Somnambulism, Extrapyramidal disorder
Drugs: DEPAKOTE, ARIPIPRAZOLE, MIRTAZAPINE +1
- Safetyreportversion
- 1
- Safetyreportid
- 27325188
- Primarysourcecountry
- EU
- Occurcountry
- EU
- Transmissiondateformat
- 102
- Transmissiondate
- 20261010
- Reporttype
- 1
- Serious
- 1
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 1
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 2
- Receivedateformat
- 102
- Receivedate
- 20260930
- Receiptdateformat
- 102
- Receiptdate
- 20260930
- Fulfillexpeditecriteria
- 1
- Companynumb
- EU-ABBVIE-6955503
- Duplicate
- 1
- Reportduplicate
- Duplicatesource
- Sanofi
- Duplicatenumb
- 2026SA0216793
- Primarysource
- Reportercountry
- EU
- Qualification
- 2
- Sender
- Sendertype
- 6
- Senderorganization
- ABBVIE
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 66
- Patientonsetageunit
- 801
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Somnambulism
- Reactionoutcome
- 3
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Extrapyramidal disorder
- Reactionoutcome
- 3
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- DEPAKOTE
- Drugbatchnumb
- Not available
- Drugauthorizationnumb
- 021168
- Drugstructuredosagenumb
- 500
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- STRENGTH 500 MG?500 MG MORNING AND 1000 MG EVENING
- Drugindication
- Bipolar disorder
- Actiondrug
- 4
- Activesubstance
- Activesubstancename
- DIVALPROEX SODIUM
- Harmonized identifiers (openFDA)
- Application number
- NDA021168, NDA018723, NDA019680
- Brand name
- DEPAKOTE ER, DEPAKOTE, DEPAKOTE SPRINKLES
- Generic name
- DIVALPROEX SODIUM
- Manufacturer name
- AbbVie Inc.
- Product NDC
- 0074-7401, 0074-3826, 0074-7126, 0074-7402, 0074-7325, 0074-6212, 0074-6214, 0074-6215, 0074-7327, 0074-7326, 0074-6114
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- DIVALPROEX SODIUM
- RxCUI
- 1099563, 1099565, 1099569, 1099571, 1099625, 1099626, 1099678, 1099679, 1099870, 1099871, 1099596, 1099598
- SPL ID
- 0ee65b66-ead3-44ef-911f-14965b067903, 7cc3a0b3-93f8-4825-88e1-bf6ddb0db23d, d038b7e9-b014-4771-93be-90aeeaece03d
- SPL set ID
- 0dc024ce-efc8-4690-7cb5-639c728fccac, 08a65cf4-7749-4ceb-6895-8f4805e2b01f, 4619aff4-0f80-444f-858d-42e4137aa809
- Package NDC
- 0074-3826-13, 0074-3826-11, 0074-7401-13, 0074-7126-13, 0074-7126-53, 0074-7126-11, 0074-7126-72, 0074-7402-13, 0074-6212-13, 0074-6214-13, 0074-6214-53, 0074-6215-13, 0074-6215-53, 0074-7325-13, 0074-7327-13, 0074-7326-13, 0074-6114-13, 0074-6114-11
- UNII
- 644VL95AO6
- Drugcharacterization
- 1
- Medicinalproduct
- DEPAKOTE
- Drugbatchnumb
- Not available
- Drugauthorizationnumb
- 021168
- Drugstructuredosagenumb
- 1000
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- STRENGTH 500 MG?500 MG MORNING AND 1000 MG EVENING
- Actiondrug
- 4
- Activesubstance
- Activesubstancename
- DIVALPROEX SODIUM
- Harmonized identifiers (openFDA)
- Application number
- NDA021168, NDA018723, NDA019680
- Brand name
- DEPAKOTE ER, DEPAKOTE, DEPAKOTE SPRINKLES
- Generic name
- DIVALPROEX SODIUM
- Manufacturer name
- AbbVie Inc.
- Product NDC
- 0074-7401, 0074-3826, 0074-7126, 0074-7402, 0074-7325, 0074-6212, 0074-6214, 0074-6215, 0074-7327, 0074-7326, 0074-6114
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- DIVALPROEX SODIUM
- RxCUI
- 1099563, 1099565, 1099569, 1099571, 1099625, 1099626, 1099678, 1099679, 1099870, 1099871, 1099596, 1099598
- SPL ID
- 0ee65b66-ead3-44ef-911f-14965b067903, 7cc3a0b3-93f8-4825-88e1-bf6ddb0db23d, d038b7e9-b014-4771-93be-90aeeaece03d
- SPL set ID
- 0dc024ce-efc8-4690-7cb5-639c728fccac, 08a65cf4-7749-4ceb-6895-8f4805e2b01f, 4619aff4-0f80-444f-858d-42e4137aa809
- Package NDC
- 0074-3826-13, 0074-3826-11, 0074-7401-13, 0074-7126-13, 0074-7126-53, 0074-7126-11, 0074-7126-72, 0074-7402-13, 0074-6212-13, 0074-6214-13, 0074-6214-53, 0074-6215-13, 0074-6215-53, 0074-7325-13, 0074-7327-13, 0074-7326-13, 0074-6114-13, 0074-6114-11
- UNII
- 644VL95AO6
- Drugcharacterization
- 1
- Medicinalproduct
- ARIPIPRAZOLE
- Drugstructuredosagenumb
- 10
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugindication
- Bipolar disorder
- Actiondrug
- 4
- Activesubstance
- Activesubstancename
- ARIPIPRAZOLE
- Harmonized identifiers (openFDA)
- Application number
- ANDA207240, ANDA205064, ANDA216351, ANDA206174, ANDA090165, ANDA210479, ANDA202101, ANDA202547, ANDA216208, ANDA216150, ANDA204838, ANDA206383, ANDA204171, ANDA207105, NDA216655, ANDA202102, NDA021436, NDA202971, ANDA215595, ANDA204111, ANDA201519, NDA217006, ANDA203908, ANDA215582, ANDA212870, ANDA206251, ANDA204094, ANDA203025, ANDA203906
- Brand name
- ARIPIPRAZOLE, OPIPZA, ABILIFY, ABILIFY MAINTENA, ABILIFY ASIMTUFII
- Generic name
- ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL
- Manufacturer name
- Dr. Reddy's Laboratories Inc, Exelan Pharmaceuticals, Inc., Camber Pharmaceuticals, Inc., Advagen Pharma Ltd, ScieGen Pharmaceuticals Inc, Quallent Pharmaceuticals Health LLC, Viona Pharmaceuticals Inc., Aurobindo Pharma Limited, Alembic Pharmaceuticals Inc., XLCare Pharmaceuticals, Inc., Bionpharma Inc., Amneal Pharmaceuticals LLC, Ajanta Pharma USA Inc., Dr.Reddys Laboratories Inc, Lannett Company, Inc., Ascend Laboratories, LLC, Carwin Pharmaceutical Associates, LLC, Otsuka America Pharmaceutical, Inc., Alembic Pharmaceuticals Limited, NorthStar RxLLC, Chartwell RX, LLC, Macleods Pharmaceuticals Limited, Torrent Pharmaceuticals Limited, Otsuka America Pharmaceutical, Inc, SQUARE PHARMACEUTICALS LIMITED, QUAGEN PHARMACEUTICALS LLC, VistaPharm, LLC, Accord Healthcare, Inc., Apotex Corp., Unichem Pharmaceuticals (USA), Inc.
- Product NDC
- 43598-733, 43598-734, 76282-044, 76282-045, 76282-046, 76282-047, 76282-048, 76282-049, 31722-819, 31722-820, 31722-827, 31722-828, 31722-829, 31722-830, 72888-100, 50228-330, 50228-331, 82009-088, 82009-089, 82009-090, 82009-091, 72578-106, 72578-107, 59651-110, 62332-097, 62332-098, 62332-099, 62332-100, 62332-101, 62332-102, 72865-180, 72865-181, 72865-182, 72865-183, 72865-184, 72865-185, 69452-338, 69452-339, 59651-514, 59651-515 +127 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL, INTRAMUSCULAR
- Substance name
- ARIPIPRAZOLE
- RxCUI
- 643019, 643022, 349490, 349545, 349547, 349553, 402131, 602964, 485496, 2697158, 2697164, 2697165, 2697167, 2697168, 2697170, 352307, 352308, 352309, 352310, 404602, 615172, 1602163, 1602171, 1602604, 1602607, 1659812, 1659814, 1659816, 1659818, 2636637, 2636640, 2636645, 2636646, 643027, 643058
- SPL ID
- 9a1950c0-9796-4dc8-8ec0-47ef2d287c48, ae9e2824-8741-4973-b349-a18ce05cb334, 10628de5-d649-12ef-e063-6394a90ae380, 44f33ff5-ea1d-b6b6-e063-6394a90a40c7, 26d18fe2-326d-4214-e063-6394a90a691d, 5c525d81-2a40-4c63-a28c-94865bf0c493, 62486381-abea-40d9-aa88-bf3f3665a65f, 335e176d-01fe-4b63-9e9f-1bdf95c3ae70, 27cb5061-f64f-4328-9d1e-c18250dcb23a, a45172c6-a7a6-46f3-bfc4-a7b12eac07c5, a104bd7b-2748-450c-b4d3-9e96ccf2939d, da73c5ab-4841-4081-8fdf-adc2ea343dcb, 2e7a39b9-0db3-970e-e063-6394a90ae6ff, c125d854-8bb2-4467-83b4-c8a0e0f893c8, 2a724a23-cf45-4d22-90f5-ebe68f9b7ab9, 7b98f7e8-e2a3-4c6c-a47c-b40a6da85f4c, de0ee6f0-d4d7-4d86-9ff9-3ee2c687fccc, c99f3445-aceb-47c7-9f35-4f906aad08aa, 583fc581-09d7-4d4f-a079-08ba9d00f775, f52587a6-f60d-515d-e053-2995a90aadb8, 3dbb4e6d-14f0-4668-877c-2f4d9a94751f, ed78fbb6-5691-44be-859d-16b30f768614, 5be74c47-c62f-40f5-8aad-bd20f8f4cae3, 1b189d15-798d-4bed-a93d-a543ed7abd81, 30e40a02-9942-4914-8d84-cf5a8058cec6, 1ea06df8-17dc-46eb-921a-2b52d41ea622, 04230bfc-e6ad-1844-e063-6394a90a939e, 3540f59e-f085-8760-e063-6394a90aae82, 5108607e-5633-4b19-82f9-6c48720960c4, deb9183f-bf62-4547-9c33-b6d8af55ddd9, 264dc32a-9f5f-43be-96ee-0d30503de683, 284a898a-06c2-4ef9-9cb9-5d3e6cf94f9c, 8fbc9a67-ee90-4b5d-b9be-a037bef430de, d7622fbb-a43c-46db-bde4-d05ed7bff185, 8c97812b-1663-41cd-b80b-cff6be56d7e5, f53a4fb5-9152-4ccc-82fb-f45ea242c03d, f26f3784-b822-9efd-e053-2a95a90ab6ee, 87f75d68-e1b9-4ddc-a2ac-2398bf1b4619, 15449fee-e073-7129-e063-6294a90a3538, 40825d37-d601-2272-e063-6294a90af90d +3 more
- SPL set ID
- 394ea4a4-3991-4f98-b38f-56e9335d66b3, 705190bf-9f9d-4183-a56b-4eeafeacde59, 2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa, 4537e26b-dcf8-4a78-ab7d-57359b1d2192, 4bcfd5a7-bec7-4426-9314-17daaf715cad, 0e0d42ad-f4c6-4e30-adc2-ab1d122428ec, 73c5e380-b7b1-4362-a827-71881574ff48, fcabd777-dcb7-452c-821c-575a5991c90a, a10a5427-58b1-42dd-964c-3f8c78770534, 0a6fa113-6bb2-4f88-af07-ce0914c98ff2, 720bc395-777d-4e5d-9571-aad5827dbf6d, 476b92f3-cf7b-4c09-ac67-6ed35e6811d5, da47ad78-e62c-4bf3-9b53-d8cc246bcfb6, 06dda03f-8481-46d6-af02-4f51e1a3a065, d0f910b5-adef-4a93-9369-70f1ed541503, 0aa7e178-456a-4942-93aa-9ec18a58939f, e7292c4c-e332-4ed4-9086-f130d223b6ae, 3718e585-06b9-40fd-a3eb-18b6497a4235, c7040fef-96a7-4429-9a8e-ec3ab17a8019, a7d9d5d1-25ba-4f4e-a990-398c0bf09c7e, b47ede68-8942-4432-af7e-57afc14b2ba4, de2dc5fd-ecb4-4445-9cfb-10e64fe3269d, 178f09f0-e08e-452b-b817-717c5c49e110, c040bd1d-45b7-49f2-93ea-aed7220b30ac, ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6, 4f1691a8-724e-430d-9bab-27b59ef9bd4e, f87dbfe4-5417-47c9-a97f-d246cfc10023, 1d27462e-45c7-4335-9092-84c340e06a2c, 793fc904-2f11-4f97-a0ac-4d6910cac0f9, ab4245a1-71f7-45be-a2ef-b0636ed3cc20, 3988e66f-339c-451e-9f8a-9d0c0a2a381b, da4c07fd-1130-4341-bb44-63acfa4162be, 95954ba3-e838-4dd7-aef1-c51ac6aff76b, 0f9b1fd8-a648-45c9-8655-14de07439f34, 7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc, b12f1ff2-c0b5-47e7-8075-bf2ce79fdaf8, b284b294-40a0-4ccd-b7b7-b61267cd4e76, 06529caf-698f-41da-81ec-d0ba5ab200d7, 4a0a2f6c-d7bb-48d1-b5ca-066f27f78e41, 85cc7d25-414b-4b6f-a03a-48af908a16a1 +3 more
- Package NDC
- 43598-733-30, 43598-734-30, 76282-044-30, 76282-044-01, 76282-045-30, 76282-045-01, 76282-046-30, 76282-046-01, 76282-047-30, 76282-047-01, 76282-048-30, 76282-048-01, 76282-049-30, 76282-049-01, 31722-820-30, 31722-820-01, 31722-820-31, 31722-820-32, 31722-820-05, 31722-827-30, 31722-827-01, 31722-827-31, 31722-827-32, 31722-827-05, 31722-819-30, 31722-819-01, 31722-819-31, 31722-819-32, 31722-819-05, 31722-828-30, 31722-828-01, 31722-828-31, 31722-828-32, 31722-828-05, 31722-829-30, 31722-829-01, 31722-829-31, 31722-829-32, 31722-829-05, 31722-830-30 +437 more
- Nui
- N0000175430
- Pharm class epc
- Atypical Antipsychotic [EPC]
- UNII
- 82VFR53I78
- Drugcharacterization
- 1
- Medicinalproduct
- MIRTAZAPINE
- Drugstructuredosagenumb
- 15
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- DOSE REDUCED
- Drugindication
- Bipolar disorder
- Actiondrug
- 2
- Drugadditional
- 2
- Activesubstance
- Activesubstancename
- MIRTAZAPINE
- Harmonized identifiers (openFDA)
- Application number
- ANDA076921, ANDA076541, ANDA205798, NDA021208, NDA020415, ANDA077376, ANDA219919, ANDA076122, ANDA216751
- Brand name
- MIRTAZAPINE, REMERONSOLTAB, REMERON
- Generic name
- MIRTAZAPINE
- Manufacturer name
- Aurolife Pharma LLC, Sun Pharmaceutical Industries, Inc., SQUARE PHARMACEUTICALS LIMITED, Organon LLC, Aurobindo Pharma Limited, Rising Pharma Holdings, Inc., ANI Pharmaceuticals, Inc., Mylan Pharmaceuticals Inc., Viona Pharmaceuticals Inc., Prasco Laboratories
- Product NDC
- 13107-001, 13107-031, 13107-003, 13107-032, 57664-499, 57664-510, 57664-500, 57664-501, 76483-110, 76483-111, 76483-112, 78206-156, 78206-160, 78206-161, 78206-158, 78206-159, 65862-021, 65862-022, 65862-023, 57237-011, 57237-012, 57237-013, 70954-830, 70954-887, 70954-888, 70954-889, 0378-3515, 0378-3530, 0378-3545, 72578-103, 72578-104, 72578-105, 66993-606, 66993-607, 66993-608, 66993-609
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- MIRTAZAPINE
- RxCUI
- 311725, 311726, 314111, 476809, 283406, 283407, 283485, 211322, 211323, 752869, 752870, 752871
- SPL ID
- 4329eeed-8071-4b6c-887d-0cd00647b84c, f5e842da-4922-4f1d-b2e0-a4c0be71e2a6, d6b98cf3-2e20-47c1-bb31-e8dd31f67cdf, 8b121c7c-9bcd-4504-b789-3f551a0fe514, 04494335-fcd8-47b2-a573-98a214f07ff6, ed2cd1df-697f-4e63-8097-7802be5eb6bb, 2e513b1e-938d-44be-a6d9-9f22428aee8e, 681d9ec4-046b-4c0e-b85f-2468620c724b, 9ad8f423-a877-4069-8a11-92e1f934974a, e1a19354-1c97-49ed-8ec9-bb895dbe69f3
- SPL set ID
- aa05d606-29fd-443e-802b-1d65584d6bb1, f23631be-c7ae-46e9-b771-a70be17bc9f0, 83093852-d212-408e-98fd-33f4603a9d65, 98ad1917-a094-44f5-a28f-a64a8cfcd887, 3a8a4490-9243-4201-944d-cea27d3d69f5, 73b7bbd9-7dba-4559-890f-3f8dd821e215, bb134141-6069-4b86-abac-7783bf5df60d, 711aa80b-8fc6-49e6-9494-3db31d9b53a4, ed491abe-9412-428b-8e24-57242862c99a, 8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e4
- Package NDC
- 13107-001-30, 13107-001-60, 13107-001-90, 13107-001-01, 13107-001-05, 13107-031-30, 13107-031-34, 13107-031-60, 13107-031-90, 13107-031-01, 13107-031-05, 13107-031-32, 13107-003-30, 13107-003-34, 13107-003-60, 13107-003-90, 13107-003-01, 13107-003-05, 13107-003-32, 13107-032-34, 13107-032-60, 13107-032-90, 13107-032-01, 13107-032-05, 13107-032-32, 57664-510-83, 57664-499-83, 57664-499-18, 57664-500-83, 57664-500-18, 57664-501-83, 57664-501-18, 76483-110-00, 76483-111-00, 76483-112-00, 78206-160-01, 78206-161-01, 78206-156-99, 78206-156-01, 78206-158-99 +51 more
- UNII
- A051Q2099Q
- Drugcharacterization
- 2
- Medicinalproduct
- PRAZEPAM
- Drugstructuredosagenumb
- 10
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugindication
- Product used for unknown indication
- Activesubstance
- Activesubstancename
- PRAZEPAM
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260430