Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Adalimumab
Drug ID BADD_D00041
Description Adalimumab is a subcutaneously administered biological disease modifier for the treatment of rheumatoid arthritis and other chronic debilitating diseases mediated by tumor necrosis factor [A39984], [A39999]. It was originally launched by Abbvie in the U.S. and approved in 2002 by the FDA [A39983]. This drug is frequently known as _Humira_. It is produced by recombinant DNA technology using a mammalian cell expression system. This drug is available in a prefilled syringe form and convenient pen form for subcutaneous self-administered doses [A39983]. A new biosimilar to adalimumab, named _adalimumab-adaz_, was approved by the FDA on October 31, 2018. This biosimilar is known as _Hyrimoz_, and is a trademark of Novartis AG [L4799].
Indications and Usage The following are conditions for which adalimumab has been indicated [F2118], [FDA label], [L4805], [A40001], [A40002], [L4806]. Rheumatoid Arthritis (Moderate to Severe) Juvenile Idiopathic Arthritis (Moderately to Severely Active) Psoriatic Arthritis (Active) Ankylosing Spondylitis (Active) Crohn’s Disease (Moderately to Severely Active) Ulcerative Colitis (Moderately to Severely Active) Plaque Psoriasis (Moderate to Severe Chronic) Non-infectious Intermediate, Posterior and Panuveitis Hidradenitis Suppurativa (Moderate to Severe) Pyoderma Gangrenosum (off-label)
Marketing Status approved; experimental
ATC Code L04AB04
DrugBank ID DB00051
KEGG ID D02597
MeSH ID D000068879
PubChem ID Not Available
TTD Drug ID D0K5KS
NDC Product Code 43835-0033; 71124-0027; 0074-0124; 49502-380; 0074-2540; 43835-0036; 50090-4487; 65219-554; 0074-0817; 0074-1115; 43835-0035; 0074-0243; 49502-382; 0074-2330; 49502-418; 71124-0023; 0074-0554; 0074-0616; 65219-556; 72606-030; 0074-1117; 0074-1867; 0074-1539; 0074-3799; 0074-4339; 0074-0067; 49502-381; 49502-417; 58394-051; 69438-0009; 49502-416
UNII FYS6T7F842
Synonyms Adalimumab | Humira | Adalimumab-adbm | Amjevita | Adalimumab-atto | Cyltezo | D2E7 Antibody | Antibody, D2E7
Chemical Information
Molecular Formula Not Available
CAS Registry Number 331731-18-1
SMILES Not Available
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)
Interstitial lung disease10.02.01.033; 22.01.02.003--Not Available
Ketosis14.01.01.001--Not Available
Laboratory test abnormal13.18.01.001--Not Available
Menstrual disorder21.01.01.004--Not Available
Muscle spasms15.05.03.004--
Muscular weakness17.05.03.005; 15.05.06.001--
Myocardial infarction24.04.04.009; 02.02.02.007--
Myositis15.05.01.001--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Nephrolithiasis20.04.01.002--
Nervous system disorder17.02.10.001--Not Available
Neuroendocrine carcinoma of the skin23.08.02.008; 16.03.02.008; 05.08.01.009--Not Available
Neutropenia01.02.03.004--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Oesophagitis07.08.05.001--
Optic neuritis10.02.01.097; 17.04.05.001; 06.04.08.002--Not Available
Osteonecrosis24.04.05.004; 15.02.04.007--
Otitis media11.01.05.004; 04.05.01.001--
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Palpitations02.11.04.012--
Pancreatitis07.18.01.001--
Paraesthesia23.03.03.094; 17.02.06.005--
Parathyroid disorder05.04.03.001--Not Available
Pelvic pain21.10.01.001; 20.02.03.007; 07.01.06.012--
Pericardial effusion02.06.01.002--
Pericarditis02.06.02.001--
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pharyngitis streptococcal11.02.06.002; 22.07.04.001--Not Available
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