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Drug adverse events

api.fda.gov/drug/event/reference

An adverse event is submitted to the FDA to report any undesirable experience associated with the use of a drug, including serious drug side effects, product use errors, product quality problems, and therapeutic failures.

BasicsReference guide

About

The openFDA drug adverse event API returns data from the FDA Adverse Event Reporting System (FAERS), a database that contains information on adverse event and medication error reports submitted to FDA. Currently, this data covers publically releasable records submitted to the FDA from 2004-2013. The data is updated quarterly.

An adverse event is submitted to the FDA to report any undesirable experience associated with the use of a medical product in a patient. For drugs, this includes serious drug side effects, product use errors, product quality problems, and therapeutic failures for prescription or over-the-counter medicines and medicines administered to hospital patients or at outpatient infusion centers.

Reporting of adverse events by healthcare professionals and consumers is voluntary in the United States. FDA receives some adverse event reports directly from healthcare professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report adverse events to the products’ manufacturers. If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.

disclaimer

FAERS data does have limitations. There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event.

Further, FDA does not receive reports for every adverse event or medication error that occurs with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.

Submission of a safety report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.

In 2012, FDA changed from the Adverse Event Reporting System (AERS) to the FDA Adverse Event Reporting System (FAERS). There was a minor shift in terms as part of this transition. If you are using data from before December 2012, you should be aware of this shift.

Responsible use of the data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product.

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. In recent years the FDA has undertaken efforts to increase collection of adverse events. Increases in the total number of adverse events is likely caused by improved reporting.

How adverse events are organized

Adverse events are collected through a series of safety reports. Each is identified by a 8-digit string (for instance, 6176304-1). The first 7 digits (before the hyphen) identify the individual report, and the last digit (after the hyphen) is a checksum. Rather than updating individual records in FAERS, subsequent updates are submitted in seperate reports.

Format

Adverse event reports use the ICH E2b/M2 version 2.1 standard. OpenFDA annotates the original records with special fields.

FDA releases quarterly updates to FAERS data. OpenFDA uses these extracts, but processes the data further before supplying them through the API. There are no plans for the openFDA initiative to change the FAERS release protocols. At this time it is anticipated that FAERS downloads will continue to be available from the same site on the same quarterly schedule. OpenFDA is a research project to make access to these datasets easier, not replace the current process. The information available through openFDA is not for clinical production use. While FDA makes every effort to ensure the data is accurate, it should be assumed that all results are not validated.

Results

For non-count queries, the results section includes matching adverse event reports returned by the API.

Each adverse event report consists of these major sections:

  • Header: General information about the adverse event

  • Patient Information: Details on the patient who experienced the event, such as age, weight, sex, etc.

  • Drugs: Information on the drugs taken while the event was experienced

  • Reactions: Information on the reactions experienced by the patient

Field-by-field reference

General information about the adverse event.

{
  "safetyreport": "1234567-8",
  "safetyreportversion": "17",
  "receivedate": "20041025",
  "receivedateformat": "102",
  "receiptdate": "20040224",
  "receiptdateformat": "102",
  "serious": "1",
  "seriousnesscongenitalanomali": "1",
  "seriousnessdeath": "1",
  "seriousnessdisabling": "1",
  "seriousnesshospitalization": "1",
  "seriousnesslifethreatening": "1",
  "seriousnessother": "1",
  "transmissiondate": "1",
  "transmissiondateformat": "1",
  "duplicate": "1",
  "companynumb": "200501050",
  "occurcountry": "US",
  "primarysourcecountry": "US",
  "primarysource": {
    "qualification": "1",
    "reportercountry": "UNITED STATES"
  },
  "reportduplicate": {
    "duplicatesource": "NOVARTIS",
    "duplicatenumb": "PHEH2006US00792"
  },
  "sender": {
    "sendertype": "2",
    "senderorganization": "FDA-Public Use"
  },
  "receiver": {
    "receivertype": "6",
    "receiverorganization": "FDA"
  }
}
  • safetyreportid
    string

    The 8-digit Safety Report ID number, also known as the case report number or case ID. The first 7 digits (before the hyphen) identify an individual report and the last digit (after the hyphen) is a checksum. This field can be used to identify or find a specific adverse event report.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=safetyreportid:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=safetyreportid.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=safetyreportid
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=safetyreportid.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

  • safetyreportversion
    string

    The version number of the safetyreportid. Multiple versions of the same report may exist, it is generally best to only count the latest report and disregard others. openFDA will only return the latest version of a report.

  • receivedate
    string

    Date that the report was first received by FDA. If this report has multiple versions, this will be the date the first version was received by FDA.

  • receivedateformat
    string

    Encoding format of the transmissiondate field. Always set to 102 (YYYYMMDD).

  • receiptdate
    string

    Date that the most recent information in the report was received by FDA.

  • receiptdateformat
    string

    Encoding format of the transmissiondate field. Always set to 102 (YYYYMMDD).

  • serious
    string

    Seriousness of the adverse event.

    Value is one of the following

    • 1 = The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition

    • 2 = The adverse event did not result in any of the above

  • seriousnessdeath
    string

    This value is 1 if the adverse event resulted in death, and absent otherwise.

  • seriousnessdisabling
    string

    This value is 1 if the adverse event resulted in disability, and absent otherwise.

  • seriousnesshospitalization
    string

    This value is 1 if the adverse event resulted in a hospitalization, and absent otherwise.

  • seriousnesslifethreatening
    string

    This value is 1 if the adverse event resulted in a life threatening condition, and absent otherwise.

  • seriousnessother
    string

    This value is 1 if the adverse event resulted in some other serious condition, and absent otherwise.

  • transmissiondate
    string

    Date that the record was created. This may be earlier than the date the record was received by the FDA.

  • transmissiondateformat
    string

    Encoding format of the transmissiondate field. Always set to 102 (YYYYMMDD).

  • duplicate
    string

    This value is 1 if earlier versions of this report were submitted to FDA. openFDA only shows the most recent version.

  • companynumb
    string

    Identifier for the company providing the report. This is self-assigned.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=companynumb:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=companynumb.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=companynumb
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=companynumb.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

  • occurcountry
    string

    The name of the country where the event occurred.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=occurcountry:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=occurcountry.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=occurcountry
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=occurcountry.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

    Fore more information, see Country codes

  • primarysourcecountry
    string

    Country of the reporter of the event.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=primarysourcecountry:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=primarysourcecountry.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=primarysourcecountry
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=primarysourcecountry.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

    Fore more information, see Country codes

  • primarysource
  • primarysource.qualification
    string

    Category of individual who submitted the report.

    Value is one of the following

    • 1 = Physician

    • 2 = Pharmacist

    • 3 = Other health professional

    • 4 = Lawyer

    • 5 = Consumer or non-health professional

  • primarysource.reportercountry
    string

    Country from which the report was submitted.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=primarysource.reportercountry:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=primarysource.reportercountry.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=primarysource.reportercountry
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=primarysource.reportercountry.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

  • reportduplicate
  • reportduplicate.duplicatesource
    string

    The name of the organization providing the duplicate.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=reportduplicate.duplicatesource:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=reportduplicate.duplicatesource.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=reportduplicate.duplicatesource
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=reportduplicate.duplicatesource.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

  • reportduplicate.duplicatenumb
    string

    The case identifier for the duplicate.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=reportduplicate.duplicatenumb:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=reportduplicate.duplicatenumb.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=reportduplicate.duplicatenumb
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=reportduplicate.duplicatenumb.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

  • sender
  • sender
  • sender.sendertype
    string

    The name of the organization sending the report. Because FDA is providing these reports to you, the value is always 2.

    Value is one of the following

    • 2 = Regulatory authority

  • sender.senderorganization
    string

    Name of the organization sending the report. Because FDA is providing these reports to you, the value is always FDA-Public Use.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=sender.senderorganization:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=sender.senderorganization.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=sender.senderorganization
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=sender.senderorganization.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

  • receiver

    Information on the organization receiving the report.

Patient

Information about the patient in the adverse event report.

{
  "patientonsetage": "59",
  "patientonsetageunit": "801",
  "patientsex": "2",
  "patientweight": "78",
  "patientdeath": {
    "patientdeathdate": "20030401",
    "patientdeathdateformat": "102"
  },
  "drug": [
    {
      "actiondrug": "1",
      "drugadditional": "1",
      "drugcumulativedosagenumb": "4100",
      "drugcumulativedosageunit": "003",
      "drugdosageform": "Tablet",
      "drugintervaldosagedefinition": "804",
      "drugintervaldosageunitnumb": "1",
      "drugrecurreadministration": "3",
      "drugseparatedosagenumb": "1",
      "drugstructuredosagenumb": "600",
      "drugstructuredosageunit": "003",
      "drugadministrationroute": "048",
      "drugauthorizationnumb": "021223",
      "drugbatchnumb": "020113A",
      "drugcharacterization": "1",
      "drugdoseagetext": "3.5 MG/KG, 1 IN 1 AS NECESSARY, INTRAVENOUS DRIP",
      "drugenddate": "20020920",
      "drugenddateformat": "102",
      "drugindication": "RHEUMATOID ARTHRITIS",
      "drugstartdate": "20020903",
      "drugstartdateformat": "102",
      "drugtreatmentduration": "1",
      "drugtreatmentdurationunit": "804",
      "medicinalproduct": "ASCORBIC ACID",
      "openfda": {
        "spl_id": [
          "f67ce1df-27ea-4c67-a8a3-daf3fb3b9a92",
          "72133842-ac3f-4a39-a825-38e01930a0a7"
        ],
        "product_ndc": [
          "0389-0486",
          "67457-118",
          "67457-303"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "ASCORBIC ACID"
        ],
        "rxcui": [
          "308395"
        ],
        "spl_set_id": [
          "a6c36a36-28ee-4a1b-86fe-98ef94064b68",
          "d05200cb-cf29-4bc7-bf0c-b42ab2d20958"
        ],
        "package_ndc": [
          "67457-118-50",
          "0389-0486-50",
          "67457-303-50"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "generic_name": [
          "ASCORBIC ACID"
        ],
        "manufacturer_name": [
          "The Torrance Company",
          "Mylan Institutional LLC"
        ],
        "brand_name": [
          "ASCORBIC ACID"
        ]
      }
    }
  ],
  "reaction": [
    {
      "reactionmeddrapt": "Osteonecrosis of jaw",
      "reactionmeddraversionpt": "16.1",
      "reactionoutcome": "6"
    },
    {
      "reactionmeddrapt": "HYPERTENSION"
    },
    {
      "reactionmeddrapt": "POLYTRAUMATISM"
    }
  ]
}
  • patient.patientonsetage
    string

    Age of the patient when the event first occured.

  • patient.patientonsetageunit
    string

    The unit for the interval in the field patientonsetage.

    Value is one of the following

    • 800 = Decade

    • 801 = Year

    • 802 = Month

    • 803 = Week

    • 804 = Day

    • 805 = Hour

  • patient.patientsex
    string

    The sex of the patient.

    Value is one of the following

    • 0 = Unknown

    • 1 = Male

    • 2 = Female

  • patient.patientweight
    string

    The patient weight, in kg (kilograms).

  • patient.patientdeath
  • patient.patientdeath.patientdeathdate
    string

    If the patient died, the date that the patient died.

  • patient.patientdeath.patientdeathdateformat
    string

    Encoding format of the field patientdeathdate. Always set to 102 (YYYYMMDD).

Drugs

This section contains information about the drugs listed in the adverse event report.

  • patient.drug.actiondrug
    string

    Actions taken with the drug.

    Value is one of the following

    • 1 = Drug withdrawn

    • 2 = Dose reduced

    • 3 = Dose increased

    • 4 = Dose not changed

    • 5 = Unknown

    • 6 = Not applicable

  • patient.drug.drugadditional
    string

    Dechallenge outcome information—whether the event abated after product use stopped or the dose was reduced. Only present when this was attempted and the data was provided.

    Value is one of the following

    • 1 = Yes

    • 2 = No

    • 3 = Does not apply

  • patient.drug.drugcumulativedosagenumb
    string

    The cumulative dose taken until the first reaction was experienced, if provided.

  • patient.drug.drugcumulativedosageunit
    string

    The unit for drugcumulativedosagenumb.

    Value is one of the following

    • 001 = kg (kilograms)

    • 002 = g (grams)

    • 003 = mg (milligrams)

    • 004 = µg (micrograms)

  • patient.drug.drugdosageform
    string

    The drug’s dosage form. There is no standard, but values may include terms like tablet or solution for injection.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=patient.drug.drugdosageform:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=patient.drug.drugdosageform.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=patient.drug.drugdosageform
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=patient.drug.drugdosageform.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

  • patient.drug.drugintervaldosagedefinition
    string

    The unit for the interval in the field drugintervaldosageunitnumb.

    Value is one of the following

    • 801 = Year

    • 802 = Month

    • 803 = Week

    • 804 = Day

    • 805 = Hour

    • 806 = Minute

    • 807 = Trimester

    • 810 = Cyclical

    • 811 = Trimester

    • 812 = As necessary

    • 813 = Total

  • patient.drug.drugintervaldosageunitnumb
    string

    Number of units in the field drugintervaldosagedefinition.

  • patient.drug.drugrecurreadministration
    string

    Whether the reaction occured after readministration of the drug.

    Value is one of the following

    • 1 = Yes

    • 2 = No

    • 3 = Unknown

  • patient.drug.drugseparatedosagenumb
    string

    The number of separate doses that were administered.

  • patient.drug.drugstructuredosagenumb
    string

    The number portion of a dosage; when combined with drugstructuredosageunit the complete dosage information is represented. For example, 300 in 300 mg.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=patient.drug.drugstructuredosagenumb:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=patient.drug.drugstructuredosagenumb.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=patient.drug.drugstructuredosagenumb
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=patient.drug.drugstructuredosagenumb.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

  • patient.drug.drugstructuredosageunit
    string

    The unit for the field drugstructuredosagenumb. For example, mg in 300 mg.

    Value is one of the following

    • 001 = kg (kilograms)

    • 002 = g (grams)

    • 003 = mg (milligrams)

    • 004 = µg (micrograms)

  • patient.drug.drugadministrationroute
    string

    The drug’s route of administration.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=patient.drug.drugadministrationroute:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=patient.drug.drugadministrationroute.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=patient.drug.drugadministrationroute
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=patient.drug.drugadministrationroute.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

    Value is one of the following

    • 001 = Auricular (otic)

    • 002 = Buccal

    • 003 = Cutaneous

    • 004 = Dental

    • 005 = Endocervical

    • 006 = Endosinusial

    • 007 = Endotracheal

    • 008 = Epidural

    • 009 = Extra-amniotic

    • 010 = Hemodialysis

    • 011 = Intra corpus cavernosum

    • 012 = Intra-amniotic

    • 013 = Intra-arterial

    • 014 = Intra-articular

    • 015 = Intra-uterine

    • 016 = Intracardiac

    • 017 = Intracavernous

    • 018 = Intracerebral

    • 019 = Intracervical

    • 020 = Intracisternal

    • 021 = Intracorneal

    • 022 = Intracoronary

    • 023 = Intradermal

    • 024 = Intradiscal (intraspinal)

    • 025 = Intrahepatic

    • 026 = Intralesional

    • 027 = Intralymphatic

    • 028 = Intramedullar (bone marrow)

    • 029 = Intrameningeal

    • 030 = Intramuscular

    • 031 = Intraocular

    • 032 = Intrapericardial

    • 033 = Intraperitoneal

    • 034 = Intrapleural

    • 035 = Intrasynovial

    • 036 = Intratumor

    • 037 = Intrathecal

    • 038 = Intrathoracic

    • 039 = Intratracheal

    • 040 = Intravenous bolus

    • 041 = Intravenous drip

    • 042 = Intravenous (not otherwise specified)

    • 043 = Intravesical

    • 044 = Iontophoresis

    • 045 = Nasal

    • 046 = Occlusive dressing technique

    • 047 = Ophthalmic

    • 048 = Oral

    • 049 = Oropharingeal

    • 050 = Other

    • 051 = Parenteral

    • 052 = Periarticular

    • 053 = Perineural

    • 054 = Rectal

    • 055 = Respiratory (inhalation)

    • 056 = Retrobulbar

    • 057 = Sunconjunctival

    • 058 = Subcutaneous

    • 059 = Subdermal

    • 060 = Sublingual

    • 061 = Topical

    • 062 = Transdermal

    • 063 = Transmammary

    • 064 = Transplacental

    • 065 = Unknown

    • 066 = Urethral

    • 067 = Vaginal

  • patient.drug.drugauthorizationnumb
    string

    Drug authorization or application number (NDA or ANDA), if provided.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=patient.drug.drugauthorizationnumb:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=patient.drug.drugauthorizationnumb.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=patient.drug.drugauthorizationnumb
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=patient.drug.drugauthorizationnumb.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

  • patient.drug.drugbatchnumb
    string

    Drug product lot number, if provided.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=patient.drug.drugbatchnumb:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=patient.drug.drugbatchnumb.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=patient.drug.drugbatchnumb
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=patient.drug.drugbatchnumb.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

  • patient.drug.drugcharacterization
    string

    Reported role of the drug in the adverse event report. These values are not validated by FDA.

    Value is one of the following

    • 1 = Suspect (the drug was considered by the reporter to be the cause)

    • 2 = Concomitant (the drug was reported as being taken along with the suspect drug)

    • 3 = Interacting (the drug was considered by the reporter to have interacted with the suspect drug)

  • patient.drug.drugdosagetext
    string

    Additional detail about the dosage taken. Frequently unknown, but occasionally including information like a brief textual description of the schedule of administration.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=patient.drug.drugdosagetext:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=patient.drug.drugdosagetext.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=patient.drug.drugdosagetext
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=patient.drug.drugdosagetext.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

  • patient.drug.drugenddate
    string

    Date the patient stopped taking the drug.

  • patient.drug.drugenddateformat
    string

    Encoding format of the field drugenddateformat. Always set to 102 (YYYYMMDD).

  • patient.drug.drugindication
    string

    Indication for the drug’s use.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=patient.drug.drugindication:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=patient.drug.drugindication.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=patient.drug.drugindication
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=patient.drug.drugindication.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

  • patient.drug.drugstartdate
    string

    Date the patient began taking the drug.

  • patient.drug.drugstartdateformat
    string

    Encoding format of the field drugstartdate. Always set to 102 (YYYYMMDD).

  • patient.drug.drugtreatmentduration
    string

    The interval of the field drugtreatmentdurationunit for which the patient was taking the drug.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=patient.drug.drugtreatmentduration:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=patient.drug.drugtreatmentduration.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=patient.drug.drugtreatmentduration
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=patient.drug.drugtreatmentduration.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

  • patient.drug.drugtreatmentdurationunit
    string
    Value is one of the following

    • 801 = Year

    • 802 = Month

    • 803 = Week

    • 804 = Day

    • 805 = Hour

    • 806 = Minute

  • patient.drug.medicinalproduct
    string

    Drug name. This may be the valid trade name of the product (such as ADVIL or ALEVE) or the generic name (such as IBUPROFEN). This field is not systematically normalized. It may contain misspellings or idiosyncratic descriptions of drugs, such as combination products such as those used for birth control.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=patient.drug.medicinalproduct:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=patient.drug.medicinalproduct.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=patient.drug.medicinalproduct
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=patient.drug.medicinalproduct.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

OpenFDA fields

Different datasets use different drug identifiers—brand name, generic name, NDA, NDC, etc. It can be difficult to find the same drug in different datasets. And some identifiers, like pharmacologic class, are useful search filters but not available in all datasets.

OpenFDA features harmonization of drug identifiers, to make it easier to connect adverse event report records to other drug information. Drug products that appear in FAERS records are joined to the NDC dataset first on brand name, and if there is no brand name, on generic name. If that is succesful, further links are established to other datasets. The linked data is listed as an openfda annotation in the patient.drug section of a result.

Roughly 86% of adverse event records have at least one openfda section. Because the harmonization process requires an exact match, some drug products cannot be harmonized in this fashion—for instance, if the drug name is misspelled. Some drug products will have openfda sections, while others will never, if there was no match during the harmonization process.

    • application_number
      array of strings

      This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

      Values follow this pattern
      ^[BLA|ANDA|NDA]{3,4}[0-9]{6}$
    • brand_name
      array of strings

      Brand or trade name of the drug product.

    • generic_name
      array of strings

      Generic name(s) of the drug product.

    • manufacturer_name
      array of strings

      Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.

    • nui
      array of strings

      Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).

      Values follow this pattern
      ^[N][0-9]{10}$
    • package_ndc
      array of strings

      This number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug.

      Values follow this pattern
      ^[0-9]{5,4}-[0-9]{4,3}-[0-9]{1,2}$
    • pharm_class_cs
      array of strings

      Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by [Chemical/Ingredient] (such as Thiazides [Chemical/Ingredient] or `Antibodies, Monoclonal [Chemical/Ingredient].

    • pharm_class_epc
      array of strings

      Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by [EPC] (such as Thiazide Diuretic [EPC] or Tumor Necrosis Factor Blocker [EPC].

    • pharm_class_pe
      array of strings

      Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by [PE] (such as Increased Diuresis [PE] or Decreased Cytokine Activity [PE].

    • pharm_class_moa
      array of strings

      Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by [MoA] (such as Calcium Channel Antagonists [MoA] or Tumor Necrosis Factor Receptor Blocking Activity [MoA].

    • product_ndc
      array of strings

      The labeler manufacturer code and product code segments of the NDC number, separated by a hyphen.

      Values follow this pattern
      ^[0-9]{5,4}-[0-9]{4,3}$
    • product_type
      array of strings
    • route
      array of strings

      The route of administation of the drug product.

    • rxcui
      array of strings

      The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.

      Values follow this pattern
      ^[0-9]{6}$
    • spl_id
      array of strings

      Unique identifier for a particular version of a Structured Product Label for a product. Also referred to as the document ID.

      Values follow this pattern
      ^[a-fA-F0-9]{8}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{12}$
    • spl_set_id
      array of strings

      Unique identifier for the Structured Product Label for a product, which is stable across versions of the label. Also referred to as the set ID.

      Values follow this pattern
      ^[a-fA-F0-9]{8}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{12}$
    • substance_name
      array of strings

      The list of active ingredients of a drug product.

    • unii
      array of strings

      Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

      Values follow this pattern
      ^[A-Z0-9]{10}$

disclaimer

A single drug product listed in an adverse event report may have multiple associated manufacturer names, NDCs, and SPLs in a corresponding openfda section. That is because the drug may have multiple manufacturers, packagers, dosage forms, etc. Their inclusion in the openfda section does not mean that they had any connection to the adverse event. The ordering of data in openfda fields is not significant.

Reactions

  • patient.reaction.reactionmeddrapt
    string

    Patient reaction, as a MedDRA term. Note that these terms are encoded in British English. For instance, diarrhea is spelled diarrohea. MedDRA is a standardized medical terminology.

    This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

    • search=patient.reaction.reactionmeddrapt:"FOO+BAR"
      Searches for records where either FOO or BAR appear anywhere in this field.

    • search=patient.reaction.reactionmeddrapt.exact:"FOO+BAR"
      Searches for records where exactly and only FOO BAR appears in this field.

    • count=patient.reaction.reactionmeddrapt
      Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.

    • count=patient.reaction.reactionmeddrapt.exact
      Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.

    Fore more information, see MedDRA

  • patient.reaction.reactionmeddraversionpt
    string

    The version of MedDRA from which the term in reactionmeddrapt is drawn.

  • patient.reaction.reactionoutcome
    string

    Outcome of the reaction in reactionmeddrapt at the time of last observation.

    Value is one of the following

    • 1 = Recovered/resolved

    • 2 = Recovering/resolving

    • 3 = Not recovered/not resolved

    • 4 = Recovered/resolved with sequelae (consequent health issues)

    • 5 = Fatal

    • 6 = Unknown

Datasets

The following datasets provide data for this endpoint.

FAERS