duloxetine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
serotonin and/or norepinephrine reuptake inhibitors, fluoxetine derivatives	972	116539-59-4

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: yentreve cymbalta duloxetine (S)-Duloxetine duloxetine hydrochloride duloxetine HCl

A thiophene derivative and selective NEUROTRANSMITTER UPTAKE INHIBITOR for SEROTONIN and NORADRENALINE (SNRI). It is an ANTIDEPRESSIVE AGENT and ANXIOLYTIC, and is also used for the treatment of pain in patients with DIABETES MELLITUS and FIBROMYALGIA. Molecular weight: 297.42 Formula: C18H19NOS CLOGP: 4.26 LIPINSKI: 0 HAC: 2 HDO: 1 TPSA: 21.26 ALOGS: -5 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
60	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	2.88 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance)	8.57 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.04 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	12 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Aug. 3, 2004	FDA	LILLY

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug withdrawal syndrome	9177.30	30.10	1887	12547	4934	2338717
Dysphoria	6510.23	30.10	1122	13312	417	2343234
Affect lability	5978.41	30.10	1094	13340	1008	2342643
Irritability	5827.08	30.10	1289	13145	5138	2338513
Paraesthesia	5618.80	30.10	1597	12837	20491	2323160
Agitation	5373.99	30.10	1337	13097	9714	2333937
Dizziness	5238.14	30.10	1909	12525	56756	2286895
Insomnia	5211.57	30.10	1560	12874	24227	2319424
Anxiety	4901.50	30.10	1534	12900	27825	2315826
Suicidal ideation	4743.97	30.10	1212	13222	9875	2333776
Nausea	4337.55	30.10	2003	12431	110186	2233465
Vertigo	4282.34	30.10	1081	13353	8303	2335348
Hyperhidrosis	4131.17	30.10	1165	13269	14257	2329394
Confusional state	3742.78	30.10	1198	13236	23146	2320505
Headache	3535.04	30.10	1576	12858	78603	2265048
Fatigue	3292.90	30.10	1527	12907	83346	2260305
Sensory disturbance	3288.49	30.10	690	13744	1942	2341709
Lethargy	2516.63	30.10	701	13733	8029	2335622
Tremor	2245.65	30.10	786	13648	19875	2323776
Nightmare	2163.08	30.10	522	13912	3175	2340476
Tinnitus	2070.24	30.10	538	13896	4597	2339054
Vomiting	2034.33	30.10	1047	13387	70555	2273096
Completed suicide	1895.19	30.10	697	13737	20337	2323314
Mood swings	1811.31	30.10	442	13992	2827	2340824
Drug hypersensitivity	1577.82	30.10	770	13664	45873	2297778
Diarrhoea	1489.33	30.10	901	13533	82663	2260988
Hypomania	1457.10	30.10	288	14146	519	2343132
Sleep disorder	1357.61	30.10	407	14027	6082	2337569
Depression	1279.11	30.10	571	13863	27561	2316090
Suicide attempt	1208.76	30.10	426	14008	10856	2332795
Serotonin syndrome	1177.42	30.10	319	14115	3221	2340430
Alanine aminotransferase increased	1176.18	30.10	442	13992	13590	2330061
Toxicity to various agents	1056.93	30.10	525	13909	32229	2311422
Hepatic enzyme increased	1026.14	30.10	364	14070	9438	2334213
Aspartate aminotransferase increased	1012.01	30.10	385	14049	12227	2331424
Feeling abnormal	892.43	30.10	422	14012	23159	2320492
Disturbance in attention	829.46	30.10	271	14163	5414	2338237
Seizure	781.43	30.10	390	14044	24076	2319575
Somnolence	722.29	30.10	365	14069	23120	2320531
Withdrawal syndrome	721.45	30.10	215	14219	3122	2340529
Drug interaction	672.53	30.10	374	14060	28789	2314862
Loss of consciousness	670.04	30.10	323	14111	18444	2325207
Crying	626.60	30.10	206	14228	4190	2339461
Blood pressure increased	623.38	30.10	298	14136	16688	2326963
Hyponatraemia	566.82	30.10	259	14175	13066	2330585
Fall	535.41	30.10	386	14048	46713	2296938
Intentional product misuse	525.13	30.10	222	14212	9267	2334384
Drug ineffective	485.88	30.10	507	13927	101117	2242534
Memory impairment	480.72	30.10	229	14205	12694	2330957
Pain	468.89	30.10	399	14035	61458	2282193
Coma	439.01	30.10	193	14241	8863	2334788
Aggression	429.86	30.10	159	14275	4627	2339024
Anger	403.91	30.10	129	14305	2378	2341273
Migraine	402.85	30.10	191	14243	10462	2333189
Hypertension	401.89	30.10	263	14171	27098	2316553
Weight increased	386.01	30.10	238	14196	22099	2321552
Overdose	384.96	30.10	228	14206	19679	2323972
Exposure during pregnancy	381.56	30.10	247	14187	24972	2318679
Panic attack	379.56	30.10	138	14296	3818	2339833
Vision blurred	364.48	30.10	198	14236	14470	2329181
Hallucination	363.90	30.10	164	14270	7984	2335667
Inappropriate antidiuretic hormone secretion	356.33	30.10	115	14319	2194	2341457
Liver function test abnormal	351.22	30.10	156	14278	7334	2336317
Intentional overdose	341.45	30.10	174	14260	11147	2332504
Asthenia	337.23	30.10	294	14140	46632	2297019
Palpitations	335.21	30.10	195	14239	16261	2327390
Pneumonia aspiration	327.44	30.10	122	14312	3620	2340031
Constipation	320.05	30.10	209	14225	21420	2322231
Blood alkaline phosphatase increased	318.71	30.10	140	14294	6405	2337246
Drug abuse	317.33	30.10	169	14265	11857	2331794
Urinary retention	304.28	30.10	115	14319	3552	2340099
Amnesia	301.79	30.10	139	14295	7114	2336537
Gamma-glutamyltransferase increased	287.16	30.10	124	14310	5438	2338213
Malaise	285.40	30.10	289	14145	55296	2288355
Off label use	282.39	30.10	328	14106	73270	2270381
Cardio-respiratory arrest	259.60	30.10	135	14299	9011	2334640
Syncope	254.24	30.10	165	14269	16710	2326941
Depressed mood	249.18	30.10	110	14324	5088	2338563
Dry mouth	246.27	30.10	126	14308	8127	2335524
Respiratory arrest	240.21	30.10	113	14321	6065	2337586
Intentional self-injury	236.17	30.10	99	14335	4028	2339623
Dyspnoea	235.97	30.10	310	14124	78423	2265228
Decreased appetite	233.73	30.10	194	14240	28697	2314954
Fibromyalgia	232.83	30.10	92	14342	3208	2340443
Cardiac arrest	232.31	30.10	149	14285	14781	2328870
Gait disturbance	230.96	30.10	174	14260	22371	2321280
Hepatitis	228.34	30.10	110	14324	6227	2337424
Disorientation	227.76	30.10	110	14324	6262	2337389
Visual impairment	225.28	30.10	134	14300	11621	2332030
Muscle spasms	222.13	30.10	167	14267	21399	2322252
Hepatic steatosis	221.18	30.10	88	14346	3125	2340526
Dyskinesia	218.80	30.10	98	14336	4691	2338960
Tachycardia	217.09	30.10	148	14286	16261	2327390
Hallucination, visual	217.01	30.10	85	14349	2894	2340757
Restlessness	216.88	30.10	96	14338	4467	2339184
Influenza like illness	216.40	30.10	132	14302	11982	2331669
Balance disorder	215.67	30.10	122	14312	9625	2334026
Mania	215.04	30.10	80	14354	2360	2341291
Hot flush	215.03	30.10	110	14324	7089	2336562
Psychotic disorder	214.57	30.10	96	14338	4583	2339068
Abdominal pain	214.22	30.10	199	14235	34175	2309476
Weight decreased	207.89	30.10	180	14254	28191	2315460
Heart rate increased	206.06	30.10	124	14310	10981	2332670
Abnormal behaviour	203.50	30.10	93	14341	4667	2338984
Gastric bypass	202.86	30.10	51	14383	369	2343282
Nervousness	198.90	30.10	94	14340	5095	2338556
Gastrooesophageal reflux disease	196.26	30.10	112	14322	8983	2334668
Hypoaesthesia	193.75	30.10	150	14284	20065	2323586
Dysphagia	187.38	30.10	123	14311	12682	2330969
Abdominal pain upper	186.16	30.10	152	14282	21948	2321703
Chest pain	185.16	30.10	168	14266	27969	2315682
Gastrointestinal tube insertion	184.31	30.10	45	14389	284	2343367
Poisoning	182.89	30.10	74	14360	2746	2340905
Restless legs syndrome	180.34	30.10	69	14365	2202	2341449
Hallucination, auditory	179.10	30.10	68	14366	2124	2341527
Hospitalisation	177.75	30.10	126	14308	14727	2328924
Thinking abnormal	176.00	30.10	65	14369	1877	2341774
Abnormal dreams	171.53	30.10	68	14366	2390	2341261
Prescribed overdose	168.80	30.10	62	14372	1762	2341889
Cognitive disorder	168.77	30.10	85	14349	5296	2338355
Mood altered	167.63	30.10	69	14365	2677	2340974
Muscle twitching	167.17	30.10	69	14365	2696	2340955
Hypotension	161.23	30.10	166	14268	32270	2311381
Transaminases increased	157.30	30.10	77	14357	4510	2339141
Chills	156.86	30.10	119	14315	15433	2328218
Speech disorder	154.09	30.10	85	14349	6379	2337272
Mydriasis	153.48	30.10	61	14373	2158	2341493
Paranoia	149.50	30.10	59	14375	2048	2341603
Rash	148.68	30.10	215	14219	59343	2284308
Jaundice	146.81	30.10	78	14356	5430	2338221
Sopor	145.84	30.10	70	14364	3925	2339726
Orthostatic hypotension	144.64	30.10	63	14371	2816	2340835
Colitis microscopic	141.82	30.10	46	14388	890	2342761
Condition aggravated	141.74	30.10	154	14280	31825	2311826
Delirium	136.48	30.10	73	14361	5150	2338501
Hyperreflexia	135.38	30.10	44	14390	857	2342794
Night sweats	132.86	30.10	63	14371	3437	2340214
Generalised tonic-clonic seizure	131.78	30.10	72	14362	5300	2338351
Asphyxia	126.76	30.10	43	14391	961	2342690
Electrocardiogram QT prolonged	126.44	30.10	80	14354	7734	2335917
Product substitution issue	124.51	30.10	68	14366	5001	2338650
Myalgia	124.24	30.10	124	14310	23209	2320442
Dysarthria	123.68	30.10	73	14361	6229	2337422
Delusion	123.02	30.10	51	14383	2014	2341637
Mental disorder	121.84	30.10	62	14372	3945	2339706
Fear	117.75	30.10	53	14381	2563	2341088
Pruritus	116.21	30.10	162	14272	43178	2300473
Muscular weakness	116.06	30.10	98	14336	14799	2328852
Head injury	115.67	30.10	60	14374	3974	2339677
Death	114.96	30.10	228	14206	81240	2262411
Rhabdomyolysis	114.41	30.10	71	14363	6633	2337018
Tardive dyskinesia	111.45	30.10	45	14389	1659	2341992
Loss of personal independence in daily activities	110.76	30.10	64	14370	5247	2338404
Akathisia	108.77	30.10	44	14390	1630	2342021
Bipolar disorder	108.06	30.10	41	14393	1277	2342374
Myoclonus	107.62	30.10	49	14385	2434	2341217
Blood creatine phosphokinase increased	107.40	30.10	62	14372	5074	2338577
Blood glucose increased	106.48	30.10	86	14348	12204	2331447
Feeling jittery	105.99	30.10	45	14389	1887	2341764
Arthralgia	104.58	30.10	174	14260	54111	2289540
Cerebrovascular accident	103.26	30.10	105	14329	20081	2323570
Mental status changes	102.61	30.10	62	14372	5520	2338131
Tearfulness	102.25	30.10	36	14398	902	2342749
Sexual dysfunction	101.23	30.10	28	14406	304	2343347
Respiratory depression	100.97	30.10	45	14389	2125	2341526
Blood sodium decreased	100.21	30.10	50	14384	3050	2340601
Blood bilirubin increased	99.89	30.10	60	14374	5285	2338366
Impaired work ability	98.77	30.10	42	14392	1768	2341883
Coma blister	98.52	30.10	18	14416	15	2343636
Coordination abnormal	98.22	30.10	43	14391	1945	2341706
Arteriosclerosis coronary artery	98.01	30.10	37	14397	1136	2342515
Hypersomnia	97.24	30.10	45	14389	2321	2341330
Urinary incontinence	96.31	30.10	54	14380	4179	2339472
Abdominal discomfort	95.16	30.10	94	14340	17362	2326289
Medication error	94.78	30.10	61	14373	6070	2337581
International normalised ratio increased	94.14	30.10	65	14369	7271	2336380
Sedation	93.51	30.10	49	14385	3313	2340338
Mental impairment	92.84	30.10	44	14390	2396	2341255
Pain in extremity	90.93	30.10	143	14291	42397	2301254
Chromaturia	87.79	30.10	44	14390	2709	2340942
Liver disorder	87.45	30.10	59	14375	6355	2337296
Psychomotor hyperactivity	86.68	30.10	39	14395	1883	2341768
Photophobia	86.24	30.10	41	14393	2248	2341403
Contusion	85.13	30.10	77	14357	12733	2330918
Hypokalaemia	84.84	30.10	71	14363	10583	2333068
Hepatic failure	84.00	30.10	55	14379	5634	2338017
Road traffic accident	82.15	30.10	49	14385	4259	2339392
Emotional disorder	82.04	30.10	39	14395	2138	2341513
Dehydration	81.11	30.10	97	14337	22198	2321453
Drug intolerance	80.62	30.10	77	14357	13640	2330011
Major depression	80.38	30.10	31	14403	1010	2342641
Back pain	79.84	30.10	115	14319	31544	2312107
Oedema	79.19	30.10	67	14367	10136	2333515
Electric shock	78.98	30.10	18	14416	80	2343571
Formication	78.40	30.10	29	14405	840	2342811
Diplopia	78.27	30.10	44	14390	3421	2340230
Abdominal distension	78.01	30.10	67	14367	10344	2333307
Urinary hesitation	76.68	30.10	21	14413	219	2343432
Unresponsive to stimuli	76.56	30.10	49	14385	4827	2338824
Blood pressure systolic increased	76.40	30.10	38	14396	2301	2341350
Arrhythmia	76.37	30.10	53	14381	5975	2337676
Libido decreased	76.01	30.10	25	14409	506	2343145
Muscle rigidity	75.79	30.10	35	14399	1796	2341855
Somatic symptom disorder	74.62	30.10	22	14412	305	2343346
Urinary tract infection	74.38	30.10	108	14326	29834	2313817
Gastrostomy	74.24	30.10	20	14414	195	2343456
Depressed level of consciousness	73.99	30.10	57	14377	7547	2336104
Galactorrhoea	73.73	30.10	31	14403	1268	2342383
Exposure via ingestion	73.69	30.10	27	14407	761	2342890
Sacroiliitis	73.19	30.10	21	14413	263	2343388
Impaired driving ability	72.83	30.10	29	14405	1030	2342621
Apathy	72.65	30.10	31	14403	1316	2342335
Diabetes mellitus	72.53	30.10	56	14378	7439	2336212
Stevens-Johnson syndrome	72.38	30.10	45	14389	4214	2339437
Loss of libido	72.26	30.10	21	14413	276	2343375
Tachyphrenia	71.57	30.10	21	14413	286	2343365
Chest discomfort	71.13	30.10	74	14360	14521	2329130
Blood cholesterol increased	70.94	30.10	48	14386	5193	2338458
Homicidal ideation	70.51	30.10	23	14411	453	2343198
Dystonia	69.76	30.10	35	14399	2159	2341492
Conversion disorder	69.24	30.10	22	14412	397	2343254
Blood chloride decreased	69.03	30.10	25	14409	681	2342970
Panic disorder	68.95	30.10	23	14411	487	2343164
Depressive symptom	67.58	30.10	23	14411	519	2343132
Hypersensitivity	67.37	30.10	91	14343	23502	2320149
Tension	67.21	30.10	23	14411	528	2343123
Abortion spontaneous	67.02	30.10	69	14365	13376	2330275
Pyrexia	66.95	30.10	143	14291	53565	2290086
Neuralgia	66.92	30.10	37	14397	2785	2340866
Pancreatitis	66.72	30.10	55	14379	8024	2335627
Extrapyramidal disorder	64.67	30.10	34	14400	2313	2341338
Anorgasmia	64.53	30.10	18	14416	202	2343449
Affective disorder	64.46	30.10	25	14409	827	2342824
Bruxism	63.93	30.10	24	14410	725	2342926
Dissociation	63.30	30.10	21	14413	437	2343214
Musculoskeletal stiffness	63.12	30.10	64	14370	12183	2331468
Cold sweat	63.02	30.10	32	14402	2025	2341626
Hypertensive crisis	62.49	30.10	34	14400	2479	2341172
Clonus	61.14	30.10	22	14412	588	2343063
Muscle tightness	59.43	30.10	30	14404	1875	2341776
Oedema peripheral	59.41	30.10	86	14348	23677	2319974
Panic reaction	59.21	30.10	23	14411	764	2342887
Sleep terror	58.95	30.10	17	14417	217	2343434
Cerebellar syndrome	58.41	30.10	21	14413	560	2343091
Urticaria	58.04	30.10	86	14348	24175	2319476
Stress	56.80	30.10	47	14387	6891	2336760
Neck pain	56.57	30.10	49	14385	7648	2336003
Flat affect	56.42	30.10	17	14417	255	2343396
Sinus tachycardia	56.16	30.10	35	14399	3290	2340361
Alcoholism	55.83	30.10	18	14416	341	2343310
Feeling of despair	54.60	30.10	18	14416	367	2343284
Pulmonary eosinophilia	54.55	30.10	14	14420	111	2343540
Acute kidney injury	53.85	30.10	90	14344	28032	2315619
Feeling cold	52.81	30.10	33	14401	3117	2340534
Anal incontinence	52.64	30.10	27	14407	1745	2341906
Ventricular fibrillation	52.58	30.10	29	14405	2172	2341479
Hyperventilation	52.45	30.10	24	14410	1205	2342446
Psychotic disorder due to a general medical condition	51.64	30.10	11	14423	33	2343618
Hepatic enzyme abnormal	51.49	30.10	20	14414	664	2342987
Dysuria	50.73	30.10	35	14399	3906	2339745
Therapeutic product effect incomplete	50.59	30.10	53	14381	10478	2333173
Decreased interest	50.31	30.10	18	14416	473	2343178
Blood potassium decreased	49.94	30.10	39	14395	5266	2338385
Dyspepsia	49.92	30.10	51	14383	9793	2333858
Accidental death	49.63	30.10	16	14418	303	2343348
Hepatic function abnormal	49.31	30.10	41	14393	6051	2337600
Drug screen positive	49.04	30.10	21	14413	899	2342752
Liver injury	48.54	30.10	28	14406	2286	2341365
Aphasia	48.06	30.10	37	14397	4891	2338760
Social avoidant behaviour	48.03	30.10	18	14416	541	2343110
Self-injurious ideation	47.57	30.10	18	14416	556	2343095
Hepatotoxicity	47.38	30.10	32	14402	3449	2340202
Renal failure	46.61	30.10	65	14369	17284	2326367
Treatment noncompliance	46.37	30.10	38	14396	5496	2338155
Neuroleptic malignant syndrome	45.86	30.10	26	14408	2054	2341597
Appetite disorder	45.75	30.10	18	14416	619	2343032
Hyperacusis	45.73	30.10	16	14418	393	2343258
Nervous system disorder	45.68	30.10	30	14404	3086	2340565
Blister	45.55	30.10	41	14393	6730	2336921
Bradyphrenia	45.46	30.10	21	14413	1078	2342573
Hyperthermia	45.44	30.10	23	14411	1445	2342206
Personality change	45.33	30.10	20	14414	921	2342730
Sleep apnoea syndrome	45.33	30.10	26	14408	2100	2341551
Dysgeusia	45.04	30.10	45	14389	8414	2335237
Gastrointestinal disorder	44.85	30.10	46	14388	8871	2334780
Intraocular pressure increased	44.84	30.10	23	14411	1486	2342165
Discomfort	44.44	30.10	36	14398	5123	2338528
Ataxia	44.04	30.10	27	14407	2465	2341186
Feeling of body temperature change	43.93	30.10	18	14416	689	2342962
Drug dependence	43.87	30.10	29	14405	3016	2340635
Gestational diabetes	43.72	30.10	22	14412	1365	2342286
Emotional distress	43.54	30.10	33	14401	4262	2339389
Blood pressure decreased	43.50	30.10	46	14388	9190	2334461
Movement disorder	43.35	30.10	28	14406	2800	2340851
Trismus	43.31	30.10	19	14415	863	2342788
Food craving	43.09	30.10	14	14420	272	2343379
Angle closure glaucoma	43.04	30.10	18	14416	726	2342925
Blood prolactin increased	42.92	30.10	20	14414	1047	2342604
Middle insomnia	42.42	30.10	22	14412	1455	2342196
Gastric banding	42.27	30.10	10	14424	54	2343597
Hepatic necrosis	42.17	30.10	20	14414	1090	2342561
Parkinsonism	42.03	30.10	22	14412	1483	2342168
Foetal exposure during pregnancy	41.79	30.10	35	14399	5217	2338434
Blood triglycerides increased	41.43	30.10	25	14409	2218	2341433
Epilepsy	41.29	30.10	33	14401	4606	2339045
Screaming	40.71	30.10	17	14417	683	2342968
Autonomic dysreflexia	40.55	30.10	8	14426	14	2343637
Burning sensation	40.49	30.10	41	14393	7787	2335864
White blood cell count abnormal	40.36	30.10	17	14417	698	2342953
Hepatic cirrhosis	40.32	30.10	25	14409	2328	2341323
White blood cell count increased	40.18	30.10	39	14395	7039	2336612
Haemorrhage	40.06	30.10	48	14386	10991	2332660
Dysstasia	39.96	30.10	27	14407	2912	2340739
Incontinence	39.88	30.10	21	14413	1433	2342218
Hepatitis C	39.78	30.10	21	14413	1440	2342211
Metabolic acidosis	39.72	30.10	36	14398	5962	2337689
Poor quality sleep	39.13	30.10	23	14411	1944	2341707
Accidental overdose	39.12	30.10	30	14404	3942	2339709
Rapid eye movements sleep abnormal	38.96	30.10	9	14425	43	2343608
Maternal exposure during pregnancy	38.90	30.10	55	14379	14808	2328843
Hepatitis acute	38.81	30.10	21	14413	1514	2342137
Intestinal obstruction	38.57	30.10	31	14403	4362	2339289
Hyperchloraemia	38.45	30.10	10	14424	84	2343567
Parosmia	38.42	30.10	17	14417	788	2342863
Suicidal behaviour	38.39	30.10	15	14419	506	2343145
Retinal detachment	38.35	30.10	19	14415	1140	2342511
Eye pain	37.69	30.10	32	14402	4859	2338792
Wrong technique in product usage process	37.51	30.10	63	14371	19685	2323966
General physical health deterioration	36.53	30.10	52	14382	14087	2329564
Maternal exposure during breast feeding	36.44	30.10	15	14419	581	2343070
Injury	36.06	30.10	34	14400	5920	2337731
Alcohol use	35.95	30.10	14	14420	468	2343183
Dysphemia	35.92	30.10	14	14420	469	2343182
Premature baby	35.57	30.10	26	14408	3178	2340473
Encephalopathy	35.47	30.10	30	14404	4531	2339120
Feeling hot	35.31	30.10	36	14398	6892	2336759
Poisoning deliberate	34.95	30.10	18	14416	1173	2342478
Hyponatraemic encephalopathy	34.88	30.10	9	14425	73	2343578
Anhedonia	34.72	30.10	18	14416	1189	2342462
Photosensitivity reaction	34.69	30.10	23	14411	2404	2341247
Bursitis	34.55	30.10	21	14413	1887	2341764
Hepatocellular injury	34.30	30.10	28	14406	4027	2339624
Autonomic nervous system imbalance	34.28	30.10	13	14421	404	2343247
Surgery	34.27	30.10	32	14402	5503	2338148
Pollakiuria	34.03	30.10	27	14407	3729	2339922
White blood cells urine positive	33.95	30.10	13	14421	415	2343236
Hypotonia	33.82	30.10	20	14414	1710	2341941
Communication disorder	33.69	30.10	13	14421	424	2343227
Flatulence	33.63	30.10	29	14405	4496	2339155
Prescription form tampering	33.63	30.10	10	14424	143	2343508
Pharyngeal oedema	33.57	30.10	26	14408	3467	2340184
Tic	33.51	30.10	13	14421	430	2343221
Self esteem decreased	33.00	30.10	10	14424	153	2343498
Blood glucose decreased	32.99	30.10	25	14409	3227	2340424
Stiff person syndrome	32.82	30.10	8	14426	50	2343601
Energy increased	32.79	30.10	13	14421	456	2343195
Negative thoughts	32.79	30.10	11	14423	237	2343414
Exposure via breast milk	32.79	30.10	12	14422	337	2343314
Bradykinesia	32.74	30.10	14	14420	597	2343054
Facial paralysis	32.36	30.10	22	14412	2397	2341254
Granulomatous liver disease	32.26	30.10	9	14425	101	2343550
Bipolar I disorder	32.26	30.10	12	14422	353	2343298
Hostility	31.88	30.10	11	14423	259	2343392
Feelings of worthlessness	31.87	30.10	9	14425	106	2343545
Drug level increased	31.81	30.10	23	14411	2764	2340887
Electroencephalogram abnormal	31.72	30.10	15	14419	812	2342839
Protein total decreased	31.67	30.10	15	14419	815	2342836
Altered state of consciousness	31.28	30.10	26	14408	3834	2339817
Motion sickness	31.04	30.10	10	14424	189	2343462
Hypokinesia	30.98	30.10	19	14415	1735	2341916
Respiratory failure	30.97	30.10	47	14387	13481	2330170
Rectal haemorrhage	30.89	30.10	31	14403	5825	2337826
Aspiration	30.68	30.10	18	14416	1516	2342135
Hypernatraemia	30.61	30.10	15	14419	879	2342772
Drug ineffective for unapproved indication	30.53	30.10	23	14411	2943	2340708
Gait inability	30.45	30.10	31	14403	5924	2337727
Disorganised speech	30.38	30.10	9	14425	127	2343524
Skin laceration	30.31	30.10	22	14412	2660	2340991
Faecaloma	30.28	30.10	15	14419	900	2342751
Retching	30.13	30.10	20	14414	2094	2341557

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug withdrawal syndrome	2874.63	42.98	628	5138	3897	1737118
Affect lability	2153.91	42.98	384	5382	578	1740437
Dysphoria	2103.03	42.98	364	5402	405	1740610
Paraesthesia	1822.18	42.98	515	5251	9936	1731079
Irritability	1813.27	42.98	450	5316	5082	1735933
Anxiety	1755.65	42.98	547	5219	14980	1726035
Suicidal ideation	1732.42	42.98	474	5292	8044	1732971
Insomnia	1717.68	42.98	544	5222	15732	1725283
Agitation	1700.43	42.98	494	5272	10532	1730483
Dizziness	1616.33	42.98	628	5138	33733	1707282
Vertigo	1378.32	42.98	346	5420	4067	1736948
Nausea	1332.85	42.98	615	5151	50581	1690434
Confusional state	1256.18	42.98	461	5305	20817	1720198
Sensory disturbance	1253.69	42.98	257	5509	1067	1739948
Hyperhidrosis	1241.12	42.98	400	5366	12088	1728927
Completed suicide	1128.55	42.98	398	5368	15914	1725101
Headache	1090.95	42.98	476	5290	33900	1707115
Fatigue	957.46	42.98	491	5275	50290	1690725
Lethargy	843.26	42.98	262	5504	6922	1734093
Tremor	806.32	42.98	294	5472	12837	1728178
Tinnitus	716.29	42.98	193	5573	3002	1738013
Nightmare	670.22	42.98	178	5588	2609	1738406
Toxicity to various agents	619.02	42.98	307	5459	28834	1712181
Mood swings	529.57	42.98	138	5628	1864	1739151
Serotonin syndrome	525.18	42.98	147	5619	2641	1738374
Hypomania	449.99	42.98	95	5671	461	1740554
Vomiting	434.07	42.98	267	5499	38048	1702967
Depression	432.53	42.98	202	5564	16467	1724548
Sleep disorder	412.44	42.98	133	5633	3930	1737085
Suicide attempt	391.78	42.98	149	5617	7232	1733783
Diarrhoea	385.33	42.98	282	5484	53570	1687445
Alanine aminotransferase increased	382.04	42.98	169	5597	12109	1728906
Hepatic enzyme increased	363.38	42.98	137	5629	6484	1734531
Somnolence	335.01	42.98	170	5596	16569	1724446
Aspartate aminotransferase increased	302.31	42.98	138	5628	10618	1730397
Drug interaction	280.83	42.98	181	5585	27777	1713238
Drug hypersensitivity	280.34	42.98	146	5620	14989	1726026
Seizure	273.39	42.98	159	5607	20282	1720733
Feeling abnormal	254.42	42.98	124	5642	11042	1729973
Loss of consciousness	226.35	42.98	126	5640	14749	1726266
Overdose	215.39	42.98	127	5639	16574	1724441
Aggression	208.70	42.98	98	5668	8017	1732998
Disturbance in attention	208.29	42.98	81	5685	4153	1736862
Gastrointestinal tube insertion	202.14	42.98	46	5720	332	1740683
Blood pressure increased	196.74	42.98	103	5663	10650	1730365
Anger	190.03	42.98	67	5699	2599	1738416
Withdrawal syndrome	184.30	42.98	63	5703	2225	1738790
Liver function test abnormal	174.97	42.98	78	5688	5648	1735367
Fall	169.94	42.98	132	5634	27082	1713933
Hypertension	166.00	42.98	114	5652	19334	1721681
Urinary retention	163.26	42.98	73	5693	5322	1735693
Memory impairment	160.62	42.98	77	5689	6586	1734429
Intentional self-injury	152.48	42.98	57	5709	2616	1738399
Drug ineffective	147.64	42.98	179	5587	63622	1677393
Intentional overdose	147.44	42.98	76	5690	7594	1733421
Sexual dysfunction	146.02	42.98	50	5716	1773	1739242
Off label use	145.03	42.98	140	5626	38431	1702584
Intentional product misuse	141.69	42.98	73	5693	7285	1733730
Decreased appetite	140.74	42.98	112	5654	23759	1717256
Hyponatraemia	138.75	42.98	77	5689	8923	1732092
Gamma-glutamyltransferase increased	138.49	42.98	64	5702	5034	1735981
Delirium	133.79	42.98	67	5699	6295	1734720
Hallucination	131.71	42.98	72	5694	8098	1732917
Respiratory arrest	130.21	42.98	64	5702	5775	1735240
Disorientation	125.11	42.98	61	5705	5408	1735607
Drug abuse	123.22	42.98	83	5683	13606	1727409
Syncope	120.62	42.98	83	5683	14086	1726929
Abnormal behaviour	108.06	42.98	58	5708	6284	1734731
Psychotic disorder	105.55	42.98	53	5713	5003	1736012
Cardiac arrest	100.78	42.98	78	5688	15852	1725163
Urinary hesitation	99.95	42.98	26	5740	345	1740670
Cardio-respiratory arrest	99.86	42.98	63	5703	9230	1731785
Weight increased	97.72	42.98	67	5699	11290	1729725
Pain	94.80	42.98	94	5672	26563	1714452
Erectile dysfunction	93.44	42.98	47	5719	4450	1736565
Vision blurred	92.75	42.98	58	5708	8365	1732650
Amnesia	89.71	42.98	47	5719	4844	1736171
Migraine	88.63	42.98	37	5729	2274	1738741
Dyskinesia	88.51	42.98	43	5723	3776	1737239
Mania	88.07	42.98	36	5730	2097	1738918
Myoclonus	85.52	42.98	36	5730	2259	1738756
Road traffic accident	81.69	42.98	40	5726	3573	1737442
Restlessness	80.60	42.98	42	5724	4279	1736736
Dysphagia	80.46	42.98	57	5709	10111	1730904
Depressed mood	79.17	42.98	37	5729	2979	1738036
Foetal exposure during pregnancy	78.19	42.98	47	5719	6312	1734703
Hypotension	76.12	42.98	88	5678	29566	1711449
Inappropriate antidiuretic hormone secretion	73.86	42.98	30	5736	1718	1739297
Poisoning	72.51	42.98	33	5733	2499	1738516
Jaundice	72.45	42.98	44	5722	6018	1734997
Tachycardia	71.58	42.98	58	5708	12570	1728445
Apathy	71.55	42.98	27	5739	1269	1739746
Gait disturbance	71.41	42.98	58	5708	12612	1728403
Weight decreased	71.31	42.98	75	5691	22678	1718337
Hospitalisation	71.29	42.98	58	5708	12642	1728373
Major depression	70.78	42.98	23	5743	690	1740325
Dysuria	69.37	42.98	36	5730	3636	1737379
Orthostatic hypotension	68.75	42.98	35	5731	3396	1737619
Asthenia	68.21	42.98	90	5676	34580	1706435
Thinking abnormal	67.63	42.98	26	5740	1286	1739729
Blood alkaline phosphatase increased	65.42	42.98	39	5727	5156	1735859
Blood bilirubin increased	63.93	42.98	41	5725	6169	1734846
Balance disorder	63.89	42.98	40	5726	5772	1735243
Dystonia	63.25	42.98	28	5738	1986	1739029
Muscle twitching	62.93	42.98	27	5739	1775	1739240
Palpitations	62.85	42.98	42	5724	6772	1734243
Self esteem decreased	60.99	42.98	15	5751	156	1740859
Prescribed overdose	60.10	42.98	26	5740	1744	1739271
Liver disorder	59.97	42.98	38	5728	5598	1735417
Panic attack	58.97	42.98	26	5740	1826	1739189
Muscle spasms	58.82	42.98	50	5716	11571	1729444
Paranoia	57.99	42.98	27	5739	2154	1738861
Gastric bypass	57.07	42.98	13	5753	94	1740921
Neuroleptic malignant syndrome	56.99	42.98	30	5736	3118	1737897
Hepatic steatosis	56.58	42.98	28	5738	2556	1738459
Pulmonary congestion	56.37	42.98	25	5741	1780	1739235
Malaise	55.43	42.98	75	5691	29490	1711525
Hypoaesthesia	55.35	42.98	45	5721	9790	1731225
Altered state of consciousness	54.03	42.98	30	5736	3467	1737548
Homicidal ideation	53.21	42.98	18	5748	613	1740402
Abnormal dreams	52.11	42.98	24	5742	1867	1739148
Constipation	51.56	42.98	52	5714	14948	1726067
Dry mouth	50.89	42.98	30	5736	3883	1737132
Abdominal pain	50.48	42.98	61	5705	21429	1719586
Cardiomegaly	50.24	42.98	25	5741	2309	1738706
Condition aggravated	49.62	42.98	60	5706	21090	1719925
Chest pain	49.19	42.98	58	5708	19856	1721159
Blood creatine phosphokinase increased	48.73	42.98	40	5726	8816	1732199
Unresponsive to stimuli	48.72	42.98	31	5735	4598	1736417
Crying	47.90	42.98	21	5745	1454	1739561
Hepatitis	46.79	42.98	31	5735	4924	1736091
Alcohol abuse	46.32	42.98	16	5750	581	1740434
Heart rate increased	45.78	42.98	34	5732	6476	1734539
Mental disorder	45.59	42.98	25	5741	2818	1738197
Social avoidant behaviour	45.25	42.98	16	5750	623	1740392
Coma	44.63	42.98	35	5731	7227	1733788
Dyspnoea	43.52	42.98	92	5674	51967	1689048
Muscle rigidity	43.38	42.98	21	5745	1827	1739188
Hepatic function abnormal	43.27	42.98	34	5732	7040	1733975

Pharmacologic Action:

Source	Code	Description
ATC	N06AX21	NERVOUS SYSTEM PSYCHOANALEPTICS ANTIDEPRESSANTS Other antidepressants
MeSH PA	D000700	Analgesics
CHEBI has role	CHEBI:35469	antidepressant
MeSH PA	D000928	Antidepressive Agents
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D015259	Dopamine Agents
MeSH PA	D049990	Membrane Transport Modulators
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D014179	Neurotransmitter Uptake Inhibitors
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D011619	Psychotropic Drugs
MeSH PA	D018689	Sensory System Agents
MeSH PA	D000068760	Serotonin and Noradrenaline Reuptake Inhibitors
FDA MoA	N0000000102	Norepinephrine Uptake Inhibitors
FDA EPC	N0000175749	Serotonin and Norepinephrine Reuptake Inhibitor
FDA MoA	N0000000109	Serotonin Uptake Inhibitors

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Generalized anxiety disorder	indication	21897009	DOID:14320
Female stress incontinence	indication	60241006	DOID:724
Fibromyalgia	indication	203082005	DOID:631
Major depressive disorder	indication	370143000
Diabetic peripheral neuropathy	indication	424736006
Chronic Musculoskeletal Pain	indication
Suicidal thoughts	contraindication	6471006
Alcoholism	contraindication	7200002
Bipolar disorder	contraindication	13746004	DOID:3312
Neuroleptic malignant syndrome	contraindication	15244003	DOID:14464
Jaundice	contraindication	18165001
Cirrhosis of liver	contraindication	19943007	DOID:5082
Orthostatic hypotension	contraindication	28651003
Hypertensive disorder	contraindication	38341003	DOID:10763
Alcoholic liver damage	contraindication	41309000
Syndrome of inappropriate vasopressin secretion	contraindication	55004003	DOID:3401
Acute nephropathy	contraindication	58574008
Blood coagulation disorder	contraindication	64779008	DOID:1247
Chronic hepatitis	contraindication	76783007	DOID:2237
Hyperglycemia	contraindication	80394007	DOID:4195
Epilepsy	contraindication	84757009	DOID:1826
Hyponatremia	contraindication	89627008
Inflammatory disease of liver	contraindication	128241005
Liver function tests abnormal	contraindication	166603001
Mania	contraindication	231494001
Hypomania	contraindication	231496004
Disease of liver	contraindication	235856003	DOID:409
Retention of urine	contraindication	267064002
Serotonin syndrome	contraindication	371089000
Angle-closure glaucoma	contraindication	392291006	DOID:13550
Gastrointestinal hypomotility	contraindication	421807004

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.7	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN	INHIBITOR	Ki	8.22		CHEMBL	CHEMBL
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN	INHIBITOR	Ki	9.62		CHEMBL	CHEMBL
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN	ANTAGONIST	Ki	6		IUPHAR
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		Ki	6.62		CHEMBL
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	5.68		PDSP
5-hydroxytryptamine receptor 7	GPCR	P34969	5HT7R_HUMAN		Ki	5.65		PDSP
Histamine H1 receptor	GPCR	P35367	HRH1_HUMAN		Ki	5.64		PDSP
5-hydroxytryptamine receptor 1D	GPCR	P28221	5HT1D_HUMAN		Ki	5.52		PDSP
5-hydroxytryptamine receptor 1E	GPCR	P28566	5HT1E_HUMAN		Ki	5.43		PDSP
5-hydroxytryptamine receptor 1B	GPCR	P28222	5HT1B_HUMAN		Ki	5.40		PDSP
5-hydroxytryptamine receptor 1F	GPCR	P30939	5HT1F_HUMAN		Ki	5.35		PDSP
5-hydroxytryptamine receptor 6	GPCR	P50406	5HT6R_HUMAN	ANTAGONIST	Ki	6.40		IUPHAR
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Ki	5.30		PDSP
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN	ANTAGONIST	Ki	6.30		IUPHAR
Sodium-dependent dopamine transporter	Transporter		SC6A3_RAT		IC50	6.43		CHEMBL
Sodium-dependent serotonin transporter	Transporter		SC6A4_RAT		Ki	10.09		CHEMBL
Transporter	Transporter		Q63380_RAT		Ki	8.52		CHEMBL

External reference:

ID	Source
D000068736	MESH_DESCRIPTOR_UI
C1505021	UMLSCUI
D01179	KEGG_DRUG
407033009	SNOMEDCT_US
72625	RXNORM
4021477	VANDF
d05355	MMSL
407032004	SNOMEDCT_US
008705	NDDF
9044SC542W	UNII
136434-34-9	SECONDARY_CAS_RN
CHEBI:31526	CHEBI
CHEMBL1175	ChEMBL_ID
DB00476	DRUGBANK_ID
CHEMBL1200328	ChEMBL_ID
7012	INN_ID
202	IUPHAR_LIGAND_ID
60835	PUBCHEM_CID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Cymbalta	HUMAN PRESCRIPTION DRUG LABEL	1	0002-3235	CAPSULE, DELAYED RELEASE	20 mg	ORAL	NDA	20 sections
Cymbalta	HUMAN PRESCRIPTION DRUG LABEL	1	0002-3240	CAPSULE, DELAYED RELEASE	30 mg	ORAL	NDA	20 sections
Cymbalta	HUMAN PRESCRIPTION DRUG LABEL	1	0002-3270	CAPSULE, DELAYED RELEASE	60 mg	ORAL	NDA	20 sections
Duloxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2890	CAPSULE, DELAYED RELEASE PELLETS	20 mg	ORAL	ANDA	20 sections
Duloxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2891	CAPSULE, DELAYED RELEASE PELLETS	30 mg	ORAL	ANDA	20 sections
Duloxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2892	CAPSULE, DELAYED RELEASE PELLETS	60 mg	ORAL	ANDA	20 sections
Duloxetine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-7894	CAPSULE, DELAYED RELEASE	30 mg	ORAL	ANDA	20 sections
Duloxetine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-7895	CAPSULE, DELAYED RELEASE	60 mg	ORAL	ANDA	20 sections
Duloxetine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8034	CAPSULE, DELAYED RELEASE	30 mg	ORAL	ANDA	20 sections
Duloxetine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8035	CAPSULE, DELAYED RELEASE	60 mg	ORAL	ANDA	20 sections
Duloxetine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8203	CAPSULE, DELAYED RELEASE	30 mg	ORAL	ANDA	20 sections
Duloxetine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8204	CAPSULE, DELAYED RELEASE	60 mg	ORAL	ANDA	20 sections
Duloxetine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8290	CAPSULE, DELAYED RELEASE	20 mg	ORAL	ANDA	20 sections
Duloxetine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6452	CAPSULE, DELAYED RELEASE	20 mg	ORAL	ANDA	20 sections
Duloxetine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6453	CAPSULE, DELAYED RELEASE	30 mg	ORAL	ANDA	20 sections
Duloxetine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6454	CAPSULE, DELAYED RELEASE	60 mg	ORAL	ANDA	20 sections
Duloxetine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	13668-109	CAPSULE, DELAYED RELEASE	20 mg	ORAL	ANDA	20 sections
Duloxetine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	13668-110	CAPSULE, DELAYED RELEASE	30 mg	ORAL	ANDA	20 sections
Duloxetine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	13668-111	CAPSULE, DELAYED RELEASE	60 mg	ORAL	ANDA	20 sections
Cymbalta	HUMAN PRESCRIPTION DRUG LABEL	1	21695-145	CAPSULE, DELAYED RELEASE	30 mg	ORAL	NDA	20 sections
Cymbalta	HUMAN PRESCRIPTION DRUG LABEL	1	21695-146	CAPSULE, DELAYED RELEASE	60 mg	ORAL	NDA	20 sections
Cymbalta	HUMAN PRESCRIPTION DRUG LABEL	1	21695-657	CAPSULE, DELAYED RELEASE	20 mg	ORAL	NDA	21 sections
duloxetine	HUMAN PRESCRIPTION DRUG LABEL	1	23155-654	CAPSULE, DELAYED RELEASE	20 mg	ORAL	ANDA	20 sections
duloxetine	HUMAN PRESCRIPTION DRUG LABEL	1	23155-655	CAPSULE, DELAYED RELEASE	30 mg	ORAL	ANDA	20 sections
duloxetine	HUMAN PRESCRIPTION DRUG LABEL	1	23155-656	CAPSULE, DELAYED RELEASE	60 mg	ORAL	ANDA	20 sections
Duloxetine	HUMAN PRESCRIPTION DRUG LABEL	1	27241-097	CAPSULE, DELAYED RELEASE	20 mg	ORAL	ANDA	20 sections
Duloxetine	HUMAN PRESCRIPTION DRUG LABEL	1	27241-098	CAPSULE, DELAYED RELEASE	30 mg	ORAL	ANDA	20 sections
Duloxetine	HUMAN PRESCRIPTION DRUG LABEL	1	27241-099	CAPSULE, DELAYED RELEASE	60 mg	ORAL	ANDA	20 sections
Duloxetine	HUMAN PRESCRIPTION DRUG LABEL	1	27241-164	CAPSULE, DELAYED RELEASE	40 mg	ORAL	ANDA	20 sections
Irenka	HUMAN PRESCRIPTION DRUG LABEL	1	27437-298	CAPSULE, DELAYED RELEASE	40 mg	ORAL	ANDA	20 sections