Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ibuprofen lysine
Drug ID BADD_D01121
Description Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) derived from propionic acid and it is considered the first of the propionics.[A39074] The formula of ibuprofen is 2-(4-isobutylphenyl) propionic acid and its initial development was in 1960 while researching for a safer alternative for aspirin.[A39075] Ibuprofen was finally patented in 1961 and this drug was first launched against rheumatoid arthritis in the UK in 1969 and USA in 1974. It was the first available over-the-counter NSAID.[A39076] On the available products, ibuprofen is administered as a racemic mixture. Once administered, the R-enantiomer undergoes extensive interconversion to the S-enantiomer _in vivo_ by the activity of the alpha-methylacyl-CoA racemase. In particular, it is generally proposed that the S-enantiomer is capable of eliciting stronger pharmacological activity than the R-enantiomer.[A39194]
Indications and Usage Ibuprofen is the most commonly used and prescribed NSAID. It is very common over the counter medication widely used as an analgesic, anti-inflammatory and antipyretic.[A39096] The use of ibuprofen and its enantiomer [DB09213] in a racemic mix is common for the management of mild to moderate pain related to dysmenorrhea, headache, migraine, postoperative dental pain, spondylitis, osteoarthritis, rheumatoid arthritis, and soft tissue disorder.[A39097] Due to its activity against prostaglandin and thromboxane synthesis, ibuprofen has been attributed to alteration of platelet function and prolongation of gestation and labor.[A39092] As ibuprofen is a widely used medication, the main therapeutic indications are: * Patent Ductus Arteriosus - it is a neonatal condition wherein the ductus arteriosus (blood vessel that connects the main pulmonary artery to the proximal descending aorta) fails to close after birth causing severe risk of heart failure. The prostaglandin inhibition of ibuprofen has been studied for the treatment of this condition as it is known that prostaglandin E2 is responsible for keeping the ductus arteriosus open.[A39100] * Rheumatoid- and osteo-arthritis - ibuprofen is very commonly used in the symptomatic treatment of inflammatory, musculoskeletal and rheumatic disorders.[A39176] * Cystic fibrosis - the use of high dosages of ibuprofen has been proven to decrease inflammation and decreasing polymorphonuclear cell influx in the lungs.[A39177] * Orthostatic hypotension - ibuprofen can induce sodium retention and antagonize the effect of diuretics which has been reported to be beneficial for patients with severe orthostatic hypotension.[A1651] * Dental pain - ibuprofen is used to manage acute and chronic orofacial pain.[A10901] * Minor pain - ibuprofen is widely used to reduce minor aches and pains as well as to reduce fever and manage dysmenorrhea. It is very commonly used for the relief of acute indications such as fever and tension headaches.[A39092] * Investigational uses - efforts have been put into developing ibuprofen for the prophylaxis of Alzheimer's disease, Parkinson disease, and breast cancer.[A39092]
Marketing Status approved
ATC Code R02AX02; C01EB16; G02CC01; M02AA13; M01AE01
DrugBank ID DB01050
KEGG ID D06606
MeSH ID D007052
PubChem ID 9841440
NDC Product Code 39822-1030; 66993-490; 46438-0003; 55292-122
Synonyms Ibuprofen | alpha-Methyl-4-(2-methylpropyl)benzeneacetic Acid | Ibumetin | Ibuprofen, (+-)-Isomer | Ibuprofen, (R)-Isomer | Ibuprofen, (S)-Isomer | Ibuprofen, Aluminum Salt | Ibuprofen, Calcium Salt | Ibuprofen, Copper (2+) Salt | Ibuprofen, Magnesium Salt | Ibuprofen, Potassium Salt | Ibuprofen, Sodium Salt | Ibuprofen, Zinc Salt | Ibuprofen-Zinc | Ibuprofen Zinc | Motrin | Nuprin | Rufen | Salprofen | Trauma-Dolgit Gel | Trauma Dolgit Gel | Brufen
Chemical Information
Molecular Formula C19H32N2O4
CAS Registry Number 57469-77-9
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 distension07.01.04.001--
Adrenal insufficiency14.11.01.004;
Blood creatinine increased13.13.01.004--
Blood urea increased13.13.01.006--Not Available
Cardiac failure02.05.01.001--
Cholestasis09.01.01.001--Not Available
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal perforation07.04.04.001--Not Available
Infection11.01.08.002--Not Available
Inguinal hernia07.16.02.001--Not Available
Injection site reaction12.07.03.015;
Intraventricular haemorrhage24.07.04.008; Available
Jaundice23.03.03.030;; Available
Neutropenia01.02.03.004--Not Available
Oedema14.05.06.010; Available
Oliguria20.01.03.004--Not Available
Renal disorder20.01.02.002--Not Available
Renal failure20.01.03.005--Not Available
Respiratory failure22.02.06.002;
The 1th Page    1 2    Next   Last    Total 2 Pages