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)
Implant site extravasation12.07.02.042; 08.02.02.0420.007500%Not Available
Implant site fibrosis08.02.02.043; 12.07.02.0430.000223%Not Available
Implant site haematoma24.07.01.097; 12.07.02.044; 08.02.02.0440.000891%Not Available
Implant site induration12.07.02.049; 08.02.02.0490.000070%Not Available
Implant site inflammation12.07.02.050; 08.02.02.0500.000070%Not Available
Implant site irritation12.07.02.052; 08.02.02.0520.000153%Not Available
Implant site mass12.07.02.053; 08.02.02.0530.000968%Not Available
Implant site oedema12.07.02.057; 08.02.02.0570.000070%Not Available
Implant site rash08.02.02.061; 23.03.13.026; 12.07.02.0610.000272%Not Available
Implant site scar23.03.11.033; 12.07.02.062; 08.02.02.0620.000669%Not Available
Implant site swelling08.02.02.063; 12.07.02.0630.003238%Not Available
Implant site ulcer23.07.03.026; 12.07.02.065; 08.02.02.0650.000139%Not Available
Implant site vesicles23.03.01.035; 12.07.02.067; 08.02.02.0670.000306%Not Available
Implant site warmth08.02.02.068; 12.07.02.0680.000272%Not Available
Infusion site cyst16.02.02.015; 12.07.05.024; 08.02.05.0240.000104%Not Available
Infusion site mass12.07.05.032; 08.02.05.0320.000446%Not Available
Intestinal pseudo-obstruction07.02.02.0200.000348%Not Available
Malignant catatonia19.11.01.0030.000174%Not Available
Medical device site bruise24.07.06.031; 23.03.11.038; 12.02.21.001; 08.07.01.0170.000153%Not Available
Medical device site discharge23.03.03.090; 12.02.21.004; 08.07.01.0200.000139%Not Available
Medical device site discomfort08.07.01.021; 12.02.21.0050.000341%Not Available
Medical device site erosion23.07.03.030; 08.07.01.023; 12.02.21.0070.000327%Not Available
Medical device site erythema23.03.06.026; 12.02.21.008; 08.07.01.0240.000104%Not Available
Medical device site extravasation12.02.21.009; 08.07.01.025--Not Available
Medical device site fibrosis12.02.21.010; 08.07.01.0260.000244%Not Available
Medical device site haematoma08.07.01.028; 24.07.01.100; 12.02.21.0120.000104%Not Available
Medical device site haemorrhage24.07.01.101; 12.02.21.013; 08.07.01.0290.000104%Not Available
Medical device site hypertrophy12.02.21.014; 08.07.01.030--Not Available
Medical device site inflammation12.02.21.015; 08.07.01.0310.000104%Not Available
Medical device site irritation08.07.01.032; 12.02.21.0160.000188%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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