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ADVIL PM

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Advil Pm Adverse Events Reported to the FDA Over Time

How are Advil Pm adverse event reports trending over time?

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

Most Common Advil Pm Adverse Events Reported to the FDA

What are the most common Advil Pm adverse events reported to the FDA?

Completed Suicide
1356 (8.55%)
Drug Toxicity
538 (3.39%)
Drug Ineffective
496 (3.13%)
Cardiac Arrest
428 (2.7%)
Cardio-respiratory Arrest
394 (2.48%)
Death
385 (2.43%)
Respiratory Arrest
385 (2.43%)
Overdose
299 (1.88%)
Somnolence
217 (1.37%)
Intentional Drug Misuse
205 (1.29%)
Intentional Overdose
178 (1.12%)
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Insomnia
156 (.98%)
Vomiting
150 (.95%)
Drug Abuse
144 (.91%)
Multiple Drug Overdose
143 (.9%)
Poisoning
141 (.89%)
Dizziness
132 (.83%)
Multiple Drug Overdose Intentional
122 (.77%)
Hypotension
119 (.75%)
Suicide Attempt
118 (.74%)
Convulsion
113 (.71%)
Agitation
107 (.67%)
Tachycardia
103 (.65%)
Drug Effect Decreased
102 (.64%)
Nausea
94 (.59%)
Feeling Abnormal
89 (.56%)
Loss Of Consciousness
87 (.55%)
Coma
84 (.53%)
Incorrect Dose Administered
79 (.5%)
Heart Rate Increased
76 (.48%)
Unresponsive To Stimuli
69 (.43%)
Condition Aggravated
68 (.43%)
Dyspnoea
66 (.42%)
Fatigue
65 (.41%)
Pulmonary Oedema
64 (.4%)
Accidental Overdose
62 (.39%)
Drug Interaction
62 (.39%)
Pruritus
62 (.39%)
Restlessness
62 (.39%)
Diarrhoea
61 (.38%)
Tremor
60 (.38%)
Delirium
59 (.37%)
Aspartate Aminotransferase Increase...
58 (.37%)
Medication Error
57 (.36%)
Rash
57 (.36%)
Alanine Aminotransferase Increased
55 (.35%)
Headache
55 (.35%)
Mydriasis
55 (.35%)
Confusional State
54 (.34%)
Malaise
53 (.33%)
Anxiety
50 (.32%)
Hypersensitivity
50 (.32%)
International Normalised Ratio Incr...
48 (.3%)
Urticaria
48 (.3%)
Hallucination
46 (.29%)
Hypertension
46 (.29%)
Lethargy
46 (.29%)
Drug Screen Positive
44 (.28%)
Hyperhidrosis
43 (.27%)
Fall
41 (.26%)
Electrocardiogram Qt Prolonged
40 (.25%)
Mental Status Changes
40 (.25%)
Pyrexia
40 (.25%)
Sinus Tachycardia
40 (.25%)
Depressed Level Of Consciousness
39 (.25%)
Drug Dependence
39 (.25%)
Palpitations
39 (.25%)
Restless Legs Syndrome
39 (.25%)
Metabolic Acidosis
38 (.24%)
Swelling Face
38 (.24%)
Blood Pressure Increased
37 (.23%)
Hepatic Failure
37 (.23%)
Abdominal Pain Upper
36 (.23%)
Brain Oedema
36 (.23%)
Disorientation
36 (.23%)
Feeling Jittery
36 (.23%)
Pain
36 (.23%)
Blood Glucose Increased
35 (.22%)
Depression
35 (.22%)
Grand Mal Convulsion
35 (.22%)
Pain In Extremity
35 (.22%)
Blood Pressure Decreased
34 (.21%)
Off Label Use
34 (.21%)
Rhabdomyolysis
34 (.21%)
Asthenia
33 (.21%)
Erythema
33 (.21%)
Pulmonary Congestion
33 (.21%)
Accident
32 (.2%)
Accidental Drug Intake By Child
32 (.2%)
Multi-organ Failure
32 (.2%)
Electrocardiogram Qrs Complex Prolo...
31 (.2%)
Accidental Exposure
30 (.19%)
Drug Abuser
30 (.19%)
Chest Pain
29 (.18%)
Hepatic Necrosis
29 (.18%)
Ventricular Tachycardia
29 (.18%)
Amnesia
28 (.18%)
Contusion
28 (.18%)
Hypoaesthesia
28 (.18%)
Abnormal Behaviour
27 (.17%)
Accidental Death
27 (.17%)

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

What are the most common Advil Pm 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 Pm, 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 Pm 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 Pm According to Those Reporting Adverse Events

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

Drug Use For Unknown Indication
1018
Premedication
913
Product Used For Unknown Indication
836
Insomnia
688
Suicide Attempt
432
Sleep Disorder
186
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Pain
181
Prophylaxis
177
Hypersensitivity
130
Pruritus
118
Back Pain
65
Headache
64
Ill-defined Disorder
58
Rash
51
Completed Suicide
42
Nasopharyngitis
36
Pain In Extremity
35
Analgesic Therapy
35
Intentional Overdose
31
Sleep Disorder Therapy
31
Arthralgia
29
Urticaria
25
Accidental Exposure
25
Cough
23
Hyperemesis Gravidarum
23
Nausea
20
Allergy Prophylaxis
19
Seasonal Allergy
17
Chemotherapy
17
Multiple Allergies
15
Nasal Congestion
14
Dermatitis Contact
13
Drug Abuse
12
Myalgia
12
Vomiting
11
Anaphylactic Reaction
11
Sinusitis
11
Somnolence
9
Sedation
9
Accidental Drug Intake By Child
9
Arthritis
9
Gastrointestinal Stoma Complication
9
Musculoskeletal Pain
9
Pyrexia
8
Overdose
8
Sinus Congestion
8
Prophylactic Chemotherapy
8
Intentional Drug Misuse
8
Influenza
8
Osteoarthritis
8
Muscle Spasms
8

Drug Labels

LabelLabelerEffective
Advil PmPfizer Consumer Healthcare30-JUN-11
Advil PmLil' Drug Store Products, Inc.27-DEC-12
Advil PmPfizer Consumer Healthcare29-JAN-13

Advil Pm Case Reports

What Advil Pm 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 Pm. 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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