NAV

Indication Data Details

Refer to the tables below for indication attributes and explanations of their possible values.

Types of Treatments

The following introductory descriptors are used to describe the goals of treatment of a drug or therapy. Depending on the interpretation of the monograph label, there may be some variation in how a drug is described as some terms can be interchangeable.

AttributePossible ValuesDescription
kindtreatment_of

Using the medication will cure or eradicate the condition it is being used for. Also used if the goal of therapy is to cure, regardless of the chance of success.

e.g. Cancer treatments; infectious disease treatments; treatment of depression

prevention_of

Preventing the occurrence of a condition that may or may not occur, usually over a longer time span and for an indefinite period.

e.g. MI prevention; prevention of BMD loss; prevention of cardiac-related morbidity/mortality

prophylaxis_of

Preventing the occurrence of a specific condition that is likely to occur within a short time span.

e.g. Malaria prophylaxis; PJP prophylaxis; MAC prophylaxis; DVT prophylaxis; migraine prophylaxis

symptomatic_treatment_of

Used when a treatment is controlling or removing symptoms of a condition but isn’t curing/treating the underlying cause or resulting in disease modification. Can also be used to describe palliative treatments.

e.g. NSAIDs for osteoarthritic pain; antihistamines for allergies; palliative cancer therapies

management_of

Used when a treatment controls, periodically halts, or alters the progression of a condition/disease but doesn’t cure or reverse it.

e.g. Diabetes; hypertension; pain; autoimmune disorders (psoriasis, rheumatoid arthritis, ulcerative colitis, etc.); congenital disorders (cystic fibrosis, familial hypercholesterolemia, etc)

for_therapy

Used when the drug is indicated for use as a therapy rather than in the treatment or management of a condition or disease.

Will be used with a "therapy": { ... }.

e.g. Nutritional supplementation; Assisted Reproductive Technology (ART); contraception; abortion; Hormone Replacement Therapy; anesthesia

induction_of

Used when the drug is used to induce a very specific state, often related to the mechanism of action of the drug. Sometimes can be used interchangeably with "for_therapy".

e.g. Sedation; ovulation; smooth muscle relaxation

reversal_of

Used when the drug reverses a very specific state, often related to the mechanism of action of the drug. Frequently used for overdoses.

e.g. Cyanide poisoning; neuromuscular blockade; sedation; overdose

diagnostic_agent

When the drug is being used as a diagnostic agent, usually for diagnosis of a specific condition (ex: prostate cancer, penicillin allergy, tuberculosis, etc).

Linked with a "condition": [ ... ] and/or a "process": [ ... ] .

diagnostic_process

When the drug is used as part of a diagnostic process (ex. MRI, angiography, penicillin skin testing, etc), usually for a specific condition (ex: prostate cancer, penicillin allergy, tuberculosis, etc).

Linked with a "process": [ ... ] and usually also a "condition": [ ... ].

adjunct_therapy_in_prevention_of
adjunct_therapy_in_prophylaxis_of
adjunct_therapy_in_treatment_of
adjunct_therapy_in_management_of
adjunct_for_therapy

Used specifically for adjunct/adjuvant treatment. These drugs are not used alone, and are given to boost the efficacy* of the primary or initial drug. May be combined with the main introductory descriptors.

Usually combined with "adjunct_drugs": [ ... ], "adjunct_drug_categories": [ ... ], and/or "with_therapies": [ ... ] to specify the adjunct drugs and/or therpies.

Can also be combined with "mechanism": { ... } to indicate what part of the therapy this indication satisfies.

* Note: Used for very specific scenarios, such as cancer therapies

used_in_combination_to_treat
used_in_combination_for_symptomatic_treatment_of
used_in_combination_for_therapy
used_in_combination_to_induce
used_in_combination_to_manage
used_in_combination_to_prevent
used_in_combination_for_prophylaxis_of
used_in_combination_as_diagnostic_agent
used_in_combination_for_diagnostic_process
used_in_combination_to_reverse

When the drug is used in combination with other medications to treat the specified condition or for the specified therapy.

Generally combined with "combination_drugs": [ ... ] or "combination_drug_categories": [ ... ] to specify the other drug(s), although this field may be absent if the drug can be combined with a wide range of other drugs.

Indication of this type will also have a combination_type field to specify the combination type (see below).

used_as_adjunct_in_combination_to_treat
used_as_adjunct_in_combination_for_symptomatic_treatment_of
used_as_adjunct_in_combination_for_therapy
used_as_adjunct_in_combination_to_prevent
used_as_adjunct_in_combination_to_manage

For more complex indications involving combinations of the above treatment types.

combination_drugs

A drug or list of drugs of the format:
{ "name": ..., "drugbank_id": ... }

Used to specify another drug that the drug is combined with. Often used because indications are tied to specific combinations or because the indication is associated with a combination product.

Indications with this field will also have a combination_type field to specify the combination type (see below).

adjunct_drugs

A drug or list of drugs of the format:
{ "name": ..., "drugbank_id": ... }

Used to specify a drug that the drug is used adjunct to. Adjunct drugs differ from combinations in that the base drug may still be used on its own.

combination_drug_categoriesA drug category or list of drug categories of the format:
{ "name": ..., "drugbank_id": ... }

Used to specify a drug category that the drug is used in combination with.

Indications with this field will also have a combination_type field to specify the combination type (see below).

adjunct_drug_categoriesA drug category or list of drug categories of the format:
{ "name": ..., "drugbank_id": ... }

Used to specify a drug category that the drug is used adjunct to. Adjunct drugs differ from combinations in that the base drug may still be used on its own.

with_therapiesA therapy or list of therapies. See the Concept Attributes table below for the format.

Used to specify a therapy that the drug can be used adjunct to.

Indication Concepts

Indications most commonly include a "condition" that is being treated or modified with a drug. However, this is not the only possible concept type an indication may reference. Indications may refer to any of the following concepts, which may occur alone or in combination:

ConceptDescription
conditionA medical condition targeted by the drug, ex: diabetes.See the Concept Attributes table below for a description of the attributes that describe these concepts.
induction_ofA state induced by the drug, ex: sedation.
therapyA therapy that the drug is a part of, ex. supplementary nutrition.
processA process that the drug is used during, ex. surgery.
mechanismA specific action the drug is performing, ex. reduce dextromethorphan metabolism.
condition_associated_with

Occurs in combination with a condition when the main condition being treated is associated with or correlated with another condition or state. Can be used to narrow down a specific aspect of a condition that the drug is treating.

{
    "kind": "treatment_of",
    "condition": {
        "title": "dry mouth"
        ...
    },
    "condition_associated_with": [
        {
            "title": "Sjogren's syndrome"
            ...
        }
    ]
},
{
    "kind": "symptomatic_treatment_of",
    "condition": {
        "title": "neuropathic pain"
    },
    "condition_associated_with": [
        {
          "title": "multiple sclerosis"
        }
    ]
}
genetic_factorsPresent when the indication is based on the over/under expression of some genes. Genetic factors are divided into two groups, includes and excludes. They are objects that can be described by the following attributes:
AttributeDescription
titleA descriptive name for the gene.
synonymsAny alternate names for the gene.
geneThe gene symbol.
mutationA brief description of the mutation that this genetic factor refers to.
positive_findingA clinical finding of the genetic factor.
negative_findingA clinical finding of the absence of the genetic factor.
related_genesOther genes which may be related to this one.

Concept Attributes

Indication concepts are described by the following attributes, not all of which may be present, depending on the concept type:

AttributeDescription
titleThe name of the concept.
drugbank_idUnique identifier for the concept.
meddraLinks to MedDRA (Medical Dictionary for Regulatory Activities) the ID includes two parts llt for low-level terms or hlt for high level terms as well as the numerical identifier for example: llt/10045365
icd10Links to ICD-10 (International Statistical Classification of Diseases and Related Health Problems 10th Revision) the id includes two parts: c for context, and the alpha-numeric identifier for the ICD-10 concept. The identifier may be a single id such as c/A11, or a range, such as c/A00-B99, which indicates a concept with other concepts below it in the ICD-10 hierarchy.
uniprot_id
combination_of

Multiple conditions sometimes need to be treated as a single condition when creating indications. Some combinations may be well known, perhaps included in Meddra, ICD-10, or SNOMED, while others are more ad-hoc. For this reason, indications based on combination conditions include information on their constituent parts. This is a nested object that can contain the following attributes:

AttributeDescription
baseThe primary condition that this is a combination of, if there is one.
additional_characteristics

Used to indicate a concept which is part of the condition. This is a very general relationship, and is only used if no other specific condition descriptor relationships work. Often used to specify a sub-type of the main condition.

{
    "kind": "management_of",
      "condition": {
          "title": "grand mal seizures",
          "combination_of": {
              "base": {
                  "title": "seizures",
              },
              "additional_characteristics": [
                  "grand mal"
              ]
          }
      }
  }
caused_by

A more specific form of “condition_associated_with” used when a specific organism or drug is causing the condition. Often used for infectious diseases when the causative organism directs the choice of therapy.

{
    "kind": "treatment_of",
    "condition": {
        "title": "malaria caused by Plasmodium ovale",
        "combination_of": {
            "included_conditions": [
                {
                    "title": "malaria"
                }
            ],
            "caused_by": {
                "title": "Plasmodium ovale"
            }
        }
    }
},
{
    "kind": "treatment_of",
    "condition": {
        "title": "extrapyramidal symptoms caused by thioxanthenes ovale",
        "combination_of": {
            "included_conditions": [
                  {
                      "title": "extrapyramidal symptoms"
                  }
              ],
            "caused_by": {
                "title": "thioxanthenes"
            }
        }
    }
}
included_conditions
excluded_conditions

Conditions included in this combination and any specifically excluded conditions.

{
    "kind": "treatment_of",
    "condition": {
        "title": "pituitary insufficiency with profound LH deficiency",
        "combination_of": {
            "included_conditions": [
                {
                    "title": "pituitary insufficiency"
                },
                {
                    "title": "profound LH deficiency"
                }
            ]
        }
    }
}
modification_of

Used when the condition is represented as a modification of other condition. This is a nested object that can contain the following attributes:

AttributeDescription
baseThe condition that this is a modification of.
locationUse when an indication is specific to a particular location.
condition_stage

Condition stage descriptors are a more specific form of condition descriptors that are used to designate cancer stages. These provide a description of the extent to which a neoplasm has developed or spread from its site of origin. Because each cancer type uses its own staging system, the numbers and wording do not always mean the same thing for every kind of cancer.

For consistency, DrugBank indications mimic the wording used within the product monographs. The following table includes commonly accepted definitions of cancer stages, however clinical judgement is required when interpreting individual drug indications as they apply to cancer therapy.

Stage 0: Carcinoma in situA group of abnormal cells that have the potential of progressing and becoming a cancer.
Stage I: LocalizedThe cancer is localized to one part of the body, but have passed through the basement membrane and have started to invade neighbouring tissues.
Stage II: Early locally advancedThe cancer has spread through the lymphatic system and is localized in regional lymph nodes (regional spread).
Stage III: Late locally advancedA more advanced stage compared to II, further spread has occurred and more regional lymph nodes have cancerous tissue found within them. Size of the primary tumour may have also progressed.
Stage IV: MetastaticThe cancer has spread to a distal part of the body compared to the original site. This is achieved through further movement through the lymphatic system or through the circulatory system.

The above stages do not represent lymphomas, leukemias or multiple myeloma as these types of cancer do not typically form solid tumours.

severity

Terms that describe the severity, duration, and/or stages of a condition or disease. To allow for multiple severities values, severity is described as list of includes and excludes.

"severity": {
    "includes":  [ "acute", "severe" ],
    "excludes": [ "unresectable" ]
}

These term sets can vary between conditions and tend to be inconsistently defined. For consistency, DrugBank indications mimic the terminology used within each drug monograph when describing the condition it’s used for and can therefore be interpreted in various ways. The following table includes some of the most common condition severity terms that we have seen mentioned in drug monograph labels with commonly accepted definitions:

Acute
  1. Describing a disease of rapid onset, severe symptoms, and brief duration.
  2. Describing any intense symptoms, such as severe pain.
Chronic
  1. Describing a disease of long duration involving very slow changes. Such a disease is often of gradual onset.
  2. Describing a type of inflammation characterized by the presence of lymphocytes, plasma cells, and macrophages.
SymptomaticShowing symptoms of disease.
AsymptomaticNot showing symptoms of disease.
Mild
Moderate
Severe
Definitions for mild, moderate, and severe vary based on the condition or disease being described. They can be defined by lab values, symptoms, level of disability, amount of physiologic decompensation, risk of mortality, etc.
LocalA condition, disease, or infection that originates in and is confined to one organ system or general area of the body. Commonly used to describe neoplasms or infections. As the infection grows, it can develop into an invasive or disseminated condition.
InvasiveA more complicated form of an infection or neoplasm in which it has spread beyond the origin of infection into the surrounding tissue.
DisseminatedA more complicated form of an infection or neoplasm in which it has spread beyond the origin of infection into the bloodstream to infect other areas of the body.
UncomplicatedA condition with an easy and straight-forward treatment. Often used to describe infections that can be effectively diagnosed and treated based on symptoms alone.
ComplicatedA condition that usually requires more aggressive evaluation, treatment, and follow-up. When used to describe infections, can often mean that there is antibacterial resistance requiring evaluation of local susceptibility patterns and tailoring of therapy to these results.
LatentA condition existing in a hidden or dormant form. Commonly used to describe infections that replicate in the host without producing visible symptoms of disease.
UnresectableA condition that persists despite attempted surgical intervention.

Other terms that have been included in this category include: subclinical, aggressive, progressive, and high-risk.

condition_status

Similar to condition severity descriptors, but more closely related to the progression of the disease or the disease course. These are often used to describe chronic conditions or infections with alternating periods of active and suppressed symptoms, such as Multiple Sclerosis. See below for details on status values. Below are some of the most commonly mentioned condition status descriptors:

activeA condition that is progressing or causing degeneration, often accompanied by symptoms.
recurrentA condition that has returned following suppression or stabilization. Often used interchangeably with “relapsed”.
relapsedThe return of symptoms before a full remission has been reached. Often used interchangeably with “recurrent”.
refractoryA condition that is resistant to treatment and has progressed or continued despite attempted medical or pharmaceutical intervention(s). Often used interchangeably with “unresponsive’.
intermittentA condition that periodically worsens and then resolves, or with symptoms that come and go.
relapsing-remittingA sub-type of Multiple Sclerosis that is characterized by unpredictable relapses followed by periods of months to years of remission with no new signs of disease activity.
stableA condition that is not changing, progressing, or fluctuating.
related_concepts

Patient Specific Descriptors

Patient-specific descriptors are used to further define the patient population that the drug product can be used in. These specifiers are often a result of the patient population that was studied in clinical trials, and therefore the safety and efficacy of a given product can only be guaranteed for this population or demographic. Multiple characteristics can be included in a given indication when necessary.

AttributeDescription
sex_group

To specify if the treatment can only be used in either males or females.

Allow values are: male, female, all (if the treatment explicitly applies to all people regardless of sex).

age_groups
excluded_age_groups

Lists of age groups that the treatment can or cannot be used in.

Allowed values are: neonatal, infant, pediatric, adolescent, adult, elderly/geriatric.

min_age
max_age
To specify the minimum age in which the medication can be safely used. In the format
{ "amount": ..., "unit": ... }
patient_characteristics
excluded_patient_characteristics
To specify list of traits inherent to or absent in the patient being treated.

Product Specific Descriptors

Patient-specific descriptors are used to further define the patient population that the drug product can be used in. These specifiers are often a result of the patient population that was studied in clinical trials, and therefore the safety and efficacy of a given product can only be guaranteed for this population or demographic. Multiple characteristics can be included in a given indication when necessary.

AttributePossible ValuesDescription
combination_type
* See below for more details
regimen

For specifying when ingredient combinations are used together for the management or treatment of a condition but are NOT commercially available within a fixed dose combination (FDC).

product

For specifying when ingredient combinations are used together for the management or treatment of a condition and ARE commercially available within a fixed dose combination product (FDC).

mixture

Use to specify combinations of OTC products. Most OTC products have fixed indications that don’t need to go through clinical trials like a prescription product would before receiving approval.

dose_strengthConcentration/amountUsed when the indication is specific to a particular concentration/amount of the drug.
dose_formSee table on right

Dose form descriptors can specify the dosage form or formulation that a medication is available as. Often used to specify whether an indication is specific to the dose form.

Common dose forms include:

Enteral: A medication administered via the gastrointestinal tract, commonly with systemic absorption.Parenteral: A medication given by injection, usually with systemic absorption.Topical: A medication applied externally, usually with local absorption.
Tablet
Capsule
Delayed Release
Controlled Release (CR)
Extended Release (ER)
Immediate Release (IR)
Suppository
Intravenous (IV)
Intramuscular (IM)
Subcutaneous (SC)
Intra-Arterial
Intra-Thecal
Intra-Articular
Intra-Peritoneal
Parenteral
Cream
Ointment
Lotion
Gel
Patch
Otic
Ophthalmic
Inhalational
Intranasal
regionsCountry/regionRegions which the indication has been approved in. See the Overview page for details.
off_labeltrue or falseIn general, approved indications limit how a drug can be marketed or advertised to the public, but do not limit how a drug may be actually used by a medical practitioner. Off-label indications describe commonly prescribed uses beyond regulatory-approved indications. These uses are highly variable, but are commonly informed by available evidence in the literature, case studies, Clinical Practice Guidelines, and expert opinion. See the Overview page for details.
otc_usetrue or falseUsed to designate when an indication is linked to an over the counter product. See the Overview page for details.

Complicated Treatments

Combination Types

Drugs are frequently used in combination to treat a condition or as an ingredient within a regimen. We’ve created terms to differentiate between the following scenarios: when combinations of ingredients are commercially available as a fixed dose combination “product”; when combinations of ingredients are used for treatment or management of a condition within a “regimen” BUT are not available in a combination product; when combinations of OTC products are used together as a “mixture”.

Examples:

  1. Options for triple therapy for the management of HIV:
    Regimen: Truvada (tenofovir alafenamide + emtricitabine) + Edurant (rilpivirine)
    Combination Product: Odefsey (tenofovir alafenamide + emtricitabine + rilpivirine)
    Individual products: Vemlidy (tenofovir alafenamide) + Emtriva (emtricitabine) + Edurant (rilpivirine)
  2. Options for triple therapy regimen for treatment of H.pylori:
    Regimen: Pantoprazole + amoxicillin + clarithromycin
    Combination Product: Prevpac (lansoprazole + amoxicillin + clarithromycin)

Anti-Microbials (Antibiotics, Antifungals, Anti-yeast)

Due to resistance and varying local susceptibility patterns, accurately representing indications for antimicrobial medications can be challenging. Drug labels for these medications commonly include a list of potentially susceptible organisms, however effectiveness of the drug depends on many factors such as local resistance patterns, the Minimum Inhibitory Concentration (MIC), the infecting organisms, patient factors, dose, and duration of therapy. Clinical judgement is required when interpreting antimicrobial drug indications as incorrectly prescribed medications may poorly impact the patient or contribute to antibiotic resistance.

DrugBank indications include the condition-specific information (ex. syphilis, endocarditis, meningitis) that is included in the label, but do not specify the infecting organisms in all cases. Future versions of DrugBank indications may include more information regarding anti-microbial spectrums of activity.

Chemotherapy

Some chemotherapy medications may have complicated drug indications that are difficult to capture within a simplified indication structure. These treatments can vary between cancer type, stage of disease, and place within therapy. As a result, simplified drug label indications may not reflect the actual usage of the drug. As many of these drugs are commonly provided within a synergistic cocktail of other medications, DrugBank is working on including common chemotherapy regimens that will be provided alongside the product monograph indications.