dimethyl fumarate Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	4757	624-49-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: dimethyl fumarate tecfidera methyl fumarate boletic acid dimethyl ester BG-12	A fumarate derivative that is used as a DERMATOLOGIC AGENT in the treatment of PSORIASIS and SKIN DISEASES. It also may be used as an IMMUNOSUPPRESSIVE AGENT in the treatment of MULTIPLE SCLEROSIS. Molecular weight: 144.13 Formula: C6H8O4 CLOGP: 0.78 LIPINSKI: 0 HAC: 4 HDO: 0 TPSA: 52.60 ALOGS: -1.05 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

dimethyl fumarate
tecfidera
methyl fumarate
boletic acid dimethyl ester
BG-12

A fumarate derivative that is used as a DERMATOLOGIC AGENT in the treatment of PSORIASIS and SKIN DISEASES. It also may be used as an IMMUNOSUPPRESSIVE AGENT in the treatment of MULTIPLE SCLEROSIS.

Molecular weight: 144.13
Formula: C6H8O4
CLOGP: 0.78
LIPINSKI: 0
HAC: 4
HDO: 0
TPSA: 52.60
ALOGS: -1.05
ROTB: 4

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.48	g	O

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
March 27, 2013	FDA	BIOGEN IDEC 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
Flushing	4189.16	14.90	1782	48032	68818	53230434
Multiple sclerosis relapse	3175.42	14.90	1286	48528	43567	53255685
Multiple sclerosis	1706.15	14.90	716	49098	26437	53272815
Prescribed underdose	863.92	14.90	377	49437	15290	53283962
Lymphopenia	551.34	14.90	283	49531	16560	53282692
Lymphocyte count decreased	434.16	14.90	290	49524	27762	53271490
Abdominal pain upper	390.31	14.90	616	49198	165675	53133577
General symptom	338.86	14.90	116	49698	2399	53296853
Gastrointestinal disorder	299.76	14.90	394	49420	89610	53209642
Central nervous system lesion	296.09	14.90	158	49656	10004	53289248
Hot flush	282.54	14.90	280	49534	46880	53252372
Memory impairment	266.81	14.90	361	49453	84396	53214856
Intentional underdose	265.90	14.90	91	49723	1880	53297372
Rheumatoid arthritis	254.14	14.90	9	49805	314522	52984730
Underdose	252.73	14.90	188	49626	21334	53277918
Gastric disorder	226.42	14.90	203	49611	29962	53269290
Diarrhoea	210.95	14.90	1142	48672	624404	52674848
Abortion spontaneous	196.68	14.90	230	49584	46405	53252847
Gait disturbance	186.55	14.90	439	49375	158403	53140849
Magnetic resonance imaging abnormal	180.98	14.90	76	49738	2793	53296459
Fall	175.56	14.90	730	49084	357710	52941542
Pruritus	170.18	14.90	631	49183	293201	53006051
Toxicity to various agents	168.30	14.90	9	49805	219589	53079663
Nausea	164.49	14.90	1235	48579	754856	52544396
Off label use	155.60	14.90	128	49686	472084	52827168
Balance disorder	153.40	14.90	258	49556	72949	53226303
Burning sensation	145.66	14.90	201	49613	47812	53251440
Vomiting	143.03	14.90	871	48943	496268	52802984
Seizure	140.23	14.90	347	49467	129162	53170090
Hypoaesthesia	138.40	14.90	351	49463	132644	53166608
Lymphocyte count abnormal	133.40	14.90	42	49772	660	53298592
Maternal exposure during pregnancy	132.10	14.90	381	49433	155258	53143994
Breast cancer	131.15	14.90	194	49620	49164	53250088
Optic neuritis	123.54	14.90	80	49734	7255	53291997
Acute kidney injury	122.75	14.90	42	49772	253826	53045426
Invasive ductal breast carcinoma	117.53	14.90	75	49739	6632	53292620
Drug hypersensitivity	113.33	14.90	53	49761	265189	53034063
Loss of control of legs	111.59	14.90	44	49770	1371	53297881
Urinary tract infection	110.48	14.90	480	49334	239423	53059829
Drug interaction	106.50	14.90	36	49778	219293	53079959
Paraesthesia	102.25	14.90	306	49508	127209	53172043
Muscular weakness	101.34	14.90	263	49551	100729	53198523
Dyspnoea	100.79	14.90	252	49562	585980	52713272
Product use issue	100.16	14.90	8	49806	139576	53159676
Cognitive disorder	96.67	14.90	160	49654	44618	53254634
Adverse reaction	95.52	14.90	74	49740	8913	53290339
Joint swelling	94.03	14.90	51	49763	234587	53064665
Condition aggravated	93.46	14.90	84	49730	297050	53002202
White blood cell count decreased	92.61	14.90	291	49523	124184	53175068
Chromaturia	85.06	14.90	89	49725	15861	53283391
Contraindicated product administered	84.18	14.90	13	49801	135616	53163636
Gait inability	80.17	14.90	135	49679	38176	53261076
Anaemia	79.18	14.90	85	49729	276633	53022619
Urticaria	78.54	14.90	292	49522	135593	53163659
Completed suicide	77.71	14.90	17	49797	138184	53161068
Glossodynia	77.11	14.90	4	49810	100287	53198965
Arthralgia	77.05	14.90	187	49627	439596	52859656
Secondary progressive multiple sclerosis	76.44	14.90	33	49781	1299	53297953
Abdominal discomfort	75.46	14.90	406	49408	220656	53078596
Relapsing-remitting multiple sclerosis	71.82	14.90	25	49789	544	53298708
Exposure during pregnancy	70.93	14.90	15	49799	124845	53174407
Hypotension	70.53	14.90	80	49734	253996	53045256
Injection site pain	70.06	14.90	11	49803	113380	53185872
Systemic lupus erythematosus	69.36	14.90	16	49798	125398	53173854
Drug intolerance	68.49	14.90	375	49439	205118	53094134
Synovitis	65.46	14.90	11	49803	107882	53191370
Product dose omission issue	65.42	14.90	352	49462	191268	53107984
Progressive multiple sclerosis	62.95	14.90	25	49789	794	53298458
Stress	62.80	14.90	154	49660	56930	53242322
Feeling hot	62.49	14.90	127	49687	41417	53257835
Oedema peripheral	61.57	14.90	42	49772	170745	53128507
Musculoskeletal disorder	60.30	14.90	78	49736	17421	53281831
Herpes zoster	58.68	14.90	177	49637	73842	53225410
Dyspepsia	58.20	14.90	182	49632	77418	53221834
Pancytopenia	58.07	14.90	8	49806	90920	53208332
Yellow skin	57.85	14.90	32	49782	2174	53297078
Thrombocytopenia	57.23	14.90	29	49785	138698	53160554
Cough	57.09	14.90	95	49719	256798	53042454
Product use in unapproved indication	57.00	14.90	17	49797	112272	53186980
Injection site erythema	56.61	14.90	4	49810	77245	53222007
Paternal exposure before pregnancy	55.90	14.90	12	49802	33	53299219
Peroneal nerve palsy	54.97	14.90	40	49774	4383	53294869
Mobility decreased	54.56	14.90	176	49638	76095	53223157
Malignant neoplasm progression	54.53	14.90	3	49811	71538	53227714
Malignant melanoma	53.57	14.90	58	49756	10744	53288508
Trigeminal neuralgia	53.52	14.90	35	49779	3226	53296026
Arthropathy	53.41	14.90	33	49781	141420	53157832
Stomatitis	53.33	14.90	13	49801	98145	53201107
Haemoglobin decreased	51.89	14.90	32	49782	137275	53161977
Blood creatinine increased	51.10	14.90	8	49806	82654	53216598
Hyponatraemia	50.66	14.90	19	49795	108588	53190664
Abdominal pain	50.07	14.90	409	49405	255494	53043758
Decreased immune responsiveness	49.34	14.90	36	49778	3961	53295291
Hemianaesthesia	48.96	14.90	18	49796	461	53298791
Neutropenia	48.79	14.90	46	49768	159139	53140113
Oxygen saturation decreased	48.40	14.90	7	49807	76718	53222534
Progressive multifocal leukoencephalopathy	48.09	14.90	58	49756	12071	53287181
Therapeutic product effect decreased	47.87	14.90	29	49785	125626	53173626
Muscle spasms	46.90	14.90	249	49565	134546	53164706
Renal impairment	45.32	14.90	11	49803	83307	53215945
Wound	44.44	14.90	15	49799	91542	53207710
Agraphia	43.92	14.90	10	49804	39	53299213
Caesarean section	43.02	14.90	66	49748	17254	53281998
CD4 lymphocytes decreased	42.76	14.90	24	49790	1677	53297575
Loss of personal independence in daily activities	42.60	14.90	7	49807	69808	53229444
Blindness unilateral	41.87	14.90	38	49776	5689	53293563
Abdominal distension	41.58	14.90	166	49648	79624	53219628
Hypersensitivity	40.80	14.90	336	49478	210329	53088923
Pleural effusion	40.47	14.90	16	49798	88563	53210689
Swelling	40.31	14.90	73	49741	191032	53108220
Papillary thyroid cancer	40.17	14.90	25	49789	2115	53297137
Ophthalmic herpes zoster	39.25	14.90	23	49791	1744	53297508
Drug abuse	39.04	14.90	7	49807	65519	53233733
Productive cough	38.66	14.90	4	49810	56725	53242527
Alopecia	37.61	14.90	359	49455	234224	53065028
Impaired self-care	37.32	14.90	23	49791	1912	53297340
Dyspnoea exertional	37.17	14.90	4	49810	54996	53244256
Wheezing	36.73	14.90	8	49806	65267	53233985
Erythema	36.31	14.90	261	49553	156708	53142544
Sinusitis	35.89	14.90	64	49750	168500	53130752
Hypoglycaemia	35.82	14.90	6	49808	59007	53240245
Skin burning sensation	35.77	14.90	49	49765	11561	53287691
Nasal congestion	35.69	14.90	4	49810	53283	53245969
Temperature intolerance	35.66	14.90	41	49773	8112	53291140
Disease progression	35.48	14.90	26	49788	101894	53197358
Hypoxia	35.31	14.90	5	49809	55675	53243577
Discomfort	35.03	14.90	23	49791	95449	53203803
Motor dysfunction	34.99	14.90	41	49773	8277	53290975
Ocular icterus	34.96	14.90	29	49785	3850	53295402
Sensory disturbance	34.70	14.90	51	49763	12835	53286417
Flatulence	34.62	14.90	85	49729	31432	53267820
Blindness	33.90	14.90	62	49752	18701	53280551
Thyroid cancer	33.82	14.90	30	49784	4360	53294892
Lower limb fracture	33.70	14.90	53	49761	14152	53285100
Relapsing multiple sclerosis	33.65	14.90	10	49804	128	53299124
International normalised ratio increased	33.52	14.90	3	49811	47758	53251494
Cardiac failure	32.43	14.90	20	49794	85824	53213428
Band sensation	32.19	14.90	15	49799	708	53298544
Hip fracture	31.88	14.90	77	49737	28180	53271072
Electrocardiogram QT prolonged	31.56	14.90	7	49807	56396	53242856
JC polyomavirus test positive	31.55	14.90	17	49797	1096	53298156
Exposure via father	31.53	14.90	12	49802	339	53298913
Hemiparesis	31.52	14.90	65	49749	21410	53277842
Cardio-respiratory arrest	31.48	14.90	8	49806	58750	53240502
Major depression	31.28	14.90	37	49777	7545	53291707
Multiple organ dysfunction syndrome	30.97	14.90	7	49807	55670	53243582
Wrong technique in product usage process	30.62	14.90	9	49805	60023	53239229
Visual impairment	29.07	14.90	140	49674	72772	53226480
Adverse event	28.67	14.90	94	49720	40967	53258285
Dehydration	28.60	14.90	261	49553	168149	53131103
Hypertension	28.56	14.90	111	49703	225320	53073932
Hypokalaemia	28.28	14.90	29	49785	96488	53202764
Depressed level of consciousness	28.05	14.90	8	49806	54420	53244832
Hysterectomy	27.70	14.90	37	49777	8524	53290728
Urosepsis	27.65	14.90	53	49761	16557	53282695
Bradycardia	27.62	14.90	16	49798	71040	53228212
Intraductal proliferative breast lesion	27.38	14.90	22	49792	2792	53296460
Pyrexia	27.27	14.90	243	49571	402950	52896302
Renal failure	27.03	14.90	43	49771	118409	53180843
Neuropathy peripheral	26.97	14.90	34	49780	103153	53196099
Psoriasis	26.86	14.90	25	49789	87064	53212188
Ankle fracture	26.64	14.90	52	49762	16463	53282789
Ascites	26.57	14.90	3	49811	39732	53259520
Feeding disorder	26.43	14.90	42	49772	11312	53287940
CD8 lymphocytes decreased	26.20	14.90	9	49805	188	53299064
Therapy cessation	26.06	14.90	71	49743	27954	53271298
Gastrointestinal haemorrhage	26.05	14.90	22	49792	80308	53218944
Depression	25.86	14.90	273	49541	182779	53116473
Pericarditis	25.75	14.90	14	49800	64392	53234860
Prolonged labour	25.49	14.90	12	49802	580	53298672
C-reactive protein increased	25.38	14.90	16	49798	67870	53231382
Pain	24.99	14.90	393	49421	588005	52711247
Lower respiratory tract infection	24.82	14.90	29	49785	90952	53208300
Oedema	24.56	14.90	20	49794	74326	53224926
Lactic acidosis	24.44	14.90	3	49811	37250	53262002
Appendicitis	24.32	14.90	31	49783	6823	53292429
Uterine leiomyosarcoma	24.08	14.90	6	49808	37	53299215
Tachycardia	24.01	14.90	40	49774	108172	53191080
Herpes zoster meningomyelitis	23.91	14.90	4	49810	0	53299252
Road traffic accident	23.89	14.90	65	49749	25566	53273686
Respiratory failure	23.39	14.90	36	49778	100476	53198776
Plasma cell myeloma	22.95	14.90	8	49806	47866	53251386
Blood pressure fluctuation	22.92	14.90	3	49811	35467	53263785
Mental disorder	22.91	14.90	62	49752	24314	53274938
Muscle spasticity	22.74	14.90	51	49763	17787	53281465
Asthma	22.62	14.90	42	49772	108930	53190322
Dysstasia	22.57	14.90	53	49761	19046	53280206
Miliaria	22.40	14.90	13	49801	968	53298284
Neoplasm malignant	21.97	14.90	63	49751	25538	53273714
Overdose	21.95	14.90	42	49772	107694	53191558
Gallbladder operation	21.88	14.90	17	49797	2055	53297197
Gastric bypass	21.79	14.90	15	49799	1505	53297747
Rhabdomyolysis	21.65	14.90	7	49807	43916	53255336
Myelitis	21.64	14.90	14	49800	1267	53297985
Myelitis transverse	21.25	14.90	13	49801	1067	53298185
Glioblastoma	21.23	14.90	12	49802	850	53298402
Cervix carcinoma	20.98	14.90	19	49795	2836	53296416
Weight increased	20.93	14.90	109	49705	204458	53094794
General physical health deterioration	20.82	14.90	69	49745	146873	53152379
Hyperglycaemia	20.45	14.90	6	49808	40078	53259174
Duodenal ulcer perforation	20.44	14.90	4	49810	35179	53264073
Cardiac arrest	20.43	14.90	35	49779	93632	53205620
Peripheral swelling	20.43	14.90	111	49703	205997	53093255
Injection site bruising	20.41	14.90	5	49809	37641	53261611
Genital hypoaesthesia	20.25	14.90	4	49810	6	53299246
Pulmonary hypertension	20.11	14.90	5	49809	37265	53261987
Cervical spinal stenosis	19.53	14.90	16	49798	2087	53297165
Bladder disorder	19.50	14.90	30	49784	7858	53291394
Gastrointestinal pain	19.46	14.90	31	49783	8368	53290884
Coronavirus infection	19.44	14.90	19	49795	3121	53296131
Invasive lobular breast carcinoma	19.30	14.90	11	49803	792	53298460
Noninfectious myelitis	19.20	14.90	4	49810	9	53299243
Somnolence	19.12	14.90	86	49728	167648	53131604
T-lymphocyte count decreased	19.10	14.90	8	49806	292	53298960
Hospitalisation	18.97	14.90	23	49791	70989	53228263
Hepatic failure	18.94	14.90	5	49809	35801	53263451
Micturition urgency	18.90	14.90	31	49783	8571	53290681
Primary progressive multiple sclerosis	18.73	14.90	6	49808	100	53299152
Diplopia	18.70	14.90	52	49762	20713	53278539
COVID-19	18.61	14.90	76	49738	36812	53262440
Drug reaction with eosinophilia and systemic symptoms	18.49	14.90	4	49810	32796	53266456
Blood pressure systolic increased	18.44	14.90	5	49809	35172	53264080
Concussion	18.35	14.90	29	49785	7775	53291477
Pancreatic failure	18.33	14.90	11	49803	872	53298380
Pulmonary oedema	18.31	14.90	14	49800	53709	53245543
Influenza like illness	18.20	14.90	108	49706	60751	53238501
Cardiac failure congestive	18.17	14.90	37	49777	92720	53206532
Decubitus ulcer	18.11	14.90	34	49780	10459	53288793
Nephrolithiasis	17.98	14.90	75	49739	36672	53262580
Facial spasm	17.72	14.90	10	49804	706	53298546
Lymphocyte percentage abnormal	17.69	14.90	4	49810	15	53299237
Epistaxis	17.58	14.90	23	49791	68687	53230565
Tibia fracture	17.46	14.90	22	49792	4785	53294467
Cholestasis	17.23	14.90	3	49811	28692	53270560
Pneumonia	17.22	14.90	272	49542	406897	52892355
Head injury	17.02	14.90	58	49756	25775	53273477
Fibromyalgia	17.02	14.90	10	49804	44065	53255187
Pneumonitis	16.95	14.90	4	49810	30884	53268368
Bronchitis	16.94	14.90	51	49763	111848	53187404
Squamous cell carcinoma of the vulva	16.76	14.90	4	49810	20	53299232
Unevaluable event	16.74	14.90	13	49801	49485	53249767
Intentional overdose	16.68	14.90	23	49791	67182	53232070
Accident	16.56	14.90	23	49791	5498	53293754
Gait spastic	16.52	14.90	7	49807	263	53298989
Chronic kidney disease	16.52	14.90	10	49804	43360	53255892
Fluid overload	16.52	14.90	3	49811	27828	53271424
Injury	16.47	14.90	14	49800	50957	53248295
Dermatitis allergic	16.42	14.90	38	49776	13530	53285722
Bone pain	16.31	14.90	14	49800	50708	53248544
Neurogenic bladder	16.20	14.90	17	49797	3039	53296213
Cervical dysplasia	16.08	14.90	17	49797	3064	53296188
Blood pressure increased	16.02	14.90	72	49742	140407	53158845
Nasal sinus cancer	16.01	14.90	4	49810	25	53299227
Sedation	15.97	14.90	4	49810	29671	53269581
Malignant neoplasm of unknown primary site	15.92	14.90	7	49807	288	53298964
Uterine cancer	15.87	14.90	19	49795	3922	53295330
Septic shock	15.75	14.90	21	49793	62208	53237044
Metabolic acidosis	15.73	14.90	10	49804	42232	53257020
Hypocalcaemia	15.70	14.90	4	49810	29333	53269919
Haematoma	15.64	14.90	6	49808	33838	53265414
Breast cancer female	15.61	14.90	25	49789	6779	53292473
Musculoskeletal pain	15.59	14.90	29	49785	75171	53224081
Melaena	15.54	14.90	4	49810	29125	53270127
Herpes simplex encephalitis	15.53	14.90	7	49807	306	53298946
Injection site reaction	15.41	14.90	15	49799	51151	53248101
Ataxia	15.40	14.90	39	49775	14698	53284554
Human papilloma virus test positive	15.40	14.90	8	49806	479	53298773
Amnesia	15.28	14.90	83	49731	45205	53254047
Accidental exposure to product by child	15.18	14.90	11	49803	1197	53298055
Platelet count decreased	15.15	14.90	51	49763	108048	53191204
Premature delivery	15.09	14.90	3	49811	26101	53273151
Impaired healing	14.93	14.90	23	49791	64182	53235070

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
Multiple sclerosis relapse	1494.81	20.42	422	12325	11359	32489420
Multiple sclerosis	1019.30	20.42	285	12462	7359	32493420
Flushing	996.50	20.42	395	12352	30732	32470047
Prescribed underdose	228.58	20.42	96	12651	8563	32492216
Lymphopenia	178.80	20.42	95	12652	14361	32486418
Lymphocyte count decreased	165.29	20.42	103	12644	21016	32479763
Central nervous system lesion	141.74	20.42	61	12686	5771	32495008
General symptom	131.23	20.42	36	12711	856	32499923
Relapsing-remitting multiple sclerosis	129.24	20.42	33	12714	589	32500190
Memory impairment	129.02	20.42	115	12632	40364	32460415
Balance disorder	111.87	20.42	105	12642	39354	32461425
Gastric disorder	108.01	20.42	63	12684	11393	32489386
Gait disturbance	100.71	20.42	140	12607	80268	32420511
Fall	98.66	20.42	229	12518	195972	32304807
Urinary tract infection	87.94	20.42	131	12616	79940	32420839
Muscle spasticity	85.71	20.42	43	12704	5762	32495017
Abdominal discomfort	78.72	20.42	100	12647	52524	32448255
Gait spastic	76.59	20.42	21	12726	498	32500281
Acute kidney injury	74.12	20.42	13	12734	293455	32207324
Gastrointestinal disorder	72.12	20.42	74	12673	30857	32469922
Hot flush	69.68	20.42	54	12693	15592	32485187
Needle fatigue	66.17	20.42	18	12729	414	32500365
Abdominal pain upper	65.22	20.42	104	12643	67234	32433545
Loss of control of legs	64.91	20.42	19	12728	574	32500205
Mobility decreased	60.92	20.42	65	12682	28344	32472435
Magnetic resonance imaging abnormal	59.79	20.42	23	12724	1628	32499151
Toxicity to various agents	57.54	20.42	3	12744	178038	32322741
Muscular weakness	55.21	20.42	97	12650	67832	32432947
Progressive multiple sclerosis	52.35	20.42	13	12734	206	32500573
CD8 lymphocytes decreased	52.33	20.42	11	12736	78	32500701
Hypertonic bladder	52.32	20.42	20	12727	1391	32499388
Paraesthesia	51.60	20.42	87	12660	58857	32441922
Intentional underdose	49.84	20.42	17	12730	851	32499928
Underdose	49.44	20.42	41	12706	13028	32487751
Hypoaesthesia	48.28	20.42	84	12663	58269	32442510
Ataxia	48.26	20.42	40	12707	12701	32488078
Cognitive disorder	48.16	20.42	55	12692	25839	32474940
Herpes zoster	46.03	20.42	60	12687	32281	32468498
Hypotension	45.72	20.42	14	12733	216096	32284683
Lymphocyte count abnormal	45.55	20.42	15	12732	673	32500106
Seizure	45.34	20.42	115	12632	103739	32397040
Product dose omission issue	41.09	20.42	110	12637	102465	32398314
Monoparesis	40.44	20.42	18	12729	1843	32498936
Adverse reaction	40.39	20.42	21	12726	3029	32497750
Anaemia	39.80	20.42	19	12728	223605	32277174
Gait inability	39.70	20.42	44	12703	20003	32480776
Malignant melanoma stage I	38.95	20.42	9	12738	103	32500676
Musculoskeletal disorder	38.02	20.42	25	12722	5577	32495202
T-lymphocyte count decreased	33.21	20.42	9	12738	204	32500575
Off label use	33.16	20.42	43	12704	306277	32194502
Thrombocytopenia	32.45	20.42	9	12738	148290	32352489
Secondary progressive multiple sclerosis	31.96	20.42	10	12737	380	32500399
Haemoglobin decreased	30.79	20.42	5	12742	119666	32381113
Micturition urgency	29.36	20.42	21	12726	5365	32495414
Road traffic accident	29.12	20.42	35	12712	17346	32483433
Neutropenia	28.64	20.42	10	12737	142165	32358614
Optic neuritis	27.61	20.42	17	12730	3385	32497394
Progressive multifocal leukoencephalopathy	26.27	20.42	25	12722	9506	32491273
Trigeminal neuralgia	25.70	20.42	11	12736	1025	32499754
Dyspnoea	24.87	20.42	67	12680	361978	32138801
Oedema peripheral	24.80	20.42	7	12740	114084	32386695
Diarrhoea	24.56	20.42	234	12513	364568	32136211
Hemianaesthesia	24.35	20.42	6	12741	92	32500687
Feeling hot	23.50	20.42	31	12716	16855	32483924
Drug ineffective	23.39	20.42	241	12506	383236	32117543
Drug intolerance	23.32	20.42	57	12690	50178	32450601
Renal impairment	23.30	20.42	4	12743	91968	32408811
Hemiparesis	22.26	20.42	29	12718	15578	32485201
Ear canal stenosis	21.60	20.42	4	12743	13	32500766
Movement disorder	21.54	20.42	24	12723	10967	32489812
Decreased immune responsiveness	21.49	20.42	11	12736	1536	32499243
Dysarthria	21.44	20.42	43	12704	33158	32467621
Pleural effusion	21.00	20.42	3	12744	78989	32421790
Keratoacanthoma	20.97	20.42	8	12739	553	32500226
Chromaturia	20.80	20.42	27	12720	14451	32486328
Nausea	20.67	20.42	204	12543	320645	32180134
Depression	20.65	20.42	84	12663	96976	32403803

Pharmacologic Action:

Source	Code	Description
ATC	L04AX07	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Other immunosuppressants
MeSH PA	D003879	Dermatologic Agents
MeSH PA	D007155	Immunologic Factors
MeSH PA	D007166	Immunosuppressive Agents
MeSH PA	D011838	Radiation-Sensitizing Agents
CHEBI has role	CHEBI:76924	plant metabolites
CHEBI has role	CHEBI:77746	H. sapiens metabolites
CHEBI has role	CHEBI:50748	antipsoriatic agent
CHEBI has role	CHEBI:50846	Biomodulator

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Plaque psoriasis	indication	200965009
Relapsing remitting multiple sclerosis	indication	426373005	DOID:2378

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	8399514	Feb. 7, 2028	METHOD OF TREATING MULTIPLE SCLEROSIS
240MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	8399514	Feb. 7, 2028	METHOD OF TREATING MULTIPLE SCLEROSIS
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10391160	March 13, 2035	METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10555993	March 13, 2035	METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10994003	March 13, 2035	METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
240MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10391160	March 13, 2035	METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
240MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10555993	March 13, 2035	METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
240MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10994003	March 13, 2035	METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10959972	Nov. 16, 2035	METHOD OF TREATING MULTIPLE SCLEROSIS
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	11007166	Nov. 16, 2035	METHOD OF TREATING MULTIPLE SCLEROSIS
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	11007167	Nov. 16, 2035	METHOD OF TREATING MULTIPLE SCLEROSIS
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	11129806	Nov. 16, 2035	METHOD OF TREATING MULTIPLE SCLEROSIS
240MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10959972	Nov. 16, 2035	METHOD OF TREATING MULTIPLE SCLEROSIS
240MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	11007166	Nov. 16, 2035	METHOD OF TREATING MULTIPLE SCLEROSIS
240MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	11007167	Nov. 16, 2035	METHOD OF TREATING MULTIPLE SCLEROSIS
240MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	11129806	Nov. 16, 2035	METHOD OF TREATING MULTIPLE SCLEROSIS

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	Feb. 5, 2023	INFORMATION ADDED TO THE LABELING DESCRIBING A RANDOMIZED, OPEN-LABEL STUDY THAT EXAMINED THE CONCOMITANT USE OF DIMETHYL FUMARATE AND SEVERAL NON-LIVE VACCINES IN ADULTS 27-55 YEARS OF AGE WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
240MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	Feb. 5, 2023	INFORMATION ADDED TO THE LABELING DESCRIBING A RANDOMIZED, OPEN-LABEL STUDY THAT EXAMINED THE CONCOMITANT USE OF DIMETHYL FUMARATE AND SEVERAL NON-LIVE VACCINES IN ADULTS 27-55 YEARS OF AGE WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Kelch-like ECH-associated protein 1	Cytosolic other	Q14145	KEAP1_HUMAN	INHIBITOR				CHEMBL	CHEMBL
Hydroxycarboxylic acid receptor 2	GPCR	Q8TDS4	HCAR2_HUMAN		Ki	6.74		CHEMBL

External reference:

ID	Source
FO2303MNI2	UNII
D03846	KEGG_DRUG
4032290	VUID
N0000186952	NUI
4032290	VANDF
C0058218	UMLSCUI
CHEBI:76004	CHEBI
9HB	PDB_CHEM_ID
CHEMBL2107333	ChEMBL_ID
637568	PUBCHEM_CID
DB08908	DRUGBANK_ID
CHEMBL589586	ChEMBL_ID
D000069462	MESH_DESCRIPTOR_UI
7045	IUPHAR_LIGAND_ID
1373478	RXNORM
200501	MMSL
29369	MMSL
337937	MMSL
d08079	MMSL
009199	NDDF
724035008	SNOMEDCT_US
764365009	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0093-9218	CAPSULE	120 mg	ORAL	NDA	26 sections
dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0093-9219	CAPSULE	240 mg	ORAL	NDA	26 sections
Dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0396	CAPSULE, DELAYED RELEASE	120 mg	ORAL	ANDA	27 sections
Dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0399	CAPSULE, DELAYED RELEASE	240 mg	ORAL	ANDA	27 sections
dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	24979-127	CAPSULE, DELAYED RELEASE	120 mg	ORAL	ANDA	18 sections
dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	24979-128	CAPSULE, DELAYED RELEASE	240 mg	ORAL	ANDA	18 sections
Dimethyl Fumarate	Human Prescription Drug Label	1	31722-657	CAPSULE, DELAYED RELEASE	120 mg	ORAL	ANDA	26 sections
Dimethyl Fumarate	Human Prescription Drug Label	1	31722-658	CAPSULE, DELAYED RELEASE	240 mg	ORAL	ANDA	26 sections
Dimethyl Fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	43598-429	CAPSULE, DELAYED RELEASE	120 mg	ORAL	ANDA	25 sections
Dimethyl Fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	43598-430	CAPSULE, DELAYED RELEASE	240 mg	ORAL	ANDA	25 sections
Dimethyl Fumarate	Human Prescription Drug Label	1	50090-5288	CAPSULE, DELAYED RELEASE	240 mg	ORAL	ANDA	26 sections
dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	51407-441	CAPSULE, DELAYED RELEASE	240 mg	ORAL	ANDA	18 sections
dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	51407-442	CAPSULE, DELAYED RELEASE	120 mg	ORAL	ANDA	18 sections
TECFIDERA	HUMAN PRESCRIPTION DRUG LABEL	1	64406-005	CAPSULE	120 mg	ORAL	NDA	25 sections
TECFIDERA	HUMAN PRESCRIPTION DRUG LABEL	1	64406-006	CAPSULE	240 mg	ORAL	NDA	25 sections
Dimethyl fumarate	Human Prescription Drug Label	1	67877-555	CAPSULE, DELAYED RELEASE	120 mg	ORAL	ANDA	26 sections
Dimethyl fumarate	Human Prescription Drug Label	1	67877-556	CAPSULE, DELAYED RELEASE	240 mg	ORAL	ANDA	26 sections
DIMETHYL FUMARATE	HUMAN PRESCRIPTION DRUG LABEL	1	68180-776	CAPSULE, DELAYED RELEASE	120 mg	ORAL	ANDA	26 sections
DIMETHYL FUMARATE	HUMAN PRESCRIPTION DRUG LABEL	1	68180-777	CAPSULE, DELAYED RELEASE	240 mg	ORAL	ANDA	26 sections
DIMETHYL FUMARATE	HUMAN PRESCRIPTION DRUG LABEL	1	68462-307	CAPSULE	120 mg	ORAL	ANDA	26 sections
DIMETHYL FUMARATE	HUMAN PRESCRIPTION DRUG LABEL	1	68462-308	CAPSULE	240 mg	ORAL	ANDA	26 sections
DIMETHYL FUMARATE	HUMAN PRESCRIPTION DRUG LABEL	1	69097-322	CAPSULE, DELAYED RELEASE	120 mg	ORAL	ANDA	24 sections
DIMETHYL FUMARATE	HUMAN PRESCRIPTION DRUG LABEL	1	69097-323	CAPSULE, DELAYED RELEASE	240 mg	ORAL	ANDA	24 sections
Dimethyl Fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	69238-1318	CAPSULE, DELAYED RELEASE	120 mg	ORAL	ANDA	25 sections
Dimethyl Fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	69238-1319	CAPSULE, DELAYED RELEASE	240 mg	ORAL	ANDA	25 sections
Dimethyl Fumarate	Human Prescription Drug Label	1	69539-042	CAPSULE, DELAYED RELEASE	120 mg	ORAL	ANDA	24 sections
Dimethyl Fumarate	Human Prescription Drug Label	1	69539-043	CAPSULE, DELAYED RELEASE	240 mg	ORAL	ANDA	24 sections
dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	70710-1204	CAPSULE, DELAYED RELEASE	120 mg	ORAL	ANDA	24 sections
dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	70710-1205	CAPSULE, DELAYED RELEASE	240 mg	ORAL	ANDA	24 sections
dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	70771-1530	CAPSULE, DELAYED RELEASE	120 mg	ORAL	ANDA	1 sections