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Paracetamol Side Effects

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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.

Paracetamol Side Effects Reported to FDA



Paracetamol Side Effect Report#9999105
Hypertransaminasaemia
This is a report of a 49-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: pyrexia, who was treated with Paracetamol (dosage: Unk, start time:
Feb 01, 2014), combined with:
  • Humalog
  • Cardioaspirin
  • Ramipril (2.5 Mg)
and developed a serious reaction and side effect(s): Hypertransaminasaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paracetamol treatment in female patients, resulting in Hypertransaminasaemia side effect. The patient was hospitalized.
Paracetamol Side Effect Report#9995006
Hepatic Failure
This report suggests a potential Paracetamol Hepatic Failure side effect(s) that can have serious consequences. A 38-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Paracetamol (dosage: NA) starting NS. After starting Paracetamol the patient began experiencing various side effects, including: Hepatic FailureAdditional drugs used concurrently: NA.The patient was hospitalized. Although Paracetamol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatic Failure, may still occur.
Paracetamol Side Effect Report#9980726
Mania
This Mania problem was reported by a consumer or non-health professional from US. A 65-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: postoperative analgesia,procedural vomiting,prophylaxis against gastrointestinal ulcer. On
Sep 24, 2013 this consumer started treatment with Paracetamol (dosage: 1 G, Qid). The following drugs were being taken at the same time:
  • 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)
When using Paracetamol, the patient experienced the following unwanted symptoms/side effects: ManiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Mania, may become evident only after a product is in use by the general population.
Paracetamol Side Effect Report#9958407
Face Oedema, Lip Oedema, Pruritus, Urticaria, Anaphylactic Reaction
This Face Oedema side effect was reported by a health professional from IT. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: influenza,headache.The patient was prescribed Paracetamol (drug dosage: 1000 Mg), which was initiated on
Dec 06, 2013. Concurrently used drugs:
  • Brufen (600 Mg)
.After starting to take Paracetamol the consumer reported adverse symptoms, such as: Face Oedema, Lip Oedema, Pruritus, Urticaria, Anaphylactic ReactionThese side effects may potentially be related to Paracetamol.
Paracetamol Side Effect Report#9931842
Febrile Neutropenia, Pneumonia
This is a report of a 70-year-old female patient (weight: NA) from CN, suffering from the following health symptoms/conditions: allergy prophylaxis, who was treated with Paracetamol (dosage: NA, start time:
Feb 14, 2013), combined with:
  • 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)
and developed a serious reaction and side effect(s): Febrile Neutropenia, Pneumonia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paracetamol treatment in female patients, resulting in Febrile Neutropenia side effect. The patient was hospitalized.
Paracetamol Side Effect Report#9929951
Hepatotoxicity, Decreased Appetite, Nausea, Vomiting, Abdominal Pain, Accidental Overdose
This report suggests a potential Paracetamol Hepatotoxicity side effect(s) that can have serious consequences. A 56-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pain and used Paracetamol (dosage: 2 Df, Q4h) starting NS. After starting Paracetamol the patient began experiencing various side effects, including: Hepatotoxicity, Decreased Appetite, Nausea, Vomiting, Abdominal Pain, Accidental OverdoseAdditional drugs used concurrently:
  • Hydrocodone Bitartrate And Acetaminophen (1 Df, Q4h)
The patient was hospitalized. Although Paracetamol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatotoxicity, may still occur.
Paracetamol Side Effect Report#9927803
Toxicity To Various Agents, Acute Hepatic Failure
This Toxicity To Various Agents problem was reported by a health professional from CN. A 24-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Paracetamol (dosage: 100 Tablets). The following drugs were being taken at the same time: NA. When using Paracetamol, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various Agents, Acute Hepatic FailureThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Paracetamol Side Effect Report#9926107
Hepatic Necrosis
This Hepatic Necrosis side effect was reported by a health professional from FR. A 45-year-old male patient (weight:NA) experienced the following symptoms/conditions: sepsis.The patient was prescribed Paracetamol (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Rifampicin
  • Thiamphenicol
.After starting to take Paracetamol the consumer reported adverse symptoms, such as: Hepatic NecrosisThese side effects may potentially be related to Paracetamol.
Paracetamol Side Effect Report#9926098
Hepatic Necrosis, Suicide Attempt
This is a report of a 31-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Paracetamol (dosage: 30 G, Unk, start time: NS), combined with:
  • Tramadol
  • Bromazepam
  • Zolpidem
  • Cetirizine
and developed a serious reaction and side effect(s): Hepatic Necrosis, Suicide Attempt after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paracetamol treatment in female patients, resulting in Hepatic Necrosis side effect.
Paracetamol Side Effect Report#9926095
Hepatic Necrosis
This report suggests a potential Paracetamol Hepatic Necrosis side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: abdominal pain and used Paracetamol (dosage: 8 G, Unk) starting NS. After starting Paracetamol the patient began experiencing various side effects, including: Hepatic NecrosisAdditional drugs used concurrently: NA. Although Paracetamol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatic Necrosis, may still occur.
Paracetamol Side Effect Report#9922436
Hepatic Necrosis, Cholestasis
This Hepatic Necrosis problem was reported by a health professional from FR. A 27-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: craniocerebral injury. On NS this consumer started treatment with Paracetamol (dosage: 2 G, Unk). The following drugs were being taken at the same time:
  • Tramadol
When using Paracetamol, the patient experienced the following unwanted symptoms/side effects: Hepatic Necrosis, CholestasisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatic Necrosis, may become evident only after a product is in use by the general population.
Paracetamol Side Effect Report#9922435
Hepatic Necrosis
This Hepatic Necrosis side effect was reported by a health professional from FR. A 59-year-old male patient (weight:NA) experienced the following symptoms/conditions: abdominal pain.The patient was prescribed Paracetamol (drug dosage: 4 G, Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Paracetamol the consumer reported adverse symptoms, such as: Hepatic NecrosisThese side effects may potentially be related to Paracetamol.
Paracetamol Side Effect Report#9917559
Toxicity To Various Agents, Acute Hepatic Failure, Abdominal Pain, Vomiting, Overdose
This is a report of a 24-year-old female patient (weight: NA) from CN, suffering from the following health symptoms/conditions: NA, who was treated with Paracetamol (dosage: 100 Df, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Toxicity To Various Agents, Acute Hepatic Failure, Abdominal Pain, Vomiting, Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paracetamol treatment in female patients, resulting in Toxicity To Various Agents side effect. The patient was hospitalized.
Paracetamol Side Effect Report#9915298
Face Oedema, Oedema Peripheral, Urticaria
This report suggests a potential Paracetamol Face Oedema side effect(s) that can have serious consequences. A 53-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: NA and used Paracetamol (dosage: 3 Dosage Units Daily) starting
Dec 27, 2013. After starting Paracetamol the patient began experiencing various side effects, including: Face Oedema, Oedema Peripheral, UrticariaAdditional drugs used concurrently: NA. Although Paracetamol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Face Oedema, may still occur.
Paracetamol Side Effect Report#9911434
Toxicity To Various Agents, Loss Of Consciousness, Dyspnoea, Convulsion, Unresponsive To Stimuli
This Toxicity To Various Agents problem was reported by a health professional from FI. A 77-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Paracetamol (dosage: NA). The following drugs were being taken at the same time:
  • Oxazepam
  • Chlordiazepoxide
  • Morphine
  • Carbamazepine
  • Desmethyldiazepam
When using Paracetamol, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various Agents, Loss Of Consciousness, Dyspnoea, Convulsion, Unresponsive To StimuliAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Paracetamol Side Effect Report#9910739
Psychotic Disorder
This Psychotic Disorder side effect was reported by a physician from TR. A 34-year-old female patient (weight:NA) experienced the following symptoms/conditions: upper respiratory tract infection.The patient was prescribed Paracetamol+phenylephrine+chlorphenamine (drug dosage: 650 Mg/10 Mg/4 Mg Per Tablet Bid), which was initiated on 2013. Concurrently used drugs:
  • Clarithromycin (500 Mg Per Tablet)
  • Butamirate Citrate (50 Mg Per Tablet)
.After starting to take Paracetamol+phenylephrine+chlorphenamine the consumer reported adverse symptoms, such as: Psychotic DisorderThese side effects may potentially be related to Paracetamol+phenylephrine+chlorphenamine. The patient was hospitalized.
Paracetamol Side Effect Report#9893284
Bezoar, Overdose, Tachycardia
This is a report of a 28-year-old male patient (weight: NA) from CH, suffering from the following health symptoms/conditions: NA, who was treated with Paracetamol (dosage: Unk, start time: NS), combined with:
  • Paliperidone Xr (Unk)
  • Codeine (Unk)
  • Seroquel Xr (24.4 G (61 Tablets))
and developed a serious reaction and side effect(s): Bezoar, Overdose, Tachycardia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paracetamol treatment in male patients, resulting in Bezoar side effect. The patient was hospitalized.
Paracetamol Side Effect Report#9887387
Anxiety, Chills, Feeling Cold, Rash
This report suggests a potential Paracetamol Anxiety side effect(s) that can have serious consequences. A 42-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Paracetamol (dosage: NA) starting
Jan 28, 2014. After starting Paracetamol the patient began experiencing various side effects, including: Anxiety, Chills, Feeling Cold, RashAdditional drugs used concurrently: NA. Although Paracetamol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anxiety, may still occur.
Paracetamol Side Effect Report#9883810
Hypersensitivity Vasculitis
This Hypersensitivity Vasculitis problem was reported by a health professional from IT. A 10-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: influenza like illness. On NS this consumer started treatment with Paracetamol (dosage: Unk). The following drugs were being taken at the same time: NA. When using Paracetamol, the patient experienced the following unwanted symptoms/side effects: Hypersensitivity VasculitisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypersensitivity Vasculitis, may become evident only after a product is in use by the general population.
Paracetamol Side Effect Report#9879742
Sopor, Respiratory Acidosis, Respiratory Depression
This Sopor side effect was reported by a physician from IT. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Paracetamol (drug dosage: 28 Dosage Forms Daily;), which was initiated on
Aug 05, 2012. Concurrently used drugs:
  • 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;)
.After starting to take Paracetamol the consumer reported adverse symptoms, such as: Sopor, Respiratory Acidosis, Respiratory DepressionThese side effects may potentially be related to Paracetamol. The patient was hospitalized.
Paracetamol Side Effect Report#9877102
Hypertransaminasaemia, Overdose
This is a report of a 20-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Paracetamol (dosage: 8 G Complete, start time:
Jun 19, 2012), combined with: NA. and developed a serious reaction and side effect(s): Hypertransaminasaemia, Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paracetamol treatment in female patients, resulting in Hypertransaminasaemia side effect. The patient was hospitalized.
Paracetamol Side Effect Report#9872296
Hepatic Enzyme Increased, International Normalised Ratio Increased
This report suggests a potential Paracetamol Hepatic Enzyme Increased side effect(s) that can have serious consequences. A 85-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: abdominal pain and used Paracetamol (dosage: NA) starting
Jan 03, 2014. After starting Paracetamol the patient began experiencing various side effects, including: Hepatic Enzyme Increased, International Normalised Ratio IncreasedAdditional drugs used concurrently:
  • Enoxaparin
  • Amitriptyline
  • Indapamide
  • Laxido
  • Oramorph
  • Seretide
  • Spiriva
  • Aspirin
The patient was hospitalized. Although Paracetamol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatic Enzyme Increased, may still occur.
Paracetamol Side Effect Report#9866472
Rash Pruritic
This Rash Pruritic problem was reported by a physician from GB. A 45-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 22, 2014 this consumer started treatment with Paracetamol (dosage: NA). The following drugs were being taken at the same time: NA. When using Paracetamol, the patient experienced the following unwanted symptoms/side effects: Rash PruriticAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rash Pruritic, may become evident only after a product is in use by the general population.
Paracetamol Side Effect Report#9865126
Hypersensitivity Vasculitis, Pruritus, Purpura, Rash Erythematous, Lymphocytic Infiltration, Extravasation
This Hypersensitivity Vasculitis side effect was reported by a health professional from IT. A 10-year-old male patient (weight:NA) experienced the following symptoms/conditions: influenza like illness,pyrexia.The patient was prescribed Paracetamol (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Paracetamol the consumer reported adverse symptoms, such as: Hypersensitivity Vasculitis, Pruritus, Purpura, Rash Erythematous, Lymphocytic Infiltration, ExtravasationThese side effects may potentially be related to Paracetamol.
Paracetamol Side Effect Report#9859851
Intentional Overdose, Sopor
This is a report of a 36-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: suicide attempt, who was treated with Paracetamol (dosage: 3000 Mg, Total, start time:
Sep 13, 2013), combined with:
  • 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
and developed a serious reaction and side effect(s): Intentional Overdose, Sopor after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paracetamol treatment in male patients, resulting in Intentional Overdose side effect. The patient was hospitalized.


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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.


What are common Paracetamol Side Effects for Women?

Women Side EffectsReports
Overdose 208
Toxicity To Various Agents 115
Intentional Overdose 91
Hepatic Failure 80
Acute Hepatic Failure 72
Vomiting 50
Metabolic Acidosis 45
Liver Injury 44
Hepatotoxicity 37
Renal Failure Acute 31

What are common Paracetamol Side Effects for Men?

Men Side EffectsReports
Overdose 131
Toxicity To Various Agents 52
Intentional Overdose 41
Acute Hepatic Failure 39
Hepatotoxicity 36
Hepatic Failure 35
Renal Failure Acute 35
Vomiting 31
Hepatic Necrosis 25
Liver Injury 24

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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 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.

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