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ALEVE COLD AND SINUS

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

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

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

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

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

Insomnia
29 (5.21%)
Nasopharyngitis
26 (4.67%)
Headache
24 (4.31%)
Sinus Headache
15 (2.69%)
Dizziness
14 (2.51%)
Anorexia
12 (2.15%)
Unevaluable Event
12 (2.15%)
Weight Decreased
12 (2.15%)
Nausea
11 (1.97%)
Heart Rate Increased
10 (1.8%)
Sinus Congestion
10 (1.8%)
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Abdominal Pain Upper
9 (1.62%)
Hypersensitivity
9 (1.62%)
Palpitations
9 (1.62%)
Dyspnoea
8 (1.44%)
Nasal Congestion
8 (1.44%)
Sleep Disorder
8 (1.44%)
Fatigue
7 (1.26%)
Hiatus Hernia
7 (1.26%)
Paraesthesia
7 (1.26%)
Pruritus
7 (1.26%)
Asthenia
6 (1.08%)
Chest Pain
6 (1.08%)
Feeling Jittery
6 (1.08%)
Hyperhidrosis
6 (1.08%)
Rhinorrhoea
6 (1.08%)
Vomiting
6 (1.08%)
Anxiety
5 (.9%)
Blood Pressure Increased
5 (.9%)
Flushing
5 (.9%)
Initial Insomnia
5 (.9%)
Cerebrovascular Accident
4 (.72%)
Chest Discomfort
4 (.72%)
Chills
4 (.72%)
Confusional State
4 (.72%)
Dyspepsia
4 (.72%)
Epistaxis
4 (.72%)
Gastritis
4 (.72%)
Nervousness
4 (.72%)
Somnolence
4 (.72%)
Ulcer Haemorrhage
4 (.72%)
Back Pain
3 (.54%)
Condition Aggravated
3 (.54%)
Diarrhoea
3 (.54%)
Disorientation
3 (.54%)
Faeces Discoloured
3 (.54%)
Feeling Abnormal
3 (.54%)
Feeling Hot
3 (.54%)
Haematochezia
3 (.54%)
Haemoglobin Decreased
3 (.54%)
Hyperglycaemia
3 (.54%)
Hypoglycaemia
3 (.54%)
Loss Of Consciousness
3 (.54%)
Mental Impairment
3 (.54%)
Neck Pain
3 (.54%)
Pain In Extremity
3 (.54%)
Pyrexia
3 (.54%)
Swollen Tongue
3 (.54%)
Throat Irritation
3 (.54%)
Abdominal Pain
2 (.36%)
Abortion Spontaneous
2 (.36%)
Ageusia
2 (.36%)
Anosmia
2 (.36%)
Blister
2 (.36%)
Blood Glucose Fluctuation
2 (.36%)
Burning Sensation
2 (.36%)
Cold Sweat
2 (.36%)
Constipation
2 (.36%)
Cough
2 (.36%)
Decreased Appetite
2 (.36%)
Depressed Level Of Consciousness
2 (.36%)
Drug Ineffective
2 (.36%)
Drug Withdrawal Syndrome
2 (.36%)
Dry Skin
2 (.36%)
Duodenitis
2 (.36%)
Dysphagia
2 (.36%)
Eye Haemorrhage
2 (.36%)
Eye Swelling
2 (.36%)
Flatulence
2 (.36%)
Foetal Heart Rate Abnormal
2 (.36%)
Gastric Dilatation
2 (.36%)
Haemoptysis
2 (.36%)
Hypertension
2 (.36%)
Hypoaesthesia
2 (.36%)
Increased Appetite
2 (.36%)
Influenza Like Illness
2 (.36%)
Intra-uterine Death
2 (.36%)
Lethargy
2 (.36%)
Malaise
2 (.36%)
Maternal Drugs Affecting Foetus
2 (.36%)
Menstruation Irregular
2 (.36%)
Nasal Dryness
2 (.36%)
Night Sweats
2 (.36%)
Oedema Peripheral
2 (.36%)
Psychomotor Hyperactivity
2 (.36%)
Rash
2 (.36%)
Rash Generalised
2 (.36%)
Rectal Haemorrhage
2 (.36%)
Restlessness
2 (.36%)
Sinus Disorder
2 (.36%)
Sluggishness
2 (.36%)

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

What are the most common Aleve 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 Aleve 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 Aleve 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 Aleve Cold And Sinus According to Those Reporting Adverse Events

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

Nasopharyngitis
98
Drug Use For Unknown Indication
31
Sinus Headache
23
Nasal Congestion
13
Sinus Congestion
10
Sinus Disorder
8
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Headache
8
Influenza
3
Accidental Exposure
2
Cough
2
Seasonal Allergy
1
Hypersensitivity
1
Pharyngolaryngeal Pain
1
Feeling Cold
1
Sinusitis
1
Hangover
1
Pain
1
Migraine
1
Allergic Sinusitis
1
Multiple Allergies
1
Back Pain
1

Aleve Cold And Sinus Case Reports

What Aleve 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 Aleve 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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