Apparent death, Joint swelling, Urticaria +28
Drugs: HUMIRA, REMICADE, RITUXAN +22
- Safetyreportversion
- 1
- Safetyreportid
- 27325175
- Primarysourcecountry
- CA
- Occurcountry
- CA
- Transmissiondateformat
- 102
- Transmissiondate
- 20261010
- Reporttype
- 2
- Serious
- 1
- Seriousnessdeath
- 1
- Seriousnesslifethreatening
- 1
- Seriousnesshospitalization
- 1
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 1
- Receivedateformat
- 102
- Receivedate
- 20260930
- Receiptdateformat
- 102
- Receiptdate
- 20260930
- Fulfillexpeditecriteria
- 1
- Companynumb
- CA-ABBVIE-6955228
- Duplicate
- 1
- Reportduplicate
- Duplicatesource
- Health Canada
- Duplicatenumb
- E2B_05579311
- Primarysource
- Reportercountry
- CA
- Qualification
- 3
- Sender
- Sendertype
- 6
- Senderorganization
- ABBVIE
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 58
- Patientonsetageunit
- 801
- Patientsex
- 1
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Apparent death
- Reactionoutcome
- 5
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Joint swelling
- Reactionoutcome
- 5
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Urticaria
- Reactionoutcome
- 5
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Thrombosis
- Reactionoutcome
- 5
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Terminal state
- Reactionoutcome
- 5
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Stomatitis
- Reactionoutcome
- 5
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Renal failure
- Reactionoutcome
- 5
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Red blood cell sedimentation rate increased
- Reactionoutcome
- 5
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Off label use
- Reactionoutcome
- 5
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Haemoglobin decreased
- Reactionoutcome
- 5
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Feeling abnormal
- Reactionoutcome
- 5
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Drug intolerance
- Reactionoutcome
- 5
- +19 more not shown
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- HUMIRA
- Drugbatchnumb
- NOT AVAILABLE
- Drugauthorizationnumb
- 125057
- Drugseparatedosagenumb
- 1
- Drugdosageform
- Solution for injection
- Drugindication
- Rheumatoid arthritis
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- ADALIMUMAB
- Harmonized identifiers (openFDA)
- Application number
- BLA125057
- Brand name
- HUMIRA
- Generic name
- ADALIMUMAB
- Manufacturer name
- Cordavis Limited, AbbVie Inc.
- Product NDC
- 83457-124, 83457-554, 83457-243, 83457-616, 83457-817, 0074-0124, 0074-3799, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 0074-0067, 0074-2540, 0074-1539, 0074-0616, 0074-0817
- Product type
- HUMAN PRESCRIPTION DRUG
- RxCUI
- 797544, 1726844, 1726846, 1872979, 1872980, 1921009, 1921010, 1921016, 1921017, 1921238, 1921240, 727703, 727705, 763564, 763565, 825169, 825170, 1594352, 1594357, 1594358, 1655726, 1655728, 1656703, 1801277, 1801278, 1855523, 1855524, 1855526, 1855527, 1872983, 1872984, 1872985, 1872986, 1873086, 1873087, 1921244, 1921245, 1921467, 1921468, 2531133 +1 more
- SPL ID
- 5fe81b1a-cc31-444e-a0f1-1ea4f7334b89, 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
- SPL set ID
- 4977567e-3525-44ac-9ff5-f1e74b053950, 608d4f0d-b19f-46d3-749a-7159aa5f933d
- Package NDC
- 83457-554-02, 83457-553-01, 83457-927-01, 83457-124-02, 83457-123-01, 83457-243-02, 83457-242-01, 83457-616-02, 83457-615-01, 83457-817-02, 83457-816-01, 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-4339-02, 0074-4339-07, 0074-4339-71, 0074-4339-73, 0074-4339-01, 0074-4339-74, 0074-9374-71, 0074-0243-02, 0074-0243-71, 0074-0554-01, 0074-0554-02, 0074-0554-04, 0074-0554-06, 0074-0554-71, 0074-0554-74, 0074-0554-73, 0074-0067-02, 0074-2540-01, 0074-2540-03, 0074-0124-74, 0074-0124-73, 0074-0124-01, 0074-0124-03, 0074-0124-02, 0074-0124-04 +4 more
- Drugcharacterization
- 1
- Medicinalproduct
- HUMIRA
- Drugauthorizationnumb
- 125057
- Drugindication
- Systemic lupus erythematosus
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- ADALIMUMAB
- Harmonized identifiers (openFDA)
- Application number
- BLA125057
- Brand name
- HUMIRA
- Generic name
- ADALIMUMAB
- Manufacturer name
- Cordavis Limited, AbbVie Inc.
- Product NDC
- 83457-124, 83457-554, 83457-243, 83457-616, 83457-817, 0074-0124, 0074-3799, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 0074-0067, 0074-2540, 0074-1539, 0074-0616, 0074-0817
- Product type
- HUMAN PRESCRIPTION DRUG
- RxCUI
- 797544, 1726844, 1726846, 1872979, 1872980, 1921009, 1921010, 1921016, 1921017, 1921238, 1921240, 727703, 727705, 763564, 763565, 825169, 825170, 1594352, 1594357, 1594358, 1655726, 1655728, 1656703, 1801277, 1801278, 1855523, 1855524, 1855526, 1855527, 1872983, 1872984, 1872985, 1872986, 1873086, 1873087, 1921244, 1921245, 1921467, 1921468, 2531133 +1 more
- SPL ID
- 5fe81b1a-cc31-444e-a0f1-1ea4f7334b89, 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
- SPL set ID
- 4977567e-3525-44ac-9ff5-f1e74b053950, 608d4f0d-b19f-46d3-749a-7159aa5f933d
- Package NDC
- 83457-554-02, 83457-553-01, 83457-927-01, 83457-124-02, 83457-123-01, 83457-243-02, 83457-242-01, 83457-616-02, 83457-615-01, 83457-817-02, 83457-816-01, 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-4339-02, 0074-4339-07, 0074-4339-71, 0074-4339-73, 0074-4339-01, 0074-4339-74, 0074-9374-71, 0074-0243-02, 0074-0243-71, 0074-0554-01, 0074-0554-02, 0074-0554-04, 0074-0554-06, 0074-0554-71, 0074-0554-74, 0074-0554-73, 0074-0067-02, 0074-2540-01, 0074-2540-03, 0074-0124-74, 0074-0124-73, 0074-0124-01, 0074-0124-03, 0074-0124-02, 0074-0124-04 +4 more
- Drugcharacterization
- 1
- Medicinalproduct
- HUMIRA
- Drugbatchnumb
- NOT AVAILABLE
- Drugauthorizationnumb
- 125057
- Drugseparatedosagenumb
- 1
- Drugdosageform
- Solution for injection
- Drugadministrationroute
- 058
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- ADALIMUMAB
- Harmonized identifiers (openFDA)
- Application number
- BLA125057
- Brand name
- HUMIRA
- Generic name
- ADALIMUMAB
- Manufacturer name
- Cordavis Limited, AbbVie Inc.
- Product NDC
- 83457-124, 83457-554, 83457-243, 83457-616, 83457-817, 0074-0124, 0074-3799, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 0074-0067, 0074-2540, 0074-1539, 0074-0616, 0074-0817
- Product type
- HUMAN PRESCRIPTION DRUG
- RxCUI
- 797544, 1726844, 1726846, 1872979, 1872980, 1921009, 1921010, 1921016, 1921017, 1921238, 1921240, 727703, 727705, 763564, 763565, 825169, 825170, 1594352, 1594357, 1594358, 1655726, 1655728, 1656703, 1801277, 1801278, 1855523, 1855524, 1855526, 1855527, 1872983, 1872984, 1872985, 1872986, 1873086, 1873087, 1921244, 1921245, 1921467, 1921468, 2531133 +1 more
- SPL ID
- 5fe81b1a-cc31-444e-a0f1-1ea4f7334b89, 8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
- SPL set ID
- 4977567e-3525-44ac-9ff5-f1e74b053950, 608d4f0d-b19f-46d3-749a-7159aa5f933d
- Package NDC
- 83457-554-02, 83457-553-01, 83457-927-01, 83457-124-02, 83457-123-01, 83457-243-02, 83457-242-01, 83457-616-02, 83457-615-01, 83457-817-02, 83457-816-01, 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-4339-02, 0074-4339-07, 0074-4339-71, 0074-4339-73, 0074-4339-01, 0074-4339-74, 0074-9374-71, 0074-0243-02, 0074-0243-71, 0074-0554-01, 0074-0554-02, 0074-0554-04, 0074-0554-06, 0074-0554-71, 0074-0554-74, 0074-0554-73, 0074-0067-02, 0074-2540-01, 0074-2540-03, 0074-0124-74, 0074-0124-73, 0074-0124-01, 0074-0124-03, 0074-0124-02, 0074-0124-04 +4 more
- Drugcharacterization
- 1
- Medicinalproduct
- REMICADE
- Drugseparatedosagenumb
- 1
- Drugindication
- Rheumatoid arthritis
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- INFLIXIMAB
- Harmonized identifiers (openFDA)
- Application number
- BLA103772
- Brand name
- REMICADE
- Generic name
- INFLIXIMAB
- Manufacturer name
- Janssen Biotech, Inc.
- Product NDC
- 57894-030
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- INFLIXIMAB
- RxCUI
- 213361, 310994
- SPL ID
- 36afec96-dd29-9328-e063-6294a90af8e4
- SPL set ID
- a0a046c1-056d-45a9-bfd9-13b47c24f257
- Package NDC
- 57894-030-01
- Nui
- N0000175610, N0000175451
- Pharm class epc
- Tumor Necrosis Factor Blocker [EPC]
- Pharm class moa
- Tumor Necrosis Factor Receptor Blocking Activity [MoA]
- UNII
- B72HH48FLU
- Drugcharacterization
- 1
- Medicinalproduct
- REMICADE
- Drugindication
- Systemic lupus erythematosus
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- INFLIXIMAB
- Harmonized identifiers (openFDA)
- Application number
- BLA103772
- Brand name
- REMICADE
- Generic name
- INFLIXIMAB
- Manufacturer name
- Janssen Biotech, Inc.
- Product NDC
- 57894-030
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- INFLIXIMAB
- RxCUI
- 213361, 310994
- SPL ID
- 36afec96-dd29-9328-e063-6294a90af8e4
- SPL set ID
- a0a046c1-056d-45a9-bfd9-13b47c24f257
- Package NDC
- 57894-030-01
- Nui
- N0000175610, N0000175451
- Pharm class epc
- Tumor Necrosis Factor Blocker [EPC]
- Pharm class moa
- Tumor Necrosis Factor Receptor Blocking Activity [MoA]
- UNII
- B72HH48FLU
- Drugcharacterization
- 1
- Medicinalproduct
- RITUXAN
- Drugseparatedosagenumb
- 1
- Drugindication
- Rheumatoid arthritis
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- RITUXIMAB
- Harmonized identifiers (openFDA)
- Application number
- BLA103705
- Brand name
- RITUXAN
- Generic name
- RITUXIMAB
- Manufacturer name
- Genentech, Inc.
- Product NDC
- 50242-051, 50242-053
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- RITUXIMAB
- RxCUI
- 1657862, 1657864, 1657867, 1657868
- SPL ID
- 3a716937-c2af-4bf9-976c-c34746b22ff0
- SPL set ID
- b172773b-3905-4a1c-ad95-bab4b6126563
- Package NDC
- 50242-051-21, 50242-051-10, 50242-053-06
- Nui
- N0000175078, N0000175657
- Pharm class moa
- CD20-directed Antibody Interactions [MoA]
- Pharm class epc
- CD20-directed Cytolytic Antibody [EPC]
- UNII
- 4F4X42SYQ6
- Drugcharacterization
- 1
- Medicinalproduct
- RITUXAN
- Drugindication
- Systemic lupus erythematosus
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- RITUXIMAB
- Harmonized identifiers (openFDA)
- Application number
- BLA103705
- Brand name
- RITUXAN
- Generic name
- RITUXIMAB
- Manufacturer name
- Genentech, Inc.
- Product NDC
- 50242-051, 50242-053
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- RITUXIMAB
- RxCUI
- 1657862, 1657864, 1657867, 1657868
- SPL ID
- 3a716937-c2af-4bf9-976c-c34746b22ff0
- SPL set ID
- b172773b-3905-4a1c-ad95-bab4b6126563
- Package NDC
- 50242-051-21, 50242-051-10, 50242-053-06
- Nui
- N0000175078, N0000175657
- Pharm class moa
- CD20-directed Antibody Interactions [MoA]
- Pharm class epc
- CD20-directed Cytolytic Antibody [EPC]
- UNII
- 4F4X42SYQ6
- Drugcharacterization
- 1
- Medicinalproduct
- GOLD SODIUM THIOMALATE
- Drugseparatedosagenumb
- 1
- Drugindication
- Rheumatoid arthritis
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- GOLD SODIUM THIOMALATE
- Drugcharacterization
- 1
- Medicinalproduct
- GOLD SODIUM THIOMALATE
- Drugindication
- Systemic lupus erythematosus
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- GOLD SODIUM THIOMALATE
- Drugcharacterization
- 1
- Medicinalproduct
- ARAVA
- Drugseparatedosagenumb
- 1
- Drugindication
- Systemic lupus erythematosus
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- LEFLUNOMIDE
- Harmonized identifiers (openFDA)
- Application number
- NDA020905
- Brand name
- ARAVA
- Generic name
- LEFLUNOMIDE
- Manufacturer name
- sanofi-aventis U.S. LLC
- Product NDC
- 0088-2160, 0088-2161, 0088-2162
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- LEFLUNOMIDE
- RxCUI
- 205284, 205285, 205286, 213377, 213379, 213380
- SPL ID
- 765327c7-cb5b-4637-84da-4fd9a024ad96
- SPL set ID
- 320f63f2-fac3-4aee-aff8-85724e00ef52
- Package NDC
- 0088-2160-30, 0088-2161-30, 0088-2162-33
- Nui
- N0000175713
- Pharm class epc
- Antirheumatic Agent [EPC]
- UNII
- G162GK9U4W
- Drugcharacterization
- 1
- Medicinalproduct
- ARAVA
- Drugindication
- Rheumatoid arthritis
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- LEFLUNOMIDE
- Harmonized identifiers (openFDA)
- Application number
- NDA020905
- Brand name
- ARAVA
- Generic name
- LEFLUNOMIDE
- Manufacturer name
- sanofi-aventis U.S. LLC
- Product NDC
- 0088-2160, 0088-2161, 0088-2162
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- LEFLUNOMIDE
- RxCUI
- 205284, 205285, 205286, 213377, 213379, 213380
- SPL ID
- 765327c7-cb5b-4637-84da-4fd9a024ad96
- SPL set ID
- 320f63f2-fac3-4aee-aff8-85724e00ef52
- Package NDC
- 0088-2160-30, 0088-2161-30, 0088-2162-33
- Nui
- N0000175713
- Pharm class epc
- Antirheumatic Agent [EPC]
- UNII
- G162GK9U4W
- Drugcharacterization
- 1
- Medicinalproduct
- CANNABIS SATIVA SUBSP. INDICA TOP
- Drugseparatedosagenumb
- 1
- Drugindication
- Pain
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- CANNABIS SATIVA SUBSP. INDICA TOP
- +32 more not shown