Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pramoxine hydrochloride
Drug ID BADD_D01821
Description Pramocaine (also known as pramoxine or pramoxine HCI) is a topical anesthetic and antipruritic. It is used for many dermatological and anorectal/anogenital conditions including minor cuts/burns, insect bites, hives/rashes due to poison ivy exposure, hemorrhoids and other anorectal/anogenital disorders. Pramocaine is available by itself and in combination with other medications in various topical preparations. It works by preventing ionic fluctuations needed for neuron membrane depolarization and action potential propagation.
Indications and Usage It is indicated for temporary relief of pain and pruritus from minor lip and skin irritations as well as for temporary relief from pain, burning, itching and discomfort associated with hemorrhoids and other anorectal/anogenital disorders.
Marketing Status approved
ATC Code C05AD07; D04AB07
DrugBank ID DB09345
KEGG ID D00739
MeSH ID C005548
PubChem ID 73957
TTD Drug ID D0V4UF
NDC Product Code 49452-5972; 82481-026; 24330-130; 50268-682; 0496-0586; 12258-223; 51862-180; 0037-6823; 81032-422; 82637-9363; 49967-970; 59088-685; 69968-0637; 75087-141; 38779-0458; 0496-0748; 71554-119; 71573-120; 82637-9370; 82060-002; 22568-1076; 51927-1914; 11509-5058; 49967-512; 0316-0230; 69968-0796; 54871-0101; 11509-5035
UNII 88AYB867L5
Synonyms pramoxine | pramocaine | 4-(3-(4-butoxyphenoxy)propyl)morpholine | 4-(3-(p-butoxyphenoxy)propyl)morpholine | Fleet Pain Relief | Itch-X | PrameGel | Pramox | Tronothane | Prax | proctoFoam | Tronolane | Balsabit | pramoxine hydrochloride | pramocaine hydrochloride
Chemical Information
Molecular Formula C17H28ClNO3
CAS Registry Number 637-58-1
SMILES CCCCOC1=CC=C(C=C1)OCCCN2CCOCC2.Cl
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)
Burning sensation17.02.06.001; 08.01.09.029--Not Available
Dermatitis23.03.04.002--Not Available
Dermatitis acneiform23.02.01.004--
Dermatitis contact23.03.04.004; 12.03.01.040; 10.01.01.003--Not Available
Dry skin23.03.03.001--
Folliculitis23.11.04.003; 11.02.01.053--
Hypertrichosis23.02.04.002--
Infection11.01.08.002--Not Available
Miliaria23.02.03.014--Not Available
Pruritus23.03.12.001--
Skin atrophy23.01.05.001--
Skin hypopigmentation23.05.02.003--
Skin irritation23.03.04.009--Not Available
Skin striae23.01.05.002--Not Available
Skin maceration23.03.03.016--Not Available
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