cyclobenzaprine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	751	303-53-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: cyclobenzaprine proheptatrien proheptatriene cyclobenzaprine hydrochloride cyclobenzaprine HCl	structurally related to tricyclic antidepressants relieves skeletal muscle spasm of local origin without interfering with muscle function, it is ineffective in muscle spasm due to central nervous system disease Molecular weight: 275.40 Formula: C20H21N CLOGP: 4.96 LIPINSKI: 1 HAC: 1 HDO: 0 TPSA: 3.24 ALOGS: -4.60 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

cyclobenzaprine
proheptatrien
proheptatriene
cyclobenzaprine hydrochloride
cyclobenzaprine HCl

structurally related to tricyclic antidepressants relieves skeletal muscle spasm of local origin without interfering with muscle function, it is ineffective in muscle spasm due to central nervous system disease

Molecular weight: 275.40
Formula: C20H21N
CLOGP: 4.96
LIPINSKI: 1
HAC: 1
HDO: 0
TPSA: 3.24
ALOGS: -4.60
ROTB: 3

Status: OFP

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

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	200 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.37 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	55 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
fu (Fraction unbound in plasma)	0.01 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

Date	Agency	Company	Orphan
Aug. 26, 1977	FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Completed suicide	1058.82	10.72	1166	89320	144507	63254029
Toxicity to various agents	768.92	10.72	1311	89175	245939	63152597
Sedation complication	617.52	10.72	329	90157	13493	63385043
Sedation	568.49	10.72	459	90027	38350	63360186
Creatinine renal clearance decreased	561.33	10.72	327	90159	15981	63382555
Orthostatic hypotension	492.54	10.72	410	90076	35750	63362786
Drug abuse	450.63	10.72	536	89950	71982	63326554
Blood calcium decreased	437.19	10.72	336	90150	26115	63372421
Cognitive disorder	424.07	10.72	458	90028	55357	63343179
Constipation	370.33	10.72	918	89568	224025	63174511
Balance disorder	357.92	10.72	517	89969	83905	63314631
Temperature regulation disorder	343.44	10.72	170	90316	5962	63392574
Depressed level of consciousness	342.15	10.72	432	90054	61646	63336890
Food allergy	259.70	10.72	176	90310	11225	63387311
Coeliac disease	230.09	10.72	171	90315	12626	63385910
Immunodeficiency	212.29	10.72	198	90288	20056	63378480
Glossodynia	186.91	10.72	19	90467	178857	63219679
Hand deformity	180.22	10.72	12	90474	159445	63239091
Respiratory arrest	177.90	10.72	226	90260	32419	63366117
Pain	174.37	10.72	1713	88773	738915	62659621
Systemic lupus erythematosus	173.86	10.72	42	90444	208876	63189660
Fall	172.11	10.72	1050	89436	391284	63007252
Cardio-respiratory arrest	157.44	10.72	296	90190	59663	63338873
Mobility decreased	152.21	10.72	448	90038	120711	63277825
Maternal exposure during pregnancy	151.48	10.72	62	90424	220000	63178536
Pericarditis	151.38	10.72	9	90477	131570	63266966
Synovitis	150.84	10.72	40	90446	186878	63211658
Back pain	149.77	10.72	758	89728	263387	63135149
Anti-cyclic citrullinated peptide antibody positive	143.27	10.72	5	90481	116207	63282329
Hyperhidrosis	141.46	10.72	405	90081	107431	63291105
Bursitis	135.66	10.72	212	90274	36829	63361707
Fluid retention	121.37	10.72	265	90221	59421	63339115
Product dose omission issue	118.06	10.72	651	89835	233662	63164874
Migraine	112.88	10.72	364	90122	102982	63295554
Upper respiratory tract infection	111.34	10.72	312	90174	81735	63316801
Rash erythematous	106.81	10.72	206	90280	42304	63356232
Rheumatoid factor positive	106.30	10.72	3	90483	84403	63314133
Wound	104.46	10.72	51	90435	163212	63235324
Hypotension	100.58	10.72	699	89787	271905	63126631
Lower respiratory tract infection	99.94	10.72	32	90454	132275	63266261
Drug hypersensitivity	98.31	10.72	768	89718	309919	63088617
Therapeutic product effect decreased	89.46	10.72	86	90400	193101	63205435
Blepharospasm	87.89	10.72	71	90415	5925	63392611
Pulmonary malformation	85.45	10.72	27	90459	272	63398264
Intentional product misuse	83.96	10.72	233	90253	60684	63337852
Respiratory depression	79.57	10.72	98	90388	13617	63384919
Anxiety	77.36	10.72	553	89933	216988	63181548
Arthropathy	77.31	10.72	135	90351	234657	63163879
Alopecia	75.90	10.72	238	90248	337298	63061238
Asthma	75.63	10.72	371	90115	127190	63271346
Psoriasis	75.58	10.72	284	90202	86673	63311863
Poisoning	74.86	10.72	95	90391	13605	63384931
Cardiac arrest	74.51	10.72	295	90191	92250	63306286
Decorticate posture	72.55	10.72	24	90462	283	63398253
Muscle injury	70.72	10.72	6	90480	65339	63333197
Taste disorder	67.28	10.72	90	90396	13572	63384964
Hyponatraemia	67.06	10.72	38	90448	111862	63286674
Headache	66.74	10.72	1269	89217	631972	62766564
Memory impairment	65.97	10.72	309	90177	103949	63294587
Neutropenia	65.80	10.72	92	90394	174913	63223623
Discomfort	63.92	10.72	87	90399	167287	63231249
Folliculitis	62.79	10.72	12	90474	70305	63328231
C-reactive protein increased	58.43	10.72	31	90455	94676	63303860
Abdominal discomfort	58.42	10.72	247	90239	320638	63077898
Lung cyst	58.40	10.72	21	90465	323	63398213
Respiratory tract malformation	57.54	10.72	18	90468	175	63398361
Drug ineffective	56.78	10.72	1100	89386	1043665	62354871
General physical health deterioration	56.62	10.72	127	90359	201275	63197261
Exposure during pregnancy	56.28	10.72	84	90402	155463	63243073
Febrile neutropenia	55.66	10.72	52	90434	118397	63280139
Liver injury	50.62	10.72	12	90474	60508	63338028
Impaired healing	48.20	10.72	45	90441	102497	63296039
Joint swelling	47.65	10.72	273	90213	327393	63071143
Blister	46.09	10.72	71	90415	129743	63268793
Swelling	45.88	10.72	219	90267	275159	63123377
Anaemia	45.66	10.72	239	90247	293191	63105345
Leukopenia	45.23	10.72	27	90459	77263	63321273
Gastrointestinal disorder	44.50	10.72	74	90412	131165	63267371
Acute kidney injury	44.16	10.72	209	90277	263206	63135330
Contraindicated product administered	43.74	10.72	161	90325	217487	63181049
Alanine aminotransferase increased	43.72	10.72	50	90436	103720	63294816
Cardiac failure	43.23	10.72	38	90448	89104	63309432
Spinal operation	43.06	10.72	56	90430	8215	63390321
Cryopyrin associated periodic syndrome	43.02	10.72	17	90469	343	63398193
Post-traumatic neck syndrome	42.48	10.72	30	90456	2044	63396492
Myocardial depression	40.70	10.72	18	90468	486	63398050
Pancytopenia	40.52	10.72	47	90439	96886	63301650
Suspected suicide	39.83	10.72	48	90438	6520	63392016
Muscle spasms	37.26	10.72	363	90123	155787	63242749
Overdose	37.13	10.72	286	90200	114792	63283744
Stomatitis	36.95	10.72	90	90396	138635	63259901
Bronchitis	36.76	10.72	304	90182	124631	63273905
Depression	36.75	10.72	435	90051	196057	63202479
Pyrexia	36.68	10.72	462	90024	470016	62928520
Hyperkalaemia	36.08	10.72	16	90470	54187	63344349
Infusion related reaction	35.96	10.72	204	90282	245317	63153219
Hypoaesthesia	35.20	10.72	381	90105	168012	63230524
Neck pain	35.09	10.72	193	90293	69125	63329411
Lactation disorder	34.99	10.72	15	90471	375	63398161
Electrocardiogram QT prolonged	34.54	10.72	21	90465	59509	63339027
Malignant neoplasm progression	34.13	10.72	40	90446	82081	63316455
Hostility	33.61	10.72	25	90461	1847	63396689
Libido increased	33.61	10.72	22	90464	1323	63397213
Aspartate aminotransferase increased	33.37	10.72	48	90438	90229	63308307
Confusional state	33.23	10.72	199	90287	236181	63162355
Multiple drug therapy	33.20	10.72	33	90453	3613	63394923
Intervertebral disc protrusion	32.96	10.72	91	90395	23618	63374918
Renal impairment	32.64	10.72	47	90439	88308	63310228
Type 2 diabetes mellitus	32.47	10.72	26	90460	63842	63334694
Fibromyalgia	32.43	10.72	211	90275	80209	63318327
Soft tissue injury	31.78	10.72	23	90463	1629	63396907
Surgery	31.77	10.72	118	90368	35794	63362742
Exposure via ingestion	31.56	10.72	29	90457	2880	63395656
Stress	31.35	10.72	183	90303	66984	63331552
Irritable bowel syndrome	31.28	10.72	43	90443	82369	63316167
Hyperaesthesia	30.75	10.72	51	90435	9307	63389229
Foot fracture	30.53	10.72	89	90397	23825	63374711
Blood creatinine increased	30.26	10.72	49	90437	87795	63310741
Gamma-glutamyltransferase increased	29.97	10.72	6	90480	34025	63364511
Pre-existing condition improved	29.91	10.72	47	90439	8197	63390339
Drug-induced liver injury	29.88	10.72	10	90476	40212	63358324
Dysphoria	29.64	10.72	36	90450	4930	63393606
Treatment failure	29.35	10.72	165	90321	198878	63199658
International normalised ratio increased	28.92	10.72	15	90471	46410	63352126
Concussion	28.54	10.72	49	90437	9195	63389341
Gastrooesophageal reflux disease	28.28	10.72	233	90253	95406	63303130
Poor sucking reflex	27.99	10.72	12	90474	300	63398236
Therapy cessation	27.72	10.72	101	90385	30356	63368180
Decreased appetite	27.61	10.72	227	90259	250825	63147711
Sternal fracture	27.48	10.72	24	90462	2230	63396306
Unresponsive to stimuli	27.36	10.72	108	90378	33708	63364828
Therapy interrupted	27.35	10.72	105	90381	32350	63366186
Erythema	27.30	10.72	376	90110	175375	63223161
Rash	26.59	10.72	603	89883	560268	62838268
Drug intolerance	26.35	10.72	297	90189	308364	63090172
Pleural effusion	25.99	10.72	59	90427	93151	63305385
Back disorder	25.98	10.72	52	90434	10965	63387571
Thrombocytopenia	25.86	10.72	119	90367	151038	63247498
Vascular malformation	25.72	10.72	12	90474	368	63398168
Hypokalaemia	25.59	10.72	70	90416	103734	63294802
Off label use	25.13	10.72	751	89735	673711	62724825
Paranasal cyst	24.94	10.72	12	90474	395	63398141
Bedridden	24.68	10.72	51	90435	11000	63387536
Bone marrow failure	24.11	10.72	6	90480	29284	63369252
Emotional distress	23.99	10.72	101	90385	32448	63366088
Toxic epidermal necrolysis	23.31	10.72	4	90482	25330	63373206
Exposure via breast milk	23.28	10.72	21	90465	2036	63396500
Hepatic function abnormal	23.14	10.72	12	90474	37130	63361406
Infection	23.07	10.72	212	90274	228961	63169575
Therapy non-responder	22.86	10.72	46	90440	75855	63322681
Gluten sensitivity	22.84	10.72	13	90473	607	63397929
Blood lactate dehydrogenase increased	22.76	10.72	3	90483	23113	63375423
Mucosal inflammation	22.75	10.72	20	90466	46908	63351628
Drug resistance	22.53	10.72	3	90483	22930	63375606
Irritability	22.32	10.72	97	90389	31597	63366939
Jaundice	22.21	10.72	7	90479	29244	63369292
Middle insomnia	22.21	10.72	53	90433	12590	63385946
Dental restoration failure	21.91	10.72	15	90471	972	63397564
Interstitial lung disease	21.83	10.72	34	90452	61874	63336662
Urinary incontinence	21.80	10.72	97	90389	31917	63366619
Pulmonary fibrosis	21.79	10.72	15	90471	39794	63358742
Blood bilirubin increased	21.69	10.72	13	90473	37127	63361409
Feeling abnormal	21.25	10.72	313	90173	148079	63250457
Blood alkaline phosphatase increased	21.21	10.72	18	90468	42949	63355587
Atrial fibrillation	21.04	10.72	90	90396	116546	63281990
Meniscus injury	21.04	10.72	37	90449	7077	63391459
Ankylosing spondylitis	20.70	10.72	46	90440	10428	63388108
Dermatitis atopic	20.70	10.72	44	90442	9680	63388856
Abortion spontaneous	20.69	10.72	22	90464	47173	63351363
Multiple sclerosis	20.66	10.72	79	90407	24293	63374243
Liver disorder	20.38	10.72	28	90458	53659	63344877
Dyspnoea	20.23	10.72	755	89731	660558	62737978
Lactic acidosis	20.21	10.72	15	90471	38272	63360264
Drug eruption	19.85	10.72	8	90478	28686	63369850
Paraesthesia	19.77	10.72	324	90162	156642	63241894
Serum sickness-like reaction	19.61	10.72	11	90475	499	63398037
Device expulsion	19.33	10.72	13	90473	34909	63363627
Agranulocytosis	19.11	10.72	6	90480	25128	63373408
Ascites	18.98	10.72	18	90468	40710	63357826
Hip arthroplasty	18.96	10.72	24	90462	47622	63350914
Rib fracture	18.95	10.72	73	90413	22524	63376012
Neck injury	18.95	10.72	19	90467	2102	63396434
Knee arthroplasty	18.89	10.72	30	90456	54176	63344360
Ill-defined disorder	18.78	10.72	57	90429	81698	63316838
Mastoiditis	18.74	10.72	14	90472	1041	63397495
Panic attack	18.61	10.72	72	90414	22259	63376277
Premature delivery	18.54	10.72	10	90476	30271	63368265
Product use issue	18.10	10.72	214	90272	220306	63178230
Neutrophil count decreased	18.02	10.72	33	90453	56373	63342163
Maternal exposure during breast feeding	17.98	10.72	26	90460	4215	63394321
Fear of disease	17.89	10.72	15	90471	1319	63397217
Nasal discharge discolouration	17.87	10.72	19	90467	2252	63396284
Oedema peripheral	17.50	10.72	179	90307	189332	63209204
Suicidal ideation	17.35	10.72	150	90336	62271	63336265
Somnolence	17.31	10.72	354	90132	178331	63220205
Platelet count decreased	17.24	10.72	96	90390	116026	63282510
Disease progression	16.89	10.72	104	90382	122654	63275882
Opiates positive	16.70	10.72	9	90477	377	63398159
Lymphatic system neoplasm	16.63	10.72	5	90481	42	63398494
Uterine perforation	16.58	10.72	33	90453	6930	63391606
Tubulointerstitial nephritis	16.53	10.72	4	90482	19899	63378637
Liver function test abnormal	16.48	10.72	27	90459	48154	63350382
Withdrawal syndrome	16.28	10.72	64	90422	19933	63378603
Infrequent bowel movements	16.15	10.72	14	90472	1288	63397248
Blood cholesterol increased	16.09	10.72	74	90412	93958	63304578
Hypothyroidism	16.06	10.72	110	90376	42522	63356014
Muscle strain	15.97	10.72	36	90450	8238	63390298
Hypoglycaemia	15.96	10.72	39	90447	60026	63338510
Multiple sclerosis relapse	15.91	10.72	121	90365	48357	63350179
Melaena	15.89	10.72	12	90474	30353	63368183
Myalgia	15.78	10.72	295	90191	146234	63252302
Sepsis	15.68	10.72	141	90345	152982	63245554
Fracture pain	15.66	10.72	11	90475	743	63397793
Stevens-Johnson syndrome	15.63	10.72	8	90478	24942	63373594
Poor quality sleep	15.59	10.72	63	90423	19872	63378664
Circulatory collapse	15.37	10.72	6	90480	21932	63376604
Nightmare	15.28	10.72	61	90425	19133	63379403
Muscle twitching	15.25	10.72	62	90424	19606	63378930
Electrocardiogram QRS complex prolonged	15.18	10.72	29	90457	5909	63392627
Peritonitis	15.16	10.72	3	90483	17151	63381385
Rash maculo-papular	14.98	10.72	14	90472	31882	63366654
Cholestasis	14.94	10.72	12	90474	29422	63369114
Epilepsy	14.81	10.72	77	90409	26988	63371548
Hypocalcaemia	14.80	10.72	14	90472	31699	63366837
Illness	14.75	10.72	120	90366	48939	63349597
Catheter site bruise	14.69	10.72	9	90477	482	63398054
Seasonal allergy	14.66	10.72	64	90422	20886	63377650
Myelodysplastic syndrome	14.66	10.72	3	90483	16751	63381785
Insomnia	14.60	10.72	406	90080	214846	63183690
Cardiac failure congestive	14.51	10.72	75	90411	92358	63306178
Hepatotoxicity	14.38	10.72	19	90467	37022	63361514
Hot flush	14.25	10.72	123	90363	51036	63347500
Thyrotoxic crisis	14.19	10.72	11	90475	865	63397671
Intervertebral disc degeneration	14.17	10.72	52	90434	15680	63382856
Obstructive airways disorder	13.95	10.72	6	90480	20693	63377843
Drug withdrawal syndrome	13.94	10.72	76	90410	27118	63371418
Toxicologic test abnormal	13.78	10.72	10	90476	711	63397825
Foetal exposure timing unspecified	13.69	10.72	7	90479	263	63398273
Cholecystitis chronic	13.65	10.72	39	90447	10322	63388214
Ankle fracture	13.62	10.72	56	90430	17799	63380737
Transaminases increased	13.33	10.72	15	90471	31352	63367184
Lower limb fracture	13.31	10.72	69	90417	24152	63374384
Personality disorder	13.19	10.72	27	90459	5784	63392752
Medication error	13.08	10.72	35	90451	52249	63346287
Lip dry	13.07	10.72	3	90483	15467	63383069
Neurotoxicity	13.01	10.72	4	90482	16986	63381550
Muscle neoplasm	12.96	10.72	4	90482	37	63398499
Acute hepatic failure	12.86	10.72	5	90481	18322	63380214
Rheumatoid arthritis	12.82	10.72	462	90024	253357	63145179
Ejection fraction decreased	12.78	10.72	8	90478	22324	63376212
Gallbladder neoplasm	12.78	10.72	4	90482	39	63398497
Respiratory acidosis	12.72	10.72	29	90457	6686	63391850
Lower respiratory tract congestion	12.69	10.72	18	90468	2868	63395668
Gastrointestinal haemorrhage	12.66	10.72	66	90420	81110	63317426
Amphetamines positive	12.51	10.72	6	90480	196	63398340
Spinal cord neoplasm	12.47	10.72	7	90479	318	63398218
Pelvic pain	12.44	10.72	45	90441	13474	63385062
Haematemesis	12.43	10.72	15	90471	30397	63368139
Choroid melanoma	12.34	10.72	4	90482	44	63398492
Vitamin B6 deficiency	12.34	10.72	5	90481	108	63398428
Basal cell carcinoma	12.32	10.72	13	90473	27978	63370558
Injection site mass	12.31	10.72	56	90430	18600	63379936
Anhedonia	12.28	10.72	39	90447	10935	63387601
Pregnancy	12.26	10.72	21	90465	36815	63361721
Congenital cystic lung	12.26	10.72	4	90482	45	63398491
Tooth abscess	12.26	10.72	48	90438	14921	63383615
Tenderness	12.19	10.72	64	90422	22514	63376022
Injection site pain	12.19	10.72	256	90230	129544	63268992
Disseminated intravascular coagulation	12.10	10.72	6	90480	19045	63379491
Anaphylactic shock	12.09	10.72	66	90420	23567	63374969
Sleep apnoea syndrome	12.08	10.72	77	90409	29056	63369480
Drug interaction	12.08	10.72	242	90244	228889	63169647
Multiple organ dysfunction syndrome	12.04	10.72	41	90445	56711	63341825
Upper gastrointestinal haemorrhage	11.88	10.72	6	90480	18846	63379690
Spinal disorder	11.83	10.72	36	90450	9866	63388670
Poor venous access	11.78	10.72	47	90439	14738	63383798
Prescribed underdose	11.76	10.72	15	90471	29674	63368862
Rotator cuff syndrome	11.64	10.72	44	90442	13458	63385078
Liver function test increased	11.58	10.72	18	90468	32793	63365743
Drug reaction with eosinophilia and systemic symptoms	11.53	10.72	19	90467	33817	63364719
Lymphopenia	11.30	10.72	6	90480	18321	63380215
Exposure via inhalation	11.28	10.72	4	90482	59	63398477
Bladder discomfort	11.28	10.72	9	90477	738	63397798
Hepatic failure	11.26	10.72	21	90465	35635	63362901
Condition aggravated	11.21	10.72	464	90022	401753	62996783
Fatigue	11.15	10.72	1436	89050	886592	62511944
Prescribed overdose	11.07	10.72	85	90401	34068	63364468
Pruritus	10.93	10.72	413	90073	361040	63037496
Cardiogenic shock	10.86	10.72	6	90480	17926	63380610
Electric shock sensation	10.85	10.72	9	90477	779	63397757
Proteinuria	10.77	10.72	7	90479	19138	63379398
Body height increased	10.76	10.72	4	90482	68	63398468

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
Completed suicide	580.81	13.00	508	23969	97660	34834794
Drug abuse	264.86	13.00	336	24141	98760	34833694
Toxicity to various agents	239.54	13.00	469	24008	199893	34732561
Respiratory arrest	108.09	13.00	115	24362	27928	34904526
Cardio-respiratory arrest	63.97	13.00	128	24349	55145	34877309
Back pain	61.26	13.00	206	24271	121583	34810871
Milk-alkali syndrome	57.52	13.00	20	24457	585	34931869
Product dose omission issue	56.29	13.00	198	24279	119513	34812941
General physical health deterioration	49.91	13.00	14	24463	128255	34804199
Intentional product misuse	46.17	13.00	100	24377	45511	34886943
Back disorder	42.30	13.00	36	24441	6615	34925839
Multiple organ dysfunction syndrome	42.02	13.00	3	24474	76563	34855891
Spinal operation	39.46	13.00	25	24452	2919	34929535
Cardiac arrest	39.25	13.00	152	24325	96007	34836447
Pain	36.09	13.00	256	24221	204419	34728035
Suspected suicide	32.89	13.00	27	24450	4721	34927733
Lymphocyte count abnormal	32.02	13.00	16	24461	1182	34931272
Interstitial lung disease	32.00	13.00	4	24473	65278	34867176
Asthma-chronic obstructive pulmonary disease overlap syndrome	30.93	13.00	16	24461	1271	34931183
Bronchial hyperreactivity	29.31	13.00	17	24460	1692	34930762
C-reactive protein increased	27.30	13.00	3	24474	54095	34878359
Leukopenia	26.09	13.00	6	24471	62850	34869604
Back injury	25.96	13.00	22	24455	4019	34928435
Serotonin syndrome	25.27	13.00	48	24429	19885	34912569
Drug hypersensitivity	24.87	13.00	117	24360	80412	34852042
Overdose	24.35	13.00	127	24350	90932	34841522
Spinal fracture	24.13	13.00	28	24449	7470	34924984
Anaemia	22.97	13.00	85	24392	233250	34699204
Thrombocytopenia	22.77	13.00	47	24430	156200	34776254
Death	22.44	13.00	397	24080	397652	34534802
Product communication issue	22.21	13.00	9	24468	405	34932049
Arthralgia	21.39	13.00	197	24280	169844	34762610
Hyponatraemia	21.36	13.00	16	24461	82675	34849779
Exposure via ingestion	20.80	13.00	15	24462	2166	34930288
Pulmonary function test abnormal	20.55	13.00	16	24461	2594	34929860
Muscle spasms	20.32	13.00	105	24372	74896	34857558
Poisoning	20.10	13.00	33	24444	12193	34920261
Ankylosing spondylitis	19.86	13.00	22	24455	5582	34926872
Cardiac failure	19.56	13.00	21	24456	91227	34841227
Peripheral swelling	19.26	13.00	105	24372	76436	34856018
Respiratory failure	19.12	13.00	29	24448	108543	34823911
Anion gap	18.63	13.00	10	24467	857	34931597
Neck pain	18.53	13.00	49	24428	25300	34907154
Product use in unapproved indication	18.28	13.00	34	24443	117465	34814989
Ascites	18.25	13.00	5	24472	46566	34885888
Pain in extremity	18.20	13.00	151	24326	126362	34806092
Feeling abnormal	17.46	13.00	89	24388	63146	34869308
Hepatic function abnormal	16.94	13.00	5	24472	44358	34888096
Postoperative delirium	16.84	13.00	6	24471	189	34932265
Off label use	16.28	13.00	202	24275	419322	34513132
Blood creatinine increased	16.12	13.00	26	24451	94950	34837504
Vasoplegia syndrome	15.98	13.00	12	24465	1844	34930610
Metabolic alkalosis	15.88	13.00	11	24466	1490	34930964
Psoriasis	15.52	13.00	61	24416	38751	34893703
Melaena	15.45	13.00	3	24474	35377	34897077
Intervertebral disc protrusion	15.20	13.00	26	24451	9930	34922524
Pyrexia	15.01	13.00	155	24322	332858	34599596
Ischaemic cardiomyopathy	14.43	13.00	20	24457	6369	34926085
Tremor	14.33	13.00	103	24374	82484	34849970
Unresponsive to stimuli	14.14	13.00	47	24430	27522	34904932
Irritable bowel syndrome	14.13	13.00	15	24462	3628	34928826
Renal impairment	14.12	13.00	28	24449	94485	34837969
Febrile neutropenia	14.00	13.00	49	24428	136800	34795654
Accidental poisoning	13.93	13.00	8	24469	782	34931672
Painful ejaculation	13.66	13.00	4	24473	66	34932388
Neutropenia	13.58	13.00	60	24417	156718	34775736
Respiratory depression	13.53	13.00	33	24444	16212	34916242
Insomnia	13.35	13.00	121	24356	103786	34828668
Adverse drug reaction	13.29	13.00	48	24429	29294	34903160
Anion gap abnormal	13.12	13.00	5	24472	191	34932263

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Completed suicide	1599.16	11.07	1690	91754	244077	79406867
Toxicity to various agents	944.44	11.07	1733	91711	419807	79231137
Sedation complication	671.28	11.07	340	93104	15329	79635615
Drug abuse	631.71	11.07	862	92582	161829	79489115
Creatinine renal clearance decreased	606.87	11.07	339	93105	18663	79632281
Sedation	556.95	11.07	472	92972	51423	79599521
Blood calcium decreased	467.10	11.07	348	93096	31471	79619473
Orthostatic hypotension	434.25	11.07	425	93019	55739	79595205
Cognitive disorder	430.23	11.07	468	92976	69458	79581486
Balance disorder	383.60	11.07	524	92920	98333	79552611
Temperature regulation disorder	360.42	11.07	163	93281	5690	79645254
Constipation	349.06	11.07	917	92527	282133	79368811
Depressed level of consciousness	324.27	11.07	478	92966	96174	79554770
Pain	309.44	11.07	1631	91813	702171	78948773
Food allergy	278.87	11.07	168	93276	10656	79640288
Coeliac disease	261.40	11.07	164	93280	11187	79639757
Respiratory arrest	252.33	11.07	324	93120	57226	79593718
Cardio-respiratory arrest	211.86	11.07	422	93022	108088	79542856
Immunodeficiency	211.18	11.07	187	93257	21581	79629363
Mobility decreased	207.89	11.07	449	92995	121726	79529218
Back pain	179.66	11.07	769	92675	303411	79347533
Fall	159.07	11.07	1046	92398	486583	79164361
Bursitis	157.39	11.07	202	93242	35642	79615302
Intentional product misuse	128.03	11.07	319	93125	94846	79556098
Migraine	123.77	11.07	299	93145	87194	79563750
Fluid retention	120.32	11.07	258	93186	69551	79581393
Product dose omission issue	115.92	11.07	585	92859	246952	79403992
Drug hypersensitivity	110.20	11.07	662	92782	298254	79352690
Upper respiratory tract infection	109.63	11.07	293	93151	90875	79560069
Cardiac arrest	100.59	11.07	434	93010	171662	79479282
Hand deformity	94.85	11.07	7	93437	103912	79547032
General physical health deterioration	92.30	11.07	112	93332	275126	79375818
Rash erythematous	92.17	11.07	207	93237	57562	79593382
Neutropenia	90.36	11.07	123	93321	287587	79363357
Hyperhidrosis	90.03	11.07	384	93060	151108	79499836
Pericarditis	89.74	11.07	9	93435	104227	79546717
Acute kidney injury	88.63	11.07	312	93132	519092	79131852
Hyponatraemia	88.60	11.07	49	93395	177799	79473145
Synovitis	85.08	11.07	35	93409	150699	79500245
Poisoning	84.67	11.07	125	93319	25147	79625797
Asthma	83.04	11.07	346	93098	134749	79516195
Febrile neutropenia	82.86	11.07	89	93355	230910	79420034
Headache	82.40	11.07	1146	92298	652626	78998318
Anaemia	80.88	11.07	260	93184	444755	79206189
Decorticate posture	74.62	11.07	24	93420	318	79650626
C-reactive protein increased	72.75	11.07	30	93414	128997	79521947
Pulmonary malformation	70.47	11.07	21	93423	212	79650732
Systemic lupus erythematosus	68.58	11.07	28	93416	121121	79529823
Cardiac failure	67.09	11.07	50	93394	154792	79496152
Lower respiratory tract infection	65.23	11.07	35	93409	129185	79521759
Glossodynia	65.13	11.07	20	93424	103317	79547627
Psoriasis	63.53	11.07	240	93204	89347	79561597
Pyrexia	62.32	11.07	503	92941	678206	78972738
Blepharospasm	60.22	11.07	52	93392	5799	79645145
Leukopenia	59.63	11.07	31	93413	116482	79534462
Respiratory depression	59.41	11.07	112	93332	27518	79623426
Thrombocytopenia	58.53	11.07	141	93303	265118	79385826
Suspected suicide	58.48	11.07	67	93377	10509	79640435
Overdose	57.91	11.07	392	93052	183814	79467130
Hypotension	57.85	11.07	778	92666	439539	79211405
Spinal operation	57.60	11.07	58	93386	7859	79643085
Renal impairment	55.23	11.07	62	93382	157721	79493223
Interstitial lung disease	53.26	11.07	33	93411	112567	79538377
Maternal exposure during pregnancy	53.08	11.07	49	93395	136489	79514455
Anxiety	51.78	11.07	481	92963	248031	79402913
Lung cyst	51.46	11.07	18	93426	313	79650631
Blood creatinine increased	50.99	11.07	64	93380	154993	79495951
Malignant neoplasm progression	50.31	11.07	51	93393	135939	79515005
Memory impairment	50.07	11.07	261	93183	111473	79539471
Alanine aminotransferase increased	49.50	11.07	71	93373	162499	79488445
Neck pain	49.36	11.07	197	93247	75220	79575724
Multiple organ dysfunction syndrome	48.12	11.07	42	93402	120204	79530740
Rheumatoid arthritis	47.78	11.07	412	93032	208058	79442886
Exposure via ingestion	47.31	11.07	43	93401	5131	79645813
Pancytopenia	46.99	11.07	76	93368	165669	79485275
Taste disorder	46.98	11.07	74	93370	15749	79635195
Hepatic function abnormal	46.33	11.07	14	93430	73093	79577851
Fibromyalgia	46.13	11.07	173	93271	64167	79586777
Wound	45.98	11.07	41	93403	116138	79534806
Back disorder	45.79	11.07	62	93382	11516	79639428
Post-traumatic neck syndrome	45.08	11.07	29	93415	2065	79648879
Drug interaction	44.63	11.07	294	93150	414889	79236055
Cryopyrin associated periodic syndrome	44.56	11.07	17	93427	382	79650562
Hepatocellular injury	44.02	11.07	3	93441	47590	79603354
Gamma-glutamyltransferase increased	43.88	11.07	6	93438	54674	79596270
Off label use	43.26	11.07	776	92668	906439	78744505
Myocardial depression	43.26	11.07	18	93426	511	79650433
Respiratory tract malformation	41.21	11.07	12	93432	111	79650833
Ascites	40.33	11.07	19	93425	75543	79575401
Hyperaesthesia	38.86	11.07	59	93385	12163	79638781
International normalised ratio increased	38.47	11.07	26	93418	84695	79566249
Electrocardiogram QT prolonged	38.10	11.07	30	93414	90356	79560588
Melaena	37.98	11.07	12	93432	60878	79590066
Bone marrow failure	37.88	11.07	7	93437	51100	79599844
Decreased appetite	37.53	11.07	241	93203	342177	79308767
Muscle injury	37.42	11.07	6	93438	48555	79602389
Hypoaesthesia	37.26	11.07	347	93097	179005	79471939
Platelet count decreased	37.23	11.07	111	93333	194553	79456391
Bronchitis	36.93	11.07	271	93173	130373	79520571
Lactation disorder	36.80	11.07	13	93431	233	79650711
Concussion	36.24	11.07	50	93394	9453	79641491
Aspartate aminotransferase increased	36.16	11.07	67	93377	138574	79512370
Poor sucking reflex	35.82	11.07	11	93433	124	79650820
Multiple drug therapy	35.55	11.07	33	93411	4045	79646899
Toxic epidermal necrolysis	35.52	11.07	5	93439	44576	79606368
Unresponsive to stimuli	35.13	11.07	144	93300	55644	79595300
Soft tissue injury	34.28	11.07	23	93421	1758	79649186
Lactic acidosis	34.14	11.07	20	93424	70339	79580605
Sepsis	34.11	11.07	181	93263	269247	79381697
Therapy cessation	33.88	11.07	109	93335	37453	79613491
Intervertebral disc protrusion	33.67	11.07	81	93363	23540	79627404
Hostility	33.29	11.07	25	93419	2285	79648659
Therapeutic product effect decreased	33.12	11.07	91	93353	163772	79487172
Pleural effusion	32.98	11.07	76	93368	145186	79505758
Fatigue	32.64	11.07	1365	92079	928362	78722582
Surgery	32.24	11.07	98	93346	32668	79618276
Blood lactate dehydrogenase increased	32.15	11.07	4	93440	39166	79611778
Gastrointestinal disorder	31.92	11.07	59	93385	122146	79528798
Libido increased	31.86	11.07	23	93421	1978	79648966
Milk-alkali syndrome	31.40	11.07	20	93424	1400	79649544
Hypoglycaemia	31.28	11.07	44	93400	101550	79549394
Sternal fracture	31.27	11.07	25	93419	2505	79648439
Cholestasis	31.22	11.07	11	93433	52098	79598846
Drug eruption	30.53	11.07	7	93437	43928	79607016
Cardiogenic shock	30.51	11.07	6	93438	41908	79609036
Drug-induced liver injury	30.41	11.07	20	93424	66097	79584847
Death	30.19	11.07	873	92571	565641	79085303
Hyperkalaemia	30.09	11.07	55	93389	114343	79536601
Hypokalaemia	29.85	11.07	79	93365	143961	79506983
Cytomegalovirus infection	29.22	11.07	7	93437	42637	79608307
Tubulointerstitial nephritis	28.85	11.07	5	93439	38230	79612714
Drug resistance	28.79	11.07	7	93437	42206	79608738
Rash maculo-papular	28.57	11.07	15	93429	56063	79594881
Stomatitis	28.55	11.07	83	93361	146674	79504270
Blood alkaline phosphatase increased	28.29	11.07	20	93424	63644	79587300
Ankylosing spondylitis	28.15	11.07	51	93393	12154	79638790
Folliculitis	27.94	11.07	15	93429	55365	79595579
Blood bilirubin increased	27.89	11.07	22	93422	66210	79584734
Atrial fibrillation	27.88	11.07	128	93316	197758	79453186
Agranulocytosis	27.86	11.07	9	93435	45021	79605923
Liver injury	27.60	11.07	16	93428	56598	79594346
Jaundice	27.58	11.07	14	93430	53335	79597609
Depression	27.55	11.07	381	93063	216409	79434535
Pneumocystis jirovecii pneumonia	27.48	11.07	3	93441	32505	79618439
Vascular malformation	27.44	11.07	12	93432	386	79650558
Exposure via breast milk	27.06	11.07	16	93428	980	79649964
Muscle spasms	26.82	11.07	318	93126	174412	79476532
Gluten sensitivity	26.74	11.07	12	93432	411	79650533
Erythema	26.61	11.07	388	93056	222902	79428042
Circulatory collapse	26.17	11.07	6	93438	37662	79613282
Impaired healing	25.97	11.07	39	93405	87616	79563328
Hypocalcaemia	25.96	11.07	13	93431	49911	79601033
Paranasal cyst	25.90	11.07	12	93432	443	79650501
Neutrophil count decreased	25.77	11.07	44	93400	93915	79557029
Foot fracture	25.75	11.07	70	93374	21911	79629033
Neck injury	25.21	11.07	23	93421	2758	79648186
Serotonin syndrome	25.08	11.07	112	93332	44915	79606029
Feeling abnormal	25.00	11.07	291	93153	158908	79492036
Meniscus injury	24.90	11.07	35	93409	6733	79644211
Gastrooesophageal reflux disease	24.37	11.07	207	93237	104039	79546905
Hepatotoxicity	24.35	11.07	15	93429	51337	79599607
Disease progression	23.80	11.07	123	93321	184239	79466705
Uterine perforation	23.79	11.07	33	93411	6270	79644674
Emotional distress	23.47	11.07	101	93343	39868	79611076
Maternal exposure during breast feeding	23.25	11.07	22	93422	2763	79648181
Respiratory failure	22.63	11.07	122	93322	180789	79470155
Oedema peripheral	22.59	11.07	188	93256	252100	79398844
Disseminated intravascular coagulation	22.46	11.07	7	93437	35835	79615109
Prescribed overdose	22.45	11.07	96	93348	37787	79613157
Stress	22.41	11.07	165	93279	79447	79571497
Pre-existing condition improved	22.32	11.07	30	93414	5533	79645411
Multiple sclerosis	22.26	11.07	67	93377	22215	79628729
Electrocardiogram QRS complex prolonged	22.16	11.07	43	93401	10790	79640154
Dental restoration failure	22.11	11.07	14	93430	970	79649974
Injection site pain	22.04	11.07	241	93203	129597	79521347
Therapy non-responder	22.01	11.07	47	93397	92258	79558686
Confusional state	21.75	11.07	253	93191	317744	79333200
Withdrawal syndrome	21.62	11.07	75	93369	26779	79624165
Fear of disease	20.92	11.07	15	93429	1277	79649667
Foetal exposure timing unspecified	20.65	11.07	6	93438	55	79650889
Pneumonia aspiration	20.62	11.07	29	93415	66938	79584006
Back injury	20.60	11.07	41	93403	10482	79640462
Acute hepatic failure	20.52	11.07	5	93439	30108	79620836
Hepatic failure	20.39	11.07	25	93419	61187	79589757
Infection	20.36	11.07	183	93261	241529	79409415
Dyspnoea	20.34	11.07	810	92634	856215	78794729
Intervertebral disc degeneration	20.25	11.07	52	93392	15733	79635211
Bedridden	20.06	11.07	44	93400	12035	79638909
Septic shock	20.05	11.07	75	93369	122726	79528218
Therapy interrupted	19.81	11.07	81	93363	31260	79619684
Transaminases increased	19.59	11.07	19	93425	51724	79599220
Serum sickness-like reaction	19.37	11.07	11	93433	624	79650320
Nasal discharge discolouration	19.32	11.07	19	93425	2502	79648442
Arthropathy	19.20	11.07	125	93319	176986	79473958
Painful ejaculation	18.96	11.07	4	93440	7	79650937
Rhinorrhoea	18.82	11.07	153	93291	75921	79575023
Personality disorder	18.60	11.07	29	93415	6117	79644827
Application site burn	18.55	11.07	12	93432	863	79650081
Dysphoria	18.19	11.07	25	93419	4709	79646235
Bronchial hyperreactivity	18.07	11.07	20	93424	3020	79647924
Fracture pain	17.87	11.07	11	93433	725	79650219
Haematemesis	17.78	11.07	21	93423	52243	79598701
Cerebral haemorrhage	17.73	11.07	25	93419	57648	79593296
Gastrointestinal haemorrhage	17.71	11.07	101	93343	147618	79503326
Lymphopenia	17.39	11.07	7	93437	30550	79620394
Muscle strain	17.25	11.07	36	93408	9519	79641425
Blood creatine phosphokinase increased	17.17	11.07	32	93412	66058	79584886
Liver disorder	17.16	11.07	37	93407	72380	79578564
Upper gastrointestinal haemorrhage	17.10	11.07	14	93430	41366	79609578
Renal failure	16.99	11.07	152	93292	200816	79450128
Liver function test abnormal	16.95	11.07	31	93413	64444	79586500
Pulmonary fibrosis	16.93	11.07	16	93428	44096	79606848
Catheter site bruise	16.91	11.07	9	93435	449	79650495
Mucosal inflammation	16.78	11.07	40	93404	75540	79575404
Cardiac failure congestive	16.73	11.07	98	93346	142304	79508640
Rib fracture	16.70	11.07	71	93373	27876	79623068
Middle insomnia	16.70	11.07	49	93395	16020	79634924
Ischaemic stroke	16.67	11.07	9	93435	33122	79617822
Bronchopulmonary aspergillosis	16.63	11.07	3	93441	22291	79628653
Foetal death	16.54	11.07	32	93412	8012	79642932
Stevens-Johnson syndrome	16.50	11.07	13	93431	39153	79611791
Polyneuropathy	16.48	11.07	4	93440	24147	79626797
Panic attack	16.44	11.07	64	93380	24152	79626792
Syncope	16.39	11.07	133	93311	179316	79471628
Pneumonia	16.29	11.07	621	92823	659625	78991319
Lower limb fracture	16.29	11.07	62	93382	23153	79627791
Haemoglobin decreased	16.25	11.07	174	93270	221945	79428999
Proteinuria	16.11	11.07	9	93435	32493	79618451
Lung disorder	16.07	11.07	45	93399	80512	79570432
Myocarditis	16.05	11.07	3	93441	21730	79629214
Lymphatic system neoplasm	16.00	11.07	5	93439	60	79650884
Cerebral infarction	15.91	11.07	18	93426	45658	79605286
Application site perspiration	15.86	11.07	4	93440	20	79650924
Hyperglycaemia	15.80	11.07	37	93407	70298	79580646
Allodynia	15.67	11.07	14	93430	1634	79649310
Road traffic accident	15.59	11.07	96	93348	43568	79607376
Tremor	15.57	11.07	283	93161	169800	79481144
Spinal disorder	15.51	11.07	36	93408	10224	79640720
Sinusitis	15.42	11.07	318	93126	195183	79455761
Poor quality sleep	15.38	11.07	60	93384	22662	79628282
Mastoiditis	15.26	11.07	14	93430	1690	79649254
Pain in extremity	15.26	11.07	546	92898	363992	79286952
Cholecystitis chronic	15.24	11.07	35	93409	9871	79641073
Peritonitis	15.03	11.07	7	93437	28029	79622915
Basal cell carcinoma	15.01	11.07	13	93431	37362	79613582
Extrapyramidal disorder	15.00	11.07	4	93440	22675	79628269
Dermatitis atopic	14.89	11.07	35	93409	10021	79640923
Opiates positive	14.77	11.07	11	93433	993	79649951
Throat irritation	14.60	11.07	90	93354	40856	79610088
Drug ineffective	14.34	11.07	1082	92362	1079831	78571113
Injection site mass	14.24	11.07	54	93390	20130	79630814
Insomnia	14.18	11.07	382	93062	244788	79406156
Myelodysplastic syndrome	14.16	11.07	9	93435	30292	79620652
Osteonecrosis of jaw	14.04	11.07	18	93426	43208	79607736
Abdominal discomfort	14.00	11.07	208	93236	250519	79400425
Hot flush	13.91	11.07	111	93333	54766	79596178
Asthma-chronic obstructive pulmonary disease overlap syndrome	13.89	11.07	18	93426	3203	79647741
Thrombosis	13.76	11.07	155	93289	83945	79566999
Altered state of consciousness	13.47	11.07	19	93425	43803	79607141
Discomfort	13.44	11.07	89	93355	125528	79525416
Arthralgia	13.42	11.07	808	92636	570995	79079949
Rash	13.38	11.07	548	92896	577810	79073134
Anuria	13.31	11.07	4	93440	20959	79629985
Injury	13.22	11.07	144	93300	77352	79573592
Product prescribing error	13.21	11.07	20	93424	44793	79606151
Blister	13.11	11.07	84	93360	119392	79531552
Catheter site pain	13.02	11.07	23	93421	5373	79645571
Paraesthesia	12.99	11.07	284	93160	176039	79474905
Type 2 diabetes mellitus	12.87	11.07	30	93414	57092	79593852
Urinary incontinence	12.80	11.07	87	93357	40822	79610122
Rotator cuff syndrome	12.80	11.07	41	93403	14054	79636890
Exposure during pregnancy	12.75	11.07	68	93376	101064	79549880
Cytokine release syndrome	12.75	11.07	14	93430	35984	79614960
Ejection fraction decreased	12.74	11.07	13	93431	34564	79616380
Myocardial ischaemia	12.74	11.07	7	93437	25512	79625432
Hypophagia	12.66	11.07	21	93423	45346	79605598
Seasonal allergy	12.50	11.07	45	93399	16361	79634583
Thyrotoxic crisis	12.39	11.07	11	93433	1273	79649671
Skin necrosis	12.33	11.07	3	93441	18084	79632860
Status epilepticus	12.31	11.07	7	93437	25034	79625910
Muscle neoplasm	12.30	11.07	4	93440	55	79650889
Illness	12.30	11.07	95	93349	46416	79604528
Lower respiratory tract congestion	12.29	11.07	19	93425	3978	79646966
Irritable bowel syndrome	12.24	11.07	35	93409	62206	79588738
Neurotoxicity	12.24	11.07	12	93432	32506	79618438
Pelvic pain	12.22	11.07	39	93405	13342	79637602
Rectal haemorrhage	12.19	11.07	47	93397	76253	79574691
Aggression	12.10	11.07	26	93418	50932	79600012
Insurance issue	12.03	11.07	23	93421	5710	79645234
Product communication issue	12.03	11.07	10	93434	1059	79649885
Irritability	11.99	11.07	86	93358	41058	79609886
Nightmare	11.99	11.07	61	93383	25800	79625144
Tooth abscess	11.96	11.07	44	93400	16166	79634778
Major depression	11.96	11.07	30	93414	8950	79641994
Haematuria	11.93	11.07	41	93403	68795	79582149
Choroid melanoma	11.92	11.07	4	93440	61	79650883
Priapism	11.92	11.07	20	93424	4485	79646459
Toxicologic test abnormal	11.85	11.07	11	93433	1349	79649595
Medication error	11.81	11.07	41	93403	68601	79582343
Multiple sclerosis relapse	11.73	11.07	94	93350	46439	79604505
Prostate cancer	11.71	11.07	13	93431	33255	79617689
Ankle fracture	11.64	11.07	45	93399	16924	79634020
Vaginal infection	11.62	11.07	23	93421	5857	79645087
Poor venous access	11.54	11.07	47	93397	18102	79632842
Pallor	11.51	11.07	26	93418	50036	79600908
Blood urea increased	11.50	11.07	25	93419	48765	79602179
Oropharyngeal pain	11.47	11.07	186	93258	109167	79541777
Sinus headache	11.43	11.07	21	93423	5059	79645885
Gait disturbance	11.34	11.07	321	93123	207185	79443759
Bradycardia	11.24	11.07	103	93341	135454	79515490
Hyperthyroidism	11.22	11.07	6	93438	22203	79628741
Muscle twitching	11.19	11.07	58	93386	24706	79626238
Ligament sprain	11.18	11.07	38	93406	13426	79637518
Hypomagnesaemia	11.09	11.07	24	93420	46887	79604057

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	M03BX08	MUSCULO-SKELETAL SYSTEM MUSCLE RELAXANTS MUSCLE RELAXANTS, CENTRALLY ACTING AGENTS Other centrally acting agents
MeSH PA	D000928	Antidepressive Agents
MeSH PA	D000929	Antidepressive Agents, Tricyclic
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D009125	Muscle Relaxants, Central
MeSH PA	D009465	Neuromuscular Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D011619	Psychotropic Drugs
MeSH PA	D014149	Tranquilizing Agents
CHEBI has role	CHEBI:35469	antidepressants
CHEBI has role	CHEBI:35473	tranquilizing drugs
CHEBI has role	CHEBI:51371	muscle relaxants
FDA PE	N0000175730	Centrally-mediated Muscle Relaxation
FDA EPC	N0000175737	Muscle Relaxant

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Spasticity	indication	221360009
Fibromyalgia	off-label use	203082005	DOID:631
Sinus tachycardia	contraindication	11092001
Glaucoma	contraindication	23986001	DOID:1686
Hyperthyroidism	contraindication	34486009	DOID:7998
Conduction disorder of the heart	contraindication	44808001
Chronic heart failure	contraindication	48447003
Hepatic failure	contraindication	59927004
Open-angle glaucoma	contraindication	84494001	DOID:1067
Heart block	contraindication	233916004
Retention of urine	contraindication	267064002
Myocardial infarction in recovery phase	contraindication	418044006

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.66	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
15MG	AMRIX	TEVA PHARMS INTL	N021777	Feb. 1, 2007	RX	CAPSULE, EXTENDED RELEASE	ORAL	7544372	Nov. 14, 2023	RELIEF OF MUSCLE SPASM
15MG	AMRIX	TEVA PHARMS INTL	N021777	Feb. 1, 2007	RX	CAPSULE, EXTENDED RELEASE	ORAL	7829121	Nov. 14, 2023	RELIEF OF MUSCLE SPASM
15MG	AMRIX	TEVA PHARMS INTL	N021777	Feb. 1, 2007	RX	CAPSULE, EXTENDED RELEASE	ORAL	8877245	Nov. 14, 2023	RELIEF OF MUSCLE SPASM
15MG	AMRIX	TEVA PHARMS INTL	N021777	Feb. 1, 2007	RX	CAPSULE, EXTENDED RELEASE	ORAL	9375410	Nov. 14, 2023	RELIEF OF MUSCLE SPASM
15MG	AMRIX	TEVA PHARMS INTL	N021777	Feb. 1, 2007	RX	CAPSULE, EXTENDED RELEASE	ORAL	9399025	Nov. 14, 2023	RELIEF OF MUSCLE SPASM
30MG	AMRIX	TEVA PHARMS INTL	N021777	Feb. 1, 2007	RX	CAPSULE, EXTENDED RELEASE	ORAL	7544372	Nov. 14, 2023	RELIEF OF MUSCLE SPASM
30MG	AMRIX	TEVA PHARMS INTL	N021777	Feb. 1, 2007	RX	CAPSULE, EXTENDED RELEASE	ORAL	7829121	Nov. 14, 2023	RELIEF OF MUSCLE SPASM
30MG	AMRIX	TEVA PHARMS INTL	N021777	Feb. 1, 2007	RX	CAPSULE, EXTENDED RELEASE	ORAL	8877245	Nov. 14, 2023	RELIEF OF MUSCLE SPASM
30MG	AMRIX	TEVA PHARMS INTL	N021777	Feb. 1, 2007	RX	CAPSULE, EXTENDED RELEASE	ORAL	9375410	Nov. 14, 2023	RELIEF OF MUSCLE SPASM
30MG	AMRIX	TEVA PHARMS INTL	N021777	Feb. 1, 2007	RX	CAPSULE, EXTENDED RELEASE	ORAL	9399025	Nov. 14, 2023	RELIEF OF MUSCLE SPASM

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN	ANTAGONIST	Ki	7.54	WOMBAT-PK	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		IC50	4.73	WOMBAT-PK
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		Ki	6.97	WOMBAT-PK
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	7.44	WOMBAT-PK
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN	ANTAGONIST	Ki	7.24	WOMBAT-PK
5-hydroxytryptamine receptor 6	GPCR	P50406	5HT6R_HUMAN		Ki	6.84	WOMBAT-PK
5-hydroxytryptamine receptor 7	GPCR	P34969	5HT7R_HUMAN		Ki	6.82	WOMBAT-PK
Histamine H1 receptor	GPCR	P35367	HRH1_HUMAN		Ki	8.83	WOMBAT-PK
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		IC50	6.95	WOMBAT-PK
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN		Ki	7.22	PDSP
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN		Ki	8.22	PDSP
Aldehyde oxidase	Enzyme	Q06278	AOXA_HUMAN		IC50	5.51	WOMBAT-PK
Proto-oncogene tyrosine-protein kinase receptor Ret	Kinase	P07949	RET_HUMAN		IC50	6.52	CHEMBL
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	6.81	WOMBAT-PK
Voltage-dependent N-type calcium channel subunit alpha-1B	Ion channel	Q00975	CAC1B_HUMAN		IC50	5	CHEMBL

External reference:

ID	Source
4019699	VUID
N0000147791	NUI
D00772	KEGG_DRUG
6202-23-9	SECONDARY_CAS_RN
21949	RXNORM
4017956	VANDF
4019699	VANDF
C0056732	UMLSCUI
CHEBI:3996	CHEBI
CHEMBL669	ChEMBL_ID
DB00924	DRUGBANK_ID
CHEMBL1200636	ChEMBL_ID
C004704	MESH_SUPPLEMENTAL_RECORD_UI
2895	PUBCHEM_CID
7152	IUPHAR_LIGAND_ID
791	INN_ID
69O5WQQ5TI	UNII
217	MMSL
4517	MMSL
d00963	MMSL
001678	NDDF
004680	NDDF
373779004	SNOMEDCT_US
63083007	SNOMEDCT_US
80802008	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1920	CAPSULE, EXTENDED RELEASE	15 mg	ORAL	NDA authorized generic	30 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1920	CAPSULE, EXTENDED RELEASE	15 mg	ORAL	NDA authorized generic	30 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1920	CAPSULE, EXTENDED RELEASE	15 mg	ORAL	NDA authorized generic	30 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1921	CAPSULE, EXTENDED RELEASE	30 mg	ORAL	NDA authorized generic	30 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1921	CAPSULE, EXTENDED RELEASE	30 mg	ORAL	NDA authorized generic	30 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1921	CAPSULE, EXTENDED RELEASE	30 mg	ORAL	NDA authorized generic	30 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3420	TABLET, FILM COATED	5 mg	ORAL	ANDA	20 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3421	TABLET, FILM COATED	7.50 mg	ORAL	ANDA	20 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3422	TABLET, FILM COATED	10 mg	ORAL	ANDA	20 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1436	CAPSULE, EXTENDED RELEASE	15 mg	ORAL	NDA AUTHORIZED GENERIC	28 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1436	CAPSULE, EXTENDED RELEASE	15 mg	ORAL	NDA AUTHORIZED GENERIC	28 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1437	CAPSULE, EXTENDED RELEASE	30 mg	ORAL	NDA AUTHORIZED GENERIC	28 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1437	CAPSULE, EXTENDED RELEASE	30 mg	ORAL	NDA AUTHORIZED GENERIC	28 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0440-1350	TABLET, FILM COATED	10 mg	ORAL	ANDA	20 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0440-7350	TABLET, FILM COATED	10 mg	ORAL	ANDA	19 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3256	TABLET, FILM COATED	5 mg	ORAL	ANDA	20 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3330	TABLET, FILM COATED	7.50 mg	ORAL	ANDA	20 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0591-5658	TABLET, FILM COATED	10 mg	ORAL	ANDA	20 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8084	TABLET, FILM COATED	10 mg	ORAL	ANDA	21 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8084	TABLET, FILM COATED	10 mg	ORAL	ANDA	21 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8182	TABLET, FILM COATED	5 mg	ORAL	ANDA	14 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7809	TABLET, FILM COATED	10 mg	ORAL	ANDA	20 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	10544-072	TABLET, FILM COATED	10 mg	ORAL	ANDA	23 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	10544-159	TABLET	10 mg	ORAL	ANDA	13 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	10544-200	TABLET, FILM COATED	5 mg	ORAL	ANDA	13 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	10702-006	TABLET, FILM COATED	5 mg	ORAL	ANDA	13 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	10702-007	TABLET, FILM COATED	10 mg	ORAL	ANDA	13 sections
Cyclobenzaprine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	12634-528	TABLET	10 mg	ORAL	ANDA	20 sections
Cyclobenzaprine Hydrochloride	Human Prescription Drug Label	1	16571-782	TABLET, FILM COATED	5 mg	ORAL	ANDA	23 sections
Cyclobenzaprine Hydrochloride	Human Prescription Drug Label	1	16571-783	TABLET, FILM COATED	10 mg	ORAL	ANDA	23 sections