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Tylenol (Acetaminophen) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (114)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Tylenol (Acetaminophen) all cases. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 114   Next >>

Possible Tylenol side effects in male

Reported by a lawyer from United States on 2012-08-27

Patient: male

Reactions: Confusional State, Anxiety, Post-Traumatic Stress Disorder, Toxic Epidermal Necrolysis, Skin Disorder, Pulmonary Oedema, Respiratory Distress, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advil
    Dosage: 200 mg, unk
    Indication: Headache
    Start date: 2010-04-20

Motrin
    Dosage: unk
    Indication: Pain

Tylenol
    Dosage: unk
    Indication: Pain



Possible Tylenol side effects in male

Reported by a physician from United States on 2012-08-24

Patient: male

Reactions: Transient Ischaemic Attack

Drug(s) suspected as cause:
Tylenol
    Indication: Product Used FOR Unknown Indication

Tylenol

Xarelto
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Mylanta (Aluminium Hydroxide / Magnesium Hydroxide); Aspirin; Multiple Medications



Possible Tylenol side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Choking, Urticaria, Gastric Disorder

Drug(s) suspected as cause:
Tylenol

Tylenol
    Indication: Product Used FOR Unknown Indication



Possible Tylenol side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 63 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Abdominal Discomfort, Abdominal Pain Upper

Drug(s) suspected as cause:
Flector
    Dosage: unk, 2x/day (1 patch every 12 hours)
    Indication: Fractured Coccyx
    Start date: 2012-08-13

Tylenol
    Dosage: unk
    Administration route: Oral



Possible Tylenol side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 66 year old female, weighing 68.0 kg (149.7 pounds)

Reactions: Hepatic Cirrhosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tylenol
    Dosage: 2 caplets every 4-6 hours
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 1993-01-01
    End date: 2006-01-01

Tylenol
    Administration route: Oral

Other drugs received by patient: Xanax; Unspecified Sleeping Agents



Possible Tylenol side effects in female

Reported by a pharmacist from United States on 2012-08-24

Patient: female

Reactions: Bone Loss, Ankle Fracture

Drug(s) suspected as cause:
Tylenol
    Administration route: Oral

Tylenol
    Dosage: taking for years, last dose taken 4-5 days ago.
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-01-01



Possible Tylenol side effects in 22 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 22 year old female

Reactions: Medication Error, Maternal Exposure During Pregnancy, Hepatic Failure, Foetal Death, Accidental Overdose

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Dosage: unk
    Indication: Oral Pain

Tylenol
    Dosage: 300/30 mg
    Indication: Toothache



Possible Tylenol side effects in male

Reported by a pharmacist from Canada on 2012-08-24

Patient: male

Reactions: Hypersensitivity, Urticaria, Eye Swelling, Local Swelling

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advil Cold and Sinus
    Indication: Pain

Advil Cold and Sinus

Tylenol
    Indication: Pain

Tylenol



Possible Tylenol side effects in 77 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 77 year old female, weighing 71.2 kg (156.6 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Activities of Daily Living Impaired, Drug Ineffective, Nausea, Hearing Impaired, Memory Impairment

Drug(s) suspected as cause:
Advil
    Dosage: 200 mg, unk
    Indication: Pain

Celebrex
    Indication: Neck Pain

Celebrex
    Dosage: 200 mg, daily
    Indication: Arthritis

Celebrex
    Dosage: 200 mg, alternate day
    Indication: Headache

Tylenol
    Dosage: unk
    Indication: Pain

Other drugs received by patient: Lisinopril



Possible Tylenol side effects in female

Reported by a lawyer from United States on 2012-08-23

Patient: female

Reactions: Overdose, Acute Hepatic Failure, Suicide Attempt, Toxicity To Various Agents, Upper Gastrointestinal Haemorrhage, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Advil
    Administration route: Oral
    Indication: Joint Injury

Tylenol
    Dosage: taken for 2-3 weeks of unknown amounts
    Indication: Joint Injury
    Start date: 2010-06-01

Tylenol
    Dosage: taken for 2-3 weeks of unknown amounts
    Indication: Pyrexia
    Start date: 2010-06-01

Tylenol
    Dosage: taken for 2-3 weeks of unknown amounts
    Indication: Pain
    Start date: 2010-06-01

Other drugs received by patient: Omeprazole; Meloxicam; Ketorolac; ALL Other Therapeutic Products; Cyclobenzaprine; Trazodone Hydrochloride



Possible Tylenol side effects in 18 month old male

Reported by a consumer/non-health professional from Canada on 2012-08-23

Patient: 18 month old male

Reactions: Product Packaging Issue, Accidental Drug Intake by Child

Drug(s) suspected as cause:
Tylenol
    Administration route: Oral
    Indication: Accidental Exposure

Tylenol
    Administration route: Oral



Possible Tylenol side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: male

Reactions: Confusional State, Anxiety, Post-Traumatic Stress Disorder, Toxic Epidermal Necrolysis, Skin Disorder, Pulmonary Oedema, Respiratory Distress, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advil
    Indication: Headache
    Start date: 2010-04-01

Motrin
    Indication: Pain

Motrin

Tylenol

Tylenol
    Indication: Pain



Possible Tylenol side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Bedridden, Emphysema, Off Label Use, Lung Disorder, Amnesia, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Aspirin
    Dosage: 81 mg, prn
    Indication: Chest Pain

Atenolol
    Dosage: 25 mg, qd
    Administration route: Oral
    Indication: Hypertension

Ativan
    Dosage: 1 mg, tid
    Administration route: Oral
    Indication: Nervousness

Atropine Sulfate
    Dosage: 2.5 mg, qid
    Administration route: Oral
    Indication: Crohn's Disease

Depakote
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Convulsion

Dilantin
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: Convulsion

Furosemide
    Dosage: 40 mg, bid
    Administration route: Oral
    Indication: Diuretic Therapy

Generlac
    Dosage: 30 mg, prn
    Indication: Crohn's Disease

Humulin R
    Dosage: 24 units
    Indication: Diabetes Mellitus

Imdur
    Dosage: 30 mg, tid
    Indication: Cardiac Disorder

Lantus
    Dosage: 80 units in the moring and 90 units at night
    Indication: Diabetes Mellitus

Lantus
    Dosage: unk

Methocarbamol
    Indication: Neuropathy Peripheral

Methocarbamol
    Dosage: 750 mg, prn
    Administration route: Oral
    Indication: Muscle Spasms

Nitrostat
    Dosage: 0.4 mg, prn
    Indication: Chest Pain

Norvasc
    Administration route: Oral
    Indication: Palpitations

Potassium Chloride

Potassium Chloride (KV / 24)
    Dosage: 8 meq, qd
    Indication: Blood Potassium

Remeron
    Dosage: 30 mg, qd
    Administration route: Oral
    Indication: Insomnia

Tylenol
    Dosage: unk unk, qd
    Indication: Migraine

Zantac
    Dosage: 30 mg, tid
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Zocor
    Dosage: 40 mg, qd
    Administration route: Oral



Possible Tylenol side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: female

Reactions: Overdose, Yellow Skin, Ocular Icterus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tylenol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Tylenol
    Administration route: Oral

Other drugs received by patient: Invega



Possible Tylenol side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-22

Patient: female, weighing 52.6 kg (115.7 pounds)

Reactions: Lung Disorder, Pneumonia, Renal Disorder, Drug-Induced Liver Injury, Pneumothorax, Memory Impairment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Administration route: Oral
    Indication: Blood Cholesterol Abnormal
    Start date: 2001-01-01
    End date: 2012-01-01

Tylenol

Other drugs received by patient: Thyroid Medications; Lung Medications



Possible Tylenol side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Urticaria, Choking, Gastric Disorder

Drug(s) suspected as cause:
Tylenol
    Indication: Product Used FOR Unknown Indication

Tylenol



Possible Tylenol side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Hepatic Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tylenol
    Indication: Analgesic Therapy
    Start date: 2011-01-01

Tylenol



Possible Tylenol side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: female

Reactions: Posterior Reversible Encephalopathy Syndrome, Coagulopathy, Acute Hepatic Failure, Visual Acuity Reduced, Cholecystitis, Hallucination, Renal Failure Acute

Drug(s) suspected as cause:
Nyquil
    Indication: Upper Respiratory Tract Infection

Theraflu
    Indication: Upper Respiratory Tract Infection

Tylenol

Tylenol
    Indication: Upper Respiratory Tract Infection



Possible Tylenol side effects in 70 year old female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 70 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Osteoarthritis, Drug Ineffective

Drug(s) suspected as cause:
Celebrex
    Dosage: 100 mg, 2x/day
    Indication: Osteoarthritis

Tylenol
    Indication: Headache

Tylenol
    Dosage: 650 mg, 2x/day
    Indication: Osteoarthritis
    Start date: 2012-01-01

Other drugs received by patient: Metoprolol



Possible Tylenol side effects in 61 year old male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 61 year old male, weighing 78.5 kg (172.6 pounds)

Reactions: Hypotension, Drug Hypersensitivity, Abasia, Intentional Drug Misuse, Hernia, Abdominal Pain Upper, Arthritis Infective, TOE Amputation, Gastric Fistula

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: unk

Chantix
    Dosage: 0.5 mg, daily
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2008-07-01
    End date: 2008-01-01

Chantix
    Dosage: 0.5 mg, daily
    Administration route: Oral
    Start date: 2012-07-01

Lasix
    Dosage: 40-80mg daily
    Administration route: Oral
    Indication: Oedema

Tylenol
    Dosage: unk

Other drugs received by patient: Fentanyl; Oxycodone; Spironolactone; Flomax



Possible Tylenol side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: 73 year old female

Reactions: Metabolic Acidosis, Pneumonia, Coagulopathy, Urinary Tract Infection, Atrial Fibrillation, Antinuclear Antibody Positive, Hepatic Encephalopathy, Diarrhoea, Acute Hepatic Failure, Acute Respiratory Failure, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Multaq
    Start date: 2011-07-01

Tylenol
    Dosage: 2 tabs 500mg or 650mg (1000mg) (1300mg) prn
    Administration route: Oral

Vicodin
    Dosage: 500/5mg 1-2 tabs prn
    Administration route: Oral

Other drugs received by patient: Alendronate Sodium; Potassium Chloride; Metoprolol Tartrate; Coumadin; Lasix; Iron; Aspirin; Diltiazem; Diltiazem; Vitamin D; Vitamin TAB; Calcium



Possible Tylenol side effects in 83 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: 83 year old female

Reactions: Pulmonary Embolism

Adverse event resulted in: death

Drug(s) suspected as cause:
Tylenol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Tylenol
    Administration route: Oral

Xarelto
    Administration route: Oral
    Indication: Thrombosis Prophylaxis
    Start date: 2012-08-09
    End date: 2012-08-09

Xarelto
    Administration route: Oral
    Indication: HIP Fracture
    Start date: 2012-08-09
    End date: 2012-08-09

Other drugs received by patient: Reglan; Dextrose 5%; Ascorbic Acid; Folic Acid; Norco



Possible Tylenol side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: female

Reactions: LOW Birth Weight Baby, Premature Baby

Drug(s) suspected as cause:
Remicade
    Dosage: the baby's mother was treated with infliximab, recombinant 500 mg once every 4 weeks
    Indication: Foetal Exposure During Pregnancy

Tylenol

Tylenol
    Indication: Foetal Exposure During Pregnancy

Zyrtec
    Indication: Foetal Exposure During Pregnancy

Zyrtec

Other drugs received by patient: Trandate



Possible Tylenol side effects in 77 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 77 year old female, weighing 86.2 kg (189.6 pounds)

Reactions: Nausea, Drug Ineffective, Pain, Headache, Tremor, Abdominal Discomfort, Malaise, Pulmonary Thrombosis

Drug(s) suspected as cause:
Gabapentin
    Dosage: unk
    Indication: Fibromyalgia

Gabapentin
    Dosage: 400 mg, 2x/day
    Start date: 2012-08-09

Neurontin
    Dosage: 400 mg, 3x/day
    Indication: Fibromyalgia

Neurontin
    Dosage: unk
    End date: 2012-01-01

Tylenol
    Dosage: unk
    Indication: Pain in Extremity
    Start date: 2012-01-01
    End date: 2012-01-01

Other drugs received by patient: Toprol-XL; Lipitor; Dexilant; Temazepam



Possible Tylenol side effects in 18 month old male

Reported by a consumer/non-health professional from Canada on 2012-08-16

Patient: 18 month old male

Reactions: Product Packaging Issue, Accidental Drug Intake by Child

Drug(s) suspected as cause:
Tylenol
    Administration route: Oral
    Indication: Accidental Exposure

Tylenol
    Administration route: Oral



Possible Tylenol side effects in male

Reported by a pharmacist from Canada on 2012-08-16

Patient: male

Reactions: Hypersensitivity, Urticaria, Eye Swelling, Local Swelling

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advil Cold and Sinus
    Indication: Pain

Tylenol
    Administration route: Oral

Tylenol
    Administration route: Oral
    Indication: Pain



Possible Tylenol side effects in male

Reported by a lawyer from United States on 2012-08-14

Patient: male

Reactions: Confusional State, Anxiety, Post-Traumatic Stress Disorder, Toxic Epidermal Necrolysis, Skin Disorder, Pulmonary Oedema, Respiratory Distress, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advil
    Dosage: 200 mg, unk
    Indication: Headache
    Start date: 2010-04-20

Motrin
    Dosage: unk
    Indication: Pain

Tylenol
    Dosage: unk
    Indication: Pain



Possible Tylenol side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: female

Reactions: Pneumonia, Foreign Body Aspiration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-02-20

Tylenol

Tylenol
    Indication: Product Used FOR Unknown Indication



Possible Tylenol side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: male

Reactions: Premature Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Excedrin (Acetaminophen / Caffeine)
    Indication: Foetal Exposure During Pregnancy
    Start date: 2010-01-01
    End date: 2012-01-01

Excedrin (Migraine)
    Indication: Foetal Exposure During Pregnancy
    Start date: 2007-01-01

Excedrin (Migraine)
    Start date: 2007-01-01
    End date: 2010-01-01

Tylenol
    Indication: Foetal Exposure During Pregnancy

Tylenol



Possible Tylenol side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 52 year old female, weighing 73.5 kg (161.7 pounds)

Reactions: Vitamin D Deficiency, Liver Injury, Hepatic Pain, Drug Ineffective, Pain, Urticaria, Anxiety, Weight Increased, Systemic Lupus Erythematosus, Feeling Jittery, Blood Cholesterol Increased, Drug Administration Error, Hypertension

Drug(s) suspected as cause:
Acetaminophen
    Indication: Pain

Acetaminophen
    Dosage: caplet, 1 caplet nightly at bedtime for about 4 months
    Administration route: Oral
    Indication: Sleep Disorder Therapy

Advil
    Dosage: 3-4 daily for few months 2-3 years ago
    Indication: Pain

Chantix
    Dosage: tablet, for 3 weeks 3-4 years ago
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2008-01-01

Extra Strength Tylenol
    Dosage: caplet, 2 caplets every 6 hours while awake for
    Administration route: Oral
    Indication: Pain

Naproxen (Aleve)
    Dosage: unspecified, 1 occasionally for few months 2-3 years ago
    Indication: Pain

Percocet
    Dosage: unk
    Indication: Pain

Tylenol
    Dosage: 1-2 tablets every 6 hours while awake for 3 weeks
    Administration route: Oral
    Indication: Pain

Other drugs received by patient: Diazepam



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