Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Oxymetazoline
Drug ID BADD_D02579
Description Oxymetazoline is an imidazole derivative and a potent, direct-acting alpha (α)-adrenergic agonist with affinity to both α1- and α2-adrenoceptors.[A215542] Oxymetazoline is available in various formulations with a wide variety of clinical implications. The topical formulation of the drug is used to treat persistent facial redness in adults.[L15062] As an effective decongestant, oxymetazoline is available in over-the-counter intranasal sprays used to relieve nasal and sinus congestion caused by a wide variety of conditions, such as common cold, hay fever, and upper respiratory allergies.[A215587, L15092] In dentistry, oxymetazoline and tetracaine combination intranasal spray (Kovanaze) is used for regional anesthesia during dental procedures in children and adults.[L15057] In July 2020, the FDA approved the use of an ophthalmic formulation of oxymetazoline (Upneeq) in adults with acquired blepharoptosis, or ptosis, making it the first FDA-approved medical treatment for this medical condition.[L15042, L15067]
Indications and Usage Oxymetazoline is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.[L15062] Ophthalmic oxymetazoline is indicated for the treatment of acquired blepharoptosis in adults.[L15067] When used in combination with tetracaine intranasally, oxymetazoline is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more.[L15057] Oxymetazoline can be found in over-the-counter nasal products as a nasal decongestant.[L15092] For off-label uses, oxymetazoline has been used during nasal intubation and during ear, nose, and throat surgery to improve visualization of the airway and to minimize post-operative bleeding.[A215542]
Marketing Status approved; investigational
ATC Code D11AX27; R01AA05; R01AB07; S01GA04
DrugBank ID DB00935
KEGG ID D08322
MeSH ID D010109
PubChem ID 4636
TTD Drug ID D09EBS
NDC Product Code Not Available
UNII 8VLN5B44ZY
Synonyms Oxymetazoline | Oxymetazoline Hydrochloride | Hydrochloride, Oxymetazoline
Chemical Information
Molecular Formula C16H24N2O
CAS Registry Number 1491-59-4
SMILES CC1=CC(=C(C(=C1CC2=NCCN2)C)O)C(C)(C)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)
Vitreous floaters06.09.01.0050.000480%
Vitreous haemorrhage06.10.03.001; 24.07.05.0050.000480%
Application site paraesthesia08.02.01.026; 12.07.01.026; 17.02.06.0120.001631%-
Foreign body sensation in eyes06.01.01.0060.001631%-
Eye pruritus06.04.05.0060.004894%-
Eyelid irritation06.04.04.007; 23.03.04.0230.001631%-
Eyelid disorder06.08.03.010; 23.03.03.0280.001631%-
Application site burn08.02.01.038; 12.07.01.038; 23.03.11.013---
Swelling of eyelid06.04.04.018; 10.01.05.026; 23.04.01.0260.007341%-
Therapeutic product effect decreased08.06.01.0500.001631%-
Therapeutic product effect incomplete08.06.01.0520.001631%-
Therapeutic product effect variable08.06.01.055---
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