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Nyquil Adverse Events Reported to the FDA Over Time

How are Nyquil adverse event reports trending over time?

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

Most Common Nyquil Adverse Events Reported to the FDA

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

Age 10-19 Years

Completed Suicide
81 (.46%)
Drug Abuse
50 (.28%)
Intentional Overdose
46 (.26%)
Cardiac Arrest
38 (.22%)
Vomiting
37 (.21%)
Drug Toxicity
35 (.2%)
Respiratory Arrest
33 (.19%)
Rhabdomyolysis
32 (.18%)
Loss Of Consciousness
31 (.18%)
Tachycardia
29 (.16%)
Dilatation Intrahepatic Duct Acquir...
28 (.16%)
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Intentional Drug Misuse
28 (.16%)
Multiple Drug Overdose Intentional
28 (.16%)
Cardio-respiratory Arrest
27 (.15%)
Hepatotoxicity
27 (.15%)
Convulsion
26 (.15%)
Blood Creatine Phosphokinase Increa...
25 (.14%)
Myalgia
25 (.14%)
Overdose
25 (.14%)
Pyrexia
22 (.13%)
Liver Function Test Abnormal
20 (.11%)
Suicide Attempt
19 (.11%)
Alanine Aminotransferase Increased
17 (.1%)
Death
17 (.1%)
Nausea
17 (.1%)
Confusional State
16 (.09%)
Pulmonary Oedema
15 (.09%)
Heart Rate Increased
14 (.08%)
Hypotension
14 (.08%)
Incorrect Dose Administered
14 (.08%)
Venoocclusive Liver Disease
14 (.08%)
Arrhythmia
13 (.07%)
Dyspnoea
13 (.07%)
Headache
13 (.07%)
Shock
13 (.07%)
Somnolence
13 (.07%)
Venoocclusive Disease
13 (.07%)
Blood Ph Decreased
12 (.07%)
Dizziness
12 (.07%)
Pallor
12 (.07%)
Alcohol Use
11 (.06%)
Blood Bilirubin Increased
11 (.06%)
Brain Oedema
11 (.06%)
Malaise
11 (.06%)
Metabolic Acidosis
11 (.06%)
Multiple Drug Overdose
11 (.06%)
Asthenia
10 (.06%)
Hallucination
10 (.06%)
Mydriasis
10 (.06%)
Po2 Increased
10 (.06%)
Unresponsive To Stimuli
10 (.06%)
Aspartate Aminotransferase Increase...
9 (.05%)
Blood Alkaline Phosphatase Increase...
9 (.05%)
Diarrhoea
9 (.05%)
Grand Mal Convulsion
9 (.05%)
Insomnia
9 (.05%)
Nystagmus
9 (.05%)
Stevens-johnson Syndrome
9 (.05%)
Blood Pressure Increased
8 (.05%)
Chest Pain
8 (.05%)
Coma
8 (.05%)
Conduction Disorder
8 (.05%)
Hepatic Failure
8 (.05%)
Hypertension
8 (.05%)
Thinking Abnormal
8 (.05%)
Tremor
8 (.05%)
Underdose
8 (.05%)
Anxiety
7 (.04%)
Drug Administration Error
7 (.04%)
Multiple Drug Overdose Accidental
7 (.04%)
Palpitations
7 (.04%)
Pruritus
7 (.04%)
Renal Impairment
7 (.04%)
Abdominal Pain Upper
6 (.03%)
Accidental Overdose
6 (.03%)
Agitation
6 (.03%)
Apnoea
6 (.03%)
Blood Potassium Decreased
6 (.03%)
Cyanosis
6 (.03%)
Decreased Appetite
6 (.03%)
Disorientation
6 (.03%)
Drug Exposure During Pregnancy
6 (.03%)
Dry Skin
6 (.03%)
Medication Error
6 (.03%)
Sedation
6 (.03%)
Sinus Tachycardia
6 (.03%)
Anger
5 (.03%)
Body Temperature Decreased
5 (.03%)
Body Temperature Increased
5 (.03%)
Dehydration
5 (.03%)
Drug Abuser
5 (.03%)
Electrocardiogram Qt Prolonged
5 (.03%)
Erythema
5 (.03%)
Fatigue
5 (.03%)
Feeling Abnormal
5 (.03%)
Flat Affect
5 (.03%)
Hallucination, Visual
5 (.03%)
Hypothermia
5 (.03%)
Hypotonia
5 (.03%)
Pco2 Increased
5 (.03%)
Poisoning
5 (.03%)

All Ages and Genders

Completed Suicide
417 (2.37%)
Drug Toxicity
369 (2.1%)
Overdose
277 (1.57%)
Cardiac Arrest
196 (1.11%)
Drug Abuse
196 (1.11%)
Dyspnoea
193 (1.1%)
Vomiting
189 (1.07%)
Death
177 (1.01%)
Intentional Overdose
173 (.98%)
Intentional Drug Misuse
161 (.92%)
Respiratory Arrest
158 (.9%)
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Cardio-respiratory Arrest
155 (.88%)
Convulsion
154 (.88%)
Drug Interaction
145 (.82%)
Loss Of Consciousness
145 (.82%)
Dizziness
135 (.77%)
Heart Rate Increased
135 (.77%)
Drug Dependence
130 (.74%)
Somnolence
125 (.71%)
Blood Pressure Increased
124 (.7%)
Nausea
118 (.67%)
Drug Ineffective
115 (.65%)
Agitation
112 (.64%)
Headache
107 (.61%)
Suicide Attempt
99 (.56%)
Tachycardia
99 (.56%)
Insomnia
98 (.56%)
Dysarthria
94 (.53%)
Fatigue
94 (.53%)
Palpitations
94 (.53%)
Tremor
92 (.52%)
Incorrect Dose Administered
89 (.51%)
Hypertension
88 (.5%)
Malaise
86 (.49%)
Pyrexia
86 (.49%)
Anxiety
85 (.48%)
Hypersensitivity
85 (.48%)
Medication Error
85 (.48%)
Serotonin Syndrome
83 (.47%)
Confusional State
82 (.47%)
Accidental Overdose
78 (.44%)
Multiple Drug Overdose
78 (.44%)
Feeling Abnormal
74 (.42%)
Chest Pain
73 (.41%)
Drug Exposure During Pregnancy
70 (.4%)
Hallucination
70 (.4%)
Toxic Anterior Segment Syndrome
69 (.39%)
Psychotic Disorder
68 (.39%)
Abnormal Behaviour
67 (.38%)
Aggression
67 (.38%)
Depression
67 (.38%)
Multiple Drug Overdose Intentional
65 (.37%)
Pulmonary Oedema
65 (.37%)
Hypotension
64 (.36%)
Pruritus
64 (.36%)
Suicidal Ideation
63 (.36%)
Sudden Infant Death Syndrome
62 (.35%)
Asthenia
60 (.34%)
Disturbance In Attention
60 (.34%)
Pneumonia
60 (.34%)
Cardiac Disorder
59 (.34%)
Coma
59 (.34%)
Condition Aggravated
59 (.34%)
Hyperhidrosis
58 (.33%)
Unresponsive To Stimuli
58 (.33%)
Urticaria
58 (.33%)
Wrong Drug Administered
58 (.33%)
Alanine Aminotransferase Increased
57 (.32%)
Lethargy
57 (.32%)
Rash
57 (.32%)
Poisoning
56 (.32%)
Fall
54 (.31%)
Mydriasis
54 (.31%)
Drug Administration Error
53 (.3%)
Drug Hypersensitivity
53 (.3%)
Incorrect Drug Administration Durat...
53 (.3%)
Accidental Drug Intake By Child
52 (.3%)
Flat Affect
51 (.29%)
Heart Rate Irregular
51 (.29%)
Hallucination, Visual
50 (.28%)
Ventricular Extrasystoles
50 (.28%)
Disorientation
49 (.28%)
Atrioventricular Block
48 (.27%)
Diarrhoea
46 (.26%)
Rhabdomyolysis
46 (.26%)
Blood Creatine Phosphokinase Increa...
45 (.26%)
Chest Discomfort
45 (.26%)
Anoxic Encephalopathy
44 (.25%)
Nasal Congestion
44 (.25%)
Pain
44 (.25%)
Tangentiality
44 (.25%)
Drug Screen Positive
43 (.24%)
Vision Blurred
43 (.24%)
Abdominal Pain Upper
42 (.24%)
Dehydration
41 (.23%)
Hepatotoxicity
41 (.23%)
Restlessness
41 (.23%)
Aspartate Aminotransferase Increase...
40 (.23%)
Erythema
40 (.23%)
Euphoric Mood
40 (.23%)
Cardiotoxicity
39 (.22%)

ExportShare/Embed GraphExport Export Data

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

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

Age 10-19 Years

Show More Show More

All Ages and Genders

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ExportShare/Embed Graph Export Export Data

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

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

Drug Use For Unknown Indication
704
Product Used For Unknown Indication
585
Nasopharyngitis
473
Cough
341
Premedication
212
Hypersensitivity
190
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Nasal Congestion
184
Upper Respiratory Tract Infection
92
Influenza
90
Suicide Attempt
84
Preoperative Care
82
Pruritus
69
Sinus Disorder
68
Prophylaxis
63
Hypotension
62
Sinus Congestion
55
Pyrexia
55
Mydriasis
54
Ill-defined Disorder
53
Sinusitis
53
Seasonal Allergy
46
Rhinitis
45
Multiple Allergies
45
Intentional Overdose
43
Cataract Operation
42
Sinus Headache
41
Bronchitis
36
Drug Abuse
32
Headache
30
Rhinitis Allergic
29
Accidental Exposure
29
Insomnia
26
Influenza Like Illness
25
Pain
23
Rhinorrhoea
23
Ophthalmological Examination
21
Sleep Disorder
21
Rash
21
Off Label Use
19
Antiallergic Therapy
18
Drug Exposure During Pregnancy
18
Nasal Decongestion Therapy
17
Dyspnoea
16
Respiratory Tract Infection
15
Reversible Ischaemic Neurological D...
14
Antitussive Therapy
14
Upper Respiratory Tract Inflammatio...
13
Anaesthesia
13
Completed Suicide
13
Pharyngitis
13
Blood Pressure Management
13

Child Safety Precautions


Drug Labels

LabelLabelerEffective
Vicks Alcohol Free Nyquil Cold And Flu Nighttime ReliefProcter & Gamble Manufacturing Company02-JUN-10
Vicks Nyquil Cold And FluMechanical Servants, Inc.23-JAN-12
Vicks Childrens Nyquil Cold And Cough Multi-symptom ReliefThe Procter & Gamble Manufacturing Company26-JUL-12
Vicks Nyquil CoughThe Procter & Gamble Manufacturing Company26-JUL-12
Vicks Nyquil Cold And Flu Nighttime ReliefThe Procter & Gamble Manufacturing Company27-JUL-12
Vicks Alcohol Free Nyquil Cold And Flu Nighttime ReliefProcter & Gamble Manufacturing Company30-JUL-12
Vicks Nyquil SinexProcter & Gamble Manufacturing Company30-JUL-12
Vicks Nyquil Cold And Flu Nighttime Relief And Vicks Childrens Nyquil Cold And Cough The Procter & Gamble Manufacturing Company31-JUL-12
Vicks Nyquil Cold And Flu Nighttime ReliefProcter & Gamble Manufacturing Company21-AUG-12
Vicks Nyquilcold And Flu Nighttime ReliefProcter & Gamble Manufacturing Company21-AUG-12
Vicks Nyquil D Cold And Flu Nighttime ReliefThe Procter & Gamble Manufacturing Company21-AUG-12
Vicks Nyquilcold And Flu Nighttime ReliefProcter & Gamble Manufacturing Company21-AUG-12
Nyquil Cold And FluLil' Drug Store Products, Inc.26-DEC-12
Vicks Nyquil Nature Fusion Cold And Flu Nighttime ReliefProcter & Gamble Manufacturing Company29-JAN-13

Nyquil Case Reports

What Nyquil 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 Nyquil. 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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