TYLENOL

Adverse Events

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Tylenol Adverse Events Reported to the FDA Over Time

How are Tylenol adverse event reports trending over time?

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

Adverse Event Categories for Tylenol

What are commonly reported adverse events by category for Tylenol?

Gastrointestinal Signs	5413 (6.77%)
Product Quality Issues	5190 (6.49%)
Medication Errors	4761 (5.95%)
Neurological	4135 (5.17%)
Respiratory	2995 (3.74%)
Suicidal And Self-injurious Behavio...	2340 (2.93%)
Chemical Injury And Poisoning	2118 (2.65%)
Epidermal And Dermal Conditions	2107 (2.63%)
Cardiac Arrhythmias	2020 (2.53%)
Therapeutic And Nontherapeutic Effe...	1918 (2.4%)
Infections - Pathogen Unspecified	1809 (2.26%)
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Gastrointestinal Motility And Defec...	1797 (2.25%)
Hepatic And Hepatobiliary	1724 (2.16%)
Ancillary Infectious Topics	1662 (2.08%)
Psychiatric	1381 (1.73%)
Body Temperature Conditions	1320 (1.65%)
Cardiac And Vascular Investigations	1301 (1.63%)
Hepatobiliary	1239 (1.55%)
Seizures	1107 (1.38%)
Fatal Outcomes	1019 (1.27%)
Allergic Conditions	850 (1.06%)
Disturbances In Thinking	765 (.96%)
Hematology Investigations	755 (.94%)
Injuries	755 (.94%)
Gastrointestinal Hemorrhages	695 (.87%)
Physical Examination Topics	694 (.87%)
Headaches	658 (.82%)
Bacterial Infectious	649 (.81%)
Renal Disorders	635 (.79%)
Anxiety Disorders	622 (.78%)
Lower Respiratory Tract Disorders	598 (.75%)
Metabolic, Nutritional And Blood Ga...	549 (.69%)
Movement Disorders	546 (.68%)
Sleep Disorders	534 (.67%)
Electrolyte And Fluid Balance Condi...	529 (.66%)
Deliria	521 (.65%)
Muscle	509 (.64%)
Musculoskeletal And Connective Tiss...	485 (.61%)
Viral Infectious	444 (.56%)
Decreased And Nonspecific Blood Pre...	441 (.55%)
Cardiac Disorder Signs	431 (.54%)
Bronchial Disorders	420 (.53%)
Appetite And General Nutritional	404 (.51%)
Lifestyle Issues	403 (.5%)
Urinary Tract Signs	391 (.49%)
Upper Respiratory Tract Disorders	365 (.46%)
Renal And Urinary Tract Investigati...	360 (.45%)
Toxicology And Therapeutic Drug Mon...	342 (.43%)
Water, Electrolyte And Mineral	342 (.43%)
Angiedema And Urticaria	340 (.43%)
Skin Appendage Conditions	321 (.4%)
Central Nervous System Vascular	320 (.4%)
Mental Impairment	320 (.4%)
Vision	293 (.37%)
Ocular Neuromuscular	283 (.35%)
Vascular Hypertensive	273 (.34%)
Enzyme	266 (.33%)
Eye	261 (.33%)
Therapeutic Procedures And Supporti...	253 (.32%)
Joint	250 (.31%)
Coronary Artery	245 (.31%)
Acid-base	241 (.3%)
Mood Disorders	238 (.3%)
Gastrointestinal Conditions	235 (.29%)
Neuromuscular	234 (.29%)
Oral Soft Tissue Conditions	230 (.29%)
Depressed Mood Disorders	228 (.29%)
Gastrointestinal Inflammatory Condi...	220 (.28%)
Vascular	205 (.26%)
Procedural And Device Related Injur...	199 (.25%)
Personality Disorders	197 (.25%)
Psychiatric And Behavioural Symptom...	179 (.22%)
Encephalopathies	168 (.21%)
Ocular Infections, Irritations And ...	168 (.21%)
Inner Ear And Viiith Cranial Nerve	164 (.21%)
Gastrointestinal Ulceration And Per...	156 (.2%)
White Blood Cell	142 (.18%)
Tongue Conditions	140 (.18%)
Changes In Physical Activity	137 (.17%)
Heart Failures	126 (.16%)
Coagulopathies And Bleeding Diathes...	118 (.15%)
Vascular Hemorrhagic	118 (.15%)
Hearing	117 (.15%)
Bone And Joint Injuries	114 (.14%)
Myocardial	113 (.14%)
Schizophrenia And Other Psychotic	113 (.14%)
Glucose Metabolism Disorders	107 (.13%)
Abortions And Stillbirth	106 (.13%)
Exocrine Pancreas Conditions	105 (.13%)
Pleural	104 (.13%)
Eating Disorders	102 (.13%)
Salivary Gland Conditions	100 (.13%)
Sleep Disturbances	99 (.12%)
Anemias Nonhemolytic And Marrow Dep...	98 (.12%)
Bone Disorders	98 (.12%)
Legal Issues	95 (.12%)
Spleen, Lymphatic And Reticulendoth...	95 (.12%)
Increased Intracranial Pressure And...	91 (.11%)
Skin Vascular Abnormalities	91 (.11%)
Tissue	83 (.1%)
Fungal Infectious	78 (.1%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Tylenol, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q2 2011. Adverse events are counted if Tylenol is flagged as a suspect drug causing the adverse event.

Most Common Tylenol Adverse Events Reported to the FDA

What are the most commonly reported Tylenol adverse events to the FDA?

Product Quality Issue	4507 (5.64%)
Vomiting (Throwing Up)	2040 (2.55%)
Completed Suicide	1730 (2.16%)
Transmission Of An Infectious Agent...	1648 (2.06%)
Diarrhoea	1396 (1.75%)
Drug Toxicity	1340 (1.68%)
Pyrexia (Fever)	1261 (1.58%)
Nausea	1254 (1.57%)
Drug Ineffective (Drug Did Not Work)	1125 (1.41%)
Overdose	975 (1.22%)
Abdominal Pain Upper (Upper Belly Pain)	884 (1.11%)
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Dyspnoea (Shortness Of Breath)	825 (1.03%)
Death	775 (.97%)
Malaise (Uneasy)	769 (.96%)
Convulsion (Uncontrolled Shaking)	756 (.95%)
Dizziness	687 (.86%)
Intentional Overdose	665 (.83%)
Cardiac Arrest (Blood Circulation Stopped)	589 (.74%)
Loss Of Consciousness (Fainting)	557 (.7%)
Headache	556 (.7%)
Somnolence (Sleepy)	520 (.65%)
Intentional Drug Misuse	491 (.61%)
Respiratory Arrest (Lung Failure)	490 (.61%)
Rash	458 (.57%)
Pneumonia	446 (.56%)
Accidental Overdose	424 (.53%)
Cardio-respiratory Arrest	420 (.53%)
Suicide Attempt	408 (.51%)
Hypersensitivity	407 (.51%)
Drug Interaction	401 (.5%)
Abdominal Pain (Belly Pain)	394 (.49%)
Multiple Drug Overdose	381 (.48%)
Hallucination	380 (.48%)
Asthenia (Weakness)	367 (.46%)
Weight Decreased (Weight Loss)	350 (.44%)
Insomnia (Difficulty Sleeping)	346 (.43%)
Drug Exposure During Pregnancy	343 (.43%)
Dehydration	342 (.43%)
Hepatic Failure (Liver Failure)	339 (.42%)
Drug Abuse	329 (.41%)
Alanine Aminotransferase Increased	327 (.41%)
Cough	327 (.41%)
Heart Rate Increased	325 (.41%)
Pain	325 (.41%)
Hypotension (Low Blood Pressure)	322 (.4%)
Fatigue (Tired)	317 (.4%)
Multiple Drug Overdose Intentional	316 (.4%)
Lethargy (Tired)	310 (.39%)
Incorrect Dose Administered	309 (.39%)
Blood Pressure Increased (High Blood Pressure)	302 (.38%)
Confusional State (Confused)	296 (.37%)
Urticaria (Hives)	295 (.37%)
Medication Error	281 (.35%)
Aspartate Aminotransferase Increase...	271 (.34%)
Accidental Drug Intake By Child	263 (.33%)
Feeling Abnormal (Not Feeling Normal)	256 (.32%)
Agitation	248 (.31%)
Chest Pain	247 (.31%)
Hypertension (High Blood Pressure)	246 (.31%)
Tremor (Involuntary Shaking)	246 (.31%)
Haematochezia (Bright Red Blood In Stool)	245 (.31%)
Coma	244 (.31%)
Pruritus (Itchy)	244 (.31%)
Tachycardia (Heart Rate Increased)	242 (.3%)
Bacterial Infection	241 (.3%)
Decreased Appetite	234 (.29%)
Hyperhidrosis (Excessive Sweating)	226 (.28%)
Poisoning	217 (.27%)
Fall (Falling)	213 (.27%)
Renal Failure (Kidney Failure)	212 (.27%)
Constipation	204 (.26%)
Unresponsive To Stimuli	199 (.25%)
Condition Aggravated (Worsening Condition)	198 (.25%)
Febrile Convulsion	194 (.24%)
Product Odour Abnormal	192 (.24%)
Drug Administration Error	185 (.23%)
Hepatic Enzyme Increased	185 (.23%)
Palpitations (Abnormal Heart Beat)	183 (.23%)
Oedema Peripheral (Limb Swelling)	180 (.23%)
Back Pain	178 (.22%)
Pulmonary Oedema (Fluid In Lung)	176 (.22%)
Drug Hypersensitivity	175 (.22%)
Liver Function Test Abnormal	172 (.22%)
Wrong Drug Administered	172 (.22%)
Wheezing	169 (.21%)
Drug Dependence	165 (.21%)
Chills (Shivering)	164 (.21%)
Anxiety	158 (.2%)
Depression	158 (.2%)
Syncope (Fainting)	158 (.2%)
Abdominal Discomfort	157 (.2%)
Depressed Level Of Consciousness (Decreased Alertness)	155 (.19%)
Erythema (Redness)	152 (.19%)
Asthma	151 (.19%)
Expired Drug Administered	149 (.19%)
Abnormal Behaviour	147 (.18%)
Haematemesis (Vomiting Blood)	145 (.18%)
Metabolic Acidosis	142 (.18%)
Renal Failure Acute (Kidney Failure)	142 (.18%)
International Normalised Ratio Incr...	141 (.18%)
Rectal Haemorrhage (Rectal Bleeding)	141 (.18%)

Share/Embed Graph Export Data

This graph shows the top adverse events submitted to the FDA for Tylenol, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q2 2011. Adverse events are counted if Tylenol is flagged as a suspect drug causing the adverse event.

Common Uses of Tylenol According to Those Reporting Adverse Events

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

Drug Use For Unknown Indication	6273
Pain	3512
Premedication	2058
Product Used For Unknown Indication	1772
Pyrexia	1695
Headache	1236
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Cough	852
Nasopharyngitis	837
Arthritis	814
Arthralgia	623
Suicide Attempt	599
Back Pain	587
Insomnia	525
Teething	349
Rheumatoid Arthritis	276
Hypersensitivity	246
Migraine	241
Prophylaxis	232
Ill-defined Disorder	179
Osteoarthritis	174
Nasal Congestion	162
Influenza	150
Sleep Disorder	138
Pain In Extremity	129
Pruritus	128
Accidental Exposure	128
Analgesic Therapy	126
Musculoskeletal Pain	118
Ear Infection	116
Oropharyngeal Pain	111
Myalgia	103
Malaise	100
Sinus Headache	98
Upper Respiratory Tract Infection	94
Sinus Disorder	90
Diarrhoea	90
Fibromyalgia	89
Bronchitis	87
Toothache	86
Abdominal Pain	85
Sinusitis	84
Rhinorrhoea	84
Intentional Overdose	82
Drug Exposure During Pregnancy	79
Analgesic Effect	77
Multiple Allergies	75
Sinus Congestion	72
Procedural Pain	69
Completed Suicide	67
Rash	63
Muscle Spasms	60

Drug Labels

Label	Labeler	Effective
Childrens Tylenol	McNeil Consumer Healthcare Div. McNeil-PPC, Inc	08-NOV-11
Childrens Tylenol	McNeil Consumer Healthcare Div McNeil-PPC, Inc	18-JUN-10
Childrens Tylenol	McNeil Consumer Healthcare Div. McNeil-PPC, Inc	26-MAY-11
Infants Tylenol	McNeil Consumer Healthcare Div. McNeil-PPC, Inc	01-NOV-11
Tylenol Cold Multi-symptom	McNeil Consumer Healthcare Div McNeil-PPC, Inc	16-SEP-10
Tylenol Cold Multi-symptom	McNeil Consumer Healthcare Div McNeil-PPC, Inc	14-SEP-10
Tylenol Coldcough And Severe Congestion	McNeil Consumer Healthcare Div McNeil-PPC, Inc	11-FEB-11
Tylenol Cough And Sore Throat	McNeil Consumer Healthcare Div McNeil-PPC, Inc	28-SEP-10
Tylenol Cold And Flu Severe	McNeil Consumer Healthcare Div McNeil-PPC, Inc	21-JUL-11
Tylenol Cold Multi-symptom Severe	McNeil Consumer Healthcare Div McNeil-PPC, Inc	26-MAY-11
Tylenol Cold Sore Throat Extra Strength	McNeil Consumer Healthcare Div McNeil-PPC, Inc	23-JUN-10
Tylenol Cold And Flu Severe	McNeil Consumer Healthcare Div McNeil-PPC, Inc	19-AUG-10
Tylenol Sinus Congestion And Pain Severe	McNeil Consumer Healthcare Div. McNeil-PPC, Inc	13-JUN-11
Tylenol Sinus Congestion And Pain	McNeil Consumer Healthcare Div McNeil-PPC, Inc	29-NOV-10
Tylenol With Codeine	Cardinal Health	07-DEC-10
Tylenol With Codeine	Janssen Pharmaceuticals, Inc.	26-JUL-11
Tylenolsore Throat	McNeil Consumer Healthcare Div McNeil-PPC, Inc	06-OCT-10
Tylenol	Cardinal Health	05-JUL-11
Tylenol Allergy Multi-symptom Nighttime	McNeil Consumer Healthcare Div McNeil-PPC, Inc	22-APR-10
Tylenol Arthritis Pain	McNeil Consumer Healthcare Div McNeil-PPC, Inc	13-NOV-09
Tylenol Arthritis Pain	McNeil Consumer Healthcare Div McNeil-PPC, Inc	28-AUG-09
Tylenol Cold Head Congestion Severe	Lil' Drug Store Products, Inc.	11-MAY-10
Tylenol Cold Multi-symptom	McNeil Consumer Healthcare Div McNeil-PPC, Inc	09-JUN-10
Tylenol Coldhead Congestion Severe	McNeil Consumer Healthcare Div. McNeil-PPC, Inc	01-OCT-09
Tylenol Pm Extra Strength	McNeil Consumer Healthcare Div. McNeil-PPC, Inc	25-APR-11
Tylenol Pm Extra Strength	McNeil Consumer Healthcare Div McNeil-PPC, Inc	02-APR-10
Tylenol Pm Extra Strength	McNeil Consumer Healthcare Div McNeil-PPC, Inc	25-MAR-10

Tylenol Case Reports

What Tylenol safety concerns are being reported by doctors and researchers in the medical literature?

About Results

This report contains aggregated drug side effects and adverse events for Tylenol. 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.