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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
This is a report of a 49-year-old female patient (weight: NA) from IT, suffering from the following 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). The consumer presented with:
  • Hypertransaminasaemia
which developed 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.

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. Soon after starting Paracetamol the patient began experiencing various side effects, including:
  • Hepatic Failure
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.

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 commencing Paracetamol, the patient experienced the following unwanted symptoms/side effects:
  • Mania
The 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.

Face Oedema, Lip Oedema, Pruritus, Urticaria, Anaphylactic Reaction
This is a report of a 53-year-old female patient (weight: NA) from IT. The patient developed the following symptoms/conditions: influenza,headache and was treated with Paracetamol (dosage: 1000 Mg) starting Dec 06, 2013. Concurrently used drugs:
  • Brufen (600 Mg)
Soon after that, the consumer experienced the following side effects:
  • Face Oedema
  • Lip Oedema
  • Pruritus
  • Urticaria
  • Anaphylactic Reaction
This opens a possibility that Paracetamol treatment could cause the above reactions, including face oedema, and some female subjects may be more susceptible.


Febrile Neutropenia, Pneumonia
A 70-year-old female patient (weight: NA) from CN with the following symptoms/conditions: allergy prophylaxis started Paracetamol treatment (dosage: NA) on Feb 14, 2013. Soon after starting Paracetamol treatment, the subject experienced various side effects, including:
  • Febrile Neutropenia
  • Pneumonia
Concurrently used drugs:
  • 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)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Paracetamol.

Hepatotoxicity, Decreased Appetite, Nausea, Vomiting, Abdominal Pain, Accidental Overdose
A 56-year-old male patient from US (weight: NA) experienced symptoms, such as: pain and was treated with Paracetamol(dosage: 2 Df, Q4h). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Hepatotoxicity
  • Decreased Appetite
  • Nausea
  • Vomiting
  • Abdominal Pain
  • Accidental Overdose
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Paracetamol efficacy:
  • Hydrocodone Bitartrate And Acetaminophen (1 Df, Q4h)
The patient was hospitalized.

Toxicity To Various Agents, Acute Hepatic Failure
In this report, Paracetamol was administered for the following condition: NA.A 24-year-old female consumer from CN (weight: NA) started Paracetamol treatment (dosage: 100 Tablets) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Toxicity To Various Agents
  • Acute Hepatic Failure
A possible interaction with other drugs could have contributed to this reaction: NA.The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Paracetamol treatment could be related to the listed above side effect(s).

Hepatic Necrosis
This is a report of the following Paracetamol side effect(s):
  • Hepatic Necrosis
A 45-year-old male patient from FR (weight: NA) presented with the following condition: sepsis and received a treatment with Paracetamol (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions:
  • Rifampicin
  • Thiamphenicol
This report suggests that a Paracetamol treatment could be associated with the listed above side effect(s).

Hepatic Necrosis, Suicide Attempt
This Paracetamol report was submitted by a 31-year-old female consumer from FR (weight: NA). The patient was diagnosed with: NA and Paracetamol was administered (dosage: 30 G, Unk) starting: NS. The consumer developed a set of symptoms:
  • Hepatic Necrosis
  • Suicide Attempt
Other drugs used simultaneously:
  • Tramadol
  • Bromazepam
  • Zolpidem
  • Cetirizine
Those unexpected symptoms could be linked to a Paracetamol treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Hepatic Necrosis
This is a report of a possible correlation between Paracetamol use and the following symptoms/side effect(s):
  • Hepatic Necrosis
which could contribute to an assessment of Paracetamol risk profile.A 54-year-old male consumer from FR (weight: NA) was suffering from abdominal pain and was treated with Paracetamol (dosage: 8 G, Unk) starting NS.Other concurrent medications: NA.

Hepatic Necrosis, Cholestasis
A 27-year-old male patient from FR (weight: NA) presented with the following symptoms: craniocerebral injury and after a treatment with Paracetamol (dosage: 2 G, Unk) experienced the following side effect(s):
  • Hepatic Necrosis
  • Cholestasis
The treatment was started on NS. Paracetamol was used in combination with the following drugs:
  • Tramadol
This report could alert potential Paracetamol consumers.

Hepatic Necrosis
In this report, a 59-year-old male patient from FR (weight: NA) was affected by a possible Paracetamol side effect.The patient was diagnosed with abdominal pain. After a treatment with Paracetamol (dosage: 4 G, Unk, start date: NS), the patient experienced the following side effect(s):
  • Hepatic Necrosis
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Paracetamol treatment.

Toxicity To Various Agents, Acute Hepatic Failure, Abdominal Pain, Vomiting, Overdose
This is a report of a 24-year-old female patient from CN (weight: NA), who used Paracetamol (dosage: 100 Df, Unk) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Toxicity To Various Agents
  • Acute Hepatic Failure
  • Abdominal Pain
  • Vomiting
  • Overdose
The following drugs could possibly have interacted with the Paracetamol treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Paracetamol treatment could be related to side effect(s), such as Toxicity To Various Agents, Acute Hepatic Failure, Abdominal Pain, Vomiting, Overdose.

Face Oedema, Oedema Peripheral, Urticaria
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: NA. The patient was prescribed Paracetamol (dosage: 3 Dosage Units Daily), which was started on Dec 27, 2013. Concurrently used drugs: NA. When starting to take Paracetamol the consumer reported the following symptoms:
  • Face Oedema
  • Oedema Peripheral
  • Urticaria
These side effects may potentially be related to Paracetamol.

Toxicity To Various Agents, Loss Of Consciousness, Dyspnoea, Convulsion, Unresponsive To Stimuli
This is a Paracetamol side effect report of a 77-year-old female patient (weight:NA) from FI, suffering from the following symptoms/conditions: NA, who was treated with Paracetamol (dosage:NA, start time: NS), combined with:
  • Oxazepam
  • Chlordiazepoxide
  • Morphine
  • Carbamazepine
  • Desmethyldiazepam
, and developed a serious reaction and a toxicity to various agents side effect. The patient presented with:
  • Toxicity To Various Agents
  • Loss Of Consciousness
  • Dyspnoea
  • Convulsion
  • Unresponsive To Stimuli
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Paracetamol treatment in female patients suffering from NA, resulting in toxicity to various agents.

Psychotic Disorder
This report suggests a potential Paracetamol+phenylephrine+chlorphenamine psychotic disorder side effect(s) that can have serious consequences. A 34-year-old female patient from TR (weight:NA) was diagnosed with the following health condition(s): upper respiratory tract infection and used Paracetamol+phenylephrine+chlorphenamine (dosage: 650 Mg/10 Mg/4 Mg Per Tablet Bid) starting 2013. Soon after starting Paracetamol+phenylephrine+chlorphenamine the patient began experiencing various side effects, including:
  • Psychotic Disorder
Drugs used concurrently:
  • Clarithromycin (500 Mg Per Tablet)
  • Butamirate Citrate (50 Mg Per Tablet)
The patient was hospitalized. Although Paracetamol+phenylephrine+chlorphenamine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as psychotic disorder, may still occur.

Bezoar, Overdose, Tachycardia
This bezoar problem was reported by a health professional from CH. A 28-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Paracetamol (dosage: Unk). The following drugs/medications were being taken at the same time:
  • Paliperidone Xr (Unk)
  • Codeine (Unk)
  • Seroquel Xr (24.4 G (61 Tablets))
When commencing Paracetamol, the patient experienced the following unwanted symptoms /side effects:
  • Bezoar
  • Overdose
  • Tachycardia
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as bezoar, may become evident only after a product is in use by the general population.

Anxiety, Chills, Feeling Cold, Rash
This is a Paracetamol side effect report of a 42-year-old female patient (weight: NA) from GB. The patient developed the following symptoms/conditions: NA and was treated with Paracetamol (dosage: NA) starting Jan 28, 2014. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Anxiety
  • Chills
  • Feeling Cold
  • Rash
This opens a possibility that Paracetamol could cause anxiety and that some female patients may be more susceptible.

Hypersensitivity Vasculitis
A 10-year-old patient (weight: NA) from IT with the following symptoms: influenza like illness started Paracetamol treatment (dosage: Unk) on NS. Soon after starting Paracetamol treatment, the consumer experienced several side effects, including:
  • Hypersensitivity Vasculitis
. Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Paracetamol side effects, such as hypersensitivity vasculitis.

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 (dosage: 28 Dosage Forms Daily;), which was started 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;)
.When starting to take Paracetamol the consumer reported symptoms, such as:
  • Sopor
  • Respiratory Acidosis
  • Respiratory Depression
These side effects may potentially be related to Paracetamol. The patient was hospitalized.

Hypertransaminasaemia, Overdose
This is a report of a 20-year-old female patient (weight: NA) from IT, suffering from the following 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). The consumer presented with:
  • Hypertransaminasaemia
  • Overdose
which developed 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.

Hepatic Enzyme Increased, International Normalised Ratio Increased
This report suggests a potential Paracetamol Hepatic Enzyme Increased, International Normalised Ratio 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. Soon after starting Paracetamol the patient began experiencing various side effects, including:
  • Hepatic Enzyme Increased
  • International Normalised Ratio Increased
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.

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 commencing Paracetamol, the patient experienced the following unwanted symptoms/side effects:
  • Rash Pruritic
Although 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.

Hypersensitivity Vasculitis, Pruritus, Purpura, Rash Erythematous, Lymphocytic Infiltration, Extravasation
This is a report of a 10-year-old male patient (weight: NA) from IT. The patient developed the following symptoms/conditions: influenza like illness,pyrexia and was treated with Paracetamol (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Hypersensitivity Vasculitis
  • Pruritus
  • Purpura
  • Rash Erythematous
  • Lymphocytic Infiltration
  • Extravasation
This opens a possibility that Paracetamol treatment could cause the above reactions, including hypersensitivity vasculitis, and some male subjects may be more susceptible.

Intentional Overdose, Sopor
A 36-year-old male patient (weight: NA) from IT with the following symptoms/conditions: suicide attempt started Paracetamol treatment (dosage: 3000 Mg, Total) on Sep 13, 2013. Soon after starting Paracetamol treatment, the subject experienced various side effects, including:
  • Intentional Overdose
  • Sopor
Concurrently used drugs:
  • 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
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Paracetamol.

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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

    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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