Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Baclofen
Drug ID BADD_D00209
Description Baclofen is a gamma-aminobutyric acid (GABA) agonist used as a skeletal muscle relaxant used for the relief of painful and uncomfortable muscle spasms caused by a variety of conditions. It is particularly useful in treating muscle spasticity associated with spinal cord injury. This drug has recently been studied for the management of alcohol withdrawal, however, a conclusion has not been made regarding baclofen efficacy in this condition. [A173908,A173911,A173938] This drug was first approved by the FDA in 1992.[F4570]
Indications and Usage Baclofen is indicated for the treatment of spasticity resulting from multiple sclerosis and is particularly useful for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.[L39434] It may also be of value in the treatment of patients with spinal cord injuries or diseases. Baclofen is also indicated as an intrathecal injection for the management of severe spasticity of cerebral or spinal original in patients 4 years of age and older.[L39429] Patients who respond to bolus intrathecal doses of baclofen, and who require chronic therapy, can use an implantable intrathecal pump to administer baclofen via long-term infusion.
Marketing Status approved
ATC Code M03BX01
DrugBank ID DB00181
KEGG ID D00241
MeSH ID D001418
PubChem ID 2284
TTD Drug ID D01AJY
NDC Product Code 72888-145; 0395-8032; 12658-0508; 12658-0583; 51552-0613; 63275-9992; 65015-635; 82245-0205; 0172-4096; 55154-7635; 55700-974; 61919-093; 61919-095; 63629-2081; 68071-2841; 70257-412; 70257-561; 70518-3467; 71335-0344; 71335-1664; 71335-1796; 71335-9681; 71610-446; 71610-452; 72162-1079; 72162-1080; 73320-003; 80425-0157; 68055-001; 68055-002; 76420-930; 82393-207; 29300-344; 50090-4682; 50090-5855; 55700-403; 63629-2130; 67457-563; 67544-671; 69528-301; 70121-2496; 70121-2503; 70257-560; 70518-2804; 70934-918; 71205-474; 71225-140; 0603-2406; 0615-8467; 49452-0807; 50218-010; 51014-7035; 51927-2007; 68055-003; 68055-945; 68055-947; 81371-6004; 29300-343; 50268-107; 52536-600; 55289-757; 63629-2129; 63629-2131; 64896-077; 68071-2289; 0527-1330; 70518-3089; 0603-2407; 62135-473; 63187-274; 67457-564; 68071-3468; 70257-563; 70518-3115; 71610-614; 0615-3541; 71930-006; 71930-007; 72888-146; 73320-001; 80425-0081; 80425-0205; 48954-469; 10135-533; 16714-072; 25021-679; 0172-4097; 50090-2493; 50090-5838; 63187-280; 63629-1227; 63629-2083; 63629-2084; 67457-562; 68071-2414; 70121-2502; 70511-124; 70771-1448; 70771-1449; 71335-0103; 71335-0949; 71930-066; 0615-8411; 73320-002; 12658-0480; 12658-0582; 0904-7341; 53747-075; 68055-946; 76420-931; 29300-474; 0115-1011; 50268-105; 50268-106; 52817-319; 52817-320; 61919-026; 64896-078; 68788-8333; 70121-2504; 70511-122; 70511-123; 70518-0362; 70756-288; 71610-660; 72789-312; 72888-010; 72888-147; 76420-242; 80425-0080; 0904-6476; 46014-1035; 46014-1124; 51927-0146; 65628-100; 68981-007; 79572-003; 43063-865; 45865-452; 55154-7876; 63739-480; 64896-076; 68071-3001; 68134-401; 70710-1286; 71335-1356; 72888-011; 12658-0562; 17511-130; 38779-0388; 51927-0147; 65628-101; 16714-071; 25021-678; 52817-321; 55700-408; 59651-394; 60687-503; 63187-147; 63187-313; 68071-5249; 68071-5252; 68788-9246; 70121-2501; 71335-1797; 71335-9638; 0615-3542; 76420-241; 80425-0156; 0832-1054; 0832-1055; 80425-0282; 38779-3209; 62991-1013; 68055-004; 25021-680; 50090-6149; 62135-472; 63629-1224; 63629-1225; 63629-1228; 63629-2080; 63629-2082; 63739-479; 68084-868; 68788-6384; 0527-1337; 70257-414; 70257-562; 70511-121; 70518-0215; 70710-1285; 70710-1609; 70756-085; 70771-1586; 71335-1643; 0615-8412; 80425-0112; 12658-0448; 12658-0462; 76420-165; 25021-681; 60687-514; 62135-474; 63629-1226; 63629-2128; 68071-3407; 68084-855; 0527-1333; 70121-2505; 70257-416; 70518-2662; 70518-3614; 70756-289; 71335-0206; 0615-8466; 72888-009; 83008-015; 0904-6475; 12658-0584; 10135-532; 59651-395; 68055-948; 0115-1010; 0115-1012; 43063-864; 45865-355; 52652-6001
UNII H789N3FKE8
Synonyms Baclofen | Baclophen | PCP-GABA | beta-(Aminomethyl)-4-chlorobenzenepropanoic Acid | Chlorophenyl GABA | GABA, Chlorophenyl | beta-(p-Chlorophenyl)-gamma-aminobutyric Acid | Clofen | Gen-Baclofen | Gen Baclofen | GenBaclofen | Genpharm | Apo-Baclofen | Apo Baclofen | ApoBaclofen | Atrofen | Baclofène-Irex | Baclofène Irex | BaclofèneIrex | Baclofen AWD | AWD, Baclofen | Lebic | Lioresal | Liorésal | Nu-Baclo | Nu Baclo | NuBaclo | PMS-Baclofen | PMS Baclofen | PMSBaclofen | Baclospas | Ba-34,647 | Ba34,647 | Ba-34647 | Ba34647 | CIBA-34,647-BA | CIBA34,647BA
Chemical Information
Molecular Formula C10H12ClNO2
CAS Registry Number 1134-47-0
SMILES C1=CC(=CC=C1C(CC(=O)O)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)
Medical device site mass08.07.01.035; 12.02.21.0190.000272%-
Medical device site pain08.07.01.037; 12.02.21.0210.000223%-
Medical device site reaction08.07.01.038; 12.02.21.0220.000174%-
Medical device site swelling08.07.01.040; 12.02.21.0240.000550%-
Medical device site warmth08.07.01.042; 12.02.21.0260.000070%-
Organic brain syndrome19.07.03.0110.000070%-
Suspected suicide08.04.01.017; 19.12.01.0090.000244%-
Symptom recurrence08.01.03.1010.000237%-
Therapeutic product effect decreased08.06.01.0500.001671%-
Therapeutic product effect variable08.06.01.0550.000070%-
Therapeutic product ineffective08.06.01.0570.000272%-
Therapeutic response changed08.06.01.0590.000292%-
Therapy non-responder08.06.01.0630.009060%-
Therapy partial responder08.06.01.0640.000070%-
Treatment noncompliance08.06.01.067; 12.09.02.0060.001595%-
Vulvovaginal inflammation21.14.02.014---
The 19th Page    First    Pre   19    Total 19 Pages
ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene