Iopromide 623mg/ml (Iodine 300mg/ml) solution for injection 75ml bottles
Iopromide is a low osmolar, non-ionic X-ray contrast agent for intravascular administration.
Active ingredients:
Iopromide
1 safety notice
Safety information for pregnancy and breastfeeding
Pregnancy
There are no data on iopromide use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Iopromide crosses the placenta and reaches fetal tissues in small amounts.
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
Official documents, adverse reaction reporting, and safety monitoring
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Safety monitoring data
Yellow Card reports
MHRA
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Iopromide
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Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
EMA
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Iopromide
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Learn about EU pharmacovigilance and safety monitoring
EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
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Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
Clinical guidelines and formulary information
British National Formulary
Iopromide
BNF
Drug monograph — bnf.nice.org.ukSource: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
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Supply & product information
Official product databases and supply status monitoring
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. emc (electronic medicines compendium) is operated by Datapharm Ltd. Shortage information sourced from NHS Specialist Pharmacy Service (SPS), sps.nhs.uk.
Codes for healthcare professionals and prescribing systems
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These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA). ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
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Searching UK clinical trials...
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
0.24 hours
Mechanism
Iopromide is a nonionic iodinated, water-soluble, radiographic contrast medium t…
Food interactions
None known
Human targets
None mapped
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
Immediately following intravascular injection, iopromide reaches peak plasma concentrations and is then rapidly distributed throughout the extracellular fluid compartment.…
Half-life
0.24 hours
After intravenous administration to healthy adult subjects, the plasma iopromide concentration-time profile shows an initial distribution phase with a half-life of 0.24…
Protein binding
1%
The plasma protein binding of iopromide is 1%.
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Volume of distribution
16 L
The total volume of distribution at steady state is about 16 L, suggesting distribution into extracellular space.
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Metabolism
Iopromide does not undergo significant metabolism, deiodination, or biotransformation.
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Elimination
97%
The amounts excreted unchanged in urine represent 97% of the dose in adult healthy subjects.…
Clearance
107 mL/min
The mean total and renal clearances are 107 mL/min and 104 mL/min, respectively.
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Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Status:
Approved
Small molecule
About this compound
Iopromide is a low osmolar, non-ionic X-ray contrast agent for intravascular administration. It functions as a contrast agent by opacifying blood vessels in the flow path of the contrast agent, permitting radiographic visualization of the internal structures until significant hemodilution occurs.[A225366] Although iopromide can cause several serious adverse effects, including cardiac events, thromboembolism, hypersensitivity reaction, and even death if administered intrathecally inadvertently, it is still deemed to have a favorable safety profile, with only 0.7% of patients in a 2 years study experiencing adverse events.[A260751] Although the mechanism is unclear, women and outpatients tend to have a higher incidence of adverse events compared to other population groups.[A260751]
Approved by the FDA in 1995 and Health Canada in 1994 under the brand name ULTRAVIST, iopromide is used in radiological diagnosis, including, but not limited to, intra-arterial digital subtraction angiography (IA-DSA), cerebral and peripheral arteriography, peripheral venography, excretory urography, brain computer tomography (CT), coronary arteriography, left ventriculography, visceral angiography, and orthography.[L46906][L46911]
Approved by the FDA in 1995 and Health Canada in 1994 under the brand name ULTRAVIST, iopromide is used in radiological diagnosis, including, but not limited to, intra-arterial digital subtraction angiography (IA-DSA), cerebral and peripheral arteriography, peripheral venography, excretory urography, brain computer tomography (CT), coronary arteriography, left ventriculography, visceral angiography, and orthography.[L46906][L46911]
Properties:
View FDA drug labelsolid
Avg. mass: 791.11 Da
DrugBank indication
Iopromide, as the product IOVIST, is approved by the FDA for use as an intra-arterial or intravenous X-ray contrast agent.
[L46906]
For intra-arterial administration, iopromide is indicated for cerebral arteriography, peripheral arteriography, coronary arteriography, left ventriculography, visceral angiography, and aortography in adults and radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older.
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For intravenous administration, iopromide is indicated for excretory urography in adults and pediatric patients aged 2 years and older, contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal, and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions in adults and pediatric patients aged 2 years and older, and contrast mammography to visualize known or suspected lesions of the breast in adults, as an adjunct following mammography and/or ultrasound.
[L46906]
Iopromide is also approved by Health Canada as an intravascular contrasting agent, although the indications differ depending on the dosage. At 300 mg I/mL, iopromide is indicated for computed tomography (CT), excretory urography, pediatric excretory urography, renal arteriography, peripheral arteriography (bifemoral pelvis/leg), cerebral arteriography, phlebography of the extremities, and arthrography.
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For intra-arterial administration, iopromide is indicated for cerebral arteriography, peripheral arteriography, coronary arteriography, left ventriculography, visceral angiography, and aortography in adults and radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older.
[L46906]
For intravenous administration, iopromide is indicated for excretory urography in adults and pediatric patients aged 2 years and older, contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal, and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions in adults and pediatric patients aged 2 years and older, and contrast mammography to visualize known or suspected lesions of the breast in adults, as an adjunct following mammography and/or ultrasound.
[L46906]
Iopromide is also approved by Health Canada as an intravascular contrasting agent, although the indications differ depending on the dosage. At 300 mg I/mL, iopromide is indicated for computed tomography (CT), excretory urography, pediatric excretory urography, renal arteriography, peripheral arteriography (bifemoral pelvis/leg), cerebral arteriography, phlebography of the extremities, and arthrography.
[L46911]
Also known as(3)
Iopromida
Iopromide
N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methylisophthalamide
Dosage forms(31)
Injection (Parenteral) — 300 mg/ImL
Injection, solution (Parenteral) — 370 mgI/mL
Injection, solution (Intravascular)
Injection (Intra-arterial) — 311.7 mg/1mL
Injection (Intra-arterial; Intravenous) — 240 mg/1mL
Injection (Intra-arterial; Intravenous) — 300 mg/1mL
Injection (Intra-arterial; Intravenous) — 370 mg/1mL
Injection, solution (Intravenous) — 150 mg/mL
Molecular properties(19)
Drug interactions(733)
Known interactions with other medications. Always consult a healthcare professional.
Aldesleukin
Moderate
The risk of a hypersensitivity reaction to Iopromide is increased when it is combined with Aldesleukin.
The risk or severity of lactic acidosis can be increased when Iopromide is combined with Metformin.
Cyclosporine
Moderate
Cyclosporine may decrease the excretion rate of Iopromide which could result in a higher serum level.
Icosapent may decrease the excretion rate of Iopromide which could result in a higher serum level.
Cefotiam may decrease the excretion rate of Iopromide which could result in a higher serum level.
Mesalazine
Moderate
Mesalazine may decrease the excretion rate of Iopromide which could result in a higher serum level.
Cefmenoxime
Moderate
Cefmenoxime may decrease the excretion rate of Iopromide which could result in a higher serum level.
Cefmetazole
Moderate
Cefmetazole may decrease the excretion rate of Iopromide which could result in a higher serum level.
Pamidronic acid
Moderate
Pamidronic acid may decrease the excretion rate of Iopromide which could result in a higher serum level.
Tenofovir disoproxil
Moderate
Tenofovir disoproxil may decrease the excretion rate of Iopromide which could result in a higher serum level.
Indomethacin
Moderate
Indomethacin may decrease the excretion rate of Iopromide which could result in a higher serum level.
Cidofovir may decrease the excretion rate of Iopromide which could result in a higher serum level.
Cefpiramide
Moderate
Cefpiramide may decrease the excretion rate of Iopromide which could result in a higher serum level.
Ceftazidime
Moderate
Ceftazidime may decrease the excretion rate of Iopromide which could result in a higher serum level.
Loracarbef
Moderate
Loracarbef may decrease the excretion rate of Iopromide which could result in a higher serum level.
Cefalotin may decrease the excretion rate of Iopromide which could result in a higher serum level.
Nabumetone
Moderate
Nabumetone may decrease the excretion rate of Iopromide which could result in a higher serum level.
Ketorolac may decrease the excretion rate of Iopromide which could result in a higher serum level.
Tenoxicam may decrease the excretion rate of Iopromide which could result in a higher serum level.
Celecoxib may decrease the excretion rate of Iopromide which could result in a higher serum level.
Cefotaxime
Moderate
Cefotaxime may decrease the excretion rate of Iopromide which could result in a higher serum level.
Tolmetin may decrease the excretion rate of Iopromide which could result in a higher serum level.
Foscarnet may decrease the excretion rate of Iopromide which could result in a higher serum level.
Rofecoxib may decrease the excretion rate of Iopromide which could result in a higher serum level.
Piroxicam may decrease the excretion rate of Iopromide which could result in a higher serum level.
Methotrexate
Moderate
Methotrexate may decrease the excretion rate of Iopromide which could result in a higher serum level.
Cephalexin
Moderate
Cephalexin may decrease the excretion rate of Iopromide which could result in a higher serum level.
Fenoprofen
Moderate
Fenoprofen may decrease the excretion rate of Iopromide which could result in a higher serum level.
Valaciclovir
Moderate
Valaciclovir may decrease the excretion rate of Iopromide which could result in a higher serum level.
Valdecoxib
Moderate
Valdecoxib may decrease the excretion rate of Iopromide which could result in a higher serum level.
Diclofenac
Moderate
Diclofenac may decrease the excretion rate of Iopromide which could result in a higher serum level.
Sulindac may decrease the excretion rate of Iopromide which could result in a higher serum level.
Bacitracin
Moderate
Bacitracin may decrease the excretion rate of Iopromide which could result in a higher serum level.
Amphotericin B
Moderate
Amphotericin B may decrease the excretion rate of Iopromide which could result in a higher serum level.
Cephaloglycin
Moderate
Cephaloglycin may decrease the excretion rate of Iopromide which could result in a higher serum level.
Flurbiprofen
Moderate
Flurbiprofen may decrease the excretion rate of Iopromide which could result in a higher serum level.
Adefovir dipivoxil
Moderate
Adefovir dipivoxil may decrease the excretion rate of Iopromide which could result in a higher serum level.
Pentamidine
Moderate
Pentamidine may decrease the excretion rate of Iopromide which could result in a higher serum level.
Etodolac may decrease the excretion rate of Iopromide which could result in a higher serum level.
Mefenamic acid
Moderate
Mefenamic acid may decrease the excretion rate of Iopromide which could result in a higher serum level.
Acyclovir may decrease the excretion rate of Iopromide which could result in a higher serum level.
Naproxen may decrease the excretion rate of Iopromide which could result in a higher serum level.
Sulfasalazine
Moderate
Sulfasalazine may decrease the excretion rate of Iopromide which could result in a higher serum level.
Phenylbutazone
Moderate
Phenylbutazone may decrease the excretion rate of Iopromide which could result in a higher serum level.
Meloxicam may decrease the excretion rate of Iopromide which could result in a higher serum level.
Carprofen may decrease the excretion rate of Iopromide which could result in a higher serum level.
Cefaclor may decrease the excretion rate of Iopromide which could result in a higher serum level.
Diflunisal
Moderate
Diflunisal may decrease the excretion rate of Iopromide which could result in a higher serum level.
Tacrolimus
Moderate
Tacrolimus may decrease the excretion rate of Iopromide which could result in a higher serum level.
Ceforanide
Moderate
Ceforanide may decrease the excretion rate of Iopromide which could result in a higher serum level.
Showing 50 of 733 interactions
Toxicity & overdose
There are no data on iopromide use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Iopromide crosses the placenta and reaches fetal tissues in small amounts. In animal reproduction studies, intravenous administration of iopromide to pregnant rats and rabbits during organogenesis at doses up to 0.35 and 0.7 times, respectively, the maximum recommended human dose based on body surface area resulted in no relevant adverse developmental effects.
[L46906]
The safety and efficacy of iopromide have been established in pediatric patients aged 2 years and older for radiographic evaluation of cardiac chambers and related arteries, excretory urography, and contrast computed tomography of the head and body.
The use of iopromide in these age groups for these indications is supported by evidence from adequate and well-controlled studies in adults and additional safety data in pediatric patients aged 2 years and older, including data from published studies.
[L46906]
Pediatric patients who are at higher risk of experiencing an adverse reaction during and after the administration of any contrast agent include those with asthma, sensitivity to medication and/or allergens, cyanotic and acyanotic heart disease, congestive
heart failure, or serum creatinine greater than 1.5 mg/dL.
[L46906]
Thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been reported following iodinated contrast media administration in pediatric patients, including term and preterm neonates; Some patients were treated for hypothyroidism. After exposure to iodinated contrast media, individualize thyroid function monitoring in pediatric patients 0 to 3 years of age based on underlying risk factors, especially in term and preterm neonates.
[L46906]
The clearance of iopromide decreases with increasing degree of renal impairment and results in delayed opacification of the urinary system. In addition, preexisting renal impairment increases the risk of acute kidney injury.
Iopromide can be removed by dialysis.
[L46906]
Long-term animal studies have not been performed with iopromide to evaluate carcinogenic potential or effects on fertility. Iopromide was not genotoxic in a series of studies including the Ames test, an in vitro human lymphocytes analysis of chromosomal aberrations, an in vivo mouse micronucleus assay, and an in vivo mouse dominant lethal assay.
[L46906]
The manifestations of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy.
[L46906]
The most common adverse reactions (>1%) are headache, nausea, injection site and infusion site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision.
Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
[L46906]
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The safety and efficacy of iopromide have been established in pediatric patients aged 2 years and older for radiographic evaluation of cardiac chambers and related arteries, excretory urography, and contrast computed tomography of the head and body.
The use of iopromide in these age groups for these indications is supported by evidence from adequate and well-controlled studies in adults and additional safety data in pediatric patients aged 2 years and older, including data from published studies.
[L46906]
Pediatric patients who are at higher risk of experiencing an adverse reaction during and after the administration of any contrast agent include those with asthma, sensitivity to medication and/or allergens, cyanotic and acyanotic heart disease, congestive
heart failure, or serum creatinine greater than 1.5 mg/dL.
[L46906]
Thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been reported following iodinated contrast media administration in pediatric patients, including term and preterm neonates; Some patients were treated for hypothyroidism. After exposure to iodinated contrast media, individualize thyroid function monitoring in pediatric patients 0 to 3 years of age based on underlying risk factors, especially in term and preterm neonates.
[L46906]
The clearance of iopromide decreases with increasing degree of renal impairment and results in delayed opacification of the urinary system. In addition, preexisting renal impairment increases the risk of acute kidney injury.
Iopromide can be removed by dialysis.
[L46906]
Long-term animal studies have not been performed with iopromide to evaluate carcinogenic potential or effects on fertility. Iopromide was not genotoxic in a series of studies including the Ames test, an in vitro human lymphocytes analysis of chromosomal aberrations, an in vivo mouse micronucleus assay, and an in vivo mouse dominant lethal assay.
[L46906]
The manifestations of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy.
[L46906]
The most common adverse reactions (>1%) are headache, nausea, injection site and infusion site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision.
Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
[L46906]
How it works
Mechanism of action
Iopromide is a nonionic iodinated, water-soluble, radiographic contrast medium that is available in two stable, ready-to-use solutions of different concentrations (i.e., 300 mg I/mL and 370 mg I/mL). Following intravascular injection, iopromide provides radiographic opacification of the vasculature and extracellular space in the path of flow of the agent, allowing diagnostic assessment of the limbs and internal organs until significant dilution occurs.[L46911]
Pharmacodynamics
After intravenous injection, opacification of the renal parenchyma begins within 1 minute. Excretion of the contrast agent becomes apparent in 1 to 3 minutes with optimal contrast in the calyces and collecting system occurring between 5 and 15 minutes. In nephropathic conditions, particularly when excretory capacity has been altered, the excretion rate varies unpredictably and opacification may be delayed for several hours after injection.[L46911] the degree of contrast enhancement is related to the iodine concentration in the tissue of interest.[L46906]
Pharmacokinetics
How the body processes this drug — absorption, distribution, metabolism, and elimination
Absorption
Immediately following intravascular injection, iopromide reaches peak plasma concentrations and is then rapidly distributed throughout the extracellular fluid compartment. It displays little tendency to bind to serum or plasma proteins.
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Iodinated contrast agents cross a disrupted blood-brain barrier.
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Iodinated contrast agents cross a disrupted blood-brain barrier.
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Half-life
After intravenous administration to healthy adult subjects, the plasma iopromide concentration-time profile shows an initial distribution phase with a half-life of 0.24 hours; a main elimination phase with a half-life of 2 hours; and a terminal elimination phase with a half-life of 6.2 hours.
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Protein binding
The plasma protein binding of iopromide is 1%.
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Volume of distribution
The total volume of distribution at steady state is about 16 L, suggesting distribution into extracellular space.
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Metabolism
Iopromide does not undergo significant metabolism, deiodination, or biotransformation.
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Route of elimination
The amounts excreted unchanged in urine represent 97% of the dose in adult healthy subjects. Only 2% of the dose is recovered in the feces. Similar recoveries in urine and feces are observed in middle-aged and elderly patients.
This finding suggests that, compared to the renal route, biliary and/or gastrointestinal excretion is not important for iopromide. During the slower terminal phase, only 3% of the dose is eliminated; 97% of the dose is disposed of during the earlier phases, the largest part of which occurs during the main elimination phase.
[L46906]
The ratio of the renal clearance of iopromide to the creatinine clearance is 0.82, suggesting that iopromide is mainly excreted by glomerular filtration. Additional tubular reabsorption is possible.
[L46906]
This finding suggests that, compared to the renal route, biliary and/or gastrointestinal excretion is not important for iopromide. During the slower terminal phase, only 3% of the dose is eliminated; 97% of the dose is disposed of during the earlier phases, the largest part of which occurs during the main elimination phase.
[L46906]
The ratio of the renal clearance of iopromide to the creatinine clearance is 0.82, suggesting that iopromide is mainly excreted by glomerular filtration. Additional tubular reabsorption is possible.
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Clearance
The mean total and renal clearances are 107 mL/min and 104 mL/min, respectively.
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Scientific references(2)
Gharekhanloo F., Torabian S.
Comparison of allergic adverse effects and contrast enhancement between iodixanol and iopromide.
Iran Journal Radiology
2012 Jun9(2):63-6. doi: 10.5812/iranjradiol.7696. Epub 2012 Jun 30
Mortele K.J., Oliva M.R., Ondategui S., Ros P.R., Silverman S.G.
Universal use of nonionic iodinated contrast medium for CT: evaluation of safety in a large urban teaching hospital.
AJR American Journal Roentgenol
2005 Jan184(1):31-4. doi: 10.2214/ajr.184.1.01840031
ATC classification(1 code)
ATC V08AB05
Commercial products(9)
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Iopromide
DrugBank citations
If you use DrugBank data in your research, please cite the following publications:
Knox C., Wilson M., Klinger C.M., et al
DrugBank 6.
0: the DrugBank Knowledgebase for 2024
Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
Wishart D.S., Feunang Y.D., Guo A.C., et al
DrugBank 5.
0: a major update to the DrugBank database for 2018
Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
Show earlier publications
Law V., Knox C., Djoumbou Y., et al
DrugBank 4.
0: shedding new light on drug metabolism
Nucleic Acids Res. 2014 Jan 142(1):D1091-7
Knox C., Law V., Jewison T., et al
DrugBank 3.
0: a comprehensive resource for 'omics' research on drugs
Nucleic Acids Res. 2011 Jan39(Database issue):D1035-41
Wishart D.S., Knox C., Guo A.C., et al
DrugBank: a knowledgebase for drugs, drug actions and drug targets.
Nucleic Acids Research
2008 Jan36(Database issue):D901-6
Wishart D.S., Knox C., Guo A.C., et al
DrugBank: a comprehensive resource for in silico drug discovery and exploration.
Nucleic Acids Research
2006 Jan 134(Database issue):D668-72
Source: go.drugbank.comCC BY-NC 4.0
Updated about 1 month ago(4 Mar 2026)