Injection site pain, Erythema, Scab +7
Drugs: UNAPPROVED DRUG COSMETIC PRODUCTS, STEM CELL, EXOSOME, GROWTH FACTOR OR TISSUE DERIVED UNAPPROVED PRODUCT, ZYRTEC +5
- Safetyreportversion
- 1
- Safetyreportid
- 26884216
- Primarysourcecountry
- US
- Transmissiondateformat
- 102
- Transmissiondate
- 20260709
- Reporttype
- 1
- Serious
- 1
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 1
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 2
- Receivedateformat
- 102
- Receivedate
- 20260615
- Receiptdateformat
- 102
- Receiptdate
- 20260615
- Fulfillexpeditecriteria
- 3
- Authoritynumb
- 826382
- Primarysource
- Reportercountry
- US
- Qualification
- 5
- Sender
- Sendertype
- 6
- Senderorganization
- FDA-CTU
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 57
- Patientonsetageunit
- 801
- Patientweight
- 51.75
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Injection site pain
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Erythema
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Scab
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Skin burning sensation
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Skin discolouration
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Sepsis
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Localised oedema
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Erythema
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Pruritus
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Tenderness
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Skin induration
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- UNAPPROVED DRUG COSMETIC PRODUCTS
- Drugdosagetext
- TOPICAL
- Drugadministrationroute
- 061
- Drugstartdateformat
- 102
- Drugstartdate
- 20260602
- Drugenddateformat
- 102
- Drugenddate
- 20260602
- Drugadditional
- 2
- Activesubstance
- Activesubstancename
- UNAPPROVED DRUG COSMETIC PRODUCTS
- Drugcharacterization
- 1
- Medicinalproduct
- UNAPPROVED DRUG COSMETIC PRODUCTS
- Activesubstance
- Activesubstancename
- UNAPPROVED DRUG COSMETIC PRODUCTS
- Drugcharacterization
- 1
- Medicinalproduct
- STEM CELL, EXOSOME, GROWTH FACTOR OR TISSUE DERIVED UNAPPROVED PRODUCT
- Activesubstance
- Activesubstancename
- STEM CELL, EXOSOME, GROWTH FACTOR OR TISSUE DERIVED UNAPPROVED PRODUCTS
- Drugcharacterization
- 2
- Medicinalproduct
- ZYRTEC
- Activesubstance
- Activesubstancename
- CETIRIZINE HYDROCHLORIDE
- Harmonized identifiers (openFDA)
- Application number
- NDA021621
- Brand name
- ZYRTEC
- Generic name
- CETIRIZINE HYDROCHLORIDE
- Manufacturer name
- Kenvue Brands LLC
- Product NDC
- 50580-753
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Substance name
- CETIRIZINE HYDROCHLORIDE
- RxCUI
- 1014674, 1020022
- SPL ID
- 506ace58-15cc-77b4-e063-6394a90a0813
- SPL set ID
- dc613bd5-70fd-1d9b-e053-2995a90a41cd
- Package NDC
- 50580-753-24
- UNII
- 64O047KTOA
- Drugcharacterization
- 2
- Medicinalproduct
- DOXYCYCLINE
- Activesubstance
- Activesubstancename
- DOXYCYCLINE
- Harmonized identifiers (openFDA)
- Application number
- ANDA201678, ANDA204234, ANDA065053, ANDA217098, ANDA218753, ANDA210664, ANDA065285, ANDA218034, ANDA217674, NDA050805, ANDA065454, ANDA210381, ANDA091605, ANDA217487, ANDA065055, ANDA209165, ANDA204446, ANDA209582, ANDA062992, ANDA205115, ANDA065070, ANDA209402, ANDA062475, ANDA217854, ANDA215583, NDA050641, ANDA217794, ANDA065356, ANDA219978, ANDA207289, ANDA218888, ANDA217972, ANDA216631, ANDA216690, ANDA218053, ANDA091406, ANDA207757
- Brand name
- DOXYCYCLINE, DOXYCYCLINE DOXYCYCLINE, ORACEA, DOXY 100, DOXYCYCLINE HYCLATE
- Generic name
- DOXYCYCLINE, DOXYCYCLINE HYCLATE
- Manufacturer name
- Lupin Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc., Solco Healthcare US,LLC, Dr. Reddy's Laboratories, Inc., Acella Pharmaceuticals, LLC, Lannett Company, Inc., Dr.Reddys Laboratories Inc, Alembic Pharmaceuticals Limited, Galderma Laboratories, L.P., Chartwell Governmental & Specialty RX, LLC, Macleods Pharmaceuticals Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Chartwell RX, LLC, Amneal Pharmaceuticals LLC, Strides Pharma Science Limited, Lupin Pharmaceuticals,Inc., Zydus Pharmaceuticals USA Inc., Hikma Pharmaceuticals USA Inc., Cranbury Pharmaceuticals, LLC, Fresenius Kabi USA, LLC, Alembic Pharmaceuticals Inc., Avenacy Inc., JVET PHARMACEUTICALS LLC, Wellhouse Pharma, LLC, Zydus Lifesciences Limited, Mayne Pharma Inc., Sun Pharmaceutical Industries Inc., AiPing Pharmaceutical, Inc., Piramal Critical Care Inc, Gland Pharma Limited, Amneal Pharmaceuticals NY LLC, FOSUN PHARMA USA INC, Camber Pharmaceuticals, Inc., Steriscience Specialties Private Limited, Par Health USA, LLC, Meitheal Pharmaceuticals Inc., Mylan Institutional LLC
- Product NDC
- 68180-657, 68180-650, 68180-651, 68180-652, 63304-614, 63304-615, 63304-616, 43547-590, 43598-086, 42192-501, 0527-1335, 0527-1535, 0527-1338, 0527-1537, 43598-457, 46708-785, 0299-3822, 68999-417, 68999-625, 68999-626, 68999-984, 68999-985, 33342-346, 23155-133, 23155-134, 23155-135, 23155-136, 62135-725, 62135-726, 70121-1616, 64380-179, 64380-180, 64380-181, 46708-249, 46708-250, 43386-790, 43386-791, 43386-792, 70710-1121, 70710-1122 +51 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL, INTRAVENOUS
- Substance name
- DOXYCYCLINE, DOXYCYCLINE HYCLATE
- RxCUI
- 1650030, 700408, 1649401, 1649990, 901399, 310027, 1650143, 1649429, 1650142, 1650444, 1652673, 901401, 1649405, 1649988, 1652674, 728207, 544840, 1998483
- SPL ID
- 6e5c9f41-4304-4121-845f-b894a4fd5d95, 771f820a-2e1b-4a25-91cb-ba7a068abc70, 338488d1-e9d8-6b00-e063-6294a90a37c0, 1d96d5b0-a628-437f-8150-b3ee29c15fae, d81118bc-54c2-51cd-4ddd-d3afcf12ddf8, 5957035d-19d3-b251-e063-6394a90a0561, dc960a6c-1b09-4049-a1e9-0109576b1d30, 3fea16fe-25ae-5b3c-8b49-686e6afc69c7, 8e78dc54-8322-435d-8879-4bfe37f1b98c, 67eef1b6-593a-4277-abd3-f3e60e7557b0, 40076faf-09c3-f4ab-e063-6394a90ab3c1, 79ccf038-ab96-4ea7-a7cf-c56be45e3f57, ec6854e5-3f41-4b8f-be77-49e3bd19f7c4, 45899031-dfb9-a7d6-e063-6294a90a80c6, b34b4a98-fd44-4569-a530-0bc4f9046a75, 170d0f42-f785-4f77-a5cf-45c1e8c45f1e, 7bd9362d-42fd-4f01-bed9-3797d0c1d6ee, a3ed2ee4-163c-4167-abf2-59a7e1d66a61, 24db9fe2-5c05-42d0-b113-307484699e9a, fa074f92-7cf9-4290-8cf7-7a2b94447cf3, 9486a93f-bc2a-444a-a8d4-3bce410d21c7, 27575633-ff92-45c4-a365-510f656d68dc, 916c7c28-037e-40aa-a97f-d9d5c4fc43f9, b4654993-19ce-4911-a0d0-4836f357223d, c89c0388-cc32-4fa4-a954-678d7448d4c1, 2dbadeae-fea5-4a18-90cf-ee669b8e71cb, ed95709e-2a1a-4deb-88bd-5b99f02b7a26, 575c46be-1210-fb40-e063-6294a90a8d0f, 1f788250-9643-4c64-bb4e-4dfefabb8c01, 4600dc6a-950d-4d84-aed9-da01fbd0db8b, d9de3252-a876-482e-be60-0a47eb985aa8, 8aa2cef1-9f23-46ed-bd30-d54812779f6b, fd417a50-69b5-40b4-89fd-58aea77ab547, ed0afbd5-2f21-48d3-a1a2-a253b4ad707a, 3f7348fd-b9f3-a104-e063-6394a90a0642, ca2211dc-d46a-4069-8aa3-a146475427a2, d114fe27-0716-4e35-be8d-e69bd5a3cbb5, 22ec807c-14e3-4b73-baa8-931ade7d3203, 31ba285b-5aef-ff76-e063-6294a90a9321, 44923ffd-23df-ccf8-e063-6394a90aeff5 +11 more
- SPL set ID
- e0e80435-1b6a-4361-8c8a-e432f8f23a1b, bcc65910-30d8-4807-ab61-607a56382924, 829dbd3d-5c2b-47b8-96a5-423af78c93b9, 99305d9a-d058-45d6-8dec-19308b1fc5a9, c0206e91-d87f-311c-80dc-aad543d001e8, 3fb9f5ad-90a2-4858-bc34-f800d8b2fa90, 4999bbd9-44ed-4749-9730-be2337bdf490, 7a28cce1-4805-b3d1-4484-e7a49c597660, 8e78dc54-8322-435d-8879-4bfe37f1b98c, aa15c93a-ff4c-447a-8a21-96da506d8997, b8486639-7eb9-4610-9cd4-0e922045d592, 10aca485-850b-4c82-bb7e-5fac2d7a62ce, 2bcde264-5f6f-47f6-ae2e-1b7010deacf7, 5bebf320-1395-43b9-9404-fe479d70b240, 95ba4d68-2519-4edd-b9a2-5cd2fd00b250, 9e710113-f25e-46fb-8327-7a8e649613a2, 3dfa486c-4665-4882-93ac-9259708f899c, 6512bf22-c211-4127-a8c8-2419656580f6, bc321932-b600-4659-a499-1853991b4ab9, 2aa835bd-6fac-46b8-9716-9622fb550c8f, fef9580d-8850-4cbb-89eb-2b4d40ee59c9, 3b9888a2-ca16-43f7-ab6d-f03188ec2c0d, 43ceb0ee-268a-424c-a6a8-88e824c5ed04, b256babb-1bba-4b0c-8837-d13ba3af7659, a50e953d-447b-4b66-b567-04586174d3f9, 429813b4-0223-4d85-a844-b1227ff63b1e, ed95709e-2a1a-4deb-88bd-5b99f02b7a26, 57f97f68-11fb-4900-9efb-ca3b00818d8e, c886b2e4-494a-4325-abaf-981fc3d01c66, 0e6b3e17-aeee-4910-8e94-c7ac925b9cca, aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9, 2946fc05-78e5-4669-85d1-3a3979eceae0, 8224b9c5-5c4b-4dda-bc58-47b6604c2884, a894f4be-19e5-4785-8d0b-5e0d5626300e, fd672959-014f-8300-e053-6394a90a5ec5, 6a5780a9-4548-427c-972a-ef49fdcbc84d, 49ecbf95-58e8-4f3c-b5d5-650a15d866cb, b0894010-39bd-459f-8563-cf83343105ee, fa3fbb09-b830-60c5-e053-6394a90a4165, 0faee97d-2707-48fe-a739-143cd1a1c4e3 +11 more
- Package NDC
- 68180-657-01, 68180-650-01, 68180-651-01, 68180-652-29, 68180-652-08, 63304-614-20, 63304-614-05, 63304-614-01, 63304-614-13, 63304-615-05, 63304-615-11, 63304-615-01, 63304-616-20, 63304-616-05, 63304-616-01, 63304-616-13, 63304-616-50, 43547-590-03, 43598-086-58, 42192-501-50, 42192-501-05, 0527-1335-01, 0527-1535-01, 0527-1338-50, 0527-1338-25, 0527-1537-30, 0527-1537-01, 43598-457-30, 46708-785-30, 0299-3822-30, 0299-3822-06, 0299-3822-05, 0299-3822-04, 0299-3822-02, 0299-3822-07, 68999-625-60, 68999-626-02, 68999-626-28, 68999-626-30, 68999-626-50 +185 more
- Nui
- N0000175882, N0000007948
- Pharm class epc
- Tetracycline-class Drug [EPC]
- Pharm class cs
- Tetracyclines [Chemical/Ingredient]
- UNII
- N12000U13O, 19XTS3T51U
- Drugcharacterization
- 2
- Medicinalproduct
- METHYLPREDNISOLONE
- Activesubstance
- Activesubstancename
- METHYLPREDNISOLONE
- Harmonized identifiers (openFDA)
- Application number
- NDA011153, ANDA204072, ANDA040183, ANDA206751, ANDA212396, ANDA207549, ANDA209097
- Brand name
- MEDROL, METHYLPREDNISOLONE, METHYLPREDNISOLONE SODIUM SUCCINATE
- Generic name
- METHYLPREDNISOLONE
- Manufacturer name
- Pharmacia & Upjohn Company LLC, Epic Pharma, LLC, Par Health USA, LLC, Mylan Pharmaceuticals Inc., Zydus Lifesciences Limited, BluePoint Laboratories, Tianjin Kingyork Pharmaceuticals Co., Ltd, Tianjin Tianyao Pharmaceuticals Co., Ltd., Zydus Pharmaceuticals USA Inc., Amneal Pharmaceuticals LLC, Chartwell RX, LLC
- Product NDC
- 0009-0020, 0009-0049, 0009-0056, 0009-0022, 0009-0073, 0009-0176, 42806-400, 0603-4593, 59762-0049, 59762-4440, 59762-0050, 59762-0051, 70771-1348, 70771-1349, 70771-1350, 70771-1351, 68001-624, 82094-401, 82094-402, 82094-403, 82094-404, 82094-405, 57582-101, 68382-916, 68382-917, 68382-918, 68382-919, 70121-1000, 70121-1001, 62135-759, 62135-760, 62135-761, 62135-762, 62135-763
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL, INTRAMUSCULAR, INTRAVENOUS
- Substance name
- METHYLPREDNISOLONE, METHYLPREDNISOLONE SODIUM SUCCINATE
- RxCUI
- 197969, 197971, 197973, 207136, 207137, 207138, 207141, 259966, 260330, 328161, 762675, 834023, 311659, 314099, 1357886, 1743704
- SPL ID
- e4a8e5b4-af77-4eca-92de-cd0982969b82, a7416892-37af-4d45-ab52-5e5700e6b3e5, 61876830-b7d4-464d-b825-75e7a08627e3, bc3419a0-22a3-4eaf-a4f2-3133e9380663, 99239c7c-b107-454a-8cee-9dd6cbd5647b, 5267c1af-043e-c1e6-e063-6294a90a42d1, 94c8ce6b-7622-4d1f-8b54-0ce959752ae5, 925bd0e3-3f69-411c-ad1e-7db010ec17be, 6cebff10-362f-41a7-8f66-3d9e878760fd, 3eb27de6-9e1c-4ef4-bb31-2458b9360582, 225669c1-9479-52eb-e063-6394a90a649b
- SPL set ID
- 39d5270b-d957-4821-93d6-501b7b9f02d4, b1908c2a-c596-4e2a-b2bd-0745d4fea31a, c84cf5e6-746d-41fb-b3d8-2c0b8ba989af, 22dd75d6-f89a-44f7-8ca6-b64c4e9806dd, fe9c15b5-4264-45f1-87b5-f7e1d6e6ddee, 7092df48-4904-4047-9916-e585417a216f, 77a8d96c-37df-4f3a-9757-b2d4131ff82b, e09eefd2-f423-40cb-87b6-3ee97e7f831b, eaa9c932-c659-4ef6-bf5a-186545d87320, e86fbda8-00e4-4d54-841a-59dea6c15e70, bdd048bb-7e6c-45c7-b51a-075e83ca9f5b
- Package NDC
- 0009-0049-02, 0009-0056-02, 0009-0056-04, 0009-0022-01, 0009-0073-01, 0009-0176-01, 0009-0020-01, 42806-400-01, 42806-400-21, 0603-4593-21, 0603-4593-15, 59762-4440-3, 59762-4440-2, 59762-0049-1, 59762-0050-1, 59762-0051-1, 70771-1348-1, 70771-1348-5, 70771-1348-3, 70771-1349-8, 70771-1349-1, 70771-1349-5, 70771-1349-2, 70771-1349-4, 70771-1350-7, 70771-1350-1, 70771-1350-5, 70771-1350-2, 70771-1350-4, 70771-1351-8, 70771-1351-1, 70771-1351-5, 70771-1351-2, 70771-1351-4, 68001-624-01, 82094-401-01, 82094-401-50, 82094-402-01, 82094-402-50, 82094-403-01 +35 more
- Nui
- N0000175576, N0000175450
- Pharm class epc
- Corticosteroid [EPC]
- Pharm class moa
- Corticosteroid Hormone Receptor Agonists [MoA]
- UNII
- X4W7ZR7023, LEC9GKY20K
- Drugcharacterization
- 2
- Medicinalproduct
- BERBERINE
- Activesubstance
- Activesubstancename
- BERBERINE
- Drugcharacterization
- 2
- Medicinalproduct
- COENZYME Q10
- Activesubstance
- Activesubstancename
- DIETARY SUPPLEMENT\UBIDECARENONE
- Drugcharacterization
- 2
- Medicinalproduct
- VITAMIN D
- Activesubstance
- Activesubstancename
- VITAMIN D NOS
- Harmonized identifiers (openFDA)
- Application number
- ANDA090455
- Brand name
- VITAMIN D
- Generic name
- ERGOCALCIFEROL
- Manufacturer name
- Strides Pharma Science Limited
- Product NDC
- 64380-737
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- ERGOCALCIFEROL
- RxCUI
- 1367410
- SPL ID
- 1cc589f7-cd6d-40a6-8fce-c965e8945eae
- SPL set ID
- 2c4c0a36-12cf-444d-9d57-de983eef4d36
- Package NDC
- 64380-737-06, 64380-737-25
- Nui
- M0007651, N0000175909
- Pharm class cs
- Ergocalciferols [CS]
- Pharm class epc
- Provitamin D2 Compound [EPC]
- UNII
- VS041H42XC
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260602