Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Acetaminophen
Drug ID BADD_D00023
Description Acetaminophen (paracetamol), also commonly known as _Tylenol_, is the most commonly taken analgesic worldwide and is recommended as first-line therapy in pain conditions by the World Health Organization (WHO).[A176318] It is also used for its antipyretic effects, helping to reduce fever.[F4124] This drug was initially approved by the U.S. FDA in 1951 and is available in a variety of forms including syrup form, regular tablets, effervescent tablets, injection, suppository, and other forms.[L5756,L5774,F4124,Label] Acetaminophen is often found combined with other drugs in more than 600 over the counter (OTC) allergy medications, cold medications, sleep medications, pain relievers, and other products.[L5783] Confusion about dosing of this drug may be caused by the availability of different formulas, strengths, and dosage instructions for children of different ages.[L5783] Due to the possibility of fatal overdose and liver failure associated with the incorrect use of acetaminophen, it is important to follow current and available national and manufacturer dosing guidelines while this drug is taken or prescribed.[L5786,L5789,Label]
Indications and Usage In general, acetaminophen is used for the treatment of mild to moderate pain and reduction of fever.[F4124] It is available over the counter in various forms, the most common being oral forms. Acetaminophen _injection_ is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.[Label] Because of its low risk of causing allergic reactions, this drug can be administered in patients who are intolerant to salicylates and those with allergic tendencies, including bronchial asthmatics.[F4124] Specific dosing guidelines should be followed when administering acetaminophen to children.[L5780]
Marketing Status approved
ATC Code N02BE01
DrugBank ID DB00316
KEGG ID D00217
MeSH ID D000082
PubChem ID 1983
TTD Drug ID D0U5QK
NDC Product Code 73408-174; 76281-501; 79903-032; 79903-174; 82501-1575; 0904-6645; 0113-4004; 0406-0422; 0406-4255; 0406-7375; 0904-6773; 0904-6883; 25000-901; 0904-7278; 0904-7320; 0924-0128; 51114-0218; 51114-0221; 53604-702; 58103-115; 59644-9910; 59644-9918; 59644-9920; 59917-026; 66326-203; 70120-021; 81919-001; 11673-133; 11673-241; 11673-759; 11673-838; 11673-841; 11822-1575; 11822-9440; 17856-0179; 21130-356; 30142-033; 30142-157; 30142-507; 36800-435; 36800-766; 36800-991; 0113-8959; 0121-1314; 0121-1781; 37808-161; 0135-0537; 41250-317; 0135-7011; 41520-709; 41520-818; 45865-656; 46122-630; 47682-174; 49035-175; 49035-741; 49348-430; 49348-973; 49638-106; 49638-110; 50580-209; 50580-451; 50580-457; 50580-460; 50580-522; 50580-937; 50844-255; 50844-951; 51672-2115; 51672-2116; 51824-060; 53943-092; 53943-449; 54257-720; 55154-4063; 55154-4064; 55154-7897; 55154-7899; 55319-494; 55319-559; 55579-405; 55910-010; 55910-749; 55910-946; 56062-650; 57896-251; 0363-0285; 62011-0247; 62011-0336; 62011-0460; 62207-188; 0363-0959; 63029-610; 63323-434; 63629-1157; 0363-9440; 0363-9781; 63868-089; 63868-503; 0363-9993; 63868-836; 66689-054; 66715-5533; 66715-9737; 67091-311; 68016-333; 68071-2201; 68071-2758; 68094-030; 68210-6113; 68788-6886; 68998-070; 69103-2522; 69676-0084; 69729-006; 69729-047; 69848-008; 70000-0306; 70000-0310; 70677-0018; 70677-1124; 70677-1127; 70692-150; 70795-1200; 71335-0804; 71335-1398; 71399-0160; 72036-104; 72189-197; 73282-1164; 73659-013; 76281-328; 76281-526; 79903-172; 81033-002; 81389-001; 0904-5847; 0113-5002; 0406-0046; 0406-4814; 0406-7250; 10888-8171; 0904-7314; 0924-0228; 69988-0024; 11822-0812; 11822-5091; 17856-0166; 24385-484; 29485-6547; 29485-7003; 0113-0212; 30142-590; 30142-766; 0113-0484; 0113-0946; 0121-1878; 37808-946; 37808-980; 41163-363; 41163-500; 41250-148; 41250-570; 41250-766; 41520-023; 41520-127; 41520-606; 42681-0025; 0143-9386; 46122-042; 46122-209; 46122-322; 47682-434; 49035-308; 49035-869; 49314-1753; 49580-0281; 49738-024; 50066-525; 50090-0395; 50090-5313; 50090-5535; 50090-5971; 50090-6059; 50269-008; 50580-177; 50580-521; 50580-555; 50580-599; 50594-045; 51013-402; 51672-5320; 51824-086; 53329-643; 53943-298; 53943-525; 55150-307; 55301-175; 55319-282; 55319-288; 55700-946; 55758-026; 55910-506; 55910-697; 55910-701; 56062-227; 56062-484; 57896-206; 58602-745; 58602-766; 58602-775; 59779-350; 59779-754; 59779-946; 60687-740; 61919-271; 62011-0001; 62011-0023; 0363-0579; 62207-183; 63187-373; 63187-588; 63187-968; 0363-5101; 63868-174; 63868-679; 68016-198; 68016-240; 68016-502; 68071-5229; 68210-3100; 68599-4679; 68788-8461; 68998-001; 68998-392; 69168-418; 69256-105; 69618-011; 69842-491; 69842-750; 69848-015; 70000-0481; 70000-0627; 70677-0093; 70692-399; 71205-322; 71205-461; 71309-077; 71335-1536; 72288-766; 76420-372; 79481-0184; 79903-107; 80267-484; 0904-5769; 82673-096; 82706-007; 0406-7233; 16528-002; 0924-0123; 50580-248; 59644-9006; 59644-9206; 59644-9913; 59644-9919; 59651-034; 61474-4265; 62485-033; 66326-100; 70120-007; 70120-036; 70120-155; 11673-105; 11673-519; 17714-012; 17856-0175; 21130-108; 21130-155; 0113-0025; 29485-6926; 30142-052; 33992-0175; 36800-632; 36800-770; 36800-946; 36800-973; 37808-120; 37808-285; 37808-747; 41226-341; 41250-501; 41520-544; 42681-7076; 45802-730; 46122-390; 46994-663; 47682-172; 49035-313; 49035-455; 49348-325
UNII 362O9ITL9D
Synonyms Acetaminophen | Acetominophen | Hydroxyacetanilide | APAP | p-Acetamidophenol | p-Hydroxyacetanilide | Paracetamol | N-(4-Hydroxyphenyl)acetanilide | Acetamidophenol | N-Acetyl-p-aminophenol | Acephen | Acetaco | Tylenol | Anacin-3 | Anacin 3 | Anacin3 | Datril | Panadol | Acamol | Algotropyl
Chemical Information
Molecular Formula C8H9NO2
CAS Registry Number 103-90-2
SMILES CC(=O)NC1=CC=C(C=C1)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.0020.000800%
Abdominal pain upper07.01.05.0030.000361%
Abdominal rigidity07.01.05.011--Not Available
Abdominal tenderness07.01.05.004--Not Available
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Acidosis14.01.03.0020.000125%
Acne23.02.01.001--Not Available
Acute hepatic failure09.01.03.0010.000750%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.0010.000071%
Administration site reaction12.07.04.011; 08.02.04.011--Not Available
Ageusia17.02.07.001; 07.14.03.003--Not Available
Aggression19.05.01.0010.000054%Not Available
Agitation19.06.02.001; 17.02.05.0120.000089%
Agranulocytosis01.02.03.001--Not Available
Alcohol abuse19.07.06.001--Not Available
Altered state of consciousness19.07.01.003; 17.02.04.001--Not Available
Alveolitis22.01.01.001--Not Available
Anaemia01.03.02.001--
Anal fissure07.03.01.002--
Anaphylactic reaction24.06.03.006; 10.01.07.0010.000054%
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema23.04.01.001; 10.01.05.009; 22.04.02.008--Not Available
Angle closure glaucoma06.03.01.001--Not Available
Ankylosing spondylitis15.01.09.001; 10.04.04.004--Not Available
Anosmia17.04.04.001; 22.04.03.006--
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ADReCS-Target
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