Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Eflornithine hydrochloride
Drug ID BADD_D00752
Description Eflornithine is a prescription drug indicated in the treatment of facial hirsutism (excessive hair growth). Eflornithine hydrochloride cream for topical application is intended for use in women suffering from facial hirsutism and is sold by Allergan, Inc. under the brand name Vaniqa. Eflornithine for injection against sleeping sickness was manufactured by Sanofi Aventis and sold under the brand name Ornidyl in the USA. It is now discontinued. Eflornithine is on the World Health Organization's List of Essential Medicines.
Indications and Usage Eflornithine is indicated in the treatment of facial hirsutism (excessive hair growth).
Marketing Status approved; withdrawn
ATC Code D11AX16; P01CX03
DrugBank ID DB06243
KEGG ID D00829
MeSH ID D000518
PubChem ID 57004
TTD Drug ID D0X7JR
NDC Product Code 0023-4857; 54245-3110; 82160-125; 65129-3110
UNII 4NH22NDW9H
Synonyms Eflornithine | DL-alpha-Difluoromethylornithine | DL alpha Difluoromethylornithine | alpha-Difluoromethylornithine | alpha Difluoromethylornithine | alpha-Difluoromethyl Ornithine | Ornithine, alpha-Difluoromethyl | alpha Difluoromethyl Ornithine | Difluoromethylornithine | MDL-71,782 A | MDL 71,782 A | MDL71,782 A | Ornidyl | Vaniqa | Eflornithine Monohydrochloride, Monohydrate | Eflornithine Hydrochloride | RMI 71782
Chemical Information
Molecular Formula C6H13ClF2N2O2
CAS Registry Number 81645-68-3
SMILES C(CC(C(F)F)(C(=O)O)N)CN.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)
Acne23.02.01.001---
Alopecia23.02.02.001--
Asthenia08.01.01.001---
Cheilitis07.05.01.001; 23.03.03.025--
Dermatitis contact10.01.01.003; 12.03.01.040; 23.03.04.004---
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dry skin23.03.03.001--
Dyspepsia07.01.02.001--
Erythema23.03.06.001---
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.004--
Folliculitis11.02.01.053; 23.11.04.003--
Headache17.14.01.001--
Herpes simplex11.05.02.001; 23.11.05.004---
Hypoaesthesia17.02.06.023; 23.03.03.081---
Lip swelling07.05.04.005; 10.01.05.005; 23.04.01.007---
Nausea07.01.07.001--
Pain of skin23.03.03.003--
Paraesthesia17.02.06.005; 23.03.03.094--
Pruritus23.03.12.001--
Rash23.03.13.001---
Rosacea23.02.08.001---
Skin irritation23.03.04.009---
Vertigo04.04.01.003; 17.02.12.002--
Ingrown hair23.02.06.008---
Skin burning sensation17.02.06.009; 23.03.03.021---
Decreased appetite08.01.09.028; 14.03.01.005--
Skin haemorrhage23.06.07.001; 24.07.01.103---
Pseudofolliculitis23.02.06.013---
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