Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Fluocinolone acetonide
Drug ID BADD_D00924
Description Fluocinolone acetonide, with the formula 6-alpha, 9-alpha-difluoro-16-alpha, 17 alpha-acetonide, is a corticosteroid that presents a high lipophilicity.[T357] It has been used extensively in dermatological preparations and it has also been investigated thoroughly for its use in implantable corticosteroid devices.[T358] This type of device containing fluocinolone acetonide was developed by Taro Pharmaceuticals and approved by FDA in May 2016.[L4676]
Indications and Usage Fluocinolone acetonide has been used extensively in different medical areas. -In dermatology, it is extensively used for the relief of inflammatory dermatosis, dermatitis, psoriasis, hypertrophic tissues, keloid tissues and atopic dermatitis.[F1955] -It has been used in shampoo products as a low to medium potency corticosteroid for the treatment of seborrheic dermatitis of the scalp.[L4682] -In ear drops, it is used as a low to medium potency corticosteroid for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.[L4683] -As an intravitreal implant, it is indicated for the treatment of diabetic macular edema with patients that have been previously treated with a course of corticosteroids and no clinically significant rise in intraocular pressure.[L4684] -Fluocinolone acetonide was announced on October 15, 2018 to be FDA approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.[L4685] -Some reports have indicated the use of fluocinolone acetonide as a vasoprotective agent and for its use in the treatment of first-degree hemorrhoids.[A39532]
Marketing Status approved; investigational; vet_approved
ATC Code C05AA10; D07AC04; S01BA15; S02BA08
DrugBank ID DB00591
KEGG ID D01825
MeSH ID D005446
PubChem ID 6215
TTD Drug ID D02QJH
NDC Product Code 43538-910; 45802-485; 51672-1357; 51672-1365; 64980-331; 53183-0261; 71161-134; 65162-704; 68462-185; 0713-0224; 76420-163; 39328-079; 43538-900; 45802-009; 71879-136; 68611-190; 71428-002; 0713-0223; 0395-8243; 24208-416; 63629-8655; 70752-156; 38779-0022; 51927-0150; 10135-670; 43386-069; 43538-901; 43538-920; 51672-1356; 68462-590; 68791-103; 46439-8709; 0299-5500; 64980-330; 65162-702; 70752-158; 49452-3156; 0168-0064; 63629-8656; 68462-591; 68791-102; 65162-703; 70752-159; 0713-0709; 68791-101; 43538-911; 43538-921; 45802-887
UNII 0CD5FD6S2M
Synonyms Fluocinolone Acetonide | Acetonide, Fluocinolone | Fluortriamcinolone Acetonide | Acetonide, Fluortriamcinolone | Flurosyn | Jellin | Jellisoft | Synalar | Synalar-HP | Synalar HP | Synemol | Synamol | Alvadermo | Capex | Co-Fluocin | Co Fluocin | Cortiespec | Derma-Smooth FS | Derma Smooth FS | Flucinar | Fluocid | Fluodermo | Fluonid | Fluotrex | Flusolgen | Gelidina
Chemical Information
Molecular Formula C24H30F2O6
CAS Registry Number 67-73-2
SMILES CC1(OC2CC3C4CC(C5=CC(=O)C=CC5(C4(C(CC3(C2(O1)C(=O)CO)C)O)F)C)F)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Discomfort08.01.08.0030.006809%-
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dizziness postural02.11.04.008; 17.02.05.004; 24.06.02.008---
Drug ineffective08.06.01.0060.029038%-
Dry eye06.08.02.001--
Dry skin23.03.03.001--
Dysgeusia07.14.03.001; 17.02.07.003--
Ear disorder04.03.01.001---
Ear infection04.03.01.006; 11.01.05.001---
Ear pain04.03.01.003--
Eczema23.03.04.006--
Endophthalmitis06.04.05.009; 11.01.06.003--
Erythema23.03.06.001---
Eye discharge06.04.05.001---
Eye disorder06.08.03.001---
Eye haemorrhage06.07.02.001; 12.02.02.012; 24.07.05.0020.001502%-
Eye infection06.04.05.007; 11.01.06.001--
Eye inflammation06.04.05.0020.006609%-
Eye irritation06.04.05.003---
Eye pain06.08.03.0020.011815%
Eye swelling06.08.03.003---
Eyelid oedema06.04.04.004; 10.01.05.001; 23.04.01.003---
Folliculitis11.02.01.053; 23.11.04.003--
Fungal skin infection11.03.05.002; 23.11.03.006---
Gastroenteritis07.19.03.001; 11.01.07.004---
Gastrointestinal disorder07.11.01.001---
Glaucoma06.03.01.0020.010514%
Headache17.14.01.001--
Herpes simplex11.05.02.001; 23.11.05.004---
Hypersensitivity10.01.03.003--
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