Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Benzalkonium chloride
Drug ID BADD_D00235
Description Benzalkonium is a quaternary ammonium compound used as a biocide, a cationic surfactant, and as a phase transfer agent [FDA Label]. Benzalkonium is more commonly contained in consumer products in its salt form, benzalkonium chloride [FDA Label]. This salt is used in a great variety of international pharmaceutical products such as eye, ear, and nasal drops or sprays as an excipient ingredient serving as an antimicrobial preservative [FDA Label]. When used as an ingredient in antiseptic and disinfectant products however, it is an active antimicrobial agent [L1806].
Indications and Usage When used as an active ingredient in products like antibacterial, antiseptic, or disinfectant soaps, topical sanitizers, or cleaning agents, benzalkonium is primarily implemented in its salt form, benzalkonium chloride, where it may often be the only active ingredient present and indicated for the primary purpose of topical washing to decrease bacteria on skin [L1806]. Conversely, when implemented as an excipient ingredient in a variety of multidose aqueous nose, eye, or ear products, benzalkonium chloride is being used as the antimicrobial preservative of choice to facilitate effective bactericidal and fungicidal actions to help minimize the growth of unwanted organisms in the multidose containers [FDA Label].
Marketing Status approved; investigational
ATC Code D09AA11; R02AA16; D08AJ01
DrugBank ID DB11105
KEGG ID D00857
MeSH ID D001548
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 72976-003; 73126-003; 73126-007; 73126-026; 73126-036; 73135-101; 73135-102; 73741-103; 73760-008; 74934-026; 74934-071; 74955-032; 74966-002; 75044-251; 75127-005; 76176-042; 76176-093; 76378-023; 76402-419; 77071-006; 77243-109; 77368-903; 77465-002; 77465-005; 78041-0023; 78161-002; 78674-100; 78691-015; 78740-006; 78823-006; 78823-008; 78823-032; 78823-035; 79021-007; 79293-001; 79432-001; 79794-700; 79903-110; 79956-000; 80204-050; 80499-012; 80499-030; 80499-105; 80618-010; 80948-011; 80948-015; 81105-001; 81232-165; 81240-001; 81353-126; 81575-002; 81608-001; 82726-001; 83535-002; 86815-005; 0420-1202; 28691-0012; 69284-001; 11344-031; 80894-010; 11429-1001; 21749-686; 24286-1532; 34645-5008; 35000-086; 35000-249; 39892-0306; 40092-500; 41163-086; 41250-754; 42326-580; 42926-162; 42926-163; 45942-1629; 47593-585; 47593-592; 47593-645; 47682-245; 47993-323; 50157-006; 50157-424; 50157-509; 50157-511; 50157-608; 50552-002; 51414-400; 51706-955; 52220-400; 52862-621; 52862-650; 54340-266; 54340-268; 55118-701; 56131-711; 56136-315; 56136-316; 56136-381; 56136-382; 56136-388; 56136-395; 56136-482; 56136-514; 56136-516; 56194-575; 0295-9049; 58503-047; 59062-4001; 59110-401; 59448-010; 59448-900; 60867-100; 61333-208; 0363-0242; 62467-265; 63146-122; 63148-198; 63148-512; 63940-575; 64009-331; 64009-333; 66715-6863; 66949-130; 66949-131; 66949-387; 66975-104; 68062-2244; 68121-004; 69243-0710; 69540-0031; 70335-304; 71020-005; 71023-445; 71310-004; 71734-210; 71734-330; 71853-007; 71853-010; 71884-011; 71884-015; 71884-017; 71884-032; 71896-400; 72146-018; 72146-028; 73118-005; 73126-002; 73360-001; 73360-003; 73741-100; 73741-108; 74602-700; 75109-522; 75266-001; 75356-0005; 75356-0007; 75447-224; 75536-0007; 76176-094; 76176-157; 76176-158; 76370-0019; 76635-004; 76635-007; 76635-008; 76891-119; 76906-005; 76982-8885; 77006-010; 77071-001; 77071-004; 77071-008; 77267-008; 77267-011; 77435-004; 77435-108; 77617-002; 77645-002; 77677-001; 77702-101; 77733-002; 78161-006; 78506-001; 78641-213; 78691-003; 78823-004; 78823-030; 78823-040; 78878-002; 78982-002; 79293-002; 79421-001; 79722-101; 79794-900; 79903-097; 80042-002; 80107-003; 80190-003; 80499-009; 80499-010; 80499-015; 80499-027; 80499-102; 80499-103; 80581-087; 80606-001; 80618-020; 81072-001; 81124-001; 81350-002; 81792-002; 82131-295; 82447-101; 82536-002; 82822-100; 83388-002; 86818-004; 90119-002; 0420-1201; 25119-0242; 80755-011; 11673-577; 11822-1240; 18949-710; 20276-145; 20276-148; 21130-017; 21749-685; 30805-015; 34645-0009; 35000-250; 35000-251; 35000-253; 35000-254; 41163-941; 41250-628; 42961-227; 44119-012; 47593-511; 47593-513; 47593-576; 47593-586; 47682-056; 48404-050; 49035-064; 49283-101; 49351-103; 49687-0029; 50157-522; 50157-605; 50241-317; 52000-044; 52000-047; 52489-003; 52862-615; 53125-717; 53329-158; 53329-181; 54622-313; 54622-315; 55316-196; 56136-204; 56136-208; 56136-383; 56136-471; 56136-481; 56136-503; 56136-513; 57337-057; 57660-004; 59050-260; 59050-264; 59050-332; 59062-4000; 59062-4200; 59088-315; 59110-400; 59900-130; 60867-150; 61139-572; 61333-500; 0363-0683; 63146-304; 63354-536; 63354-989; 63941-403; 63941-941; 65321-032; 65601-759; 66902-386; 66908-400; 67151-333; 67777-244; 68041-740; 68121-005; 68306-115; 68391-105; 68599-5806; 68654-086; 68776-1003; 69243-0820
UNII F5UM2KM3W7
Synonyms Benzalkonium Compounds | Compounds, Benzalkonium | Osvan | Zephiran | Drapolene | BTC-2125 | BTC 2125 | BTC2125 | Germex | Asepsol | Benzalkonium | Benzalkonium Chloride | Chloride, Benzalkonium | Alkyldimethylbenzylammonium Chloride | Chloride, Alkyldimethylbenzylammonium
Chemical Information
Molecular Formula Not Available
CAS Registry Number Not Available
SMILES Not Available
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)
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Restlessness17.02.05.021; 19.11.02.002--
Shock24.06.02.002--Not Available
Skin irritation23.03.04.009--Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Stomatitis07.05.06.005--
Thrombocytopenia01.08.01.002--Not Available
Thrombophlebitis24.01.02.001--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
Urticaria10.01.06.001; 23.04.02.001--
Vasculitis necrotising24.12.04.029; 10.02.02.008--Not Available
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Xanthopsia06.02.05.002--Not Available
Tubulointerstitial nephritis20.05.02.002--Not Available
Acute generalised exanthematous pustulosis11.07.01.018; 10.01.01.034; 23.03.10.002; 12.03.01.005--Not Available
Bladder spasm20.02.02.013--
Epigastric discomfort07.01.02.004--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Drug reaction with eosinophilia and systemic symptoms12.03.01.064; 23.03.05.005; 10.01.01.021--Not Available
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