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)
Abdominal pain07.01.05.002--
Abdominal tenderness07.01.05.0040.000070%Not Available
Accommodation disorder06.02.04.001--Not Available
Acidosis14.01.03.0020.000104%
Acute respiratory distress syndrome10.02.01.067; 22.01.03.001; 24.03.02.0340.000139%
Acute respiratory failure22.02.06.001; 14.01.04.0040.000174%Not Available
Affective disorder19.04.04.0010.000104%Not Available
Ageusia17.02.07.001; 07.14.03.003--Not Available
Aggression19.05.01.001--Not Available
Agitation19.06.02.001; 17.02.05.0120.003447%
Akathisia19.06.02.006; 17.01.02.0020.000139%
Albuminuria20.02.01.001--Not Available
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.0010.001504%Not Available
Amnesia19.20.01.001; 17.03.02.0010.000884%
Amyotrophic lateral sclerosis17.05.05.0040.000070%Not Available
Anaemia01.03.02.001--
Anuria20.01.03.0020.000522%Not Available
Anxiety19.06.02.002--
Aphasia19.21.01.001; 17.02.03.0010.000864%
Apnoea22.02.01.0010.000905%
Arachnoiditis17.06.01.001; 12.02.04.0020.000244%
Areflexia17.02.01.0010.001010%Not Available
Arrhythmia02.03.02.001--Not Available
Arteriosclerosis24.04.02.0010.000070%Not Available
Arthropathy15.01.01.003--Not Available
Aspartate aminotransferase increased13.03.04.011--
Asphyxia22.02.02.001; 12.01.08.0110.000174%Not Available
Aspiration22.02.07.0070.000209%
Asthenia08.01.01.001--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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