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Paracetamol Side Effects

Common Paracetamol Side Effects

The most commonly reported Paracetamol side effects (click to view or check a box to report):

Overdose (371)
Toxicity To Various Agents (169)
Intentional Overdose (140)
Acute Hepatic Failure (122)
Hepatic Failure (118)
Hepatic Necrosis (85)
Vomiting (81)
Hepatotoxicity (74)
Liver Injury (73)
Renal Failure Acute (66)
Metabolic Acidosis (64)
Completed Suicide (50)
Toxic Epidermal Necrolysis (46)
Hepatic Encephalopathy (45)
Nausea (43)
Hypotension (43)
Alanine Aminotransferase Increased (43)
Suicide Attempt (41)
Accidental Overdose (40)
Abdominal Pain (40)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Paracetamol Side Effects Reported to FDA

The following Paracetamol reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Paracetamol on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Hypertransaminasaemia
on Mar 12, 2014 Female from IT , 49 years of age, was diagnosed with and was treated with Paracetamol. Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: hypertransaminasaemia. Paracetamol dosage: Unk.
Associated medications used:
  • Humalog
  • Cardioaspirin
  • Ramipril (2.5 Mg)
Patient was hospitalized.

Hepatic Failure
Patient was taking Paracetamol. Patient felt the following Paracetamol side effects: hepatic failure on Mar 25, 2014 from GB Additional patient health information: Male , 38 years of age, . Paracetamol dosage: N/A. Patient was hospitalized.

Mania
Adverse event was reported on Mar 07, 2014 by a Male taking Paracetamol (Dosage: 1 G, Qid) was diagnosed with and. Location: US , 65 years of age, After Paracetamol was administered, patient encountered several Paracetamol side effects: mania.
Multiple concurrent drugs taken:
  • Ondansetron (4 Mg, Qd)
  • Eupantol (20 Mg, Qd)
  • Morphine (10 Mg, Qd)
  • Xarelto (10 Mg, Qd)
  • Droleptan (1 Mg, Qd)
  • Profenid (50 Mg, Qid)
  • Chlorhydrate De Nefopam (5 Mg, Q1h)
  • Dexamethason (4 Mg, Qd)
Patient was hospitalized.

Face Oedema, Lip Oedema, Pruritus, Urticaria, Anaphylactic Reaction
on Mar 05, 2014 Female from IT , 53 years of age, was diagnosed with and was treated with Paracetamol. Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: face oedema, lip oedema, pruritus, urticaria, anaphylactic reaction. Paracetamol dosage: 1000 Mg.
Associated medications used:
  • Brufen (600 Mg)



Febrile Neutropenia, Pneumonia
on Mar 17, 2014 Female from CN , 70 years of age, weighting 97.00 lb, was diagnosed with and was treated with Paracetamol. Patient felt the following Paracetamol side effects: febrile neutropenia, pneumonia. Paracetamol dosage: N/A.
Multiple prescriptions taken:
  • Solu-medrol
  • Tropisetron Hydrochloride
  • Tropisetron Hydrochloride
  • Cimetidine
  • Furosemide
  • Omeprazole Sodium
  • Obinutuzumab (Last Volume: 250 Ml, Last Dose Concentration: 4 Mg/ml)
  • Cyclophosphamide (Last Dose Prior To Sae: 14 Feb 2014, Last Dose: 1000 Mg)
Patient was hospitalized.

Hepatotoxicity, Decreased Appetite, Nausea, Vomiting, Abdominal Pain, Accidental Overdose
Patient was taking Paracetamol. After Paracetamol was administered, patient encountered several Paracetamol side effects: hepatotoxicity, decreased appetite, nausea, vomiting, abdominal pain, accidental overdose on Feb 27, 2014 from US Additional patient health information: Male , 56 years of age, was diagnosed with and. Paracetamol dosage: 2 Df, Q4h.
Multiple concurrent drugs taken:
  • Hydrocodone Bitartrate And Acetaminophen (1 Df, Q4h)
Patient was hospitalized.

Toxicity To Various Agents, Acute Hepatic Failure
Adverse event was reported on Mar 13, 2014 by a Female taking Paracetamol (Dosage: 100 Tablets) . Location: CN , 24 years of age, Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: toxicity to various agents, acute hepatic failure. Patient was hospitalized.

Hepatic Necrosis
on Feb 26, 2014 Male from FR , 45 years of age, was diagnosed with and was treated with Paracetamol. Patient felt the following Paracetamol side effects: hepatic necrosis. Paracetamol dosage: N/A.
Multiple prescriptions taken:
  • Rifampicin
  • Thiamphenicol


Hepatic Necrosis, Suicide Attempt
on Feb 26, 2014 Female from FR , 31 years of age, was treated with Paracetamol. After Paracetamol was administered, patient encountered several Paracetamol side effects: hepatic necrosis, suicide attempt. Paracetamol dosage: 30 G, Unk.
Multiple concurrent drugs taken:
  • Tramadol
  • Bromazepam
  • Zolpidem
  • Cetirizine


Hepatic Necrosis
Patient was taking Paracetamol. Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: hepatic necrosis on Feb 26, 2014 from FR Additional patient health information: Male , 54 years of age, was diagnosed with and. Paracetamol dosage: 8 G, Unk.

Hepatic Necrosis, Cholestasis
Adverse event was reported on Feb 25, 2014 by a Male taking Paracetamol (Dosage: 2 G, Unk) was diagnosed with and. Location: FR , 27 years of age, Patient felt the following Paracetamol side effects: hepatic necrosis, cholestasis.
Multiple prescriptions taken:
  • Tramadol


Hepatic Necrosis
on Feb 25, 2014 Male from FR , 59 years of age, was diagnosed with and was treated with Paracetamol. After Paracetamol was administered, patient encountered several Paracetamol side effects: hepatic necrosis. Paracetamol dosage: 4 G, Unk.

Toxicity To Various Agents, Acute Hepatic Failure, Abdominal Pain, Vomiting, Overdose
on Feb 21, 2014 Female from CN , 24 years of age, was treated with Paracetamol. Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: toxicity to various agents, acute hepatic failure, abdominal pain, vomiting, overdose. Paracetamol dosage: 100 Df, Unk. Patient was hospitalized.

Face Oedema, Oedema Peripheral, Urticaria
Patient was taking Paracetamol. Patient felt the following Paracetamol side effects: face oedema, oedema peripheral, urticaria on Feb 24, 2014 from IT Additional patient health information: Female , 53 years of age, . Paracetamol dosage: 3 Dosage Units Daily.

Toxicity To Various Agents, Loss Of Consciousness, Dyspnoea, Convulsion, Unresponsive To Stimuli
Adverse event was reported on Feb 19, 2014 by a Female taking Paracetamol (Dosage: N/A) . Location: FI , 77 years of age, After Paracetamol was administered, patient encountered several Paracetamol side effects: toxicity to various agents, loss of consciousness, dyspnoea, convulsion, unresponsive to stimuli.
Multiple concurrent drugs taken:
  • Oxazepam
  • Chlordiazepoxide
  • Morphine
  • Carbamazepine
  • Desmethyldiazepam


Psychotic Disorder
on Feb 19, 2014 Female from TR , 34 years of age, was diagnosed with and was treated with Paracetamol+phenylephrine+chlorphenamine. Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: psychotic disorder. Paracetamol+phenylephrine+chlorphenamine dosage: 650 Mg/10 Mg/4 Mg Per Tablet Bid.
Associated medications used:
  • Clarithromycin (500 Mg Per Tablet)
  • Butamirate Citrate (50 Mg Per Tablet)
Patient was hospitalized.

Bezoar, Overdose, Tachycardia
on Feb 27, 2014 Male from CH , 28 years of age, was treated with Paracetamol. Patient felt the following Paracetamol side effects: bezoar, overdose, tachycardia. Paracetamol dosage: Unk.
Multiple prescriptions taken:
  • Paliperidone Xr (Unk)
  • Codeine (Unk)
  • Seroquel Xr (24.4 G (61 Tablets))
Patient was hospitalized.

Anxiety, Chills, Feeling Cold, Rash
Patient was taking Paracetamol. After Paracetamol was administered, patient encountered several Paracetamol side effects: anxiety, chills, feeling cold, rash on Feb 11, 2014 from GB Additional patient health information: Female , 42 years of age, weighting 158.7 lb, . Paracetamol dosage: N/A.

Hypersensitivity Vasculitis
Adverse event was reported on Feb 17, 2014 by a Patient taking Paracetamol (Dosage: Unk) was diagnosed with and. Location: IT , child 10 years of age, Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: hypersensitivity vasculitis.

Sopor, Respiratory Acidosis, Respiratory Depression
on Feb 06, 2014 Female from IT , 56 years of age, was treated with Paracetamol. Patient felt the following Paracetamol side effects: sopor, respiratory acidosis, respiratory depression. Paracetamol dosage: 28 Dosage Forms Daily;.
Multiple prescriptions taken:
  • Venlafaxine (21 Dosage Forms Daily;)
  • Lexotan (51 Dosage Forms Daily;)
  • Patrol 37.5mg/325mg (4 Dosage Forms Daily; 1 Dosage Form = Tramadol 37.5mg + Paracetamol 325mg)
  • Moment (18 Dosage Forms Daily;)
  • Cipralex (18 Dosage Forms Daily;)
Patient was hospitalized.

Hypertransaminasaemia, Overdose
on Feb 21, 2014 Female from IT , 20 years of age, weighting 141.1 lb, was treated with Paracetamol. After Paracetamol was administered, patient encountered several Paracetamol side effects: hypertransaminasaemia, overdose. Paracetamol dosage: 8 G Complete. Patient was hospitalized.

Hepatic Enzyme Increased, International Normalised Ratio Increased
Patient was taking Paracetamol. Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: hepatic enzyme increased, international normalised ratio increased on Feb 05, 2014 from GB Additional patient health information: Female , 85 years of age, weighting 99.21 lb, was diagnosed with and. Paracetamol dosage: N/A.
Associated medications used:
  • Enoxaparin
  • Amitriptyline
  • Indapamide
  • Laxido
  • Oramorph
  • Seretide
  • Spiriva
  • Aspirin
Patient was hospitalized.

Rash Pruritic
Adverse event was reported on Feb 04, 2014 by a Female taking Paracetamol (Dosage: N/A) . Location: GB , 45 years of age, weighting 112.4 lb, Patient felt the following Paracetamol side effects: rash pruritic.

Hypersensitivity Vasculitis, Pruritus, Purpura, Rash Erythematous, Lymphocytic Infiltration, Extravasation
on Feb 03, 2014 Male from IT , child 10 years of age, was diagnosed with and was treated with Paracetamol. After Paracetamol was administered, patient encountered several Paracetamol side effects: hypersensitivity vasculitis, pruritus, purpura, rash erythematous, lymphocytic infiltration, extravasation. Paracetamol dosage: N/A.

Intentional Overdose, Sopor
on Jan 31, 2014 Male from IT , 36 years of age, was diagnosed with and was treated with Paracetamol. Directly after, patient experienced the unwanted or unexpected Paracetamol side effects: intentional overdose, sopor. Paracetamol dosage: 3000 Mg, Total.
Associated medications used:
  • Serenase /00015301/ (15 Ml, Total)
  • Depakin Chrono (8 Posological Units Total)
  • Seractil (10 Posolgical Units Total)
  • Spididol (6 Posological Units Total)
  • Oki (6 Posological Units Total)
  • Febrax
Patient was hospitalized.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

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