<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="3009922">
  <adverse_event_report>
    <yyqq>98Q1</yyqq>
    <isr>3017604</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>3017604-3</image>
    <event_date>1997-12-19</event_date>
    <manufacturer_date>1997-12-22</manufacturer_date>
    <fda_date>1998-01-22</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>FD E97-2590</manufacturer_number>
    <manufacturer_sending>Boehringer Ingelheim Pharmaceuticals, Inc.</manufacturer_sending>
    <age>67.0</age>
    <age_units>YR</age_units>
    <gender>M</gender>
    <is_electronic_submission>false</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date></report_date>
    <reporter_occupation></reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified>false</manufacturer_notified>
    <confidentiality_status>false</confidentiality_status>
    <reporter_country></reporter_country>
    <outcome outcome_code="HO"/>
    <outcome outcome_code="DS"/>
    <reaction reaction_preferred_term="Impotence"/>
    <reaction reaction_preferred_term="Necrosis"/>
    <reaction reaction_preferred_term="Priapism"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1000035941</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Flomax</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>U</dechallenge_code>
      <rechallenge_code>U</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1997-12-17</start_date>
        <end_date>1997-12-18</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000056175</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Levothyroxine Sodium</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000056176</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Omeprazole</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>98Q1</yyqq>
    <isr>3056136</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>1</followup_sequence>
    <image>3056136-3</image>
    <event_date>1997-12-19</event_date>
    <manufacturer_date>1997-12-22</manufacturer_date>
    <fda_date>1998-03-16</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>FD E97-2590</manufacturer_number>
    <manufacturer_sending>Boehringer Ingelheim Pharmaceutical</manufacturer_sending>
    <age>67.0</age>
    <age_units>YR</age_units>
    <gender>M</gender>
    <is_electronic_submission>false</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date></report_date>
    <reporter_occupation></reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified>false</manufacturer_notified>
    <confidentiality_status>false</confidentiality_status>
    <reporter_country></reporter_country>
    <outcome outcome_code="HO"/>
    <outcome outcome_code="DS"/>
    <reaction reaction_preferred_term="Impotence"/>
    <reaction reaction_preferred_term="Necrosis"/>
    <reaction reaction_preferred_term="Priapism"/>
    <reaction reaction_preferred_term="Protein Total Increased"/>
    <reaction reaction_preferred_term="White Blood Cell Count Increased"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="OTH"/>
    <drug_datum>
      <drug_sequence>1000106645</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Flomax</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>N</dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1997-12-17</start_date>
        <end_date>1997-12-18</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000138122</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Levothyroxine Sodium</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000138123</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Omeprazole</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
  </adverse_event_report>
</adverse_event_case>
