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File Description [top]

DIOGENES^®: Adverse Drug Events Database consists of two subfiles: Adverse Drug Reactions (ADR) and Adverse Event Reporting System (AERS). ADR records contain data regarding a single patient's experience with a drug or combination of drugs as reported to the U.S. Food and Drug Administration (FDA). Since 1969, the FDA has legally-mandated adverse drug reaction reports from pharmaceutical manufacturers and maintained them in their ADR system. The original reports varied greatly in detail, some providing only minimal details.

In November 1997, the ADR database was replaced by the Adverse Event Reporting System (AERS). AERS events are described on MedWatch form DGA-3500A and contain many more details than appeared on the earlier ADR records. Reports in the AERS file are evaluated by clinical reviewers in FDA's Center for Drug Evaluation. When information is unknown, it is omitted.

Vaccines are reported in a separate system and are not included in ADR data.

Tips [top]

Subject Coverage [top]

The scope of DIOGENES^®: Adverse Drug Events Database is FDA-related data regarding drugs as reported by drug manufacturers, individuals, health professionals, and medical studies. Records provide:

• FDA Report Number and FDA Receipt Date
• Manufacturer's Report Number
• Drug Name and Reaction Date
• Patient age and sex
• Reported reactions and Outcomes
• Concomitant drugs

Records also contain manufacturer name, dosage, administration route, and drug lot number, when this information is known.

Sources [top]

Data included in ADR records is drawn from the ADR database, which began in 1969. From November 1997 onward, the information is taken from the AERS database, as described above.

Print Counterparts [top]

• None

Dialog File Data [top]

Database Content [top]

• Directories

Document Types Indexed [top]

• Government Documents

Geographic Coverage [top]

• US Only

Geographic Restrictions [top]

• None

Special Features [top]

• ERA Available
• KWIC and HILIGHT Available

DialIndex/OneSearch Categories [top]

Contact [top]

Terms and Conditions [top]

All information and record identification in DIOGENES^® Adverse Drug Events Database is fully protected by copyright. Reproduction or photocopying even for internal use without the publisher's permission is prohibited. While every effort has been made to ensure that the information in the database is correct, FOI Services, Inc. cannot accept any responsibility for errors or omissions.

SAMPLE RECORD [top]

BASIC INDEX [top]

¹ Searchable in the Basic Index and in the Additional Indexes.

² Includes Named Suspect Drug (NS=).

³ Present only in AER subfile records.

⁴ Notes are present only in ADR subfile records.

ADDITIONAL INDEXES [top]

LIMIT [top]

SORT [top]

RANK [top]

USER-DEFINED FORMAT OPTIONS [top]

PREDEFINED FORMAT OPTIONS [top]

DIRECT RECORD ACCESS [top]

Rates [top]

Rates For File: DIOGENES®:  Adverse Drug Events Database[181]
Cost per DialUnit:                $16.96
Cost per minute:                   $3.83
Rank Elements                      $0.04

Format    Types   Prints
     1    $0.00    $0.00
     2    $1.50    $1.50
     3    $1.50    $1.50
     4    $1.50    $1.50
     5    $1.50    $1.50
     6    $0.00    $0.00
     7    $1.50    $1.50
     8    $1.50    $1.50
     9    $1.75    $1.75
KWIC95    $1.50       NA
KWIC96    $1.50       NA

REDIST/COPY Multiplier Table:

      Range      Multiplier
        1-2       1.00
       3-25       1.50
     26-100       3.00
    101-200       4.00
    201-500       6.00
   501-1000       8.00
 1001 or more    10.00

ARCHIVE Multiplier Table:

      Range      Multiplier
       1-25       1.50
     26-200       3.00
    201-500       6.00
   501-1000       8.00
 1001 or more    10.00