{
 "query": "sildenafil",
 "ingredient": "sildenafil",
 "slug": "sildenafil",
 "rxcui": "136411",
 "brands": [
  "Revatio",
  "Viagra",
  "Liqrev",
  "Vybrique"
 ],
 "names": [
  "sildenafil",
  "sildenafil citrate"
 ],
 "classes": [
  {
   "id": "G04BE",
   "name": "Drugs used in erectile dysfunction"
  }
 ],
 "alternatives": [
  "alprostadil",
  "apomorphine",
  "avanafil",
  "moxisylyte",
  "papaverine",
  "tadalafil",
  "vardenafil",
  "yohimbine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 155,
   "INTRAVENOUS": 2
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated for the treatment of erectile dysfunction. VIAGRA is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) ( 1 )",
  "contraindications": "\u2022 Administration of VIAGRA to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. VIAGRA was shown to potentiate the hypotensive effect of nitrates ( 4.1 , 7.1 , 12.2 ) \u2022 Known hypersensitivity to sildenafil or any component of tablet ( 4.2 ) \u2022 Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3 ) 4.1 Nitrates Consistent with its known effects on the nitric oxide/cGMP pathway [ see Clinical Pharmacology (12.1 , 12.2) ], VIAGRA was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated. After patients have taken VIAGRA, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [ see Dosage and Administration (2.3) , Drug Interactions (7.1) , and Clinical Pharmacology (12.2) ]. 4.2 Hypersensitivity Reactions VIAGRA is contraindicat...",
  "warnings_and_cautions": "\u2022 Patients should not use VIAGRA if sexual activity is inadvisable due to cardiovascular status ( 5.1 ) \u2022 Patients should seek emergency treatment if an erection lasts >4 hours. Use VIAGRA with caution in patients predisposed to priapism ( 5.2 ) \u2022 Patients should stop VIAGRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). VIAGRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a \"crowded\" optic disc may also be at an increased risk of NAION. ( 5.3 ) \u2022 Patients should stop VIAGRA and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4 ) \u2022 Caution is advised when VIAGRA is co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension ( 5.5 ) \u2022 Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in VIAGRA dosage is recommended ( 2.4 , 5.6 ) 5.1 Cardiovascular There i...",
  "warnings": "",
  "adverse_reactions": "The following are discussed in more detail in other sections of the labeling: \u2022 Cardiovascular [ see Warnings and Precautions (5.1) ] \u2022 Prolonged Erection and Priapism [ see Warnings and Precautions (5.2) ] \u2022 Effects on the Eye [ see Warnings and Precautions (5.3) ] \u2022 Hearing Loss [ see Warnings and Precautions (5.4) ] \u2022 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [ see Warnings and Precautions (5.5) ] \u2022 Adverse Reactions with the Concomitant Use of Ritonavir [ see Warnings and Precautions (5.6) ] \u2022 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [ see Warnings and Precautions (5.7) ] \u2022 Effects on Bleeding [ see Warnings and Precautions (5.8) ] \u2022 Counseling Patients About Sexually Transmitted Diseases [ see Warnings and Precautions (5.9) ] The most common adverse reactions reported in clinical trials (\u2265 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. Most common adverse reactions (\u2265 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1 ) To report SUSPECTED ADVERSE REACTI...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Effects on the Eye ( 5.3 ) 08/2017",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information) Nitrates Physicians should discuss with patients the contraindication of VIAGRA with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [ see Contraindications (4.1) ]. Guanylate Cyclase (GC) Stimulators Physicians should discuss with patients the contraindication of VIAGRA with use of guanylate cyclase stimulators such as riociguat [ see Contraindications (4.3) ]. Concomitant Use with Drugs Which Lower Blood Pressure Physicians should advise patients of the potential for VIAGRA to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of VIAGRA and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when VIAGRA is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at the lowest dose [ see Warnings and Precautions (5.5) ]. Cardiovascular Considerations Physicians should discuss with patients the potential cardiac risk of sexual activity in ...",
  "spl_medguide": "",
  "clinical_studies": "In clinical studies, VIAGRA was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. VIAGRA was evaluated primarily at doses of 25 mg, 50 mg and 100 mg in 21 randomized, double-blind, placebo-controlled trials of up to 6 months in duration, using a variety of study designs (fixed dose, titration, parallel, crossover). VIAGRA was administered to more than 3,000 patients aged 19 to 87 years, with ED of various etiologies (organic, psychogenic, mixed) with a mean duration of 5 years. VIAGRA demonstrated statistically significant improvement compared to placebo in all 21 studies. The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo. Efficacy Endpoints in Controlled Clinical Studies The effectiveness of VIAGRA was evaluated in most studies using several assessment instruments. The primary measure in the principal studies was a sexual function questionnaire (the International Index of Erectile Function - IIEF) administered during a 4-week t...",
  "brand_name": "Viagra",
  "manufacturer": "PFIZER LABORATORIES DIV PFIZER INC",
  "application_number": "NDA020895",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20171215",
  "set_id": "0b0be196-0c62-461c-94f4-9a35339b4501",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 96416,
  "serious": 62474,
  "death": 12576,
  "hospitalization": 35297,
  "primary_suspect": 96292,
  "top_reactions": [
   [
    "Dyspnoea",
    11497
   ],
   [
    "Headache",
    8847
   ],
   [
    "Drug Ineffective",
    7871
   ],
   [
    "Death",
    6558
   ],
   [
    "Diarrhoea",
    6507
   ],
   [
    "Nausea",
    5788
   ],
   [
    "Fatigue",
    5668
   ],
   [
    "Dizziness",
    4958
   ],
   [
    "Cough",
    4326
   ],
   [
    "Pneumonia",
    4123
   ],
   [
    "Malaise",
    3912
   ],
   [
    "Off Label Use",
    3714
   ],
   [
    "Pain",
    3294
   ],
   [
    "Vomiting",
    3274
   ],
   [
    "Hypotension",
    3234
   ]
  ],
  "by_year": {
   "2019": 10111,
   "2020": 8106,
   "2021": 6074,
   "2022": 5484,
   "2023": 5597,
   "2024": 5630,
   "2025": 5757,
   "2026": 2385
  },
  "by_year_primary": {
   "2019": 10108,
   "2020": 8105,
   "2021": 6057,
   "2022": 5456,
   "2023": 5574,
   "2024": 5602,
   "2025": 5736,
   "2026": 2385
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 58,
  "nda": 6,
  "anda": 49,
  "first_approval": "19980327",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 48,
  "labeling_recent": 0,
  "sponsors": [
   "ACTAVIS GRP PTC",
   "ACTAVIS PHARMA",
   "AJANTA PHARMA LTD",
   "ALKEM LABS LTD",
   "AMNEAL PHARMS",
   "AMNEAL PHARMS NY",
   "APOTEX CORP",
   "APPCO"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/27/1998"
 },
 "trials": {
  "total": 494,
  "completed": 294,
  "terminated": 71,
  "with_results": 109,
  "industry": 172,
  "phase3": 87,
  "results_share": 0.3707482993197279,
  "terminated_share": 0.1437246963562753
 },
 "pubmed": {
  "rct": 563,
  "meta": 68,
  "recent_rct": 51,
  "cochrane": [
   {
    "pmid": "28777888",
    "title": "Sildenafil for pulmonary hypertension in neonates",
    "year": "2017"
   },
   {
    "pmid": "22513975",
    "title": "Sildenafil citrate for erectile dysfunction in patients with multiple sclerosis",
    "year": "2012"
   },
   {
    "pmid": "21833954",
    "title": "Sildenafil for pulmonary hypertension in neonates",
    "year": "2011"
   },
   {
    "pmid": "17636802",
    "title": "Sildenafil for pulmonary hypertension in neonates",
    "year": "2007"
   },
   {
    "pmid": "15495058",
    "title": "Sildenafil for pulmonary hypertension",
    "year": "2004"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 9181.050000000001,
  "records": 22,
  "by_name": [
   [
    "Revatio",
    7853.85
   ],
   [
    "Viagra",
    1327.2
   ]
  ],
  "names_checked": [
   "sildenafil",
   "Revatio",
   "Viagra",
   "Liqrev",
   "Vybrique"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 838936,
  "beneficiaries": 240511,
  "spend": 46256548.33,
  "by_brand": [
   {
    "brand": "Sildenafil Citrate",
    "claims": 837854,
    "per_claim": 46.393798633,
    "is_generic": true
   },
   {
    "brand": "Revatio",
    "claims": 684,
    "per_claim": 10556.242895,
    "is_generic": false
   },
   {
    "brand": "Viagra",
    "claims": 398,
    "per_claim": 414.19203518,
    "is_generic": false
   }
  ],
  "per_claim": 55.137159842943916
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20140331",
   "title": "FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm390876.htm",
   "kind": "drug",
   "matched": "revatio"
  },
  {
   "date": "20120830",
   "title": "FDA recommends against use of Revatio in children with pulmonary hypertension",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm317123.htm",
   "kind": "drug",
   "matched": "revatio"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 13723,
  "fills": 838936,
  "per_million": 16357.624419502798,
  "ratio": 5.907519411325791,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 69,
   "letter": "C",
   "why": [
    "FDA issued 2 Drug Safety Communication(s) naming this drug since 2010, most recently 2014 (-16)",
    "16,358 FDA reports naming it as the suspect drug per million Medicare fills, 5.9x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (1.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 77,
   "letter": "B",
   "why": [
    "563 randomized trials and 68 systematic reviews/meta-analyses indexed in PubMed",
    "5 independent Cochrane review(s) exist",
    "Only 37% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $9,181 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 (49 applications)",
    "8 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "In 2014 the FDA issued a safety communication about this drug (FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are dyspnoea, headache, death. 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.)"
 ]
}