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

Stem definition	Drug id	CAS RN
	4163	504-24-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: fampyra dalfampridine ampyra pyridin-4-amine 4-aminopyridine fampridine	One of the POTASSIUM CHANNEL BLOCKERS with secondary effect on calcium currents which is used mainly as a research tool and to characterize channel subtypes. Molecular weight: 94.12 Formula: C5H6N2 CLOGP: 0.32 LIPINSKI: 0 HAC: 2 HDO: 1 TPSA: 38.91 ALOGS: 0.46 ROTB: 0

Drug dosage:

Dose	Unit	Route
20	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	90.30 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	3.04 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	2.60 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	9.30 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	1 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	3.60 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Jan. 22, 2010	FDA	ACORDA

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
Urinary tract infection	3044.33	32.03	892	5805	29050	2322338
Gait disturbance	1915.54	32.03	588	6109	21957	2329431
Laboratory test abnormal	1896.54	32.03	433	6264	4857	2346531
Drug ineffective	1401.66	32.03	707	5990	100917	2250471
Multiple sclerosis relapse	1142.27	32.03	336	6361	10607	2340781
Balance disorder	1104.18	32.03	319	6378	9428	2341960
Urine analysis abnormal	1042.80	32.03	185	6512	444	2350944
Fall	1023.51	32.03	451	6246	46648	2304740
Insomnia	827.92	32.03	327	6370	25460	2325928
Dizziness	805.98	32.03	410	6287	58255	2293133
Therapy cessation	546.77	32.03	161	6536	5032	2346356
Multiple sclerosis	542.68	32.03	165	6532	5769	2345619
Muscular weakness	529.92	32.03	204	6493	14693	2336695
Seizure	527.16	32.03	234	6463	24232	2327156
Inappropriate schedule of product administration	520.81	32.03	191	6506	12013	2339375
Asthenia	484.23	32.03	272	6425	46654	2304734
Escherichia urinary tract infection	446.49	32.03	103	6594	1181	2350207
Fatigue	412.21	32.03	306	6391	84567	2266821
Headache	364.31	32.03	278	6419	79901	2271487
Therapeutic response unexpected	308.90	32.03	97	6600	3762	2347626
Gait inability	267.62	32.03	97	6600	5858	2345530
Hypoaesthesia	265.65	32.03	138	6559	20077	2331311
Paraesthesia	265.35	32.03	142	6555	21946	2329442
Culture urine positive	257.52	32.03	55	6642	427	2350961
Condition aggravated	251.56	32.03	156	6541	31823	2319565
Nausea	249.77	32.03	260	6437	111929	2239459
Urine leukocyte esterase positive	235.65	32.03	45	6652	181	2351207
B-lymphocyte count decreased	231.52	32.03	42	6655	118	2351270
Memory impairment	231.49	32.03	109	6588	12814	2338574
Product dose omission	223.64	32.03	155	6542	38102	2313286
Constipation	218.26	32.03	124	6573	21505	2329883
Back pain	217.91	32.03	142	6555	31517	2319871
Dysuria	202.75	32.03	71	6626	3870	2347518
Depression	200.46	32.03	129	6568	28003	2323385
Feeling abnormal	197.91	32.03	120	6577	23461	2327927
Adverse drug reaction	186.57	32.03	82	6615	8201	2343187
Pollakiuria	183.03	32.03	65	6632	3691	2347697
Muscle spasms	176.43	32.03	108	6589	21458	2329930
Tremor	175.52	32.03	106	6591	20555	2330833
Head injury	167.39	32.03	62	6635	3972	2347416
Mobility decreased	150.56	32.03	72	6625	8738	2342650
Malaise	139.66	32.03	138	6559	55447	2295941
Flushing	138.59	32.03	75	6622	11796	2339592
Walking aid user	137.89	32.03	36	6661	706	2350682
Pain in extremity	134.41	32.03	120	6577	42420	2308968
Dysstasia	132.39	32.03	48	6649	2891	2348497
Muscle spasticity	129.86	32.03	41	6656	1612	2349776
Generalised tonic-clonic seizure	126.82	32.03	55	6642	5317	2346071
Lymphocyte count decreased	126.08	32.03	48	6649	3315	2348073
White blood cells urine positive	125.86	32.03	30	6667	398	2350990
Micturition urgency	123.45	32.03	37	6660	1219	2350169
Burning sensation	121.76	32.03	60	6637	7768	2343620
Central nervous system lesion	120.33	32.03	41	6656	2053	2349335
Pain	115.20	32.03	131	6566	61726	2289662
Movement disorder	111.93	32.03	42	6655	2786	2348602
Confusional state	110.93	32.03	85	6612	24259	2327129
Abdominal discomfort	109.44	32.03	74	6623	17382	2334006
Urinary incontinence	108.68	32.03	46	6651	4187	2347201
T-lymphocyte count increased	108.44	32.03	18	6679	23	2351365
CD4 lymphocytes increased	105.60	32.03	18	6679	30	2351358
Red blood cells urine positive	102.52	32.03	23	6674	229	2351159
Musculoskeletal stiffness	101.72	32.03	62	6635	12185	2339203
Epilepsy	101.39	32.03	45	6652	4594	2346794
Urine abnormality	98.25	32.03	26	6671	538	2350850
Glycosylated haemoglobin increased	97.95	32.03	34	6663	1800	2349588
Urine odour abnormal	96.28	32.03	27	6670	699	2350689
Peroneal nerve palsy	95.85	32.03	27	6670	711	2350677
Haemoglobin urine present	95.26	32.03	17	6680	42	2351346
Cystitis	92.98	32.03	45	6652	5597	2345791
Cognitive disorder	88.92	32.03	43	6654	5338	2346050
T-lymphocyte count decreased	88.28	32.03	17	6680	72	2351316
Hypokinesia	87.85	32.03	31	6666	1723	2349665
Pruritus	87.79	32.03	96	6601	43244	2308144
Secondary progressive multiple sclerosis	86.97	32.03	21	6676	295	2351093
Full blood count abnormal	86.84	32.03	21	6676	297	2351091
Loss of consciousness	86.48	32.03	66	6631	18701	2332687
Urinary tract infection bacterial	86.36	32.03	23	6674	488	2350900
JC polyomavirus test positive	86.05	32.03	20	6677	236	2351152
Trigeminal neuralgia	85.16	32.03	24	6673	633	2350755
Dysgraphia	85.02	32.03	23	6674	519	2350869
Wheelchair user	84.02	32.03	22	6675	436	2350952
Loss of personal independence in daily activities	83.43	32.03	41	6656	5270	2346118
Influenza like illness	82.26	32.03	54	6643	12060	2339328
Stress	81.37	32.03	44	6653	6894	2344494
Therapeutic product effect decreased	80.42	32.03	51	6646	10738	2340650
Contusion	79.52	32.03	54	6643	12756	2338632
Escherichia test positive	78.61	32.03	19	6678	268	2351120
Status epilepticus	73.97	32.03	30	6667	2448	2348940
Vitamin B12 increased	73.69	32.03	15	6682	89	2351299
CD4 lymphocytes decreased	68.49	32.03	18	6679	362	2351026
Skin laceration	68.34	32.03	29	6668	2653	2348735
Red blood cell count decreased	64.22	32.03	32	6665	4234	2347154
Protein urine present	63.25	32.03	19	6678	630	2350758
Diarrhoea	62.77	32.03	115	6582	83449	2267939
Urinary tract infection pseudomonal	60.59	32.03	13	6684	103	2351285
Bacterial test positive	60.27	32.03	18	6679	585	2350803
Feeling hot	59.87	32.03	36	6661	6892	2344496
Speech disorder	59.54	32.03	35	6662	6429	2344959
Discomfort	58.49	32.03	32	6665	5127	2346261
Depressed mood	58.26	32.03	32	6665	5166	2346222
Rash	57.94	32.03	92	6605	59466	2291922
Vision blurred	57.67	32.03	47	6650	14621	2336767
CD8 lymphocytes decreased	57.04	32.03	11	6686	47	2351341
Urine ketone body present	55.80	32.03	15	6682	330	2351058
Neutrophil count increased	55.50	32.03	23	6674	1982	2349406
Haematocrit decreased	55.17	32.03	29	6668	4289	2347099
Vertigo	54.54	32.03	38	6659	9346	2342042
Dysphagia	54.53	32.03	43	6654	12762	2338626
Urinary tract infection enterococcal	54.47	32.03	14	6683	257	2351131
Vomiting	53.04	32.03	98	6599	71504	2279884
Tongue biting	52.56	32.03	14	6683	297	2351091
Anxiety	52.48	32.03	61	6636	29298	2322090
Lymphocyte count abnormal	51.75	32.03	12	6685	140	2351248
Urinary retention	50.78	32.03	26	6671	3641	2347747
Blood immunoglobulin M decreased	50.64	32.03	11	6686	93	2351295
White blood cell count decreased	48.88	32.03	47	6650	18161	2333227
Neurogenic bladder	48.30	32.03	14	6683	409	2350979
Temperature intolerance	47.57	32.03	17	6680	980	2350408
Dysarthria	47.46	32.03	30	6667	6272	2345116
Extra dose administered	47.38	32.03	18	6679	1233	2350155
Red blood cell count abnormal	47.30	32.03	11	6686	130	2351258
Adverse event	46.82	32.03	32	6665	7627	2343761
Nasopharyngitis	46.56	32.03	50	6647	22006	2329382
Vitamin D decreased	46.53	32.03	17	6680	1044	2350344
Abdominal pain upper	46.48	32.03	50	6647	22050	2329338
Ankle fracture	46.37	32.03	21	6676	2244	2349144
Lymphocyte percentage decreased	45.00	32.03	13	6684	375	2351013
Hip fracture	44.67	32.03	26	6671	4686	2346702
Urinary sediment present	44.57	32.03	11	6686	170	2351218
Dyskinesia	44.28	32.03	26	6671	4763	2346625
Syncope	44.24	32.03	43	6654	16832	2334556
Motor dysfunction	43.95	32.03	17	6680	1223	2350165
Migraine	43.69	32.03	35	6662	10618	2340770
Nitrite urine present	43.58	32.03	10	6687	111	2351277
Palpitations	43.27	32.03	42	6655	16414	2334974
Somnolence	42.29	32.03	49	6648	23436	2327952
B-lymphocyte count abnormal	41.72	32.03	7	6690	10	2351378
Lymphopenia	41.70	32.03	20	6677	2434	2348954
Amnesia	41.27	32.03	29	6668	7224	2344164
Hemiparesis	40.77	32.03	22	6675	3428	2347960
Initial insomnia	40.46	32.03	14	6683	733	2350655
Primary progressive multiple sclerosis	40.13	32.03	8	6689	42	2351346
Feeling jittery	39.83	32.03	18	6679	1914	2349474
Influenza	39.63	32.03	36	6661	12942	2338446
Oropharyngeal pain	39.26	32.03	34	6663	11484	2339904
Ataxia	38.41	32.03	19	6678	2473	2348915
Mental status changes	38.15	32.03	25	6672	5557	2345831
Throat irritation	38.01	32.03	24	6673	5006	2346382
Diplopia	37.91	32.03	21	6676	3444	2347944
Transferrin saturation decreased	37.67	32.03	8	6689	60	2351328
Dyspepsia	37.53	32.03	31	6666	9813	2341575
White blood cell count increased	37.28	32.03	27	6670	7051	2344337
Blood thyroid stimulating hormone increased	36.52	32.03	14	6683	983	2350405
Alopecia	36.46	32.03	44	6653	21957	2329431
Coordination abnormal	36.22	32.03	17	6680	1971	2349417
Blood thyroid stimulating hormone decreased	35.70	32.03	12	6685	575	2350813
Sepsis	35.69	32.03	40	6657	18448	2332940
Mean cell haemoglobin decreased	35.39	32.03	10	6687	266	2351122
Red cell distribution width increased	35.39	32.03	12	6685	591	2350797
Urinary tract disorder	35.13	32.03	11	6686	420	2350968
Dermatomyositis	34.98	32.03	11	6686	426	2350962
Arthralgia	34.86	32.03	70	6627	54215	2297173
Visual impairment	34.71	32.03	32	6665	11723	2339665
Proteus test positive	34.46	32.03	7	6690	41	2351347
Progressive multiple sclerosis	33.96	32.03	9	6688	187	2351201
Muscle tightness	33.81	32.03	16	6681	1889	2349499
Muscle twitching	33.70	32.03	18	6679	2747	2348641
Blood glucose increased	33.49	32.03	32	6665	12258	2339130
Weight decreased	33.45	32.03	48	6649	28323	2323065
Neck pain	33.08	32.03	26	6671	7671	2343717
Optic neuritis	32.87	32.03	15	6682	1631	2349757
Nervousness	32.47	32.03	22	6675	5167	2346221

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug ineffective	671.64	37.29	307	1986	63494	1680994
Gait disturbance	669.03	37.29	201	2092	12469	1732019
Laboratory test abnormal	612.65	37.29	150	2143	4209	1740279
Urinary tract infection	487.03	37.29	150	2143	10003	1734485
Multiple sclerosis relapse	451.65	37.29	110	2183	2990	1741498
Fall	336.13	37.29	148	2145	27066	1717422
Balance disorder	303.80	37.29	92	2201	5720	1738768
Insomnia	261.67	37.29	107	2186	16169	1728319
Multiple sclerosis	207.75	37.29	55	2238	2077	1742411
Muscular weakness	201.35	37.29	78	2215	10171	1734317
Seizure	161.30	37.29	82	2211	20359	1724129
Inappropriate schedule of product administration	157.89	37.29	60	2233	7399	1737089
B-lymphocyte count decreased	151.88	37.29	25	2268	71	1744417
Dizziness	148.94	37.29	93	2200	34268	1710220
Therapy cessation	139.57	37.29	44	2249	3095	1741393
Therapeutic response unexpected	120.41	37.29	37	2256	2387	1742101
Fatigue	116.12	37.29	93	2200	50688	1693800
Asthenia	113.89	37.29	79	2214	34591	1709897
Condition aggravated	100.90	37.29	61	2232	21089	1723399
Back pain	100.70	37.29	56	2237	16557	1727931
Headache	91.48	37.29	69	2224	34307	1710181
Constipation	86.61	37.29	49	2244	14951	1729537
Gait inability	81.78	37.29	30	2263	3333	1741155
Flushing	76.28	37.29	34	2259	6245	1738243
Muscle spasticity	67.20	37.29	21	2272	1428	1743060
Paraesthesia	65.33	37.29	36	2257	10415	1734073
Adverse drug reaction	65.14	37.29	28	2265	4710	1739778
Memory impairment	61.99	37.29	30	2263	6633	1737855
Secondary progressive multiple sclerosis	60.81	37.29	12	2281	114	1744374
Full blood count abnormal	58.84	37.29	13	2280	222	1744266
Nausea	58.66	37.29	64	2229	51132	1693356
JC polyomavirus test positive	58.41	37.29	12	2281	142	1744346
Urine analysis abnormal	55.30	37.29	13	2280	296	1744192
Product dose omission	55.04	37.29	43	2250	22397	1722091
Dysuria	54.77	37.29	23	2270	3649	1740839
Walking aid user	53.16	37.29	12	2281	227	1744261
Movement disorder	52.35	37.29	18	2275	1652	1742836
Vitamin B12 increased	50.15	37.29	9	2284	48	1744440
Depression	49.88	37.29	36	2257	16633	1727855
Trigeminal neuralgia	48.43	37.29	11	2282	214	1744274
Tremor	47.81	37.29	32	2261	13099	1731389
Muscle spasms	46.39	37.29	30	2263	11591	1732897
Mobility decreased	46.33	37.29	21	2272	3999	1740489
Haematocrit decreased	45.11	37.29	21	2272	4252	1740236
Peroneal nerve palsy	44.55	37.29	12	2281	480	1744008
Hip fracture	44.13	37.29	16	2277	1714	1742774
Central nervous system lesion	43.97	37.29	14	2279	1010	1743478
Influenza like illness	43.80	37.29	23	2270	6030	1738458
Generalised tonic-clonic seizure	43.07	37.29	20	2273	4026	1740462
Cystitis	40.58	37.29	14	2279	1297	1743191
Pain in extremity	40.14	37.29	33	2260	18439	1726049
Feeling abnormal	40.12	37.29	27	2266	11139	1733349
Glycosylated haemoglobin increased	39.13	37.29	15	2278	1876	1742612

Pharmacologic Action:

Source	Code	Description
ATC	N07XX07	NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D049990	Membrane Transport Modulators
MeSH PA	D026902	Potassium Channel Blockers
CHEBI has role	CHEBI:71031	orphan drug
CHEBI has role	CHEBI:33289	avicide
FDA EPC	N0000192795	Potassium Channel Blocker
FDA MoA	N0000175448	Potassium Channel Antagonists

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Multiple sclerosis	indication	24700007	DOID:2377
Seizure disorder	contraindication	128613002
Impaired renal function disorder	contraindication	197663003

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.58	Basic

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
10MG	AMPYRA	ACORDA	N022250	Jan. 22, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8440703	April 8, 2025	IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)
10MG	AMPYRA	ACORDA	N022250	Jan. 22, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8354437	Dec. 22, 2026	IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)
10MG	AMPYRA	ACORDA	N022250	Jan. 22, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8007826	May 26, 2027	IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)

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
Voltage-gated potassium channel	Ion channel	O43525 O43526 O95259 P16389 P17658 P22001 P22459 P22460 P48547 P51787 P56696 Q03721 Q09470 Q12809 Q14003 Q14721 Q16322 Q6PIU1 Q8NCM2 Q8TAE7 Q8TDN1 Q8TDN2 Q92953 Q96KK3 Q96L42 Q96PR1 Q96RP8 Q9BQ31 Q9H252 Q9H3M0 Q9NR82 Q9NS40 Q9NSA2 Q9NZV8 Q9UIX4 Q9UJ96 Q9UK17 Q9ULD8 Q9ULS6 Q9UQ05	KCA10_HUMAN KCNA1_HUMAN KCNA2_HUMAN KCNA3_HUMAN KCNA4_HUMAN KCNA5_HUMAN KCNA6_HUMAN KCNA7_HUMAN KCNB1_HUMAN KCNB2_HUMAN KCNC1_HUMAN KCNC2_HUMAN KCNC3_HUMAN KCNC4_HUMAN KCND1_HUMAN KCND2_HUMAN KCND3_HUMAN KCNF1_HUMAN KCNG1_HUMAN KCNG2_HUMAN KCNG3_HUMAN KCNG4_HUMAN KCNH1_HUMAN KCNH2_HUMAN KCNH3_HUMAN KCNH4_HUMAN KCNH5_HUMAN KCNH6_HUMAN KCNH7_HUMAN KCNH8_HUMAN KCNQ1_HUMAN KCNQ2_HUMAN KCNQ3_HUMAN KCNQ4_HUMAN KCNQ5_HUMAN KCNS1_HUMAN KCNS2_HUMAN KCNS3_HUMAN KCNV1_HUMAN KCNV2_HUMAN	BLOCKER				CHEMBL	CHEMBL
Potassium voltage-gated channel subfamily C member 1	Unclassified		KCNC1_MOUSE	BLOCKER	IC50	4.50		IUPHAR
Potassium voltage-gated channel subfamily C member 2	Unclassified		KCNC2_RAT	BLOCKER	IC50	4.60		IUPHAR

External reference:

ID	Source
4029704	VUID
N0000180628	NUI
C0000477	UMLSCUI
D04127	KEGG_DRUG
80994002	SNOMEDCT_US
413355004	SNOMEDCT_US
NOCODE	MMSL
4025700	VANDF
4025705	VANDF
897018	RXNORM
26967	MMSL
d07546	MMSL
4029704	VANDF
006829	NDDF
BH3B64OKL9	UNII
7283	INN_ID
CHEMBL284348	ChEMBL_ID
4AP	PDB_CHEM_ID
DB06637	DRUGBANK_ID
CHEBI:34385	CHEBI
D015761	MESH_DESCRIPTOR_UI
1727	PUBCHEM_CID
2416	IUPHAR_LIGAND_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Dalfampridine	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0479	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	ANDA	17 sections
dalfampridine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0509	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA authorized generic	17 sections
AMPYRA	HUMAN PRESCRIPTION DRUG LABEL	1	10144-427	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA	18 sections
Dalfampridine	HUMAN PRESCRIPTION DRUG LABEL	1	16729-292	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	ANDA	18 sections
DALFAMPRIDINE	HUMAN PRESCRIPTION DRUG LABEL	1	42571-275	TABLET, EXTENDED RELEASE	10 mg	ORAL	ANDA	17 sections
Dalfampridine	HUMAN PRESCRIPTION DRUG LABEL	1	51407-246	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	ANDA	18 sections
Dalfampridine	HUMAN PRESCRIPTION DRUG LABEL	1	62756-429	TABLET, EXTENDED RELEASE	10 mg	ORAL	ANDA	17 sections
DALFAMPRIDINE	HUMAN PRESCRIPTION DRUG LABEL	1	65862-863	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	ANDA	17 sections
Dalfampridine	HUMAN PRESCRIPTION DRUG LABEL	1	67877-444	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	ANDA	17 sections