Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Diltiazem hydrochloride
Drug ID BADD_D00675
Description Diltiazem is a benzothiazepine derivative with antihypertensive and vasodilating properties. Approved in 1982 by the FDA, it is a member of the non-dihydropyridine calcium channel blockers drug class. It works through various mechanisms of action, but it primarily works by inhibiting the calcium influx into cardiac and vascular smooth muscle during depolarization.[L10556] Compared to dihydropyridine drugs, such as [nifedipine], that preferentially act on vascular smooth muscle and [verapamil] that directly acts on the heart muscle, diltiazem displays an intermediate specificity to target both the cardiac and vascular smooth muscle.[T28] Being a potent vasodilator, diltiazem is used clinically as an antihypertensive, anti-arrhythmic, and as an anti-anginal agent [L6289] for the management of cardiovascular conditions such as hypertension, chronic stable angina, atrial fibrillation, atrial flutter. Apart from its main FDA-approved indications, diltiazem has also been used for numerous off-label indications, such as anal fissures (in topical formulations), migraine prophylaxis, pulmonary hypertension, and rest-related cramps in the lower extremities.[L6289] Typically available in extended-release oral and intravenous formulations, diltiazem is marketed under various brand names with Cardizem and Tiazac being the most common ones.
Indications and Usage **Oral** Indicated for the management of hypertension, to lower blood pressure, alone or in combination with other antihypertensive agents.[L10556] Indicated for use to improve exercise tolerance in patients with chronic stable angina.[L10556] Indicated for the management of variant angina (Prinzmetal's angina).[L6298] **Intravenous** Indicated for the short-term management of atrial fibrillation or atrial flutter for temporary control of rapid ventricular rate.[L6292] Indicated for the rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome.[L6292] **Off-label** Indicated for off-label uses in anal fissures (as topical formulation), migraine prophylaxis, cramps in lower leg related to rest, pulmonary hypertension,[L6289] idiopathic dilated cardiomyopathy, and proteinuria associated with diabetic nephropathy.[L6298]
Marketing Status approved; investigational
ATC Code C05AE03; C08DB01
DrugBank ID DB00343
KEGG ID D00616
MeSH ID D004110
PubChem ID 62920
TTD Drug ID D0OB1J
NDC Product Code 0641-9219; 10370-831; 10370-832; 24979-028; 24979-029; 0187-0795; 50090-6146; 50228-481; 50228-496; 50228-497; 50228-499; 50742-249; 51079-926; 51862-328; 0228-2918; 52544-694; 63629-2160; 63629-7981; 63629-9102; 63739-015; 68382-597; 68462-562; 68682-006; 68682-009; 68682-367; 68788-7870; 70436-193; 70518-2683; 70518-2789; 70771-1032; 71335-0009; 71335-2129; 12828-0037; 0904-7220; 52133-0013; 53360-1210; 68981-018; 79572-015; 16714-523; 0093-0318; 42291-060; 47335-670; 0187-0796; 0187-2612; 0187-2617; 50228-498; 50742-248; 51407-475; 51655-020; 51862-329; 52544-695; 55150-425; 55150-427; 60505-0015; 62037-597; 62037-598; 62037-599; 0378-6120; 68382-595; 68682-007; 68682-370; 68682-372; 68682-521; 70518-3299; 70518-3484; 71335-1043; 71335-1585; 71335-1897; 0615-8379; 53360-1211; 16714-553; 16729-305; 24979-026; 24979-182; 42799-129; 47335-672; 47335-675; 47335-677; 50228-484; 50228-500; 51754-3000; 58118-1007; 60505-0016; 60687-206; 60687-717; 62037-699; 63304-719; 63629-2154; 0378-6060; 68382-745; 68382-747; 69097-994; 69097-997; 70436-200; 70518-0109; 70518-1017; 70518-2506; 70860-301; 71335-0634; 72189-344; 0615-8381; 62037-700; 63304-721; 63629-2157; 63629-7330; 68382-596; 70436-197; 71335-0643; 71335-1389; 71335-2029; 71335-9719; 0904-7219; 50546-328; 50546-330; 53360-1212; 43826-036; 0187-2046; 0187-2049; 0187-2614; 50090-6328; 51407-474; 51754-3500; 60505-0014; 63629-2156; 68682-371; 70771-1031; 70771-1039; 71335-0266; 71335-1063; 71335-1776; 71872-7063; 12780-2960; 16714-525; 16714-554; 42291-186; 43826-034; 43826-035; 0187-0771; 0187-0798; 0187-2613; 50090-0451; 50090-5466; 51862-330; 60687-195; 62037-697; 63629-2158; 68382-749; 68462-851; 68682-008; 69097-995; 70436-199; 70771-1038; 70771-1040; 71335-1223; 71335-1611; 0641-6014; 0641-9217; 0641-9218; 0904-7218; 50546-329; 10370-829; 65085-0002; 0093-0320; 0093-0321; 16729-303; 24979-183; 47335-669; 47335-671; 47335-673; 47335-678; 0187-0792; 50090-5416; 50090-5452; 50742-252; 60687-217; 62037-600; 62037-696; 62037-698; 63304-718; 68382-746; 68382-748; 68462-850; 68682-993; 68682-994; 68682-997; 68682-998; 69097-993; 69097-996; 70771-1034; 70771-1037; 70934-854; 71335-0579; 71335-2089; 0615-8380; 15894-0022; 53360-1213; 62331-005; 10370-830; 17478-937; 42291-184; 42799-130; 43826-037; 47335-676; 0187-2048; 0187-2050; 0187-2616; 51079-924; 51407-473; 55150-426; 63629-2159; 63629-9104; 68382-599; 0409-4350; 68682-368; 69097-992; 70436-191; 70436-196; 70436-198; 70771-1030; 70771-1033; 71335-0867; 71335-0879; 71872-7293; 0615-8033; 0641-6015; 0904-7217; 49452-4881; 16714-524; 24979-181; 42291-059; 42291-061; 42799-131; 43826-033; 0187-0772; 50090-3124; 50090-6155; 50228-482; 50228-483; 50742-250; 50742-251; 51407-476; 60687-228; 63187-769; 63304-722; 63629-2153; 63629-2155; 63629-7896; 63739-016; 0378-6090; 68382-598; 68382-750; 68682-369; 70436-192; 70771-1035; 70771-1036; 71335-0745; 71335-0839; 0615-8032; 53360-1214; 77777-110; 16714-555; 24979-027; 42291-185; 42799-132; 0187-0799; 0187-2045; 0187-2047; 0187-2615; 50228-495; 51079-925; 63304-720; 63629-3649; 63629-9099; 63739-014; 70436-195; 70518-0820; 70518-3337; 71335-1001; 71335-9708; 0641-6013; 38779-0227; 62991-1046; 0093-0319; 16729-304; 24979-030; 47335-679; 0187-0797; 52544-691; 52544-692; 52544-693; 53002-1521
UNII OLH94387TE
Synonyms Diltiazem | Cardil | Cardizem | CRD-401 | CRD 401 | CRD401 | Tiazac | Dilacor XR | Dilren | Diltiazem Hydrochloride | Diltiazem Malate | Dilzem | Aldizem | Dilacor
Chemical Information
Molecular Formula C22H27ClN2O4S
CAS Registry Number 33286-22-5
SMILES CC(=O)OC1C(SC2=CC=CC=C2N(C1=O)CCN(C)C)C3=CC=C(C=C3)OC.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)
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Alopecia23.02.02.001--
Amblyopia06.02.01.001--Not Available
Amnesia19.20.01.001; 17.03.02.001--
Angina pectoris02.02.02.002; 24.04.04.002--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Arterial injury24.11.02.002; 12.01.11.008--
Arthralgia15.01.02.001--
Atrioventricular block02.03.01.002--Not Available
Atrioventricular block first degree02.03.01.004--
Bleeding time prolonged13.01.02.002--Not Available
Blood creatine phosphokinase increased13.04.01.001--
Bradycardia02.03.02.002--Not Available
Bundle branch block02.03.01.009--Not Available
Cardiac failure02.05.01.001--
Constipation07.02.02.001--
Cough22.02.03.001--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Epistaxis24.07.01.005; 22.04.03.001--
Erythema multiforme23.03.01.003; 10.01.03.015--
Extrapyramidal disorder17.01.02.007--
Eye irritation06.04.05.003--Not Available
Face oedema10.01.05.002; 08.01.07.003; 23.04.01.004--
Fatigue08.01.01.002--
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