Drug adverse event reports (FAERS)

Loss of personal independence in daily activities, Adverse event, Condition aggravated +2

Drugs: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE

Not seriousReport 27325171
Safetyreportversion
1
Safetyreportid
27325171
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20261010
Reporttype
1
Serious
2
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
2
Receivedateformat
102
Receivedate
20260930
Receiptdateformat
102
Receiptdate
20260930
Fulfillexpeditecriteria
2
Companynumb
US-TEVA-VS-3490707
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
TEVA PHARMACEUTICALS INDUSTRIES LTD.
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Loss of personal independence in daily activities
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Adverse event
    Reactionoutcome
    6
  3. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Condition aggravated
    Reactionoutcome
    6
  4. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Adverse drug reaction
    Reactionoutcome
    6
  5. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Drug ineffective
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE
    Drugauthorizationnumb
    210876
    Drugseparatedosagenumb
    1
    Drugdosagetext
    EXTENDED RELEASE CAPSULES
    Drugindication
    Attention deficit hyperactivity disorder
    Actiondrug
    5
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    AMPHETAMINE ASPARTATE\AMPHETAMINE SULFATE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMPHETAMINE SULFATE
  2. Drugcharacterization
    1
    Medicinalproduct
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE
    Drugauthorizationnumb
    210876
    Drugseparatedosagenumb
    1
    Drugdosagetext
    EXTENDED RELEASE CAPSULES
    Actiondrug
    5
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    AMPHETAMINE ASPARTATE\AMPHETAMINE SULFATE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMPHETAMINE SULFATE
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20260101
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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.