%)
Hypoaesthesia
21 (.34%)
Decreased Appetite
20 (.32%)
Depression
20 (.32%)
Erythema
20 (.32%)
Nervousness
20 (.32%)
Oedema Peripheral
20 (.32%)
Wrong Drug Administered
20 (.32%)
Arrhythmia
19 (.3%)
Dehydration
19 (.3%)
Drug Dependence
19 (.3%)
Irritability
19 (.3%)
Alanine Aminotransferase Increased
18 (.29%)
Aspartate Aminotransferase Increase...
18 (.29%)
Cerebrovascular Accident
18 (.29%)
Chills
18 (.29%)
Coma
18 (.29%)
Confusional State
18 (.29%)
Crying
18 (.29%)
Hypotension
18 (.29%)
Multiple Drug Overdose Intentional
18 (.29%)
Agitation
17 (.27%)
Cough
17 (.27%)
Drug Exposure During Pregnancy
17 (.27%)
Lip Swelling
17 (.27%)
Liver Disorder
17 (.27%)
Psychomotor Hyperactivity
17 (.27%)
Paraesthesia
16 (.26%)
Pulmonary Oedema
16 (.26%)
Drug Abuse
15 (.24%)
Drug Administration Error
15 (.24%)
Pallor
15 (.24%)
Urinary Retention
15 (.24%)
Bronchopneumonia
14 (.22%)
Myocardial Infarction
14 (.22%)
Pneumonia
14 (.22%)
Thirst
14 (.22%)

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This graph shows the top adverse events submitted to the FDA for Advil Cold And Sinus, 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 Advil Cold And Sinus 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 Advil Cold And Sinus

What are the most common Advil Cold And Sinus adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Advil Cold And Sinus, 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 Advil Cold And Sinus 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 Advil Cold And Sinus According to Those Reporting Adverse Events

Why are people taking Advil Cold And Sinus, according to those reporting adverse events to the FDA?

Nasopharyngitis
263
Drug Use For Unknown Indication
217
Product Used For Unknown Indication
141
Nasal Congestion
126
Hypersensitivity
125
Sinus Disorder
76
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Cough
59
Sinus Headache
54
Sinusitis
54
Sinus Congestion
44
Rhinitis
39
Headache
38
Seasonal Allergy
33
Upper Respiratory Tract Infection
33
Multiple Allergies
31
Influenza
31
Suicide Attempt
27
Rhinitis Allergic
24
Rhinorrhoea
21
Ill-defined Disorder
20
Pain
18
Accidental Exposure
17
Nasal Decongestion Therapy
15
Pyrexia
14
Intentional Overdose
11
Sneezing
11
Oropharyngeal Pain
9
Bronchitis
9
Respiratory Tract Congestion
7
Chronic Sinusitis
6
Completed Suicide
6
Pharyngitis
6
Respiratory Disorder
6
Teething
5
Asthma
5
Dyspnoea
5
Ear Infection
5
Ear Pain
5
Pulmonary Congestion
5
Allergic Sinusitis
4
Postnasal Drip
4
Influenza Like Illness
4
Respiratory Tract Infection
4
Weight Loss Diet
4
Infection
4
Injury
3
Overdose
3
Antiallergic Therapy
3
Intentional Misuse
3
Ear Congestion
3
Sleep Disorder
3

Drug Labels

LabelLabelerEffective
Advil Cold And SinusPfizer Consumer Healthcare30-JUN-11
Advil Cold And SinusPfizer Consumer Healthcare27-FEB-12

Advil Cold And Sinus Case Reports

What Advil Cold And Sinus 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 Advil Cold And Sinus. 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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