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Constipation (66)
Dry Mouth (23)
Loss Of Appetite (20)
Hypotension (16)
Diarrhea (11)
Dry Mouth And Loss Of Appetite (11)
Stomach Pains (10)
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Paracetamol Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 1024 

Nausea, Thrombocytopenia, Dizziness, Dyspnoea, Cardiac Pacemaker Insertion, Blood Creatinine Increased, Contusion, Glomerular Filtration Rate Decreased, Blood Potassium Increased (8108492-1)
on Jan 30, 2012 Male from UNITED KINGDOM , 83 years of age, weighting 147.7 lb, was diagnosed with
  • osteoarthritis
and was treated with Paracetamol. Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: nausea, thrombocytopenia, dizziness, dyspnoea, cardiac pacemaker insertion, blood creatinine increased, contusion, glomerular filtration rate decreased, blood potassium increased. Paracetamol dosage: 500 Mg, 2x/day.
Associated medications used:
  • Furosemide (20 Mg Daily)
  • Loperamide (2-4 Mg Daily)
  • Atorvastatin (10 Mg Daily)
  • Acetylsalicylic Acid (75 Mg Daily)
  • Furosemide (40 Mg Daily)
  • Inspra
  • Diltiazem - Slow Release (120 Mg, 2x/day)
  • Captopril (12.5 Mg, 2x/day)


Restlessness (8074639-9)
Patient was taking Paracetamol. Patient felt the following Paracetamol side effects: restlessness on Jan 23, 2012 from UNITED KINGDOM Additional patient health information: Female , 74 years of age, weighting 154.3 lb, . Paracetamol dosage: Unk.
Multiple prescriptions taken:
  • Ramipril (Unk)
  • Fluorouracil (Unk)
  • Diltiazem Hcl (Unk)
  • Acetylsalicylic Acid (Unk)
  • Levothyroxine (Unk)
  • Simvastatin (Unk)
  • Hydroxocobalamin (Unk)
  • Simvastatin (Unk)


Atrial Fibrillation (8072602-5)
Adverse event was reported on Jan 16, 2012 by a Male taking Paracetamol (Dosage: 500 Mg, 1x/day) . Location: BULGARIA , 69 years of age, weighting 202.8 lb, After Paracetamol was administered, patient encountered several Paracetamol side effects: atrial fibrillation.
Multiple concurrent drugs taken:
  • Inotuzumab Ozogamicin (3.85 Mg, Unk)
  • Rituximab (800 Mg, Unk)
  • Sotahexal (160 Mg, 2x/day)
  • Solu-medrol (80 Mg, 1x/day)
  • Clarinase (Unk)
Patient was hospitalized.

Toxicity To Various Agents (8070518-1)
on Jan 06, 2011 Female from UNITED STATES , 31 years of age, was treated with Paracetamol/diphenhydramine. Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: toxicity to various agents. Paracetamol/diphenhydramine dosage: N/A.


Toxicity To Various Agents (8070517-X)
on Jan 06, 2011 Male from UNITED STATES , 26 years of age, was treated with Paracetamol/diphenhydramine. Patient felt the following Paracetamol side effects: toxicity to various agents. Paracetamol/diphenhydramine dosage: N/A.

Toxicity To Various Agents (8070515-6)
Patient was taking Paracetamol/diphenhydramine. After Paracetamol was administered, patient encountered several Paracetamol side effects: toxicity to various agents on Jan 06, 2011 from UNITED STATES Additional patient health information: Female , 23 years of age, . Paracetamol/diphenhydramine dosage: N/A.

Toxicity To Various Agents (8070514-4)
Adverse event was reported on Jan 06, 2011 by a Female taking Paracetamol/diphenhydramine (Dosage: N/A) . Location: UNITED STATES , 19 years of age, Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: toxicity to various agents. Patient was hospitalized.

Completed Suicide, Toxicity To Various Agents (8069934-3)
on Jan 06, 2011 Female from UNITED STATES , 17 years of age, was treated with Paracetamol/diphenhydramine. Patient felt the following Paracetamol side effects: completed suicide, toxicity to various agents. Paracetamol/diphenhydramine dosage: N/A.

Toxicity To Various Agents (8069933-1)
on Jan 06, 2011 Male from UNITED STATES , 58 years of age, was treated with Paracetamol/diphenhydramine. After Paracetamol was administered, patient encountered several Paracetamol side effects: toxicity to various agents. Paracetamol/diphenhydramine dosage: N/A.
Multiple concurrent drugs taken:
  • Ethanol
  • Carbon
  • Acetaminophen/diphenhydramine


Completed Suicide, Toxicity To Various Agents (8069931-8)
Patient was taking Paracetamol/diphenhydraine. Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: completed suicide, toxicity to various agents on Jan 06, 2011 from UNITED STATES Additional patient health information: Female , 18 years of age, . Paracetamol/diphenhydraine dosage: N/A.

Dyspnoea, Atrial Fibrillation, Hypotension, Chest Pain, Malaise, Atrial Flutter, Electrocardiogram Qt Prolonged (8068931-1)
Adverse event was reported on Jan 05, 2012 by a Female taking Paracetamol (paracetamol) (tablets) (paracetamol) (Dosage: N/A) . Location: DENMARK , 94 years of age, weighting 99.21 lb, Patient felt the following Paracetamol side effects: dyspnoea, atrial fibrillation, hypotension, chest pain, malaise, atrial flutter, electrocardiogram qt prolonged.
Multiple prescriptions taken:
  • Nitrofurantoin (nitrofurantoin) (tablets) (ntrofurantoin)
  • Trazodone Hydrochloride (50 Mg (50 Mg,1 In 1 D),oral)
  • Memantine Hydrochloride (memantine Hydrochloride) (tablets) (memantine
  • Tramadol Hydrochloride (tramadol Hydrochloride) (tablets) (tramadol Hy
  • Escitalopram Oxalate (5 Mg (5 Mg,1 In 1 D),oral)
  • Furosemide (furosemde) (tablets) (furosemide)
  • Losartan (losartan) (tablets) (losartan)
Patient was hospitalized.

Toxicity To Various Agents (8066247-0)
on Jan 06, 2011 Female from UNITED STATES , 39 years of age, was treated with Paracetamol/diphenhydramine. After Paracetamol was administered, patient encountered several Paracetamol side effects: toxicity to various agents. Paracetamol/diphenhydramine dosage: N/A.
Multiple concurrent drugs taken:
  • Ethanol
Patient was hospitalized.

Toxicity To Various Agents (8066229-9)
on Jan 06, 2011 Female from UNITED STATES , 30 years of age, was treated with Paracetamol/diphenhydramine. Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: toxicity to various agents. Paracetamol/diphenhydramine dosage: N/A.
Associated medications used:
  • Clomipramine Hcl
  • Ethanol
  • Sulfamethoxazole And Trimethoprim
  • Acetaminophen And Hydrocodone Bitartrate


Toxicity To Various Agents (8066227-5)
Patient was taking Paracetamol/diphenhydramine. Patient felt the following Paracetamol side effects: toxicity to various agents on Jan 06, 2011 from UNITED STATES Additional patient health information: Male , 27 years of age, . Paracetamol/diphenhydramine dosage: N/A.
Multiple prescriptions taken:
  • Acetaminophen And Hydrocodone Bitartrate
  • Acetaminophen With Propoxyphene Hcl Tab


Blood Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Nausea, Coagulopathy, Blood Bilirubin Increased, Overdose, Hepatic Function Abnormal, Biliary Dilatation (8063669-9)
Adverse event was reported on Jan 10, 2012 by a Female taking Paracetamol/diphenhydramine (Dosage: N/A) . Location: UNITED STATES , 56 years of age, weighting 130.1 lb, After Paracetamol was administered, patient encountered several Paracetamol side effects: blood alkaline phosphatase increased, aspartate aminotransferase increased, alanine aminotransferase increased, nausea, coagulopathy, blood bilirubin increased, overdose, hepatic function abnormal, biliary dilatation.
Multiple concurrent drugs taken:
  • Vicodin
  • Quetiapine
  • Citalopram Hydrobromide
  • Trazodone Hcl
Patient was hospitalized.

Intentional Overdose, Vomiting, Abdominal Pain, Intentional Self-injury, Transaminases Increased (8059135-7)
on Jan 10, 2012 Female from UNITED STATES , 30 years of age, weighting 156.5 lb, was treated with Paracetamol/diphenhydramine Hcl. Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: intentional overdose, vomiting, abdominal pain, intentional self-injury, transaminases increased. Paracetamol/diphenhydramine Hcl dosage: 2 'handfuls' Of The Producton 08may2011. Patient was hospitalized.

Intentional Overdose, Nausea, Aspartate Aminotransferase Increased, Intentional Self-injury, Vomiting (8059092-3)
on Jan 10, 2012 Female from UNITED STATES , 35 years of age, weighting 202.8 lb, was treated with Paracetamol/diphenhydramine. Patient felt the following Paracetamol side effects: intentional overdose, nausea, aspartate aminotransferase increased, intentional self-injury, vomiting. Paracetamol/diphenhydramine dosage: N/A. Patient was hospitalized.

Vomiting, Intentional Overdose, Nausea, Self Injurious Behaviour, Aspartate Aminotransferase Increased (8056692-1)
Patient was taking Paracetamol/diphenhydramine. After Paracetamol was administered, patient encountered several Paracetamol side effects: vomiting, intentional overdose, nausea, self injurious behaviour, aspartate aminotransferase increased on Jan 10, 2012 from UNITED STATES Additional patient health information: Female , 23 years of age, weighting 134.7 lb, . Paracetamol/diphenhydramine dosage: N/A. Patient was hospitalized.

Intentional Overdose, Somnolence, Vomiting, Intentional Self-injury (8053173-6)
Adverse event was reported on Jan 10, 2012 by a Female taking Paracetamol/diphenhydramine Hcl (Dosage: N/A) . Location: UNITED STATES , 42 years of age, weighting 198.4 lb, Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: intentional overdose, somnolence, vomiting, intentional self-injury. Patient was hospitalized.

Pleural Effusion, Pericardial Effusion, Blood Albumin Decreased (8045396-7)
on Jan 04, 2012 Female from IRELAND , 49 years of age, weighting 135.6 lb, was treated with Paracetamol. Patient felt the following Paracetamol side effects: pleural effusion, pericardial effusion, blood albumin decreased. Paracetamol dosage: 1 G, As Needed.
Multiple prescriptions taken:
  • Crizotinib (250 Mg, 2x/day)
  • Crizotinib (250 Mg, 2x/day)
Patient was hospitalized.

Toxicity To Various Agents (8034062-X)
on Jan 02, 2012 Female from UNITED STATES , 63 years of age, was treated with Paracetamol + Diphenhydramine. After Paracetamol was administered, patient encountered several Paracetamol side effects: toxicity to various agents. Paracetamol + Diphenhydramine dosage: Unk.

Toxicity To Various Agents (8031196-0)
Patient was taking Paracetamol + Diphenhydramine. Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: toxicity to various agents on Jan 02, 2012 from UNITED STATES Additional patient health information: Male , 17 years of age, . Paracetamol + Diphenhydramine dosage: N/A.
Associated medications used:
  • Acetaminophen


Toxicity To Various Agents, Completed Suicide (8030265-9)
Adverse event was reported on Jan 02, 2012 by a Female taking Paracetamol + Diphenhydramine (Dosage: N/A) . Location: UNITED STATES , 56 years of age, Patient felt the following Paracetamol side effects: toxicity to various agents, completed suicide.

Toxicity To Various Agents (8030209-X)
on Jan 02, 2012 Female from UNITED STATES , 39 years of age, was diagnosed with
  • completed suicide
and was treated with Paracetamol + Diphenhydramine. After Paracetamol was administered, patient encountered several Paracetamol side effects: toxicity to various agents. Paracetamol + Diphenhydramine dosage: N/A.
Multiple concurrent drugs taken:
  • Ethanol
  • Alprazolam
  • Venlafaxine


Respiratory Arrest, Toxicity To Various Agents, Cardiac Arrest (8030208-8)
on Jan 02, 2012 Male from UNITED STATES , 42 years of age, was treated with Paracetamol + Diphenhydramine. Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: respiratory arrest, toxicity to various agents, cardiac arrest. Paracetamol + Diphenhydramine dosage: N/A.
Associated medications used:
  • Ethanol
  • Acetaminophen W/ Propoxyphene Hcl


Showing 1-25 of 1024 

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Paracetamol Information

More About Paracetamol

Side Effects reported to FDA: 1024. View Paracetamol Adverse Reports

Paracetamol safety alerts: No

Reported deaths: 197

Reported hospitalizations: 569

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