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

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
Intentional overdose	595.33	10.21	675	88323	64269	46532795
Intentional self-injury	500.52	10.21	395	88603	23771	46573293
Serotonin syndrome	450.96	10.21	372	88626	23848	46573216
Suicide attempt	426.29	10.21	525	88473	54511	46542553
Toxicity to various agents	425.37	10.21	1116	87882	210650	46386414
Drug abuse	415.94	10.21	557	88441	62851	46534213
Sopor	376.34	10.21	308	88690	19520	46577544
Electrocardiogram QT prolonged	315.50	10.21	437	88561	50888	46546176
Suicidal ideation	302.51	10.21	450	88548	55932	46541132
Drug interaction	299.87	10.21	959	88039	202135	46394929
Completed suicide	295.57	10.21	772	88226	145148	46451916
Rheumatoid arthritis	274.85	10.21	61	88937	240154	46356910
Overdose	261.41	10.21	591	88407	101388	46495676
Hyponatraemia	246.20	10.21	575	88423	100757	46496307
Agitation	209.96	10.21	378	88620	55037	46542027
Somnolence	209.21	10.21	715	88283	155806	46441258
Confusional state	187.68	10.21	700	88298	159192	46437872
Depressed level of consciousness	171.97	10.21	318	88680	47251	46549813
Inappropriate antidiuretic hormone secretion	154.16	10.21	161	88837	13941	46583123
Depression	140.44	10.21	669	88329	169435	46427629
Drug ineffective	137.49	10.21	747	88251	677091	45919973
Muscle rigidity	135.30	10.21	128	88870	9833	46587231
Tremor	134.50	10.21	505	88493	115134	46481930
Neuroleptic malignant syndrome	134.34	10.21	134	88864	10988	46586076
Coma	131.75	10.21	322	88676	58027	46539037
Disorientation	129.91	10.21	244	88754	36674	46560390
Tachycardia	129.37	10.21	451	88547	99171	46497893
Restlessness	124.48	10.21	195	88803	25329	46571735
Depressed mood	115.73	10.21	219	88779	33100	46563964
Disturbance in attention	115.31	10.21	212	88786	31348	46565716
Fall	112.47	10.21	1037	87961	328060	46269004
Treatment failure	111.77	10.21	21	88977	93066	46503998
Anxiety	105.61	10.21	650	88348	181307	46415757
Joint swelling	103.94	10.21	98	88900	165975	46431089
Sinusitis	102.58	10.21	60	88938	129708	46467356
Akathisia	98.85	10.21	96	88902	7618	46589446
Drug hypersensitivity	98.24	10.21	198	88800	243627	46353437
Rash	96.65	10.21	352	88646	356160	46240904
Mydriasis	90.32	10.21	106	88892	10447	46586617
Aggression	88.45	10.21	157	88841	22587	46574477
Restless legs syndrome	84.23	10.21	126	88872	15717	46581347
Infusion related reaction	82.55	10.21	45	88953	101163	46495901
Injection site pain	81.25	10.21	52	88946	107100	46489964
Dysarthria	80.46	10.21	203	88795	37295	46559769
General physical health deterioration	79.10	10.21	432	88566	115337	46481727
Pain	78.99	10.21	559	88439	476389	46120675
Nasopharyngitis	78.77	10.21	107	88891	153891	46443173
Nightmare	78.42	10.21	125	88873	16473	46580591
Hallucination	78.13	10.21	241	88757	49710	46547354
Urinary retention	78.05	10.21	161	88837	25900	46571164
Rheumatoid factor negative	78.05	10.21	32	88966	525	46596539
Dissociation	77.63	10.21	47	88951	1830	46595234
Systemic lupus erythematosus	77.61	10.21	15	88983	65165	46531899
Arthralgia	77.34	10.21	395	88603	364208	46232856
Parkinsonism	75.05	10.21	84	88914	7864	46589200
Dyskinesia	72.16	10.21	166	88832	28759	46568305
Arthropathy	71.53	10.21	36	88962	84664	46512400
Depersonalisation/derealisation disorder	71.35	10.21	36	88962	974	46596090
Withdrawal syndrome	70.29	10.21	125	88873	18009	46579055
Pemphigus	70.06	10.21	4	88994	45270	46551794
Pleurothotonus	69.31	10.21	37	88961	1128	46595936
Alopecia	68.74	10.21	128	88870	162286	46434778
Sedation	67.98	10.21	141	88857	22769	46574295
Urticaria	67.56	10.21	75	88923	117817	46479247
Myoclonus	66.32	10.21	107	88891	14245	46582819
Depressive symptom	64.43	10.21	49	88949	2787	46594277
Drug withdrawal syndrome	62.71	10.21	152	88846	27232	46569832
Hallucination, visual	62.69	10.21	118	88880	17755	46579309
Delirium	62.34	10.21	184	88814	37044	46560020
Poisoning	61.51	10.21	102	88896	13892	46583172
Peripheral swelling	61.37	10.21	131	88867	157940	46439124
Swelling	61.18	10.21	89	88909	124422	46472642
Seizure	61.17	10.21	423	88575	122631	46474433
Contraindicated product administered	60.32	10.21	39	88959	79908	46517156
Tardive dyskinesia	60	10.21	73	88925	7470	46589594
Hyperhidrosis	58.14	10.21	329	88669	88979	46508085
Gastric pH decreased	57.73	10.21	23	88975	349	46596715
Psychotic disorder	56.62	10.21	130	88868	22491	46574573
Injection site erythema	53.88	10.21	38	88960	74389	46522675
Intestinal pseudo-obstruction	53.74	10.21	26	88972	641	46596423
Feeling of despair	51.97	10.21	36	88962	1769	46595295
Abdominal discomfort	51.70	10.21	134	88864	151031	46446033
Extrapyramidal disorder	50.69	10.21	83	88915	11185	46585879
Cough	50.12	10.21	247	88751	230002	46367062
Loss of consciousness	49.67	10.21	365	88633	107873	46489191
Mania	48.94	10.21	80	88918	10766	46586298
Headache	48.62	10.21	632	88366	477720	46119344
Injection site pruritus	47.61	10.21	9	88989	39734	46557330
Drug intolerance	47.54	10.21	134	88864	146915	46450149
Psychomotor retardation	46.70	10.21	43	88955	3190	46593874
Pruritus	46.64	10.21	271	88727	242081	46354983
Asphyxia	46.41	10.21	54	88944	5272	46591792
Drug dependence	45.07	10.21	110	88888	19791	46577273
Sleep disorder	44.44	10.21	192	88806	46603	46550461
Hallucination, auditory	44.09	10.21	76	88922	10680	46586384
Hypertonia	43.54	10.21	48	88950	4418	46592646
Pain in extremity	43.25	10.21	302	88696	258378	46338686
Sleep paralysis	42.97	10.21	20	88978	451	46596613
Hyperkinesia	42.70	10.21	32	88966	1780	46595284
Progressive multifocal leukoencephalopathy	42.42	10.21	77	88921	11269	46585795
Accidental overdose	42.38	10.21	108	88890	19958	46577106
Psoriasis	41.81	10.21	53	88945	78551	46518513
Therapeutic product effect decreased	41.59	10.21	58	88940	82543	46514521
Cogwheel rigidity	41.22	10.21	29	88969	1461	46595603
Hypertonia neonatal	41.14	10.21	16	88982	227	46596837
Synovitis	40.62	10.21	34	88964	61041	46536023
Polydipsia	40.50	10.21	40	88958	3239	46593825
Arthritis	40.23	10.21	53	88945	77263	46519801
Psoriatic arthropathy	40.00	10.21	10	88988	36369	46560695
Psychomotor hyperactivity	39.50	10.21	68	88930	9545	46587519
Product dose omission issue	38.86	10.21	177	88821	168343	46428721
Glossodynia	38.76	10.21	18	88980	44355	46552709
Nasal congestion	38.34	10.21	22	88976	48091	46548973
Hypersensitivity	38.28	10.21	152	88846	150169	46446895
Device expulsion	38.22	10.21	4	88994	27538	46569526
Acute motor-sensory axonal neuropathy	37.63	10.21	17	88981	357	46596707
Abnormal dreams	37.47	10.21	69	88929	10210	46586854
Major depression	36.70	10.21	54	88944	6636	46590428
Erythema	36.63	10.21	144	88854	142676	46454388
Dystonia	36.63	10.21	72	88926	11185	46585879
Abnormal behaviour	36.13	10.21	105	88893	20953	46576111
Back pain	35.69	10.21	244	88754	209795	46387269
Galactorrhoea	35.62	10.21	40	88958	3757	46593307
Derealisation	35.53	10.21	21	88977	782	46596282
Rhabdomyolysis	35.33	10.21	166	88832	41743	46555321
Product prescribing error	33.47	10.21	99	88899	19948	46577116
Delusion	33.35	10.21	69	88929	11119	46585945
Persecutory delusion	33.12	10.21	32	88966	2523	46594541
Fracture	33.08	10.21	87	88911	16384	46580680
Opisthotonus	32.90	10.21	15	88983	322	46596742
Panic attack	32.89	10.21	99	88899	20143	46576921
Off label use	32.83	10.21	518	88480	379323	46217741
Cognitive disorder	32.50	10.21	148	88850	36735	46560329
Altered state of consciousness	32.27	10.21	108	88890	23240	46573824
Abulia	32.24	10.21	15	88983	338	46596726
Gestational diabetes	32.24	10.21	53	88945	7166	46589898
Unresponsive to stimuli	32.09	10.21	134	88864	32040	46565024
Bradypnoea	31.97	10.21	34	88964	3005	46594059
Anger	31.76	10.21	70	88928	11782	46585282
Product administration error	31.73	10.21	96	88902	19585	46577479
Asthma	31.39	10.21	81	88917	91461	46505603
Histrionic personality disorder	30.55	10.21	9	88989	50	46597014
Orthostatic hypotension	30.55	10.21	110	88888	24548	46572516
Injection site bruising	30.29	10.21	15	88983	35621	46561443
Herpes zoster	30.02	10.21	52	88946	67820	46529244
Paranoia	30.01	10.21	64	88934	10533	46586531
Injection site swelling	29.97	10.21	20	88978	40307	46556757
Coma scale abnormal	29.79	10.21	42	88956	4964	46592100
Cardiac arrest	29.78	10.21	283	88715	90116	46506948
C-reactive protein abnormal	29.74	10.21	3	88995	21267	46575797
Incontinence	29.61	10.21	61	88937	9801	46587263
Pallor	29.26	10.21	104	88894	23062	46574002
Rhonchi	29.20	10.21	28	88970	2187	46594877
Drooling	28.74	10.21	33	88965	3176	46593888
Product use issue	28.58	10.21	89	88909	94555	46502509
Miosis	28.56	10.21	48	88950	6609	46590455
Dysphagia	28.50	10.21	248	88750	77064	46520000
Self-injurious ideation	28.30	10.21	28	88970	2272	46594792
Intentional product misuse	28.30	10.21	170	88828	46958	46550106
Schizophrenia	28.12	10.21	55	88943	8513	46588551
Affective disorder	28.06	10.21	40	88958	4775	46592289
Generalised tonic-clonic seizure	27.86	10.21	114	88884	27008	46570056
Fatigue	27.86	10.21	917	88081	607780	45989284
Ventricular fibrillation	27.60	10.21	65	88933	11431	46585633
Urinary hesitation	27.40	10.21	25	88973	1833	46595231
Ballismus	26.81	10.21	9	88989	81	46596983
Chemical burn of oral cavity	26.43	10.21	9	88989	85	46596979
Skull malformation	26.24	10.21	13	88985	338	46596726
Therapeutic product effect incomplete	26.15	10.21	70	88928	78083	46518981
Language disorder	25.46	10.21	22	88976	1501	46595563
Helplessness	25.31	10.21	11	88987	210	46596854
Knee arthroplasty	25.08	10.21	7	88991	23658	46573406
Agitation neonatal	24.44	10.21	14	88984	491	46596573
Salivary hypersecretion	24.42	10.21	44	88954	6401	46590663
Upper respiratory tract infection	24.36	10.21	53	88945	63503	46533561
Fungal infection	24.24	10.21	13	88985	29507	46567557
H1N1 influenza	23.93	10.21	21	88977	1463	46595601
Irritability	23.92	10.21	114	88884	28832	46568232
Tonic clonic movements	23.91	10.21	19	88979	1153	46595911
Norepinephrine increased	23.83	10.21	8	88990	72	46596992
Diarrhoea	23.73	10.21	851	88147	558751	46038313
Blood prolactin increased	23.60	10.21	29	88969	2998	46594066
Panic reaction	23.52	10.21	32	88966	3657	46593407
Breast discomfort	23.47	10.21	12	88986	334	46596730
Social avoidant behaviour	23.44	10.21	28	88970	2811	46594253
Speech disorder	23.35	10.21	133	88865	36034	46561030
Circulatory collapse	23.10	10.21	92	88906	21532	46575532
CYP3A4 polymorphism	23.09	10.21	8	88990	80	46596984
Non-cardiogenic pulmonary oedema	23.01	10.21	14	88984	550	46596514
Pyelonephritis	22.99	10.21	73	88925	15284	46581780
Facial nerve disorder	22.85	10.21	14	88984	557	46596507
Personality disorder	22.80	10.21	29	88969	3104	46593960
Infection	22.76	10.21	155	88843	133437	46463627
Impaired healing	22.58	10.21	22	88976	36721	46560343
Neonatal hypoxia	22.36	10.21	13	88985	469	46596595
Mood swings	22.30	10.21	75	88923	16177	46580887
Maternal exposure during pregnancy	22.28	10.21	110	88888	102439	46494625
Epilepsy	22.23	10.21	97	88901	23641	46573423
Orgasm abnormal	22.16	10.21	8	88990	91	46596973
Myocardial infarction	22.13	10.21	103	88895	97425	46499639
Cerebral ventricle dilatation	22.06	10.21	17	88981	986	46596078
Giant cell arteritis	21.89	10.21	22	88976	1819	46595245
Injection site reaction	21.76	10.21	36	88962	47813	46549251
Alkalosis hypochloraemic	21.71	10.21	9	88989	152	46596912
Incoherent	21.34	10.21	34	88964	4478	46592586
Euphoric mood	21.32	10.21	33	88965	4239	46592825
Tachycardia paroxysmal	21.17	10.21	11	88987	317	46596747
Pneumonia	21.14	10.21	551	88447	375769	46221295
Hypophagia	21.09	10.21	111	88887	29195	46567869
Insomnia	21.05	10.21	436	88562	164488	46432576
Agranulocytosis	21.04	10.21	91	88907	22094	46574970
Osteoporosis	20.95	10.21	28	88970	40580	46556484
Feeling jittery	20.95	10.21	57	88941	10951	46586113
Respiratory distress	20.93	10.21	18	88980	31898	46565166
Platelet count decreased	20.76	10.21	109	88889	99915	46497149
Apathy	20.70	10.21	44	88954	7224	46589840
Neuropathy peripheral	20.62	10.21	96	88902	90797	46506267
Injection site haemorrhage	20.38	10.21	7	88991	20702	46576362
Immune reconstitution inflammatory syndrome	20.33	10.21	38	88960	5687	46591377
Mutism	20.17	10.21	18	88980	1282	46595782
Autonomic nervous system imbalance	20.15	10.21	24	88974	2402	46594662
Product quality issue	20.05	10.21	23	88975	35625	46561439
Hyperthermia	19.99	10.21	46	88952	7968	46589096
Suicidal behaviour	19.97	10.21	24	88974	2424	46594640
Cataract	19.89	10.21	35	88963	45380	46551684
Thinking abnormal	19.87	10.21	52	88946	9762	46587302
Aphasia	19.74	10.21	107	88891	28460	46568604
Impulsive behaviour	19.68	10.21	19	88979	1496	46595568
Cardiac failure congestive	19.59	10.21	99	88899	91651	46505413
Thymus disorder	19.58	10.21	9	88989	197	46596867
Purple glove syndrome	19.54	10.21	9	88989	198	46596866
Parosmia	19.44	10.21	31	88967	4085	46592979
Bradyphrenia	19.25	10.21	39	88959	6191	46590873
Visceral congestion	19.22	10.21	10	88988	289	46596775
Merycism	19.20	10.21	8	88990	137	46596927
Drug dose titration not performed	19.15	10.21	11	88987	388	46596676
Reduced facial expression	19.14	10.21	17	88981	1203	46595861
Thirst	19.09	10.21	55	88943	10921	46586143
Natural killer cell count decreased	19.07	10.21	6	88992	43	46597021
Respiratory arrest	19.05	10.21	120	88878	33696	46563368
Respiratory disorder neonatal	18.83	10.21	15	88983	913	46596151
Skin exfoliation	18.80	10.21	21	88977	32917	46564147
Intentional product use issue	18.63	10.21	46	88952	52734	46544330
Sensorimotor disorder	18.58	10.21	11	88987	411	46596653
Cellulitis orbital	18.55	10.21	11	88987	412	46596652
Spina bifida	18.55	10.21	13	88985	651	46596413
Decreased appetite	18.45	10.21	492	88506	193344	46403720
Activation syndrome	18.41	10.21	9	88989	227	46596837
Osteoarthritis	18.24	10.21	59	88939	61966	46535098
Cytomegalovirus infection	18.08	10.21	6	88992	18138	46578926
Cellulitis	17.92	10.21	71	88927	70217	46526847
Syncope	17.90	10.21	290	88708	104513	46492551
Chest pain	17.80	10.21	233	88765	176091	46420973
Aspiration	17.79	10.21	49	88949	9482	46587582
Drop attacks	17.75	10.21	13	88985	698	46596366
Acute abdomen	17.66	10.21	18	88980	1514	46595550
Cerebellar syndrome	17.62	10.21	27	88971	3438	46593626
Bradykinesia	17.55	10.21	29	88969	3937	46593127
Hypokalaemia	17.51	10.21	250	88748	87774	46509290
Bursitis	17.40	10.21	8	88990	19834	46577230
Phagophobia	17.25	10.21	5	88993	26	46597038
Empty sella syndrome	17.25	10.21	5	88993	26	46597038
Dementia	17.15	10.21	65	88933	14865	46582199
Agonal rhythm	17.09	10.21	5	88993	27	46597037
Poisoning deliberate	17.09	10.21	43	88955	7883	46589181
Retinal detachment	17.05	10.21	33	88965	5067	46591997
Binge eating	16.98	10.21	10	88988	370	46596694
Mental disorder	16.87	10.21	86	88912	22339	46574725
Inflammation	16.84	10.21	43	88955	48738	46548326
Radial nerve palsy	16.71	10.21	10	88988	381	46596683
Pulmonary renal syndrome	16.69	10.21	10	88988	382	46596682
Gastrooesophageal reflux disease	16.58	10.21	79	88919	74265	46522799
Dyspraxia	16.54	10.21	8	88990	197	46596867
Febrile neutropenia	16.51	10.21	109	88889	94518	46502546
Blood pressure increased	16.49	10.21	158	88840	126508	46470556
Rhinorrhoea	16.47	10.21	42	88956	47623	46549441
Tachyphrenia	16.38	10.21	16	88982	1278	46595786
Abnormal weight gain	16.37	10.21	17	88981	1461	46595603
No adverse event	16.28	10.21	25	88973	34206	46562858
Chorea	16.15	10.21	15	88983	1125	46595939
Vitamin B12 decreased	16.09	10.21	23	88975	2752	46594312
Negative thoughts	16.03	10.21	13	88985	812	46596252
Sudden death	15.93	10.21	47	88951	9457	46587607
Drug withdrawal syndrome neonatal	15.89	10.21	19	88979	1909	46595155
Loss of libido	15.82	10.21	16	88982	1333	46595731
Productive cough	15.79	10.21	47	88951	50668	46546396
Brief psychotic disorder with marked stressors	15.76	10.21	6	88992	80	46596984
Medulloblastoma	15.75	10.21	5	88993	37	46597027
Aspergillus test positive	15.65	10.21	9	88989	318	46596746
Intrusive thoughts	15.54	10.21	7	88991	146	46596918
Drowning	15.44	10.21	10	88988	439	46596625
Interstitial lung disease	15.40	10.21	52	88946	53897	46543167
Palmar-plantar erythrodysaesthesia syndrome	15.38	10.21	10	88988	20441	46576623
Enterococcus test positive	15.34	10.21	14	88984	1027	46596037
Anaphylactic reaction	15.29	10.21	51	88947	53061	46544003
Retrograde amnesia	15.25	10.21	9	88989	334	46596730
Homicidal ideation	15.25	10.21	18	88980	1784	46595280
Substance abuse	15.22	10.21	28	88970	4139	46592925
Cardiac hypertrophy	15.15	10.21	14	88984	1043	46596021
Gamma-glutamyltransferase increased	15.09	10.21	108	88890	31632	46565432
Joint range of motion decreased	15.07	10.21	5	88993	15119	46581945
Snoring	15.01	10.21	25	88973	3417	46593647
Influenza	14.99	10.21	104	88894	89166	46507898
Mental impairment	14.95	10.21	55	88943	12401	46584663
Nephrolithiasis	14.91	10.21	25	88973	33026	46564038
Pyroglutamic acidosis	14.83	10.21	8	88990	249	46596815
Cardio-respiratory arrest	14.82	10.21	177	88821	59692	46537372
Feeling of body temperature change	14.82	10.21	28	88970	4224	46592840
Pneumonia aspiration	14.72	10.21	107	88891	31498	46565566
Compulsive sexual behaviour	14.70	10.21	5	88993	47	46597017
Disseminated intravascular coagulation	14.70	10.21	9	88989	18996	46578068
Bundle branch block right	14.69	10.21	30	88968	4789	46592275
Neck pain	14.66	10.21	55	88943	55251	46541813
Developmental hip dysplasia	14.65	10.21	15	88983	1268	46595796
Granulocytopenia neonatal	14.65	10.21	4	88994	16	46597048
Status epilepticus	14.55	10.21	59	88939	13920	46583144
Injection site rash	14.46	10.21	6	88992	15807	46581257
Viral infection	14.46	10.21	22	88976	30213	46566851
Dyspnoea	14.45	10.21	820	88178	514728	46082336
Psychiatric decompensation	14.43	10.21	14	88984	1109	46595955
Therapy non-responder	14.42	10.21	36	88962	41116	46555948
Basophil count decreased	14.39	10.21	6	88992	103	46596961
Logorrhoea	14.35	10.21	20	88978	2339	46594725
Bronchitis	14.31	10.21	131	88867	105848	46491216
Antidepressant drug level increased	14.22	10.21	8	88990	271	46596793
Vasodilatation	14.18	10.21	20	88978	2365	46594699
Motor dysfunction	14.15	10.21	38	88960	7244	46589820
Nausea	14.15	10.21	1124	87874	686330	45910734
Tearfulness	14.13	10.21	27	88971	4108	46592956
Shared psychotic disorder	14.10	10.21	4	88994	19	46597045
Indifference	14.08	10.21	6	88992	109	46596955
Selective eating disorder	14.06	10.21	17	88981	1728	46595336
Vagus nerve disorder	14.03	10.21	6	88992	110	46596954
Tongue movement disturbance	14.02	10.21	7	88991	185	46596879
Neglect of personal appearance	13.98	10.21	6	88992	111	46596953
Hypothermia	13.96	10.21	53	88945	12130	46584934
Coronary artery disease	13.90	10.21	27	88971	33725	46563339
Acute psychosis	13.81	10.21	18	88980	1974	46595090
Chemical burns of eye	13.77	10.21	5	88993	58	46597006
Congenital hand malformation	13.75	10.21	8	88990	289	46596775
Intestinal mucosal atrophy	13.72	10.21	3	88995	3	46597061
Pyrexia	13.71	10.21	535	88463	348267	46248797
Bulimia nervosa	13.68	10.21	10	88988	535	46596529
Flushing	13.63	10.21	70	88928	64544	46532520
Akinesia	13.63	10.21	17	88981	1784	46595280
Polydipsia psychogenic	13.54	10.21	5	88993	61	46597003
Hip arthroplasty	13.43	10.21	9	88989	18103	46578961
Refusal of treatment by patient	13.41	10.21	31	88967	5384	46591680
Fluid retention	13.37	10.21	51	88947	50995	46546069
Helicobacter infection	13.35	10.21	3	88995	11733	46585331
Poor feeding infant	13.34	10.21	7	88991	206	46596858
Post-traumatic stress disorder	13.30	10.21	26	88972	4022	46593042
Stupor	13.30	10.21	24	88974	3496	46593568
Cyanosis	13.27	10.21	63	88935	15908	46581156
Mixed anxiety and depressive disorder	13.20	10.21	6	88992	128	46596936
Rabbit syndrome	13.13	10.21	8	88990	315	46596749
B-lymphocyte count increased	13.11	10.21	6	88992	130	46596934
Postmortem blood drug level increased	13.10	10.21	9	88989	436	46596628
Decubitus ulcer	12.99	10.21	45	88953	9853	46587211
Dyspnoea at rest	12.97	10.21	24	88974	3564	46593500
White blood cell count decreased	12.96	10.21	144	88854	112087	46484977
Optic nerve disorder	12.95	10.21	11	88987	733	46596331
Psychotic symptom	12.94	10.21	12	88986	898	46596166
Staphylococcal infection	12.76	10.21	31	88967	35740	46561324
Phaeochromocytoma	12.70	10.21	9	88989	459	46596605
Premature delivery	12.67	10.21	14	88984	22055	46575009
Somatic delusion	12.64	10.21	10	88988	603	46596461
Resuscitation	12.63	10.21	13	88985	1106	46595958
Postural tremor	12.63	10.21	6	88992	142	46596922
Red blood cell sedimentation rate increased	12.62	10.21	15	88983	22874	46574190
Haemoptysis	12.57	10.21	19	88979	26170	46570894
Infantile apnoea	12.55	10.21	11	88987	765	46596299
Skin ulcer	12.49	10.21	27	88971	32431	46564633
Peripheral paralysis	12.48	10.21	5	88993	77	46596987
Parkinson's disease	12.41	10.21	15	88983	1524	46595540
Hypotension	12.40	10.21	552	88446	232037	46365027
Medication error	12.36	10.21	101	88897	30810	46566254
Orthostatic intolerance	12.30	10.21	13	88985	1141	46595923
Agoraphobia	12.25	10.21	8	88990	356	46596708
Breast cancer	12.23	10.21	45	88953	45473	46551591
Catatonia	12.16	10.21	24	88974	3738	46593326
Transfusion	12.13	10.21	5	88993	13226	46583838
Respiratory depression	12.10	10.21	49	88949	11551	46585513
Cerebellar haematoma	12.06	10.21	8	88990	366	46596698
Blood pressure diastolic decreased	12.05	10.21	6	88992	14205	46582859
Therapeutic response decreased	12.03	10.21	42	88956	43103	46553961
Maternal drugs affecting foetus	11.96	10.21	30	88968	5488	46591576
Antiphospholipid antibodies	11.94	10.21	6	88992	161	46596903
Hyperreflexia	11.85	10.21	29	88969	5225	46591839
Hallucinations, mixed	11.78	10.21	24	88974	3825	46593239
Neurological decompensation	11.74	10.21	16	88982	1832	46595232
Dreamy state	11.73	10.21	4	88994	38	46597026
Anaemia	11.70	10.21	385	88613	255394	46341670
Inappropriate affect	11.69	10.21	11	88987	839	46596225
Sinus tachycardia	11.68	10.21	76	88922	21573	46575491
Fibula agenesis	11.65	10.21	3	88995	9	46597055
Sepsis	11.53	10.21	186	88812	135828	46461236
Foetal exposure during pregnancy	11.51	10.21	99	88899	30648	46566416
Generalised anxiety disorder	11.51	10.21	15	88983	1645	46595419
Gamma-glutamyltransferase abnormal	11.50	10.21	7	88991	275	46596789
Anaphylactic shock	11.49	10.21	13	88985	20261	46576803
Haematemesis	11.45	10.21	94	88904	28712	46568352
Injection site warmth	11.40	10.21	6	88992	13766	46583298
Increased appetite	11.39	10.21	39	88959	8488	46588576
Hypoaesthesia oral	11.34	10.21	45	88953	10514	46586550
Respiration abnormal	11.33	10.21	26	88972	4495	46592569
Skin lesion	11.33	10.21	21	88977	26692	46570372
Formication	11.33	10.21	24	88974	3932	46593132
Sinus disorder	11.28	10.21	9	88989	16554	46580510
Gastrointestinal disorder	11.23	10.21	67	88931	59509	46537555
Antipsychotic drug level below therapeutic	11.15	10.21	7	88991	291	46596773
Muscle disorder	11.13	10.21	25	88973	4261	46592803
Catastrophic reaction	10.99	10.21	3	88995	12	46597052
Product complaint	10.99	10.21	49	88949	12052	46585012
Vaginal haemorrhage	10.97	10.21	20	88978	25584	46571480
Nail avulsion	10.97	10.21	4	88994	47	46597017
Lower respiratory tract infection	10.89	10.21	61	88937	55028	46542036
Alcoholism	10.88	10.21	17	88981	2201	46594863
Lower limb fracture	10.87	10.21	5	88993	12393	46584671
Faecaloma	10.84	10.21	36	88962	7716	46589348
Mucosal inflammation	10.83	10.21	38	88960	38938	46558126
Product availability issue	10.81	10.21	12	88986	1113	46595951
Appetite disorder	10.80	10.21	28	88970	5226	46591838
Suspected suicide	10.80	10.21	26	88972	4635	46592429
Pulse absent	10.80	10.21	27	88971	4929	46592135
Weight increased	10.76	10.21	399	88599	164074	46432990
Compulsions	10.75	10.21	6	88992	200	46596864
Tendonitis	10.71	10.21	7	88991	14270	46582794
Haemoglobin decreased	10.71	10.21	177	88821	128772	46468292
Adrenal cyst	10.69	10.21	5	88993	114	46596950
Lipohypertrophy	10.63	10.21	10	88988	762	46596302
Pharyngeal erythema	10.63	10.21	14	88984	1551	46595513
Migraine	10.60	10.21	84	88914	69942	46527122
Anticholinergic syndrome	10.52	10.21	15	88983	1791	46595273
Sleep terror	10.50	10.21	10	88988	774	46596290
Bifascicular block	10.50	10.21	5	88993	119	46596945
Paresis	10.49	10.21	16	88982	2030	46595034
C-reactive protein increased	10.46	10.21	67	88931	58523	46538541
Polyneuropathy	10.46	10.21	47	88951	11597	46585467
Poverty of thought content	10.45	10.21	3	88995	15	46597049
Sinus congestion	10.43	10.21	6	88992	13103	46583961
Nose deformity	10.42	10.21	5	88993	121	46596943
Atrial fibrillation	10.40	10.21	137	88861	103453	46493611
Swollen tongue	10.37	10.21	93	88905	29139	46567925
Multiple organ dysfunction syndrome	10.36	10.21	57	88941	51653	46545411
Hyperphagia	10.33	10.21	14	88984	1594	46595470
Potentiating drug interaction	10.32	10.21	23	88975	3900	46593164
Snake bite	10.29	10.21	3	88995	16	46597048
Failure to thrive	10.27	10.21	32	88966	6632	46590432
Injection site urticaria	10.23	10.21	5	88993	11962	46585102
Acute myeloid leukaemia	10.22	10.21	9	88989	15769	46581295

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	443.33	10.73	1074	61577	176109	29713718
Intentional overdose	415.42	10.73	472	62179	41009	29848818
Intentional self-injury	345.33	10.73	260	62391	13272	29876555
Completed suicide	299.98	10.73	650	62001	98842	29790985
Suicide attempt	297.32	10.73	375	62276	36322	29853505
Agitation	230.54	10.73	409	62242	53664	29836163
Serotonin syndrome	210.95	10.73	222	62429	17669	29872158
Overdose	200.25	10.73	502	62149	83835	29805992
Suicidal ideation	198.04	10.73	306	62345	35808	29854019
Somnolence	184.43	10.73	531	62120	96232	29793595
Confusional state	179.22	10.73	654	61997	134180	29755647
Sopor	154.46	10.73	150	62501	10841	29878986
Drug abuse	153.05	10.73	447	62204	81625	29808202
Anxiety	153.02	10.73	474	62177	89397	29800430
Depression	145.73	10.73	468	62183	89969	29799858
Restlessness	133.07	10.73	198	62453	22401	29867426
Coma	128.19	10.73	270	62381	40179	29849648
Restless legs syndrome	102.63	10.73	97	62554	6775	29883052
Extrapyramidal disorder	100.69	10.73	118	62533	10575	29879252
Fall	92.04	10.73	673	61978	181199	29708628
Aggression	90.93	10.73	223	62428	36684	29853143
Drug interaction	89.02	10.73	717	61934	198851	29690976
Delirium	88.17	10.73	234	62417	40397	29849430
Tremor	82.36	10.73	344	62307	75019	29814808
Drug withdrawal syndrome	81.95	10.73	148	62503	19661	29870166
Akathisia	81.86	10.73	80	62571	5824	29884003
Electrocardiogram QT prolonged	81.45	10.73	210	62441	35625	29854202
Nightmare	80.12	10.73	112	62539	11964	29877863
Neuroleptic malignant syndrome	79.53	10.73	131	62520	16164	29873663
Sedation	79.07	10.73	131	62520	16242	29873585
Mania	77.97	10.73	96	62555	9058	29880769
Accidental overdose	73.64	10.73	135	62516	18140	29871687
Febrile neutropenia	67.66	10.73	74	62577	106619	29783208
Hallucination, visual	66.15	10.73	120	62531	15993	29873834
Wrong patient received product	65.13	10.73	43	62608	1774	29888053
Logorrhoea	64.46	10.73	45	62606	2037	29887790
Myoclonus	63.60	10.73	106	62545	13206	29876621
Parkinsonism	63.15	10.73	77	62574	7192	29882635
Depressed mood	61.43	10.73	120	62531	16909	29872918
Muscle twitching	60.72	10.73	80	62571	8075	29881752
Depressed level of consciousness	60.72	10.73	197	62454	38025	29851802
Disorientation	60.26	10.73	173	62478	31245	29858582
Interstitial lung disease	58.98	10.73	26	62625	60171	29829656
Insomnia	58.22	10.73	364	62287	92972	29796855
Pneumonia aspiration	57.57	10.73	192	62459	37588	29852239
Bradyphrenia	57.46	10.73	55	62596	3902	29885925
Abnormal behaviour	54.98	10.73	147	62504	25476	29864351
Withdrawal syndrome	54.30	10.73	90	62561	11160	29878667
Dyskinesia	49.64	10.73	128	62523	21706	29868121
Panic attack	49.56	10.73	75	62576	8606	29881221
Hallucination	48.23	10.73	217	62434	48842	29840985
Apathy	47.74	10.73	62	62589	6170	29883657
Delusion	47.58	10.73	88	62563	11901	29877926
Myocardial infarction	47.32	10.73	122	62529	125503	29764324
Psychomotor hyperactivity	46.88	10.73	71	62580	8153	29881674
Antidepressant drug level above therapeutic	45.64	10.73	16	62635	150	29889677
Inappropriate antidiuretic hormone secretion	45.53	10.73	84	62567	11338	29878489
Progressive multifocal leukoencephalopathy	44.71	10.73	73	62578	8940	29880887
Hallucination, auditory	44.18	10.73	76	62575	9713	29880114
Sleep disorder	43.32	10.73	131	62520	24348	29865479
Disturbance in attention	42.57	10.73	122	62529	22007	29867820
Illusion	42.51	10.73	24	62627	744	29889083
Poisoning	42.01	10.73	81	62570	11301	29878526
Psychotic disorder	41.76	10.73	119	62532	21396	29868431
Rheumatoid arthritis	41.62	10.73	17	62634	41180	29848647
Cough	41.44	10.73	130	62521	125512	29764315
Illness anxiety disorder	41.32	10.73	15	62636	157	29889670
Priapism	40.80	10.73	50	62601	4693	29885134
Antipsychotic drug level above therapeutic	40.01	10.73	26	62625	1044	29888783
Loss of consciousness	39.59	10.73	293	62358	79082	29810745
Platelet count decreased	39.24	10.73	104	62547	106025	29783802
Pruritus	39.20	10.73	122	62529	118082	29771745
Muscle rigidity	39.08	10.73	74	62577	10187	29879640
Atrial fibrillation	38.45	10.73	108	62543	108016	29781811
Tachycardia	37.23	10.73	273	62378	73466	29816361
Paranoia	36.99	10.73	72	62579	10116	29879711
Hyponatraemia	36.36	10.73	253	62398	66949	29822878
Pneumonia	35.72	10.73	489	62162	333817	29556010
Renal failure	35.49	10.73	144	62507	128822	29761005
Persecutory delusion	35.43	10.73	32	62619	2108	29887719
Mental disorder	34.96	10.73	83	62568	13366	29876461
Nasopharyngitis	34.92	10.73	43	62608	58806	29831021
Rhabdomyolysis	34.77	10.73	240	62411	63340	29826487
Pyrexia	34.30	10.73	423	62228	294066	29595761
Accidental death	34.24	10.73	31	62620	2048	29887779
Major depression	33.95	10.73	42	62609	3980	29885847
Disease progression	33.70	10.73	73	62578	79801	29810026
Blood creatine phosphokinase increased	33.15	10.73	180	62471	43668	29846159
Cardiac failure congestive	32.51	10.73	81	62570	84326	29805501
Tardive dyskinesia	32.20	10.73	46	62605	5011	29884816
Hypomania	32.08	10.73	31	62620	2225	29887602
Hyponatraemic coma	31.94	10.73	9	62642	37	29889790
Selective eating disorder	31.52	10.73	27	62624	1657	29888170
Drug dependence	31.35	10.73	107	62544	21188	29868639
On and off phenomenon	30.76	10.73	34	62617	2857	29886970
Analgesic drug level above therapeutic	29.55	10.73	13	62638	232	29889595
Poisoning deliberate	29.52	10.73	48	62603	5856	29883971
Rash	29.52	10.73	258	62393	191631	29698196
Prescription drug used without a prescription	29.43	10.73	23	62628	1239	29888588
Neuropathy peripheral	29.24	10.73	65	62586	70410	29819417
Respiratory arrest	29.18	10.73	130	62521	29128	29860699
Anaemia	28.84	10.73	287	62364	207705	29682122
Hyperhidrosis	28.67	10.73	239	62412	66851	29822976
Platypnoea	28.57	10.73	8	62643	32	29889795
Oesophageal obstruction	28.31	10.73	15	62636	409	29889418
Miosis	28.29	10.73	55	62596	7721	29882106
Urinary retention	28.25	10.73	140	62511	32777	29857050
Asthma	27.77	10.73	21	62630	36153	29853674
Dystonia	27.44	10.73	62	62589	9665	29880162
Product prescribing error	27.24	10.73	87	62564	16646	29873181
Infusion related reaction	26.96	10.73	27	62624	40537	29849290
Macrophages increased	26.86	10.73	11	62640	163	29889664
Catatonia	26.66	10.73	39	62612	4341	29885486
Altered state of consciousness	26.66	10.73	97	62554	19822	29870005
Diarrhoea	26.60	10.73	516	62135	333587	29556240
Pleural effusion	26.30	10.73	74	62577	73992	29815835
Hyperreflexia	26.17	10.73	31	62620	2808	29887019
Hallucinations, mixed	26.07	10.73	29	62622	2454	29887373
Depressive symptom	26.06	10.73	24	62627	1621	29888206
Product prescribing issue	25.78	10.73	18	62633	815	29889012
Dysgraphia	25.55	10.73	23	62628	1508	29888319
Benign gastrointestinal neoplasm	25.33	10.73	10	62641	134	29889693
Cytomegalovirus infection	25.19	10.73	9	62642	23665	29866162
Alcohol use	25.16	10.73	35	62616	3720	29886107
Sarcopenia	25.07	10.73	12	62639	262	29889565
Bipolar disorder	25.01	10.73	35	62616	3741	29886086
Thrombocytopenia	24.90	10.73	176	62475	136868	29752959
Urticaria	24.64	10.73	48	62603	54558	29835269
Stomatitis	24.56	10.73	25	62626	37254	29852573
Congenital cerebrovascular anomaly	24.47	10.73	6	62645	12	29889815
Respiratory disorder neonatal	24.20	10.73	20	62631	1168	29888659
Feeling guilty	23.89	10.73	12	62639	292	29889535
Renal impairment	23.77	10.73	93	62558	84091	29805736
Aptyalism	23.59	10.73	11	62640	226	29889601
Herpes zoster	23.48	10.73	17	62634	29926	29859901
Feeling jittery	23.04	10.73	34	62617	3814	29886013
Bradykinesia	22.99	10.73	31	62620	3199	29886628
Pulmonary congestion	22.91	10.73	67	62584	12220	29877607
Cogwheel rigidity	22.88	10.73	19	62632	1117	29888710
Slow speech	22.87	10.73	18	62633	980	29888847
IVth nerve disorder	22.75	10.73	6	62645	18	29889809
Mood altered	22.63	10.73	52	62599	8198	29881629
Drug hypersensitivity	22.49	10.73	71	62580	68448	29821379
Arthralgia	22.48	10.73	179	62472	135612	29754215
Pressure of speech	22.29	10.73	13	62638	429	29889398
Ataxia	21.85	10.73	63	62588	11399	29878428
Acute psychosis	21.60	10.73	23	62628	1853	29887974
Erythema	21.59	10.73	86	62565	77365	29812462
Vestibular disorder	21.57	10.73	16	62635	797	29889030
Parkinsonian gait	21.53	10.73	13	62638	458	29889369
Injection site pain	21.52	10.73	19	62632	30291	29859536
Acute kidney injury	21.44	10.73	424	62227	273418	29616409
Perforated ulcer	21.41	10.73	9	62642	143	29889684
Irritability	21.19	10.73	100	62551	22950	29866877
Decreased gait velocity	21.06	10.73	8	62643	96	29889731
Acute myocardial infarction	21.01	10.73	50	62601	52889	29836938
Helplessness	20.94	10.73	7	62644	56	29889771
Sepsis	20.69	10.73	201	62450	146194	29743633
Psychomotor skills impaired	20.59	10.73	23	62628	1956	29887871
Activation syndrome	20.55	10.73	8	62643	103	29889724
Temperature regulation disorder	20.53	10.73	13	62638	499	29889328
Dysarthria	20.29	10.73	121	62530	30369	29859458
Depersonalisation/derealisation disorder	20.18	10.73	13	62638	514	29889313
Sinusitis	20.16	10.73	24	62627	33321	29856506
Substance abuse	20.00	10.73	45	62606	6995	29882832
Hanging	19.88	10.73	8	62643	113	29889714
Bezoar	19.83	10.73	16	62635	903	29888924
Hypertonia	19.72	10.73	34	62617	4351	29885476
Dyspnoea	19.67	10.73	539	62112	332756	29557071
Rebound effect	19.52	10.73	20	62631	1541	29888286
Loss of proprioception	19.48	10.73	10	62641	255	29889572
Mucosal inflammation	19.47	10.73	21	62630	30473	29859354
Verbal abuse	19.34	10.73	9	62642	184	29889643
Dementia with Lewy bodies	19.05	10.73	13	62638	567	29889260
Suspected suicide	19.03	10.73	28	62623	3133	29886694
Blood ethanol increased	19.00	10.73	11	62640	358	29889469
Arachnoid cyst	18.14	10.73	9	62642	213	29889614
Metabolic syndrome	18.13	10.73	19	62632	1503	29888324
Homicide	18.02	10.73	16	62635	1030	29888797
Hypervigilance	17.87	10.73	8	62643	149	29889678
Cardiac failure	17.77	10.73	102	62549	83316	29806511
Blood creatinine increased	17.75	10.73	115	62536	91260	29798567
Seizure	17.74	10.73	297	62354	98178	29791649
Renal disorder	17.71	10.73	14	62637	23570	29866257
Arthritis	17.68	10.73	15	62636	24386	29865441
Hangover	17.61	10.73	16	62635	1062	29888765
Antipsychotic drug level increased	17.57	10.73	27	62624	3139	29886688
Ejaculation failure	17.45	10.73	14	62637	784	29889043
Circulatory collapse	17.36	10.73	86	62565	20128	29869699
Drug ineffective	17.22	10.73	562	62089	339825	29550002
Loose associations	17.14	10.73	6	62645	56	29889771
Eosinophilic myocarditis	17.05	10.73	11	62640	436	29889391
Amnestic disorder	17.04	10.73	8	62643	167	29889660
Respiratory rate decreased	17.03	10.73	20	62631	1795	29888032
Myelodysplastic syndrome	17.02	10.73	9	62642	18769	29871058
Implant site extravasation	17.01	10.73	11	62640	438	29889389
Peritonitis	16.94	10.73	12	62639	21363	29868464
Peripheral swelling	16.90	10.73	68	62583	61006	29828821
Septic shock	16.87	10.73	72	62579	63535	29826292
Chest pain	16.82	10.73	161	62490	117466	29772361
Osteonecrosis of jaw	16.77	10.73	9	62642	18609	29871218
Psychiatric decompensation	16.72	10.73	17	62634	1298	29888529
Balance disorder	16.66	10.73	132	62519	36361	29853466
Sexual dysfunction	16.65	10.73	38	62613	5963	29883864
Ejaculation disorder	16.64	10.73	15	62636	985	29888842
Neonatal respiratory distress syndrome	16.61	10.73	30	62621	3982	29885845
Hepatic steatosis	16.50	10.73	68	62583	14725	29875102
Urine sodium decreased	16.34	10.73	8	62643	184	29889643
Respiratory tract infection	16.32	10.73	6	62645	15500	29874327
Oesophageal haemorrhage	16.28	10.73	16	62635	1172	29888655
Postoperative respiratory failure	16.10	10.73	6	62645	68	29889759
Alcoholism	16.05	10.73	27	62624	3387	29886440
Feelings of worthlessness	15.84	10.73	8	62643	197	29889630
Soft tissue mass	15.74	10.73	9	62642	286	29889541
Psychomotor retardation	15.68	10.73	22	62629	2357	29887470
Tubulointerstitial nephritis	15.60	10.73	9	62642	17882	29871945
Haemoglobin decreased	15.55	10.73	158	62493	113940	29775887
Hyperbilirubinaemia	15.54	10.73	8	62643	16934	29872893
Erectile dysfunction	15.53	10.73	77	62574	18025	29871802
Rapid eye movements sleep abnormal	15.48	10.73	8	62643	207	29889620
Nervousness	15.43	10.73	57	62594	11731	29878096
Off label use	15.24	10.73	401	62250	248889	29640938
Intentional product misuse	15.06	10.73	124	62527	34543	29855284
Self esteem decreased	15.06	10.73	11	62640	535	29889292
Sleep deficit	15.05	10.73	10	62641	417	29889410
Eosinophilic pleural effusion	15.04	10.73	8	62643	220	29889607
Posture abnormal	14.99	10.73	19	62632	1845	29887982
Cellulitis	14.98	10.73	49	62602	46735	29843092
Tricuspid valve sclerosis	14.96	10.73	5	62646	40	29889787
Speech disorder	14.88	10.73	95	62556	24417	29865410
Urinary hesitation	14.87	10.73	21	62630	2263	29887564
Drug withdrawal syndrome neonatal	14.78	10.73	25	62626	3150	29886677
Fear of disease	14.78	10.73	8	62643	228	29889599
Insulin resistance	14.77	10.73	11	62640	551	29889276
Gait disturbance	14.76	10.73	229	62422	74548	29815279
Stupor	14.75	10.73	24	62627	2929	29886898
Anger	14.75	10.73	54	62597	11066	29878761
Drug reaction with eosinophilia and systemic symptoms	14.70	10.73	23	62628	28465	29861362
Gout	14.69	10.73	9	62642	17306	29872521
Asphyxia	14.66	10.73	34	62617	5391	29884436
Neonatal hyponatraemia	14.65	10.73	6	62645	89	29889738
Mood swings	14.62	10.73	42	62609	7584	29882243
Pancytopenia	14.58	10.73	111	62540	84941	29804886
Fear of weight gain	14.49	10.73	4	62647	15	29889812
Xanthoma	14.47	10.73	6	62645	92	29889735
Acute myeloid leukaemia	14.41	10.73	10	62641	17996	29871831
Upper respiratory tract infection	14.36	10.73	22	62629	27454	29862373
Bronchopulmonary aspergillosis	14.26	10.73	4	62647	12280	29877547
Sudden cardiac death	14.21	10.73	27	62624	3725	29886102
Body temperature abnormal	14.18	10.73	10	62641	460	29889367
Failure to thrive	14.15	10.73	43	62608	8011	29881816
Pyroglutamic acidosis	14.07	10.73	6	62645	99	29889728
Sinus bradycardia	14.03	10.73	55	62596	11640	29878187
JC virus infection	14.01	10.73	18	62633	1772	29888055
Sepsis neonatal	14.00	10.73	8	62643	254	29889573
Psoriasis	13.97	10.73	44	62607	42462	29847365
Pelvic fracture	13.93	10.73	20	62631	2188	29887639
Non-alcoholic steatohepatitis	13.89	10.73	12	62639	745	29889082
Pulmonary fibrosis	13.85	10.73	8	62643	15882	29873945
Locked-in syndrome	13.83	10.73	8	62643	260	29889567
Dry skin	13.75	10.73	16	62635	22438	29867389
White blood cell count decreased	13.72	10.73	111	62540	83836	29805991
Mumps	13.69	10.73	6	62645	106	29889721
Palmar-plantar erythrodysaesthesia syndrome	13.67	10.73	7	62644	14863	29874964
Wrong product administered	13.66	10.73	30	62621	4588	29885239
Neutropenia	13.66	10.73	188	62463	128352	29761475
Tumour lysis syndrome	13.53	10.73	5	62646	12880	29876947
Malignant neoplasm progression	13.52	10.73	92	62559	72195	29817632
Obsessive-compulsive disorder	13.52	10.73	28	62623	4113	29885714
Polypectomy	13.34	10.73	10	62641	506	29889321
Cryptorchism	13.34	10.73	17	62634	1660	29888167
Hyporesponsive to stimuli	13.27	10.73	13	62638	949	29888878
Spinal cord injury thoracic	13.20	10.73	6	62645	116	29889711
Back pain	13.19	10.73	144	62507	102452	29787375
Mastication disorder	13.15	10.73	14	62637	1128	29888699
Sensory disturbance	13.13	10.73	34	62617	5777	29884050
Housebound	13.11	10.73	7	62644	194	29889633
Acute pulmonary oedema	13.08	10.73	40	62611	7475	29882352
Hypotonia	13.06	10.73	38	62613	6910	29882917
Pneumocystis jirovecii pneumonia	13.06	10.73	10	62641	17110	29872717
Consciousness fluctuating	12.98	10.73	13	62638	975	29888852
Alcohol poisoning	12.94	10.73	26	62625	3738	29886089
Dementia	12.90	10.73	56	62595	12405	29877422
Electrocardiogram QRS complex prolonged	12.90	10.73	28	62623	4249	29885578
Nephrolithiasis	12.83	10.73	20	62631	24790	29865037
Basal cell carcinoma	12.76	10.73	9	62642	16059	29873768
Social avoidant behaviour	12.62	10.73	22	62629	2841	29886986
Hypersomnia	12.60	10.73	52	62599	11264	29878563
Mitral valve sclerosis	12.58	10.73	6	62645	130	29889697
Dysaesthesia	12.54	10.73	19	62632	2182	29887645
Limited symptom panic attack	12.53	10.73	5	62646	69	29889758
Nasal discomfort	12.47	10.73	14	62637	1197	29888630
Incoherent	12.46	10.73	27	62624	4091	29885736
Abdominal discomfort	12.46	10.73	56	62595	48735	29841092
Diabetes insipidus	12.29	10.73	19	62632	2220	29887607
Homicidal ideation	12.28	10.73	20	62631	2443	29887384
Blood pressure increased	12.26	10.73	94	62557	71834	29817993
Epilepsy	12.14	10.73	78	62573	20091	29869736
Mutism	12.07	10.73	11	62640	733	29889094
Small for dates baby	12.05	10.73	23	62628	3185	29886642
Cold sweat	11.96	10.73	44	62607	9038	29880789
Impaired driving ability	11.96	10.73	20	62631	2498	29887329
Sinus tachycardia	11.95	10.73	64	62587	15440	29874387
Agitated depression	11.92	10.73	7	62644	234	29889593
Electric shock	11.87	10.73	6	62645	148	29889679
Implant site infection	11.79	10.73	12	62639	917	29888910
Intentional product use issue	11.78	10.73	38	62613	36402	29853425
Inappropriate schedule of product administration	11.78	10.73	43	62608	39685	29850142
Kidney congestion	11.76	10.73	7	62644	240	29889587
Rash erythematous	11.71	10.73	18	62633	22434	29867393
Contraindication to medical treatment	11.66	10.73	9	62642	476	29889351
Inferior vena caval occlusion	11.65	10.73	4	62647	35	29889792
Nasal congestion	11.61	10.73	13	62638	18553	29871274
Suprapubic pain	11.60	10.73	8	62643	355	29889472
Intentional device misuse	11.58	10.73	7	62644	247	29889580
Plasma cell myeloma	11.58	10.73	65	62586	53397	29836430
Bladder dilatation	11.56	10.73	14	62637	1298	29888529
Toxic encephalopathy	11.50	10.73	28	62623	4581	29885246
Formication	11.50	10.73	16	62635	1701	29888126
Lung disorder	11.49	10.73	31	62620	31438	29858389
Dysphoria	11.48	10.73	18	62633	2130	29887697
Splenomegaly	11.45	10.73	7	62644	13473	29876354
Blood urea increased	11.39	10.73	31	62620	31350	29858477
Respiratory depression	11.38	10.73	51	62600	11452	29878375
Fluid retention	11.25	10.73	22	62629	24976	29864851
Cerebellar ataxia	11.22	10.73	12	62639	972	29888855
Head discomfort	11.20	10.73	21	62630	2869	29886958
Cerebrovascular accident	11.20	10.73	116	62535	83361	29806466
Pseudomonas infection	11.12	10.73	4	62647	10478	29879349
Jealous delusion	11.12	10.73	7	62644	266	29889561
Panic disorder	11.11	10.73	13	62638	1162	29888665
Suspiciousness	11.10	10.73	8	62643	381	29889446
Pharyngitis bacterial	11.09	10.73	4	62647	41	29889786
Flatulence	11.01	10.73	13	62638	18116	29871711
Respiratory acidosis	10.99	10.73	26	62625	4176	29885651
Thrombotic stroke	10.93	10.73	7	62644	274	29889553
Hyperthermia	10.93	10.73	46	62605	10053	29879774
Hypertrophic scar	10.92	10.73	3	62648	11	29889816
Thinking abnormal	10.92	10.73	30	62621	5281	29884546
Staphylococcal infection	10.87	10.73	30	62621	30194	29859633
Prostate cancer	10.85	10.73	21	62630	23936	29865891
JC virus CSF test positive	10.85	10.73	5	62646	100	29889727
Pneumonitis	10.83	10.73	26	62625	27428	29862399
Agitation neonatal	10.81	10.73	12	62639	1013	29888814
Hepatic function abnormal	10.80	10.73	48	62603	41897	29847930
Joint swelling	10.76	10.73	56	62595	46890	29842937
Porphyria acute	10.76	10.73	5	62646	102	29889725

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
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
CHEBI has role	CHEBI:35474	minor tranquilisers
CHEBI has role	CHEBI:37890	alpha-adrenoceptor antagonists
CHEBI has role	CHEBI:37955	h1-receptor blockers
CHEBI has role	CHEBI:37956	histamine receptor blocker
CHEBI has role	CHEBI:48279	serotonin antagonists
CHEBI has role	CHEBI:146270	oneirogens

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Major depressive disorder	indication	370143000
Excessive vomiting in pregnancy	off-label use	14094001
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])	Mechanism action	Bioact source	MoA source
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN	ANTAGONIST	Ki	7.16		CHEMBL	CHEMBL
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN	ANTAGONIST	Ki	7.41		CHEMBL	CHEMBL
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	5.24		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-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
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN	ANTAGONIST	Ki	7.70		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
4020978	VUID
N0000148449	NUI
D00563	KEGG_DRUG
4020978	VANDF
C0049506	UMLSCUI
CHEBI:6950	CHEBI
CHEMBL654	ChEMBL_ID
D000078785	MESH_DESCRIPTOR_UI
DB00370	DRUGBANK_ID
7241	IUPHAR_LIGAND_ID
6481	INN_ID
A051Q2099Q	UNII
4205	PUBCHEM_CID
15996	RXNORM
46110	MMSL
5120	MMSL
d04025	MMSL
006054	NDDF
108430001	SNOMEDCT_US
386847004	SNOMEDCT_US

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	31 sections
REMERONSOLTAB	HUMAN PRESCRIPTION DRUG LABEL	1	0052-0106	TABLET, ORALLY DISINTEGRATING	15 mg	ORAL	NDA	31 sections
REMERON	HUMAN PRESCRIPTION DRUG LABEL	1	0052-0107	TABLET, FILM COATED	30 mg	ORAL	NDA	31 sections
REMERONSOLTAB	HUMAN PRESCRIPTION DRUG LABEL	1	0052-0108	TABLET, ORALLY DISINTEGRATING	30 mg	ORAL	NDA	31 sections
REMERON	HUMAN PRESCRIPTION DRUG LABEL	1	0052-0109	TABLET, FILM COATED	45 mg	ORAL	NDA	31 sections
REMERONSOLTAB	HUMAN PRESCRIPTION DRUG LABEL	1	0052-0110	TABLET, ORALLY DISINTEGRATING	45 mg	ORAL	NDA	31 sections
REMERON	HUMAN PRESCRIPTION DRUG LABEL	1	0052-4364	TABLET, FILM COATED	15 mg	ORAL	NDA	31 sections
REMERON	HUMAN PRESCRIPTION DRUG LABEL	1	0052-4365	TABLET, FILM COATED	30 mg	ORAL	NDA	31 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3515	TABLET, FILM COATED	15 mg	ORAL	ANDA	28 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3530	TABLET, FILM COATED	30 mg	ORAL	ANDA	28 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3545	TABLET, FILM COATED	45 mg	ORAL	ANDA	28 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8078	TABLET	7.50 mg	ORAL	ANDA	25 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8268	TABLET, FILM COATED	15 mg	ORAL	ANDA	25 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8269	TABLET, FILM COATED	30 mg	ORAL	ANDA	25 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6519	TABLET, FILM COATED	15 mg	ORAL	ANDA	24 sections
Mirtazapine	Human Prescription Drug Label	1	13107-001	TABLET, FILM COATED	7.50 mg	ORAL	ANDA	25 sections
Mirtazapine	Human Prescription Drug Label	1	13107-003	TABLET, FILM COATED	30 mg	ORAL	ANDA	25 sections
Mirtazapine	Human Prescription Drug Label	1	13107-031	TABLET, FILM COATED	15 mg	ORAL	ANDA	25 sections
Mirtazapine	Human Prescription Drug Label	1	13107-032	TABLET, FILM COATED	45 mg	ORAL	ANDA	25 sections
MIRTAZAPINE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-153	TABLET, FILM COATED	15 mg	ORAL	ANDA	26 sections
MIRTAZAPINE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-154	TABLET, FILM COATED	30 mg	ORAL	ANDA	26 sections
MIRTAZAPINE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-155	TABLET, FILM COATED	45 mg	ORAL	ANDA	26 sections
Mirtazapine	Human Prescription Drug Label	1	17856-0101	TABLET, FILM COATED	7.50 mg	ORAL	ANDA	25 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	21695-081	TABLET, FILM COATED	15 mg	ORAL	ANDA	29 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	21695-082	TABLET, FILM COATED	30 mg	ORAL	ANDA	29 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	21695-083	TABLET, FILM COATED	45 mg	ORAL	ANDA	29 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	33261-073	TABLET, FILM COATED	15 mg	ORAL	ANDA	25 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	33261-074	TABLET, FILM COATED	30 mg	ORAL	ANDA	26 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	42254-086	TABLET, FILM COATED	15 mg	ORAL	ANDA	26 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	42254-087	TABLET, FILM COATED	30 mg	ORAL	ANDA	26 sections