Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Benzydamine
Drug ID BADD_D00246
Description Benzydamine (also known as Tantum Verde or Difflam), available as the hydrochloride salt, is a locally-acting nonsteroidal anti-inflammatory drug (NSAID) with local anaesthetic and analgesic properties. It is used topically for pain relief and anti-inflammatory treatment of the mouth, throat, or muscoskeletal system. Although the indazole analogue benzydamine is a non-steroidal anti-inflammatory drug (NSAID), it has various physicochemical properties and pharmacologic activities that are different from those of traditional aspirin-like NSAIDs but facilitate benzydamine's mechanism of action as an effective locally-acting NSAID with local anaesthetic and analgesic properties. Moreover, unlike aspirin-like NSAIDs which are acids or metabolised to acids, benzydamine is in fact a weak base.
Indications and Usage Available predominantly as a liquid mouthwash, oromucosal spray, or topical cream, benzydamine is most frequently employed as a locally acting analgesic and anti-inflammatory treatment for the relief of painful inflammatory conditions. When formulated as a mouthwash or spray, benzydamine may be used to treat traumatic conditions like pharyngitis following tonsillectomy or the use of a naso-gastric tube, inflammatory conditions like pharyngitis, aphthous ulcers and oral ulceration due to radiation therapy, dentistry operations and procedures, or more general conditions like sore throat, sore tongue, sore gums, mouth ulcers, or discomfort caused by dentures. [L1121] When used as a topical cream, benzydamine may be employed to relieve symptoms associated with painful inflammatory conditions of the muscolo-skeletal system including acute inflammatory disorders such as myalgia and bursitis or traumatic conditions like sprains, strains, bruises, sore muscles, stiff joints, or even the after-effects of fractures. [ L1123]
Marketing Status approved
ATC Code A01AD02; G02CC03; M01AX07; M02AA05; R02AX03
DrugBank ID DB09084
KEGG ID D07516
MeSH ID D001591
PubChem ID 12555
TTD Drug ID D06FJO
NDC Product Code Not Available
UNII 4O21U048EF
Synonyms Benzydamine | Benzidamine | Benzindamine | Novo-Benzydamine | Novo Benzydamine | Opalgyne | PMS-Benzydamine | PMS Benzydamine | Difflam | Rosalgin | Tantum Topico | Tantum | Sun-Benz | Sun Benz | Benzydamine Hydrochloride | Hydrochloride, Benzydamine | Benzydamine Monohydrochloride | Monohydrochloride, Benzydamine | Lonol | Ratio-Benzydamine | Ratio Benzydamine
Chemical Information
Molecular Formula C19H23N3O
CAS Registry Number 642-72-8
SMILES CN(C)CCCOC1=NN(C2=CC=CC=C21)CC3=CC=CC=C3
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)
Cough22.02.03.001--
Headache17.14.01.001--
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Nausea07.01.07.001--
Pain08.01.08.004--
Sensory loss17.02.07.007--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Thirst14.03.02.007; 08.01.09.021--Not Available
Throat irritation22.12.03.029; 07.05.05.037--Not Available
Vomiting07.01.07.003--
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