EXTRA STRENGTH TYLENOL

Extra Strength Tylenol Adverse Events Reported to the FDA Over Time

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

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

Most Common Extra Strength Tylenol Adverse Events Reported to the FDA

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

Product Quality Issue	747 (6.73%)
Vomiting	384 (3.46%)
Nausea	349 (3.14%)
Diarrhoea	279 (2.51%)
Abdominal Pain Upper	220 (1.98%)
Intentional Overdose	182 (1.64%)
Overdose	177 (1.59%)
Dizziness	150 (1.35%)
Headache	145 (1.31%)
Dyspnoea	135 (1.22%)
Hepatic Failure	125 (1.13%)
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Drug Administration Error	121 (1.09%)
Drug Ineffective	104 (.94%)
Accidental Overdose	100 (.9%)
Malaise	98 (.88%)
Product Odour Abnormal	97 (.87%)
Intentional Drug Misuse	90 (.81%)
Hypersensitivity	87 (.78%)
Loss Of Consciousness	87 (.78%)
Abdominal Pain	84 (.76%)
Weight Decreased	79 (.71%)
Dehydration	74 (.67%)
Expired Drug Administered	71 (.64%)
Hallucination	71 (.64%)
Somnolence	71 (.64%)
Fatigue	68 (.61%)
Incorrect Dose Administered	68 (.61%)
Asthenia	66 (.59%)
Acute Hepatic Failure	65 (.59%)
Product Taste Abnormal	63 (.57%)
Blood Pressure Increased	62 (.56%)
Haematochezia	57 (.51%)
Alanine Aminotransferase Increased	56 (.5%)
Liver Injury	56 (.5%)
Suicide Attempt	56 (.5%)
Drug Toxicity	53 (.48%)
Convulsion	52 (.47%)
Hepatic Enzyme Increased	52 (.47%)
Rash	52 (.47%)
Chest Pain	51 (.46%)
Accidental Drug Intake By Child	50 (.45%)
Drug Exposure During Pregnancy	50 (.45%)
Feeling Abnormal	50 (.45%)
Insomnia	50 (.45%)
Incorrect Drug Administration Durat...	49 (.44%)
Aspartate Aminotransferase Increase...	47 (.42%)
Dependence	47 (.42%)
Urticaria	47 (.42%)
Hypertension	46 (.41%)
Pain	46 (.41%)
Liver Function Test Abnormal	44 (.4%)
Renal Failure	43 (.39%)
Lethargy	42 (.38%)
Palpitations	42 (.38%)
Weight Increased	42 (.38%)
Rectal Haemorrhage	41 (.37%)
Swelling	41 (.37%)
Drug Interaction	40 (.36%)
Multiple Drug Overdose	40 (.36%)
Death	39 (.35%)
Renal Failure Acute	39 (.35%)
Hypotension	38 (.34%)
Oedema Peripheral	38 (.34%)
Tremor	38 (.34%)
Acute Respiratory Distress Syndrome	37 (.33%)
Decreased Appetite	36 (.32%)
Fall	36 (.32%)
Inappropriate Schedule Of Drug Admi...	35 (.32%)
International Normalised Ratio Incr...	35 (.32%)
Product Tampering	35 (.32%)
Wheezing	35 (.32%)
Blood Urine Present	34 (.31%)
Confusional State	34 (.31%)
Haemoptysis	34 (.31%)
Hepatitis	34 (.31%)
Liver Disorder	34 (.31%)
Abdominal Discomfort	33 (.3%)
Pneumonia Aspiration	33 (.3%)
Pyrexia	33 (.3%)
Pruritus	32 (.29%)
Transmission Of An Infectious Agent...	32 (.29%)
Epistaxis	31 (.28%)
Heart Rate Increased	31 (.28%)
Cough	29 (.26%)
Drug Dependence	29 (.26%)
Foreign Body Trauma	29 (.26%)
Abdominal Distension	28 (.25%)
Agitation	28 (.25%)
Amnesia	27 (.24%)
Blood Glucose Increased	27 (.24%)
Haemorrhage	27 (.24%)
Pain In Extremity	26 (.23%)
Hepatic Steatosis	25 (.23%)
Hyperhidrosis	25 (.23%)
Pneumothorax	25 (.23%)
Prothrombin Time Prolonged	25 (.23%)
Swelling Face	25 (.23%)
Throat Irritation	25 (.23%)
Anxiety	24 (.22%)
Colitis	24 (.22%)
Hepatic Cirrhosis	24 (.22%)

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

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

Gastrointestinal Signs	1190 (10.72%)
Medication Errors	977 (8.8%)
Product Quality Issues	974 (8.78%)
Neurological	576 (5.19%)
Hepatic And Hepatobiliary	498 (4.49%)
Respiratory	358 (3.23%)
Gastrointestinal Motility And Defec...	332 (2.99%)
Hepatobiliary	272 (2.45%)
Psychiatric	240 (2.16%)
Epidermal And Dermal Conditions	197 (1.77%)
Therapeutic And Nontherapeutic Effe...	181 (1.63%)
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Headaches	165 (1.49%)
Infections - Pathogen Unspecified	163 (1.47%)
Gastrointestinal Hemorrhages	158 (1.42%)
Allergic Conditions	151 (1.36%)
Cardiac And Vascular Investigations	151 (1.36%)
Physical Examination Topics	140 (1.26%)
Injuries	125 (1.13%)
Hematology Investigations	122 (1.1%)
Renal Disorders	120 (1.08%)
Chemical Injury And Poisoning	111 (1%)
Disturbances In Thinking	105 (.95%)
Suicidal And Self-injurious Behavio...	103 (.93%)
Lower Respiratory Tract Disorders	89 (.8%)
Metabolic, Nutritional And Blood Ga...	86 (.77%)
Electrolyte And Fluid Balance Condi...	83 (.75%)
Sleep Disorders	82 (.74%)
Anxiety Disorders	80 (.72%)
Cardiac Arrhythmias	73 (.66%)
Renal And Urinary Tract Investigati...	69 (.62%)
Muscle	68 (.61%)
Urinary Tract Signs	63 (.57%)
Upper Respiratory Tract Disorders	62 (.56%)
Fatal Outcomes	61 (.55%)
Seizures	61 (.55%)
Musculoskeletal And Connective Tiss...	60 (.54%)
Deliria	59 (.53%)
Mental Impairment	58 (.52%)
Gastrointestinal Inflammatory Condi...	57 (.51%)
Cardiac Disorder Signs	56 (.5%)
Water, Electrolyte And Mineral	55 (.5%)
Angiedema And Urticaria	54 (.49%)
Bronchial Disorders	53 (.48%)
Oral Soft Tissue Conditions	50 (.45%)
Movement Disorders	48 (.43%)
Gastrointestinal Conditions	46 (.41%)
Vascular Hypertensive	46 (.41%)
Bacterial Infectious	45 (.41%)
Decreased And Nonspecific Blood Pre...	45 (.41%)
Vision	45 (.41%)
Appetite And General Nutritional	43 (.39%)
Eye	40 (.36%)
Lifestyle Issues	39 (.35%)
Skin Appendage Conditions	39 (.35%)
Viral Infectious	38 (.34%)
Body Temperature Conditions	34 (.31%)
Pleural	34 (.31%)
Therapeutic Procedures And Supporti...	34 (.31%)
Ancillary Infectious Topics	32 (.29%)
Encephalopathies	32 (.29%)
Gastrointestinal Ulceration And Per...	31 (.28%)
Inner Ear And Viiith Cranial Nerve	31 (.28%)
Central Nervous System Vascular	29 (.26%)
Pericardial	28 (.25%)
Tongue Conditions	28 (.25%)
Enzyme	27 (.24%)
Vascular Hemorrhagic	27 (.24%)
Coronary Artery	25 (.23%)
Salivary Gland Conditions	25 (.23%)
Urolithiases	23 (.21%)
Abortions And Stillbirth	22 (.2%)
Ocular Infections, Irritations And ...	22 (.2%)
Hearing	21 (.19%)
Heart Failures	21 (.19%)
Joint	20 (.18%)
Sleep Disturbances	19 (.17%)
Acid-base	18 (.16%)
Toxicology And Therapeutic Drug Mon...	18 (.16%)
Bladder And Bladder Neck Disorders	17 (.15%)
Gallbladder	17 (.15%)
Embolism And Thrombosis	16 (.14%)
Fungal Infectious	16 (.14%)
Coagulopathies And Bleeding Diathes...	15 (.14%)
Increased Intracranial Pressure And...	15 (.14%)
Personality Disorders	15 (.14%)
Vascular	15 (.14%)
Anemias Nonhemolytic And Marrow Dep...	13 (.12%)
Connective Tissue Disorders	13 (.12%)
Cranial Nerve Disorders	13 (.12%)
Eating Disorders	13 (.12%)
Glucose Metabolism Disorders	13 (.12%)
Hematological And Lymphoid Tissue T...	13 (.12%)
Lipid Analyses	13 (.12%)
Spinal Cord And Nerve Root	13 (.12%)
Vitamin Related	13 (.12%)
Bone Disorders	12 (.11%)
Gastrointestinal Neoplasms Malignan...	12 (.11%)
Psychiatric And Behavioural Symptom...	12 (.11%)
Tissue	12 (.11%)
Gastrointestinal Stenosis And Obstr...	11 (.1%)
Depressed Mood Disorders	10 (.09%)

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This graph shows the top categories of adverse events submitted to the FDA for Extra Strength Tylenol, 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 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.