{"id":"d0073b1d-95b2-522d-8240-677ee1a5ff0c","stable_key":"6660bba2-4fa0-590a-bf52-9803a24bea9f:rash-warning","predicate":"reported_relationship","statement":"Official labeling reports serious rash including SJS/TEN and systemic hypersensitivity; pediatric rash discontinuations are not equivalent to SJS incidence.","claim_class":"observational","status":"source_recorded","evidence_grade":"ungraded","direction":"neutral","is_public":true,"mechanism_event_id":"890664a2-c292-5c6e-b6e0-88d36c0696a1","mechanism_event_label":"Official labeling reports serious rash including SJS/TEN and systemic hypersensitivity; pediatric rash discontinuations are not equivalent to SJS incidence.","subject":{"id":"624e6a4b-f96d-5d12-8206-30d1e1715c26","slug":"modafinil","display_name":"Modafinil","entity_type_key":"drug"},"object":{"id":"d9c35616-8b47-5ca3-9b54-56cb3f001bc7","slug":"human-modafinil-rash-risk","display_name":"Human modafinil-associated serious rash and hypersensitivity reports","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"890664a2-c292-5c6e-b6e0-88d36c0696a1","stable_key":"6660bba2-4fa0-590a-bf52-9803a24bea9f:rash-warning-event","event_type":"experimental_observation","label":"Official labeling reports serious rash including SJS/TEN and systemic hypersensitivity; pediatric rash discontinuations are not equivalent to SJS incidence.","description":"The U.S. product is Schedule IV, approved for adult excessive sleepiness associated with narcolepsy, OSA or shift-work disorder. Serious rash is a warning, **not a boxed warning**; 13/1,585 pediatric rash-related discontinuations are not 13 SJS cases. It is not approved for children. Reported reactions include SJS/TEN and systemic hypersensitivity. The cited label provides no supported adult “1 in 3,000–10,000” incidence. It instructs discontinuation at the first rash unless clearly unrelated. [U.S. label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3b8d1c32-dac9-50e6-e063-6394a90aa5a5)","status":"provisional","compartment":null,"participants":[{"entity":{"id":"624e6a4b-f96d-5d12-8206-30d1e1715c26","slug":"modafinil","display_name":"Modafinil","entity_type_key":"drug"},"role":"tested factor","stoichiometry":null,"state_label":"as reported","sequence_order":0,"notes":""},{"entity":{"id":"d9c35616-8b47-5ca3-9b54-56cb3f001bc7","slug":"human-modafinil-rash-risk","display_name":"Human modafinil-associated serious rash and hypersensitivity reports","entity_type_key":"cellular_process"},"role":"measured outcome","stoichiometry":null,"state_label":"not_reported","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"evidence_access","value_text":"Official label description, pharmacology, pharmacokinetics, indications, interactions and relevant warnings checked.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Official U.S. label; safety reports and pediatric trial discontinuations, not supported adult incidence denominator.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"interpretation_status","value_text":"Source-derived extraction of a fact-checked reference; access is explicit, not independent raw-data verification.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Interpret only within the recorded preparation, exposure and comparator. The complete source passage retains qualifications; unspecified doses/timing have not been extracted here. No clinical efficacy, nutrient deficiency or unique molecular mediation is inferred.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"Official labeling reports serious rash including SJS/TEN and systemic hypersensitivity; pediatric rash discontinuations are not equivalent to SJS incidence.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"PROVIGIL U.S. prescribing information | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3b8d1c32-dac9-50e6-e063-6394a90aa5a5","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"source_locator","value_text":"Reviewed reference lines 166-166; exact primary location described in quoted passage where extracted.","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"fd3ae9ae-eb77-5b01-8856-50113995ca63","evidence_kind":"source_excerpt","locator":"Lines 166-166","start_line":166,"end_line":166,"excerpt":"The U.S. product is Schedule IV, approved for adult excessive sleepiness associated with narcolepsy, OSA or shift-work disorder. Serious rash is a warning, **not a boxed warning**; 13/1,585 pediatric rash-related discontinuations are not 13 SJS cases. It is not approved for children. Reported reactions include SJS/TEN and systemic hypersensitivity. The cited label provides no supported adult “1 in 3,000–10,000” incidence. It instructs discontinuation at the first rash unless clearly unrelated. [U.S. label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3b8d1c32-dac9-50e6-e063-6394a90aa5a5)","model_system":"Official U.S. label; safety reports and pediatric trial discontinuations, not supported adult incidence denominator.","directness":"reported_statement","verification_status":"source_recorded","notes":"Exact excerpt of the retained AI-assisted reviewed reference; primary sources are cited in primary_references and access scope is retained. Not a verbatim quotation from a primary paper.","relationship":"supports","weight":1.0,"link_notes":"","source":{"id":"17a64928-eaa2-5117-ba4f-52dcbdf9cc9e","stable_key":"import-6660bba2-4fa0-590a-bf52-9803a24bea9f","title":"Modafinil: detailed mechanisms of action (reviewed 3 October 2026)","document_type":"imported_text","citation_label":"Original AI-assisted review of primary studies and, where relevant, official regulatory records. Access level is retained per claim. Corrections, null results and unresolved questions remain explicit. Not publisher full text or independent replication.","file_path":"","sha256":"006008cb4cfd183dd3b0846d3abc66c8ebf40cf1b6bd1f0bcdb4f4d937a8e115","revision_id":"c85b3e2e-c18a-59fc-9e79-5c375e64d119","review_status":"source_recorded","notes":""}}],"relations":[],"conflicts":[],"corrections":[],"research":null}