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)
Abnormal sensation in eye06.01.01.0010.004078%Not Available
Anosmia22.04.03.006; 17.04.04.0010.000480%
Application site erythema23.03.06.005; 12.07.01.001; 08.02.01.0010.004078%Not Available
Application site pain12.07.01.004; 08.02.01.0040.004078%Not Available
Application site rash23.03.13.008; 12.07.01.016; 08.02.01.0160.001631%Not Available
Asthenopia06.01.01.0020.002447%Not Available
Blepharitis23.03.04.012; 06.04.04.0010.001631%Not Available
Blepharospasm17.17.02.001; 06.05.01.0010.003262%Not Available
Blindness06.02.10.003; 17.17.01.0030.000480%Not Available
Bradycardia02.03.02.0020.001535%Not Available
Burning sensation17.02.06.001; 08.01.09.0290.001631%Not Available
Condition aggravated08.01.03.0040.003262%Not Available
Conjunctival haemorrhage24.07.05.001; 06.07.01.0010.001631%Not Available
Dependence19.07.06.0080.000480%Not Available
Diplopia17.17.01.005; 06.02.06.0020.001631%Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.004318%
Drug dependence19.07.06.011--Not Available
Drug ineffective08.06.01.0060.013050%Not Available
Dry eye06.08.02.0010.010843%
Dysgeusia17.02.07.003; 07.14.03.0010.001631%
Dyspnoea02.11.05.003; 22.02.01.004--
Erythema23.03.06.0010.003262%Not Available
Erythema of eyelid23.03.06.006; 06.04.04.0030.001631%Not Available
Eye disorder06.08.03.0010.002447%Not Available
Eye inflammation06.04.05.0020.001056%Not Available
Eye irritation06.04.05.0030.017368%Not Available
Eye pain06.08.03.0020.005709%
Eye swelling06.08.03.0030.002447%Not Available
Eyelid oedema23.04.01.003; 10.01.05.001; 06.04.04.0040.001631%Not Available
Glaucoma06.03.01.002--
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