{
 "query": "cyclobenzaprine",
 "ingredient": "cyclobenzaprine",
 "slug": "cyclobenzaprine",
 "rxcui": "21949",
 "brands": [
  "Amrix",
  "Fexmid",
  "Tonmya"
 ],
 "names": [
  "cyclobenzaprine",
  "cyclobenzaprine hydrochloride"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 181,
   "SUBLINGUAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "Cyclobenzaprine hydrochloride extended-release capsules are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion. Limitations of Use: Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy. Cyclobenzaprine hydrochloride extended-release capsules are a muscle relaxant indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of mu...",
  "contraindications": "Hypersensitivity to any component of this product. Adverse reactions may include anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue cyclobenzaprine hydrochloride extended-release capsules if a hypersensitivity reaction is suspected. Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation. Hyperpyretic crisis seizures and deaths have occurred in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitor drugs. During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. Hyperthyroidism. Hypersensitivity to any component of this product ( 4 ) Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation ( 4 ) During acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure ( 4 ) Hyperthyroidism ( 4 )",
  "warnings_and_cautions": "Serotonin syndrome has been reported with cyclobenzaprine when used in combination with other serotonergic drugs ( 5.1 ) Cyclobenzaprine is structurally related to tricyclic antidepressants which have been reported to produce adverse cardiovascular effects or CNS depressant effects ( 5.2 ) Use in the elderly is not recommended ( 5.3 ) Use in patients with hepatic impairment is not recommended ( 5.4 ) Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure and in patients taking anticholinergic medications ( 5.5 ) 5.1 Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. The concomitant use of cyclobenzaprine hydrochloride extended-release capsules with MAO inhibitors is contraindicated [see Contraindications ( 4 )]. Serotonin syndrome symptoms may include mental status changes (e.g., confusion, agita...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant reactions are described in greater detail, in other sections. Serotonin Syndrome [see Warnings and Precautions ( 5.1 )] Adverse Cardiovascular Effects [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (incidence \u22653% in any treatment group and greater than placebo): dry mouth, dizziness, fatigue, constipation, nausea, dyspepsia, and somnolence ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure to cyclobenzaprine hydrochloride extended-release capsules in 253 patients in 2 clinical trials. Cyclobenzaprine hydrochloride extended-release capsules were studied in two double-blind, parallel-group, placebo-controlled, active-controlled trials of identical design [see Clinical Studies ( 14 )] . The study ...",
  "drug_abuse_and_dependence": "9.3 Dependence Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when cyclobenzaprine hydrochloride extended-release capsules are administered, even though they have not been reported to occur with this drug. Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise. These are not indicative of addiction.",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "See FDA-approved patient labeling (Patient Information). Instruct patients to swallow cyclobenzaprine hydrochloride extended-release capsules intact or to sprinkle capsule contents on a tablespoon of applesauce and swallow immediately without chewing. Advise patients to stop taking cyclobenzaprine hydrochloride extended-release capsules and to notify their physician right away if they experience symptoms of an allergic reaction, such as difficulty breathing, hives, swelling of face or tongue, or itching. Advise patients that cyclobenzaprine hydrochloride extended-release capsules should not be taken with MAO inhibitors or within 14 days after their discontinuation. Caution patients about the risk of serotonin syndrome with concomitant use of cyclobenzaprine hydrochloride extended-release capsules and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. Advise patients of the signs and symptoms of serotonin syndrome [see Warnings and Precautions ( 5.1 )] and instruct patients to seek medical care immediately if they experience these symptoms. Advise patients to stop taking cyclobenzaprine hydrochloride extended-release capsules and ...",
  "spl_medguide": "",
  "clinical_studies": "Efficacy was assessed in two double-blind, parallel-group, active-controlled, placebo-controlled studies of identical design of cyclobenzaprine hydrochloride extended-release 15 mg and 30 mg capsules taken once daily, between 6:00 and 7:00 PM, cyclobenzaprine 10 mg three times a day, or placebo for 14 days in patients with muscle spasms associated with acute painful musculoskeletal conditions. There were significant differences in the primary efficacy analysis, the patient\u2019s rating of medication helpfulness, between the cyclobenzaprine hydrochloride extended-release capsules 15 mg group and the placebo group at Days 4 and 14 in one study and between the cyclobenzaprine hydrochloride extended-release capsules 30 mg group and the placebo group at Day 4 in the second study. Table 2: Patients\u2019 Rating of Medication Helpfulness - Study 1* Day 4 Day 14 Number of Patients (%) Number of Patients (%) Placebo (N = 64) Cyclobenzaprine Hydrochloride Extended-Release Capsules 30 mg (N = 64) Placebo (N = 64) Cyclobenzaprine Hydrochloride Extended-Release Capsules 30 mg (N = 64) Excellent 1 (2%) 3 (5%) 12 (19%) 15 (23%) Very Good 5 (8%) 13 (20%) 9 (14%) 19 (30%) Good 15 (23%) 22 (34%) 10 (16%) 15 ...",
  "brand_name": "Cyclobenzaprine Hydrochloride",
  "manufacturer": "Advanced Rx of Tennessee, LLC",
  "application_number": "NDA021777",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20241029",
  "set_id": "259fb05a-4f45-9c8e-e063-6294a90a4484",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 62900,
  "serious": 39920,
  "death": 6517,
  "hospitalization": 17107,
  "primary_suspect": 62810,
  "top_reactions": [
   [
    "Pain",
    6013
   ],
   [
    "Fatigue",
    5249
   ],
   [
    "Drug Ineffective",
    4636
   ],
   [
    "Nausea",
    4453
   ],
   [
    "Headache",
    4416
   ],
   [
    "Off Label Use",
    3664
   ],
   [
    "Diarrhoea",
    3439
   ],
   [
    "Chronic Kidney Disease",
    3299
   ],
   [
    "Arthralgia",
    3093
   ],
   [
    "Fall",
    3009
   ],
   [
    "Dizziness",
    2703
   ],
   [
    "Back Pain",
    2644
   ],
   [
    "Dyspnoea",
    2644
   ],
   [
    "Vomiting",
    2495
   ],
   [
    "Constipation",
    2466
   ]
  ],
  "by_year": {
   "2019": 6955,
   "2020": 6281,
   "2021": 4993,
   "2022": 4280,
   "2023": 4046,
   "2024": 4025,
   "2025": 4435,
   "2026": 2326
  },
  "by_year_primary": {
   "2019": 6951,
   "2020": 6281,
   "2021": 4978,
   "2022": 4253,
   "2023": 4023,
   "2024": 4013,
   "2025": 4432,
   "2026": 2322
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class I",
   "date": "20250827",
   "reason": "Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).",
   "firm": "Unichem Pharmaceuticals USA Inc.",
   "status": "Ongoing"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 27,
  "nda": 3,
  "anda": 23,
  "first_approval": "19770826",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 16,
  "labeling_recent": 1,
  "sponsors": [
   "ACTAVIS LABS FL INC",
   "AIPING PHARM INC",
   "APOTEX",
   "AUROBINDO PHARMA",
   "CHARTWELL RX",
   "INVAGEN PHARMS",
   "JANSSEN RES AND DEV",
   "JUBILANT CADISTA"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/26/1977"
 },
 "trials": {
  "total": 64,
  "completed": 38,
  "terminated": 13,
  "with_results": 25,
  "industry": 41,
  "phase3": 24,
  "results_share": 0.6578947368421053,
  "terminated_share": 0.203125
 },
 "pubmed": {
  "rct": 38,
  "meta": 4,
  "recent_rct": 6,
  "cochrane": [
   {
    "pmid": "19588406",
    "title": "Cyclobenzaprine for the treatment of myofascial pain in adults",
    "year": "2009"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "cyclobenzaprine",
   "Amrix",
   "Fexmid",
   "Tonmya"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 7407401,
  "beneficiaries": 2727309,
  "spend": 64239925.22,
  "by_brand": [
   {
    "brand": "Cyclobenzaprine HCl",
    "claims": 7401986,
    "per_claim": 8.3681074444,
    "is_generic": true
   },
   {
    "brand": "Cyclobenzaprine HCl ER",
    "claims": 5267,
    "per_claim": 351.48910765,
    "is_generic": false
   },
   {
    "brand": "Amrix",
    "claims": 148,
    "per_claim": 3027.1482432,
    "is_generic": false
   }
  ],
  "per_claim": 8.672397406323757
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 10767,
  "fills": 7407401,
  "per_million": 1453.5462573175125,
  "ratio": 0.5249449742913318,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 90,
   "letter": "A",
   "why": [
    "1,454 FDA reports naming it as the suspect drug per million Medicare fills, 0.5x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.1x)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 40,
   "letter": "F",
   "why": [
    "38 randomized trials and 4 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "20% of registered trials were terminated, withdrawn, or suspended (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 85,
   "letter": "B",
   "why": [
    "Recalls since 2016: 1 Class I, 0 Class II, 0 Class III across 23 generic makers (-15)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (23 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are pain, fatigue, nausea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}