{
 "query": "tadalafil",
 "ingredient": "tadalafil",
 "slug": "tadalafil",
 "rxcui": "358263",
 "brands": [
  "Cialis",
  "Adcirca",
  "Alyq",
  "Tadliq"
 ],
 "names": [
  "tadalafil"
 ],
 "classes": [
  {
   "id": "G04BE",
   "name": "Drugs used in erectile dysfunction"
  }
 ],
 "alternatives": [
  "alprostadil",
  "apomorphine",
  "avanafil",
  "moxisylyte",
  "papaverine",
  "sildenafil",
  "vardenafil",
  "yohimbine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 137
  },
  "boxed_warning": "",
  "indications_and_usage": "TADLIQ is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II \u2013 III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). ( 1.1 ) 1.1 Pulmonary Arterial Hypertension TADLIQ \u00ae is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II \u2013 III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).",
  "contraindications": "Concomitant organic nitrates ( 4.1 ) Concomitant Guanylate Cyclase (GC) Stimulators ( 4.2 ) History of known serious hypersensitivity reaction to TADLIQ, ADCIRCA \u00ae or CIALIS \u00ae ( 4.3 ) 4.1 Concomitant Organic Nitrates TADLIQ is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. Do not use nitrates within 48 hours of the last dose of TADLIQ. TADLIQ potentiates the hypotensive effect of nitrates. This potentiation is thought to result from the combined effects of nitrates and TADLIQ on the nitric oxide/cGMP pathway [see Clinical Pharmacology ( 12.2 )] . 4.2 Concomitant Guanylate Cyclase (GC) Stimulators Coadministration of GC stimulators such as riociguat with TADLIQ is contraindicated. TADLIQ may potentiate the hypotensive effects of GC stimulators. 4.3 Hypersensitivity Reactions TADLIQ is contraindicated in patients with a known serious hypersensitivity to tadalafil (TADLIQ, ADCIRCA \u00ae or CIALIS \u00ae ). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions ( 6.2 )] .",
  "warnings_and_cautions": "Hypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of TADLIQ. Not recommended in patients with pulmonary veno-occlusive disease. ( 5.1 , 5.2 ) Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent. ( 5.3 ) Hearing impairment: Cases of sudden decrease or loss of hearing have been reported with tadalafil. ( 5.4 ) Concomitant PDE5 inhibitors: Avoid use with CIALIS, ADCIRCA or other PDE5 inhibitors. ( 5.5 ) Prolonged erection: Advise patients to seek emergency treatment if an erection lasts >4 hours. ( 5.6 ) 5.1 Hypotension TADLIQ has vasodilatory properties that may result in transient decreases in blood pressure. Prior to prescribing TADLIQ, carefully consider whether patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Patients with preexisting hypotension, with autonomic dysfunction, with left ventricular outflow obstruction, may be particularly sensitive to the actions of vasodilators. 5.2 Worsening Pulmonary Vascular Occlusive Disease Pulmonary vasodilators ...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed elsewhere in the labeling: Hypotension [see Warnings and Precautions ( 5.1 )] Visual Loss [see Warnings and Precautions ( 5.3 )] Hearing loss [see Warnings and Precautions ( 5.4 )] Priapism [see Warnings and Precautions ( 5.6 )] The most common adverse reaction is headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CMP Development, LLC at 1-844-321-1443, 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 practice. Tadalafil was administered to 398 patients with PAH during clinical trials worldwide. In trials of tadalafil, a total of 311 and 251 subjects have been treated for at least 182 days and 360 days, respectively. The overall rates of discontinuation because of an adverse event (AE) in the placebo-controlled trial were 9% for tadalafil 40 mg and 15% for placebo. The rates of discontinuation because of AEs, other than those related ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise patient to read the FDA-Approved patient labeling ( Patient Information ) Inform patients that tadalafil is also marketed as CIALIS for erectile dysfunction (ED) and for the signs and symptoms of benign prostatic hyperplasia (BPH). Advise patients taking TADLIQ not to take CIALIS or other PDE5 inhibitors. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking TADLIQ. Such an event may be a sign of NAION. Also discuss with patients that there is an increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking TADLIQ. These events may be accompanied by tinnitus and dizziness.",
  "spl_medguide": "",
  "clinical_studies": "14.1 Tadalafil for Pulmonary Arterial Hypertension A randomized, double-blind, 16 week placebo-controlled study was conducted in 405 patients with pulmonary arterial hypertension, defined as a resting mean pulmonary artery pressure (mPAP) \u226525 mm Hg, pulmonary capillary wedge pressure (PCWP) \u226415 mm Hg, and pulmonary vascular resistance (PVR) \u22653 Wood units via right heart catheterization. Allowed background therapy included bosentan (maintenance dosing up to 125 mg twice daily) and chronic anticoagulation. The use of prostacyclin or analogue, L\u2013arginine, phosphodiesterase inhibitor, or other chronic PAH medications were not permitted. Subjects were randomly assigned to 1 of 5 treatment groups (tadalafil 2.5, 10, 20, 40 mg, or placebo) in a 1:1:1:1:1 ratio. Subjects had to be at least 12 years of age and had a diagnosis of PAH that was idiopathic, heritable, related to connective tissue disease, anorexigen use, human immunodeficiency virus (HIV) infection, associated with an atrial-septal defect, or associated with surgical repair of a congenital systemic-to-pulmonary shunt of least 1 year in duration (for example, ventricular septal defect, patent ductus arteriosus). Patients with a ...",
  "brand_name": "TADLIQ",
  "manufacturer": "CMP Pharma, Inc.",
  "application_number": "NDA214522",
  "pharm_class_epc": [
   "Phosphodiesterase 5 Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20221015",
  "set_id": "7a909b25-3772-403e-a5fe-e4a040293fb7",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 100",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 87430,
  "serious": 53952,
  "death": 9514,
  "hospitalization": 32916,
  "primary_suspect": 87350,
  "top_reactions": [
   [
    "Dyspnoea",
    11295
   ],
   [
    "Headache",
    10167
   ],
   [
    "Diarrhoea",
    7827
   ],
   [
    "Nausea",
    6418
   ],
   [
    "Fatigue",
    5736
   ],
   [
    "Death",
    5106
   ],
   [
    "Dizziness",
    4967
   ],
   [
    "Cough",
    4259
   ],
   [
    "Drug Ineffective",
    4252
   ],
   [
    "Pneumonia",
    3909
   ],
   [
    "Malaise",
    3611
   ],
   [
    "Vomiting",
    3337
   ],
   [
    "Pain",
    3195
   ],
   [
    "Asthenia",
    3188
   ],
   [
    "Pain In Extremity",
    3139
   ]
  ],
  "by_year": {
   "2019": 7572,
   "2020": 6157,
   "2021": 5494,
   "2022": 5423,
   "2023": 5989,
   "2024": 5933,
   "2025": 6440,
   "2026": 2752
  },
  "by_year_primary": {
   "2019": 7572,
   "2020": 6157,
   "2021": 5487,
   "2022": 5409,
   "2023": 5984,
   "2024": 5924,
   "2025": 6400,
   "2026": 2749
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20230323",
   "reason": "cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.",
   "firm": "Preferred Pharmaceuticals, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20230316",
   "reason": "CGMP Deviations",
   "firm": "Northwind Pharmaceuticals LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20230316",
   "reason": "CGMP Deviations",
   "firm": "Northwind Pharmaceuticals LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20211025",
   "reason": "Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20211025",
   "reason": "Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  }
 ],
 "recall_total": 9,
 "drugsfda": {
  "applications": 48,
  "nda": 4,
  "anda": 44,
  "first_approval": "20031121",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 20,
  "labeling_recent": 0,
  "sponsors": [
   "ACCORD HLTHCARE",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "AMNEAL PHARMS CO",
   "AUROBINDO PHARMA LTD",
   "B BETTER",
   "CHARTWELL RX",
   "CIPLA"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/21/2003"
 },
 "trials": {
  "total": 291,
  "completed": 185,
  "terminated": 29,
  "with_results": 74,
  "industry": 122,
  "phase3": 71,
  "results_share": 0.4,
  "terminated_share": 0.09965635738831616
 },
 "pubmed": {
  "rct": 293,
  "meta": 27,
  "recent_rct": 56,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 82.55,
  "records": 5,
  "by_name": [
   [
    "Adcirca",
    82.55
   ]
  ],
  "names_checked": [
   "tadalafil",
   "Cialis",
   "Adcirca",
   "Alyq",
   "Tadliq"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 378785,
  "beneficiaries": 89968,
  "spend": 109271419.76,
  "by_brand": [
   {
    "brand": "Tadalafil",
    "claims": 365541,
    "per_claim": 221.31312233,
    "is_generic": true
   },
   {
    "brand": "Cialis",
    "claims": 7402,
    "per_claim": 498.42571467,
    "is_generic": false
   },
   {
    "brand": "Adcirca",
    "claims": 5153,
    "per_claim": 4623.5794003,
    "is_generic": false
   },
   {
    "brand": "Alyq",
    "claims": 618,
    "per_claim": 1106.6770388,
    "is_generic": false
   },
   {
    "brand": "Tadliq",
    "claims": 71,
    "per_claim": 2448.1902817,
    "is_generic": false
   }
  ],
  "per_claim": 288.4787406048286
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15073,
  "fills": 378785,
  "per_million": 39793.02242697044,
  "ratio": 14.371160896833684,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "39,793 FDA reports naming it as the suspect drug per million Medicare fills, 14.4x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (1.2x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 62,
   "letter": "D",
   "why": [
    "293 randomized trials and 27 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 40% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 94,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 9 Class II, 0 Class III across 44 generic makers (-6)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $83 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (44 applications)",
    "8 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 84,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, headache, diarrhoea, nausea. How would we recognize and handle those?",
  "Why this one over alprostadil, apomorphine, avanafil? What would make you pick one of those instead?",
  "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.)"
 ]
}