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

Stem definition	Drug id	CAS RN
psychoactive	1816	85650-52-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: mirtazapine mepirzapin mepirzepine mirtabene mirtazepine mirtazipine	A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders. Molecular weight: 265.36 Formula: C17H19N3 CLOGP: 2.81 LIPINSKI: 0 HAC: 3 HDO: 0 TPSA: 19.37 ALOGS: -2.38 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

mirtazapine
mepirzapin
mepirzepine
mirtabene
mirtazepine
mirtazipine

A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders.

Molecular weight: 265.36
Formula: C17H19N3
CLOGP: 2.81
LIPINSKI: 0
HAC: 3
HDO: 0
TPSA: 19.37
ALOGS: -2.38
ROTB: 0

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
30	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.50 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	2 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	2.83 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	4.20 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	8 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.15 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	15 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
June 14, 1996	FDA	ORGANON USA INC

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
Completed suicide	1832.93	37.28	545	5444	20489	2331607
Toxicity to various agents	1783.33	37.28	592	5397	32162	2319934
Drug abuse	1078.47	37.28	320	5669	11706	2340390
Suicide attempt	842.30	37.28	261	5728	11021	2341075
Somnolence	769.03	37.28	293	5696	23192	2328904
Overdose	759.87	37.28	278	5711	19629	2332467
Intentional overdose	704.06	37.28	228	5761	11093	2341003
Sopor	635.34	37.28	167	5822	3828	2348268
Hyponatraemia	632.42	37.28	219	5770	13106	2338990
Serotonin syndrome	606.38	37.28	157	5832	3383	2348713
Fall	587.69	37.28	298	5691	46801	2305295
Drug interaction	580.79	37.28	255	5734	28908	2323188
Confusional state	537.22	37.28	229	5760	24115	2327981
Electrocardiogram QT prolonged	512.22	37.28	164	5825	7650	2344446
Intentional self-injury	507.93	37.28	141	5848	3986	2348110
Coma	445.14	37.28	153	5836	8903	2343193
Agitation	415.36	37.28	153	5836	10898	2341198
Depression	402.92	37.28	196	5793	27936	2324160
Suicidal ideation	374.60	37.28	142	5847	10945	2341151
Inappropriate antidiuretic hormone secretion	368.94	37.28	97	5892	2212	2349884
Tachycardia	343.53	37.28	149	5840	16260	2335836
Cardiac arrest	333.65	37.28	142	5847	14788	2337308
Cardio-respiratory arrest	311.90	37.28	118	5871	9028	2343068
Hypotension	306.21	37.28	171	5818	32265	2319831
Tremor	304.57	37.28	147	5842	20514	2331582
Anxiety	291.35	37.28	160	5829	29199	2322897
Poisoning	277.49	37.28	81	5908	2739	2349357
Loss of consciousness	265.87	37.28	130	5859	18637	2333459
Drug ineffective	263.06	37.28	243	5746	101381	2250715
Depressed level of consciousness	255.16	37.28	97	5892	7507	2344589
Seizure	249.93	37.28	136	5853	24330	2327766
Insomnia	248.71	37.28	138	5851	25649	2326447
Neuroleptic malignant syndrome	232.52	37.28	66	5923	2014	2350082
Dizziness	228.98	37.28	178	5811	58487	2293609
Restless legs syndrome	213.57	37.28	63	5926	2208	2349888
Weight increased	211.06	37.28	118	5871	22219	2329877
Condition aggravated	208.56	37.28	133	5856	31846	2320250
Respiratory arrest	200.68	37.28	77	5912	6101	2345995
Sedation	189.23	37.28	63	5926	3299	2348797
Disorientation	187.77	37.28	74	5915	6298	2345798
Hyperhidrosis	183.48	37.28	95	5894	15327	2336769
Vomiting	182.22	37.28	170	5819	71432	2280664
Decreased appetite	173.13	37.28	114	5875	28777	2323319
Intentional product misuse	162.50	37.28	75	5914	9414	2342682
Disturbance in attention	160.41	37.28	64	5925	5621	2346475
Rhabdomyolysis	160.23	37.28	67	5922	6637	2345459
Death	158.25	37.28	167	5822	81301	2270795
Constipation	156.03	37.28	96	5893	21533	2330563
Restlessness	152.19	37.28	58	5931	4505	2347591
Muscle rigidity	151.37	37.28	46	5943	1785	2350311
Syncope	148.05	37.28	85	5904	16790	2335306
Dysarthria	147.31	37.28	62	5927	6240	2345856
Dyskinesia	145.92	37.28	57	5932	4732	2347364
Urinary retention	145.68	37.28	53	5936	3614	2348482
Accidental overdose	145.21	37.28	54	5935	3918	2348178
Agranulocytosis	144.59	37.28	52	5937	3430	2348666
Exposure during pregnancy	140.13	37.28	95	5894	25124	2326972
Aggression	138.92	37.28	55	5934	4731	2347365
Nausea	136.48	37.28	181	5808	112008	2240088
Nightmare	134.18	37.28	50	5939	3647	2348449
Psychotic disorder	133.11	37.28	53	5936	4626	2347470
Delirium	130.86	37.28	54	5935	5169	2346927
Oedema peripheral	130.78	37.28	89	5900	23674	2328422
Psychomotor retardation	130.04	37.28	32	5957	551	2351545
Fatigue	128.71	37.28	153	5836	84720	2267376
Depressed mood	127.72	37.28	53	5936	5145	2346951
Mania	126.50	37.28	43	5946	2397	2349699
Acute kidney injury	126.25	37.28	93	5896	28029	2324067
Myoclonus	125.76	37.28	43	5946	2440	2349656
Intestinal pseudo-obstruction	125.43	37.28	24	5965	112	2351984
Paraesthesia	124.57	37.28	84	5905	22004	2330092
Foetal exposure during pregnancy	123.83	37.28	52	5937	5200	2346896
Palpitations	121.05	37.28	74	5915	16382	2335714
Malaise	118.58	37.28	120	5869	55465	2296631
Mydriasis	118.55	37.28	40	5949	2179	2349917
General physical health deterioration	118.07	37.28	69	5920	14070	2338026
Akathisia	117.06	37.28	37	5952	1637	2350459
Generalised tonic-clonic seizure	116.08	37.28	50	5939	5322	2346774
Depressive symptom	112.09	37.28	28	5961	514	2351582
Drug hypersensitivity	111.14	37.28	107	5882	46536	2305560
Headache	110.83	37.28	138	5851	80041	2272055
Asthenia	110.59	37.28	107	5882	46819	2305277
Maternal exposure during pregnancy	109.72	37.28	67	5922	14796	2337300
Pyrexia	109.18	37.28	113	5876	53595	2298501
Abnormal dreams	106.90	37.28	38	5951	2420	2349676
Product use in unapproved indication	105.12	37.28	59	5930	11141	2340955
Feeling abnormal	101.33	37.28	76	5913	23505	2328591
Sleep disorder	100.87	37.28	48	5941	6441	2345655
Acute motor-sensory axonal neuropathy	99.31	37.28	17	5972	35	2352061
Hallucination	99.10	37.28	51	5938	8097	2343999
Abnormal behaviour	98.57	37.28	43	5946	4717	2347379
Dissociation	96.41	37.28	24	5965	434	2351662
Psychomotor hyperactivity	96.21	37.28	33	5956	1889	2350207
Withdrawal syndrome	95.59	37.28	38	5951	3299	2348797
Drug withdrawal syndrome	95.59	37.28	47	5942	6774	2345322
Product prescribing error	92.85	37.28	36	5953	2924	2349172
Dysphagia	92.64	37.28	57	5932	12748	2339348
Status epilepticus	91.68	37.28	34	5955	2444	2349652
Medication error	91.18	37.28	44	5945	6087	2346009
Alanine aminotransferase increased	90.32	37.28	58	5931	13974	2338122
Rheumatoid factor negative	89.31	37.28	14	5975	11	2352085
Muscle spasms	87.10	37.28	67	5922	21499	2330597
Neutropenia	84.96	37.28	66	5923	21482	2330614
Dyspnoea	83.30	37.28	119	5870	78614	2273482
Speech disorder	83.07	37.28	42	5947	6422	2345674
Off label use	81.93	37.28	114	5875	73484	2278612
Hepatocellular injury	81.90	37.28	36	5953	4019	2348077
Hypertonia	81.10	37.28	26	5963	1204	2350892
Ventricular fibrillation	80.69	37.28	30	5959	2171	2349925
Irritability	80.37	37.28	41	5948	6386	2345710
Orthostatic hypotension	79.73	37.28	32	5957	2847	2349249
Mood swings	79.15	37.28	33	5956	3236	2348860
Cognitive disorder	78.15	37.28	38	5951	5343	2346753
Fracture	77.87	37.28	31	5958	2700	2349396
Respiratory failure	75.11	37.28	51	5938	13477	2338619
Weight decreased	74.95	37.28	69	5920	28302	2323794
Gamma-glutamyltransferase increased	73.99	37.28	37	5952	5525	2346571
Dry mouth	73.43	37.28	42	5947	8211	2343885
Miosis	73.08	37.28	24	5965	1200	2350896
Tardive dyskinesia	72.79	37.28	26	5963	1678	2350418
Unresponsive to stimuli	72.51	37.28	35	5954	4841	2347255
Circulatory collapse	71.82	37.28	32	5957	3688	2348408
Incoherent	71.40	37.28	22	5967	893	2351203
Maternal drugs affecting foetus	71.39	37.28	25	5964	1522	2350574
Vertigo	70.99	37.28	43	5946	9341	2342755
Hypokalaemia	70.92	37.28	45	5944	10609	2341487
Gestational diabetes	70.14	37.28	24	5965	1363	2350733
Hallucination, visual	68.53	37.28	29	5960	2950	2349146
Sudden death	66.89	37.28	25	5964	1835	2350261
Anger	66.44	37.28	27	5962	2480	2349616
Hepatic steatosis	66.42	37.28	29	5960	3184	2348912
Thinking abnormal	65.84	37.28	25	5964	1917	2350179
Product complaint	65.75	37.28	32	5957	4506	2347590
Sleep paralysis	65.74	37.28	14	5975	121	2351975
Coma scale abnormal	65.24	37.28	20	5969	798	2351298
Incontinence	65.19	37.28	23	5966	1431	2350665
Parkinsonism	64.42	37.28	23	5966	1482	2350614
Hepatic enzyme increased	64.24	37.28	41	5948	9761	2342335
Dehydration	62.34	37.28	56	5933	22239	2329857
Asphyxia	61.20	37.28	20	5969	984	2351112
Liver function test abnormal	61.01	37.28	36	5953	7454	2344642
Loss of personal independence in daily activities	60.98	37.28	32	5957	5279	2346817
Affective disorder	60.25	37.28	19	5970	833	2351263
Gait disturbance	59.84	37.28	55	5934	22490	2329606
Abnormal weight gain	59.79	37.28	15	5974	280	2351816
Caesarean section	59.79	37.28	29	5960	4052	2348044
Dystonia	59.41	37.28	24	5965	2170	2349926
Blood creatine phosphokinase increased	59.13	37.28	31	5958	5105	2346991
Altered state of consciousness	58.27	37.28	28	5961	3832	2348264
Swollen tongue	57.97	37.28	31	5958	5312	2346784
Hypertonia neonatal	56.52	37.28	11	5978	57	2352039
Hypothermia	56.46	37.28	23	5966	2125	2349971
Non-Hodgkin's lymphoma recurrent	56.21	37.28	11	5978	59	2352037
Drug intolerance	56.18	37.28	43	5946	13674	2338422
Chills	53.50	37.28	44	5945	15508	2336588
Heart rate increased	52.61	37.28	38	5951	11067	2341029
Intestinal obstruction	51.95	37.28	27	5962	4366	2347730
Aphasia	51.81	37.28	28	5961	4900	2347196
Memory impairment	51.80	37.28	40	5949	12883	2339213
White blood cell count decreased	51.41	37.28	46	5943	18162	2333934
Agitation neonatal	51.35	37.28	11	5978	98	2351998
Drug level increased	50.69	37.28	23	5966	2764	2349332
Diarrhoea	50.11	37.28	98	5891	83466	2268630
Paranoia	50.09	37.28	21	5968	2086	2350010
Angioedema	49.81	37.28	33	5956	8363	2343733
Cerebral ventricle dilatation	49.75	37.28	12	5977	189	2351907
Pulmonary embolism	49.70	37.28	45	5944	18038	2334058
Arrhythmia	49.16	37.28	29	5960	5999	2346097
Bradykinesia	48.98	37.28	15	5974	596	2351500
Night sweats	48.66	37.28	24	5965	3476	2348620
Arthralgia	48.60	37.28	76	5913	54209	2297887
Hypophagia	48.49	37.28	25	5964	3975	2348121
Shock	48.47	37.28	25	5964	3979	2348117
Blood sodium decreased	48.35	37.28	23	5966	3077	2349019
Wound	48.00	37.28	22	5967	2706	2349390
Abdominal distension	47.89	37.28	35	5954	10376	2341720
Delusion	47.15	37.28	20	5969	2045	2350051
Depersonalisation/derealisation disorder	47.00	37.28	12	5977	241	2351855
Selective eating disorder	46.74	37.28	13	5976	366	2351730
Pyelonephritis	46.46	37.28	20	5969	2121	2349975
Aspartate aminotransferase increased	46.15	37.28	37	5952	12575	2339521
Panic attack	45.88	37.28	24	5965	3932	2348164
Motor dysfunction	45.80	37.28	17	5972	1223	2350873
Aspergillus test positive	45.72	37.28	9	5980	50	2352046
Opisthotonus	45.64	37.28	10	5979	100	2351996
Skull malformation	45.37	37.28	10	5979	103	2351993
Cardiac hypertrophy	44.70	37.28	11	5978	189	2351907
Tachyphrenia	44.70	37.28	12	5977	295	2351801
Bradyphrenia	44.04	37.28	16	5973	1083	2351013
Hypertension	44.00	37.28	51	5938	27310	2324786
Sinus tachycardia	43.86	37.28	22	5967	3303	2348793
Jaundice	43.61	37.28	26	5963	5482	2346614
Drug reaction with eosinophilia and systemic symptoms	43.56	37.28	26	5963	5492	2346604
Myalgia	43.53	37.28	47	5942	23286	2328810
Increased appetite	43.33	37.28	17	5972	1423	2350673
Spina bifida	43.31	37.28	10	5979	129	2351967
Persecutory delusion	43.26	37.28	13	5976	484	2351612
Breast discomfort	43.10	37.28	10	5979	132	2351964
Hyperthermia	43.01	37.28	17	5972	1451	2350645
Ventricular tachycardia	42.91	37.28	21	5968	2990	2349106
Enterococcus test positive	42.68	37.28	10	5979	138	2351958
Cogwheel rigidity	42.49	37.28	11	5978	234	2351862
Feeling of despair	42.01	37.28	12	5977	373	2351723
Swelling face	41.60	37.28	31	5958	9462	2342634
Self-injurious ideation	41.42	37.28	13	5976	561	2351535
Pneumonia aspiration	41.40	37.28	22	5967	3720	2348376
Pain	41.30	37.28	76	5913	61781	2290315
Vision blurred	41.28	37.28	37	5952	14631	2337465
Compulsive sexual behaviour	40.38	37.28	7	5982	16	2352080
Product administration error	40.32	37.28	22	5967	3921	2348175
Polydipsia	40.10	37.28	13	5976	623	2351473
Abortion spontaneous	40.00	37.28	35	5954	13410	2338686
Cellulitis orbital	39.89	37.28	9	5980	104	2351992
Orgasm abnormal	39.43	37.28	8	5981	53	2352043
Lethargy	39.36	37.28	29	5960	8701	2343395
Premature rupture of membranes	39.35	37.28	14	5975	892	2351204
Salivary hypersecretion	38.76	37.28	15	5974	1210	2350886
Feeling of body temperature change	38.75	37.28	13	5976	694	2351402
Musculoskeletal stiffness	38.69	37.28	33	5956	12214	2339882
Chemical burn of oral cavity	38.68	37.28	6	5983	4	2352092
Urinary tract infection bacterial	38.66	37.28	12	5977	499	2351597
Pancytopenia	38.54	37.28	32	5957	11420	2340676
Oral candidiasis	38.23	37.28	17	5972	1948	2350148
Hyperkinesia	38.22	37.28	10	5979	222	2351874
Mental impairment	37.74	37.28	18	5971	2422	2349674
Septic shock	37.72	37.28	26	5963	7028	2345068
Parkinson's disease	37.61	37.28	15	5974	1311	2350785
Panic reaction	37.39	37.28	13	5976	774	2351322
Encephalopathy	37.33	37.28	22	5967	4539	2347557

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
Toxicity to various agents	1558.41	40.43	551	4070	28590	1713570
Completed suicide	1284.21	40.43	414	4207	15898	1726262
Intentional overdose	670.71	40.43	212	4409	7458	1734702
Overdose	641.89	40.43	250	4371	16451	1725709
Drug abuse	634.34	40.43	235	4386	13454	1728706
Suicide attempt	554.78	40.43	182	4439	7199	1734961
Serotonin syndrome	533.96	40.43	142	4479	2646	1739514
Confusional state	479.19	40.43	218	4403	21060	1721100
Agitation	468.75	40.43	178	4443	10848	1731312
Drug interaction	466.63	40.43	233	4388	27725	1714435
Somnolence	403.32	40.43	180	4441	16559	1725601
Depression	359.50	40.43	166	4455	16503	1725657
Intentional self-injury	331.73	40.43	97	4524	2576	1739584
Anxiety	329.60	40.43	153	4468	15374	1726786
Sopor	326.83	40.43	90	4531	1911	1740249
Insomnia	307.40	40.43	148	4473	16128	1726032
Fall	296.00	40.43	171	4450	27043	1715117
Restlessness	278.01	40.43	95	4526	4226	1737934
Hyponatraemia	255.91	40.43	109	4512	8891	1733269
Pneumonia aspiration	248.53	40.43	92	4529	5174	1736986
Suicidal ideation	244.93	40.43	104	4517	8414	1733746
Coma	243.65	40.43	99	4522	7163	1734997
Respiratory arrest	242.86	40.43	93	4528	5746	1736414
Tremor	237.38	40.43	116	4505	13015	1729145
Aggression	233.03	40.43	99	4522	8016	1734144
Restless legs syndrome	219.22	40.43	57	4564	960	1741200
Cardiac arrest	216.18	40.43	116	4505	15814	1726346
Poisoning	208.06	40.43	67	4554	2465	1739695
Rhabdomyolysis	200.40	40.43	98	4523	10992	1731168
Drug ineffective	199.88	40.43	189	4432	63612	1678548
Cardio-respiratory arrest	198.03	40.43	92	4529	9201	1732959
Electrocardiogram QT prolonged	194.16	40.43	78	4543	5467	1736693
Myoclonus	189.66	40.43	61	4560	2234	1739926
Tachycardia	182.61	40.43	96	4525	12532	1729628
Neuroleptic malignant syndrome	182.18	40.43	64	4557	3084	1739076
Logorrhoea	168.39	40.43	40	4581	454	1741706
Blood creatine phosphokinase increased	165.12	40.43	80	4541	8776	1733384
Nightmare	162.54	40.43	57	4564	2730	1739430
Hallucination, visual	154.95	40.43	54	4567	2538	1739622
Mania	145.27	40.43	49	4572	2084	1740076
Seizure	139.80	40.43	96	4525	20345	1721815
Hallucination	137.93	40.43	69	4552	8101	1734059
Delirium	135.44	40.43	63	4558	6299	1735861
Condition aggravated	134.51	40.43	95	4526	21055	1721105
Intentional product misuse	132.68	40.43	65	4556	7293	1734867
Psychomotor hyperactivity	130.93	40.43	44	4577	1849	1740311
Accidental overdose	130.04	40.43	54	4567	4110	1738050
Disturbance in attention	129.17	40.43	54	4567	4180	1737980
Extrapyramidal disorder	128.63	40.43	46	4575	2331	1739829
Sedation	126.23	40.43	50	4571	3367	1738793
Dizziness	118.99	40.43	108	4513	34253	1707907
Hyperhidrosis	118.21	40.43	72	4549	12416	1729744
Altered state of consciousness	114.77	40.43	47	4574	3450	1738710
Pulmonary oedema	112.23	40.43	56	4565	6530	1735630
Hypotension	108.12	40.43	96	4525	29558	1712602
Depressed level of consciousness	106.31	40.43	54	4567	6538	1735622
Delusion	101.50	40.43	38	4583	2193	1739967
Weight increased	101.14	40.43	63	4558	11294	1730866
Depressed mood	100.55	40.43	41	4580	2975	1739185
Abnormal behaviour	99.50	40.43	51	4570	6291	1735869
Loss of consciousness	94.86	40.43	67	4554	14808	1727352
Hepatic steatosis	92.59	40.43	37	4584	2547	1739613
Psychotic disorder	92.09	40.43	45	4576	5011	1737149
Disorientation	91.67	40.43	46	4575	5423	1736737
Death	88.15	40.43	147	4474	87296	1654864
Inappropriate antidiuretic hormone secretion	87.70	40.43	32	4589	1716	1740444
Acute pulmonary oedema	86.95	40.43	29	4592	1188	1740972
Dyskinesia	84.90	40.43	39	4582	3780	1738380
Drug withdrawal syndrome	84.58	40.43	41	4580	4484	1737676
Product use in unapproved indication	83.18	40.43	52	4569	9370	1732790
Muscle twitching	83.08	40.43	31	4590	1771	1740389
Poisoning deliberate	80.36	40.43	25	4596	817	1741343
Sleep disorder	79.53	40.43	38	4583	4025	1738135
Pulmonary congestion	79.39	40.43	30	4591	1775	1740385
Epilepsy	77.41	40.43	37	4584	3922	1738238
Akathisia	76.75	40.43	27	4594	1301	1740859
Headache	76.33	40.43	85	4536	34291	1707869
Priapism	74.18	40.43	27	4594	1437	1740723
Accidental death	73.61	40.43	20	4601	400	1741760
Apathy	73.57	40.43	26	4595	1270	1740890
Hypersomnia	73.16	40.43	28	4593	1715	1740445
Urinary retention	72.13	40.43	39	4582	5356	1736804
Bezoar	71.60	40.43	16	4605	135	1742025
Oesophageal obstruction	71.59	40.43	15	4606	90	1742070
Progressive multifocal leukoencephalopathy	71.21	40.43	27	4594	1612	1740548
Speech disorder	69.64	40.43	36	4585	4512	1737648
Circulatory collapse	69.60	40.43	33	4588	3434	1738726
Mood swings	69.40	40.43	28	4593	1974	1740186
Bradyphrenia	68.80	40.43	21	4600	643	1741517
Muscle spasms	68.66	40.43	50	4571	11571	1730589
Syncope	68.34	40.43	54	4567	14115	1728045
Major depression	67.32	40.43	21	4600	692	1741468
Unresponsive to stimuli	66.19	40.43	35	4586	4594	1737566
Dysgraphia	65.84	40.43	17	4604	277	1741883
Dysarthria	64.73	40.43	36	4585	5223	1736937
Muscle rigidity	64.59	40.43	26	4595	1822	1740338
Foetal exposure during pregnancy	63.53	40.43	38	4583	6321	1735839
Gait disturbance	62.62	40.43	49	4572	12621	1729539
Agranulocytosis	62.62	40.43	31	4590	3545	1738615
On and off phenomenon	62.06	40.43	16	4605	259	1741901
Off label use	60.48	40.43	80	4541	38491	1703669
Irritability	60.36	40.43	35	4586	5497	1736663
Selective eating disorder	59.79	40.43	17	4604	404	1741756
Alcohol use	59.68	40.43	20	4601	831	1741329
Vestibular disorder	58.34	40.43	14	4607	166	1741994
Illness anxiety disorder	58.14	40.43	11	4610	35	1742125
Parkinson's disease psychosis	57.85	40.43	9	4612	3	1742157
Mental status changes	57.32	40.43	35	4586	6040	1736120
Mental disorder	56.87	40.43	27	4594	2816	1739344
Liver function test abnormal	56.63	40.43	34	4587	5692	1736468
Illusion	56.46	40.43	14	4607	192	1741968
Asphyxia	54.96	40.43	20	4601	1063	1741097
Persecutory delusion	54.54	40.43	16	4605	426	1741734
Psychomotor retardation	54.22	40.43	16	4605	435	1741725
Macrophages increased	54.20	40.43	9	4612	9	1742151
Parkinsonism	53.92	40.43	21	4600	1348	1740812
Brain oedema	53.77	40.43	24	4597	2172	1739988
Paraesthesia	52.89	40.43	41	4580	10410	1731750
Hallucinations, mixed	52.78	40.43	16	4605	478	1741682
Bradykinesia	52.10	40.43	16	4605	500	1741660
Malaise	52.08	40.43	65	4556	29500	1712660
Nausea	51.21	40.43	86	4535	51110	1691050
Sinus tachycardia	50.50	40.43	24	4597	2508	1739652
Respiratory depression	50.08	40.43	23	4598	2224	1739936
Withdrawal syndrome	49.69	40.43	23	4598	2265	1739895
Blood sodium decreased	49.53	40.43	23	4598	2281	1739879
Ataxia	49.07	40.43	23	4598	2330	1739830
Dehydration	48.57	40.43	49	4572	17609	1724551
Myalgia	47.80	40.43	46	4575	15612	1726548
Drug-induced liver injury	47.76	40.43	25	4596	3212	1738948
Paranoia	47.60	40.43	22	4599	2159	1740001
Cardiometabolic syndrome	46.45	40.43	13	4608	291	1741869
Maternal drugs affecting foetus	46.25	40.43	18	4603	1153	1741007
Antipsychotic drug level above therapeutic	45.99	40.43	12	4609	204	1741956
Electrocardiogram QRS complex prolonged	45.70	40.43	16	4605	759	1741401
Hypernatraemia	45.44	40.43	17	4604	977	1741183
Coordination abnormal	45.29	40.43	19	4602	1478	1740682
Substance abuse	45.29	40.43	17	4604	986	1741174
Alanine aminotransferase increased	45.09	40.43	40	4581	12238	1729922
Mood altered	45.05	40.43	21	4600	2101	1740059
Depressive symptom	43.89	40.43	13	4608	358	1741802
Alcohol poisoning	43.85	40.43	14	4607	498	1741662
Urine sodium decreased	43.43	40.43	8	4613	21	1742139
Anger	43.39	40.43	22	4599	2644	1739516
Product prescribing error	42.50	40.43	21	4600	2389	1739771
Hypertriglyceridaemia	42.21	40.43	17	4604	1192	1740968
Miosis	42.19	40.43	18	4603	1460	1740700
Bipolar disorder	42.15	40.43	15	4606	747	1741413
Hallucination, auditory	42.01	40.43	20	4601	2097	1740063
Vomiting	41.82	40.43	67	4554	38248	1703912
Treatment noncompliance	41.61	40.43	27	4594	5174	1736986
Hepatitis acute	41.56	40.43	17	4604	1240	1740920
Hyperreflexia	41.20	40.43	14	4607	607	1741553
Hepatic fibrosis	41.09	40.43	14	4607	612	1741548
Obsessive-compulsive disorder	40.93	40.43	15	4606	813	1741347
Feeling guilty	40.58	40.43	9	4612	73	1742087

Pharmacologic Action:

Source	Code	Description
ATC	N06AX11	NERVOUS SYSTEM PSYCHOANALEPTICS ANTIDEPRESSANTS Other antidepressants
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D058669	Adrenergic alpha-2 Receptor Antagonists
MeSH PA	D000317	Adrenergic alpha-Antagonists
MeSH PA	D018674	Adrenergic Antagonists
CHEBI has role	CHEBI:37890	alpha-adrenergic antagonist
CHEBI has role	CHEBI:48279	serotonergic antagonist
CHEBI has role	CHEBI:37956	histamine antagonist
CHEBI has role	CHEBI:35474	anxiolytic drug
CHEBI has role	CHEBI:37955	H1-receptor antagonist
CHEBI has role	CHEBI:146270	oneirogen
MeSH PA	D014151	Anti-Anxiety Agents
MeSH PA	D000928	Antidepressive Agents
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D018494	Histamine Agents
MeSH PA	D006633	Histamine Antagonists
MeSH PA	D006634	Histamine H1 Antagonists
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D011619	Psychotropic Drugs
MeSH PA	D058830	Serotonin 5-HT2 Receptor Antagonists
MeSH PA	D058831	Serotonin 5-HT3 Receptor Antagonists
MeSH PA	D018490	Serotonin Agents
MeSH PA	D012702	Serotonin Antagonists
MeSH PA	D014149	Tranquilizing Agents

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Major depressive disorder	indication	370143000
Posttraumatic stress disorder	off-label use	47505003	DOID:2055
Suicidal thoughts	contraindication	6471006
Weight gain finding	contraindication	8943002
Hypercholesterolemia	contraindication	13644009
Myocardial infarction	contraindication	22298006	DOID:5844
Hypovolemia	contraindication	28560003
Orthostatic hypotension	contraindication	28651003
Dehydration	contraindication	34095006
Low blood pressure	contraindication	45007003
Cerebrovascular disease	contraindication	62914000	DOID:6713
Hyponatremia	contraindication	89627008
Seizure disorder	contraindication	128613002
Liver function tests abnormal	contraindication	166603001
Bipolar affective disorder, current episode manic	contraindication	191618007
Angina pectoris	contraindication	194828000
Impaired renal function disorder	contraindication	197663003
Cerebrovascular accident	contraindication	230690007
Disease of liver	contraindication	235856003	DOID:409
Akathisia	contraindication	285145004
Hypertriglyceridemia	contraindication	302870006
Neutropenic disorder	contraindication	303011007	DOID:1227
Serotonin syndrome	contraindication	371089000
Obesity	contraindication	414916001	DOID:9970
Acute Thromboembolic Stroke	contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.67	Basic
pKa2	2.91	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])	Bioact source	MoA source
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN	ANTAGONIST	Ki	7.41	CHEMBL	CHEMBL
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN	ANTAGONIST	Ki	7.16	CHEMBL	CHEMBL
5-hydroxytryptamine receptor 7	GPCR	P34969	5HT7R_HUMAN		Ki	6.58	CHEMBL
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN	ANTAGONIST	IC50	6.65	CHEMBL
Alpha-2C adrenergic receptor	GPCR	P18825	ADA2C_HUMAN	ANTAGONIST	Ki	7.74	CHEMBL
5-hydroxytryptamine receptor 3A	Ion channel	P46098	5HT3A_HUMAN		Ki	5.54	CHEMBL
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Kd	5.30	CHEMBL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN	ANTAGONIST	Ki	7.70	CHEMBL
Alpha-1A adrenergic receptor	GPCR	P35348	ADA1A_HUMAN		IC50	5.50	CHEMBL
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN				WOMBAT-PK
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN				WOMBAT-PK
Histamine H1 receptor	GPCR	P35367	HRH1_HUMAN		Ki	8.80	WOMBAT-PK
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	5.34	PDSP
D(1A) dopamine receptor	GPCR	P21728	DRD1_HUMAN		Ki	5.38	PDSP
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN		Ki	5.26	PDSP
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	5.24	CHEMBL
D(1A) dopamine receptor	GPCR		DRD1_RAT		Ki	5.38	CHEMBL
D(2) dopamine receptor	GPCR		DRD2_RAT		Ki	5.84	CHEMBL
Transporter	Transporter		Q9WTR4_RAT		Ki	5.79	CHEMBL
5-hydroxytryptamine receptor 2C	GPCR		5HT2C_RAT		Ki	8.26	CHEMBL
Adrenergic receptor alpha-1	GPCR		ADA1A_RAT ADA1B_RAT ADA1D_RAT		Ki	6.22	CHEMBL
5-hydroxytryptamine receptor 2A	GPCR		5HT2A_RAT		Ki	8.70	CHEMBL

External reference:

ID	Source
D000078785	MESH_DESCRIPTOR_UI
4020978	VUID
N0000148449	NUI
C0049506	UMLSCUI
D00563	KEGG_DRUG
108430001	SNOMEDCT_US
006054	NDDF
46110	MMSL
15996	RXNORM
386847004	SNOMEDCT_US
d04025	MMSL
5120	MMSL
4020978	VANDF
A051Q2099Q	UNII
6481	INN_ID
CHEBI:6950	CHEBI
CHEMBL654	ChEMBL_ID
DB00370	DRUGBANK_ID
4205	PUBCHEM_CID
7241	IUPHAR_LIGAND_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
REMERON	HUMAN PRESCRIPTION DRUG LABEL	1	0052-0105	TABLET, FILM COATED	15 mg	ORAL	NDA	19 sections
REMERONSOLTAB	HUMAN PRESCRIPTION DRUG LABEL	1	0052-0106	TABLET, ORALLY DISINTEGRATING	15 mg	ORAL	NDA	19 sections
REMERON	HUMAN PRESCRIPTION DRUG LABEL	1	0052-0107	TABLET, FILM COATED	30 mg	ORAL	NDA	19 sections
REMERONSOLTAB	HUMAN PRESCRIPTION DRUG LABEL	1	0052-0108	TABLET, ORALLY DISINTEGRATING	30 mg	ORAL	NDA	19 sections
REMERON	HUMAN PRESCRIPTION DRUG LABEL	1	0052-0109	TABLET, FILM COATED	45 mg	ORAL	NDA	19 sections
REMERONSOLTAB	HUMAN PRESCRIPTION DRUG LABEL	1	0052-0110	TABLET, ORALLY DISINTEGRATING	45 mg	ORAL	NDA	19 sections
REMERON	HUMAN PRESCRIPTION DRUG LABEL	1	0052-4364	TABLET, FILM COATED	15 mg	ORAL	NDA	19 sections
REMERON	HUMAN PRESCRIPTION DRUG LABEL	1	0052-4365	TABLET, FILM COATED	30 mg	ORAL	NDA	19 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1653	TABLET, ORALLY DISINTEGRATING	15 mg	ORAL	ANDA	15 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1654	TABLET, ORALLY DISINTEGRATING	30 mg	ORAL	ANDA	15 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1656	TABLET, ORALLY DISINTEGRATING	45 mg	ORAL	ANDA	15 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3515	TABLET, FILM COATED	15 mg	ORAL	ANDA	18 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3530	TABLET, FILM COATED	30 mg	ORAL	ANDA	18 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3545	TABLET, FILM COATED	45 mg	ORAL	ANDA	18 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-5527	TABLET	45 mg	ORAL	ANDA	14 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-5572	TABLET, FILM COATED	15 mg	ORAL	ANDA	14 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-5573	TABLET, FILM COATED	30 mg	ORAL	ANDA	14 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-7870	TABLET, FILM COATED	7.50 mg	ORAL	ANDA	14 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8078	TABLET	7.50 mg	ORAL	ANDA	14 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8268	TABLET, FILM COATED	15 mg	ORAL	ANDA	14 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8269	TABLET, FILM COATED	30 mg	ORAL	ANDA	14 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6519	TABLET, FILM COATED	15 mg	ORAL	ANDA	14 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	13107-001	TABLET, FILM COATED	7.50 mg	ORAL	ANDA	14 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	13107-003	TABLET, FILM COATED	30 mg	ORAL	ANDA	14 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	13107-031	TABLET, FILM COATED	15 mg	ORAL	ANDA	14 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	13107-032	TABLET, FILM COATED	45 mg	ORAL	ANDA	14 sections
MIRTAZAPINE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-153	TABLET, FILM COATED	15 mg	ORAL	ANDA	14 sections
MIRTAZAPINE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-154	TABLET, FILM COATED	30 mg	ORAL	ANDA	14 sections
MIRTAZAPINE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-155	TABLET, FILM COATED	45 mg	ORAL	ANDA	14 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	16714-706	TABLET	7.50 mg	ORAL	ANDA	14 sections