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EXTRA STRENGTH TYLENOL PM

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Extra Strength Tylenol Pm Adverse Events Reported to the FDA Over Time

How are Extra Strength Tylenol Pm adverse event reports trending over time?

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

Most Common Extra Strength Tylenol Pm Adverse Events Reported to the FDA

What are the most common Extra Strength Tylenol Pm adverse events reported to the FDA?

Product Quality Issue
92 (7.8%)
Vomiting
52 (4.41%)
Nausea
42 (3.56%)
Intentional Overdose
38 (3.22%)
Diarrhoea
33 (2.8%)
Drug Administration Error
24 (2.04%)
Abdominal Pain Upper
20 (1.7%)
Dependence
18 (1.53%)
Dizziness
18 (1.53%)
Intentional Drug Misuse
16 (1.36%)
Overdose
15 (1.27%)
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Agitation
14 (1.19%)
Hallucination
14 (1.19%)
Weight Decreased
14 (1.19%)
Hypersensitivity
13 (1.1%)
Hypertension
12 (1.02%)
Suicide Attempt
12 (1.02%)
Weight Increased
12 (1.02%)
Drug Ineffective
11 (.93%)
Fatigue
11 (.93%)
Multiple Drug Overdose
11 (.93%)
Withdrawal Syndrome
11 (.93%)
Alanine Aminotransferase Increased
10 (.85%)
Headache
10 (.85%)
Product Odour Abnormal
10 (.85%)
Somnolence
10 (.85%)
Tremor
10 (.85%)
Aspartate Aminotransferase Increase...
9 (.76%)
Confusional State
9 (.76%)
Drug Dependence
9 (.76%)
Hypotension
9 (.76%)
Insomnia
9 (.76%)
Liver Injury
9 (.76%)
Malaise
9 (.76%)
Dehydration
8 (.68%)
Fall
8 (.68%)
Abdominal Pain
7 (.59%)
Anxiety
7 (.59%)
Convulsion
7 (.59%)
Hepatitis
7 (.59%)
Intentional Self-injury
7 (.59%)
Prothrombin Time Prolonged
7 (.59%)
Swelling
7 (.59%)
Transaminases Increased
7 (.59%)
Feeling Abnormal
6 (.51%)
Hepatic Pain
6 (.51%)
Pain
6 (.51%)
Renal Failure
6 (.51%)
Tachycardia
6 (.51%)
Urinary Retention
6 (.51%)
Amnesia
5 (.42%)
Back Pain
5 (.42%)
Blood Bilirubin Increased
5 (.42%)
Blood Cholesterol Increased
5 (.42%)
Blood Pressure Increased
5 (.42%)
Coma
5 (.42%)
Dysuria
5 (.42%)
Gastroenteritis
5 (.42%)
International Normalised Ratio Incr...
5 (.42%)
Liver Disorder
5 (.42%)
Loss Of Consciousness
5 (.42%)
Product Taste Abnormal
5 (.42%)
Syncope
5 (.42%)
Systemic Lupus Erythematosus
5 (.42%)
Urticaria
5 (.42%)
Vitamin D Deficiency
5 (.42%)
Blood Potassium Decreased
4 (.34%)
Contraindication To Medical Treatme...
4 (.34%)
Drug Screen Positive
4 (.34%)
Dry Mouth
4 (.34%)
Heart Rate Decreased
4 (.34%)
Incorrect Dose Administered
4 (.34%)
Ischaemic Hepatitis
4 (.34%)
Memory Impairment
4 (.34%)
Mental Status Changes
4 (.34%)
Migraine
4 (.34%)
Speech Disorder
4 (.34%)
Surgery
4 (.34%)
Therapeutic Response Unexpected
4 (.34%)
Vision Blurred
4 (.34%)
Abnormal Dreams
3 (.25%)
Asthenia
3 (.25%)
Asthma
3 (.25%)
Blood Ph Decreased
3 (.25%)
Completed Suicide
3 (.25%)
Depressed Level Of Consciousness
3 (.25%)
Diabetes Mellitus Inadequate Contro...
3 (.25%)
Disorientation
3 (.25%)
Dysgeusia
3 (.25%)
Dyspepsia
3 (.25%)
Feeling Jittery
3 (.25%)
Gastric Disorder
3 (.25%)
Haematemesis
3 (.25%)
Hepatic Enzyme Abnormal
3 (.25%)
Hepatic Failure
3 (.25%)
Hepatic Function Abnormal
3 (.25%)
Herpes Zoster
3 (.25%)
Infection
3 (.25%)
Jaundice
3 (.25%)
Liver Function Test Abnormal
3 (.25%)
Multi-organ Failure
3 (.25%)

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This graph shows the top adverse events submitted to the FDA for Extra Strength Tylenol 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 Extra Strength Tylenol 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 Extra Strength Tylenol Pm

What are the most common Extra Strength Tylenol 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 Extra Strength Tylenol 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 Extra Strength Tylenol 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 Extra Strength Tylenol Pm According to Those Reporting Adverse Events

Why are people taking Extra Strength Tylenol Pm, according to those reporting adverse events to the FDA?

Insomnia
94
Product Used For Unknown Indication
59
Pain
37
Drug Use For Unknown Indication
30
Sleep Disorder Therapy
26
Arthritis
10
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Suicide Attempt
8
Back Injury
7
Headache
5
Intentional Overdose
5
Arthralgia
3
Hypersomnia
3
Migraine
2
Initial Insomnia
2
Sleep Disorder
2
Pharyngitis
1
Homicide
1
Nasopharyngitis
1
Dysmenorrhoea
1
Accidental Exposure
1
Pyrexia
1
Depression
1
Influenza
1
Back Pain
1
Brain Operation
1

Extra Strength Tylenol Pm Case Reports

What Extra Strength Tylenol 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 Extra Strength Tylenol 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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