{
 "query": "oseltamivir",
 "ingredient": "oseltamivir",
 "slug": "oseltamivir",
 "rxcui": "260101",
 "brands": [
  "Tamiflu"
 ],
 "names": [
  "oseltamivir",
  "oseltamivir phosphate"
 ],
 "classes": [
  {
   "id": "J05AH",
   "name": "Neuraminidase inhibitors"
  }
 ],
 "alternatives": [
  "peramivir",
  "zanamivir"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 78
  },
  "boxed_warning": "",
  "indications_and_usage": "Oseltamivir phosphate for oral suspension is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. ( 1.1 ) Prophylaxis of influenza A and B in patients 1 year and older. ( 1.2 ) Limitations of Use : Not a substitute for annual influenza vaccination. ( 1.3 ) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. ( 1.3 ) Not recommended for patients with end-stage renal disease not undergoing dialysis. ( 1.3 ) 1.1 Treatment of Influenza Oseltamivir phosphate for oral suspension is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. 1.2 Prophylaxis of Influenza Oseltamivir phosphate for oral suspension is indicated for the prophylaxis of influenza A and B in patients 1 year and older. 1.3 Limitations of Use Oseltamivir phosphate for oral suspension is not a substitute for early influenza vaccination on an annual basis as recommended by the Ce...",
  "contraindications": "Oseltamivir phosphate for oral suspension is contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. Severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme [see Warnings and Precautions (5.1) ] . Patients with known serious hypersensitivity to oseltamivir or any of the components of oseltamivir phosphate for oral suspension ( 4 )",
  "warnings_and_cautions": "Serious skin/hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme: Discontinue oseltamivir phosphate for oral suspension and initiate appropriate treatment if allergic-like reactions occur or are suspected. ( 5.1 ) Neuropsychiatric events: Patients with influenza, including those receiving oseltamivir phosphate for oral suspension, particularly pediatric patients, may be at an increased risk of confusion or abnormal behavior early in their illness. Monitor for signs of abnormal behavior. ( 5.2 ) 5.1 Serious Skin/Hypersensitivity Reactions Cases of anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme have been reported in postmarketing experience with oseltamivir phosphate for oral suspension. Stop oseltamivir phosphate for oral suspension and institute appropriate treatment if an allergic-like reaction occurs or is suspected. The use of oseltamivir phosphate for oral suspension is contraindicated in patients with known serious hypersensitivity to oseltamivir phosphate for oral suspension [see Contraindications (4) and Adverse Reactions (6.2) ] . 5.2 N...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed below and elsewhere in the labeling: Serious skin and hypersensitivity reactions [see Warnings and Precautions (5.1) ] Neuropsychiatric events [see Warnings and Precautions (5.2) ] Most common adverse reactions (> 1% and more common than with placebo): Treatment studies \u2013 Nausea, vomiting, headache. ( 6.1 ) Prophylaxis studies \u2013 Nausea, vomiting, headache, pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 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. Adverse Reactions from Treatment and Prophylaxis Trials in Adult and Adolescent Subjects (13 years of age and older) The overall safety profile of oseltamivir phosphate for oral suspension is based on data from 2,646 adult and adolescent subjects that received the recommended dosage of 75 mg orally twice daily for 5 days for treatment of in...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Serious Skin/Hypersensitivity Reactions Advise patients and/or caregivers of the risk of severe allergic reactions (including anaphylaxis) or serious skin reactions. Instruct patients and/or caregiver to stop oseltamivir phosphate for oral suspension and seek immediate medical attention if an allergic-like reaction occurs or is suspected [ see Warnings and Precautions (5.1) ] . Neuropsychiatric Events Advise patients and/or caregivers of the risk of neuropsychiatric events in oseltamivir phosphate for oral suspension -treated patients with influenza and instruct patients to contact their physician if they experience signs of abnormal behavior while receiving oseltamivir phosphate for oral suspension [see Warnings and Precautions (5.2) ] . Important Dosing Information Instruct patients to begin treatment with oseltamivir phosphate for oral suspension as soon as possible from the first appearance of flu symptoms, within 48 hours of onset of symptoms. Similarly, instruct patients to start taking oseltamivir phosphate for oral suspension for prevention as soon as possible after ...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Treatment of Influenza Adults Two randomized, placebo-controlled, double-blind clinical trials of oseltamivir phosphate were conducted in adults between 18 and 65 years old, one in the U.S. and one outside the U.S., for the treatment of acute uncomplicated influenza. Eligible subjects had fever of at least 100\u00baF, accompanied by at least one respiratory symptom (cough, nasal symptoms, or sore throat) and at least one systemic symptom (myalgia, chills/sweats, malaise, fatigue, or headache), and influenza virus was known to be circulating in the community. Subjects were randomized to receive oral oseltamivir phosphate or placebo for 5 days. All enrolled subjects were allowed to take fever-reducing medications. Of 1,355 subjects enrolled in these two trials, 849 (63%) subjects were influenza-infected (median age 34 years; 52% male; 90% Caucasian; 31% smokers). Of the 849 influenza-infected subjects, 95% were infected with influenza A, 3% with influenza B, and 2% with influenza of unknown type. Study medication was started within 40 hours of onset of symptoms and administered twice daily for 5 days. Subjects were required to self-assess the influenza-associated symptoms (nasal cong...",
  "brand_name": "Oseltamivir Phosphate",
  "manufacturer": "Lannett Company, Inc.",
  "application_number": "ANDA213594",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240515",
  "set_id": "005b2784-e410-a50c-e063-6394a90a881c",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 17689,
  "serious": 10851,
  "death": 1760,
  "hospitalization": 4925,
  "primary_suspect": 17646,
  "top_reactions": [
   [
    "Off Label Use",
    2146
   ],
   [
    "Vomiting",
    1818
   ],
   [
    "Nausea",
    1417
   ],
   [
    "Drug Ineffective",
    1148
   ],
   [
    "Influenza",
    1048
   ],
   [
    "Diarrhoea",
    900
   ],
   [
    "Dyspnoea",
    899
   ],
   [
    "Headache",
    877
   ],
   [
    "No Adverse Event",
    850
   ],
   [
    "Pyrexia",
    724
   ],
   [
    "Pneumonia",
    698
   ],
   [
    "Rash",
    635
   ],
   [
    "Cough",
    609
   ],
   [
    "Hallucination",
    566
   ],
   [
    "Abdominal Pain",
    550
   ]
  ],
  "by_year": {
   "2019": 1824,
   "2020": 2131,
   "2021": 1228,
   "2022": 880,
   "2023": 798,
   "2024": 1961,
   "2025": 1014,
   "2026": 481
  },
  "by_year_primary": {
   "2019": 1824,
   "2020": 2130,
   "2021": 1223,
   "2022": 878,
   "2023": 798,
   "2024": 1941,
   "2025": 1001,
   "2026": 479
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20240213",
   "reason": "Failed Impurities/Degradation Specifications: Out-of-specification test results.",
   "firm": "Amneal Pharmaceuticals of New York, LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20210121",
   "reason": "Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 39,
  "nda": 2,
  "anda": 37,
  "first_approval": "19991027",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 48,
  "labeling_recent": 0,
  "sponsors": [
   "ACCORD HLTHCARE",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "ALVOGEN",
   "AMNEAL PHARMS",
   "AMNEAL PHARMS NY",
   "AUROBINDO PHARMA LTD",
   "BEIJING JIALIN"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/27/1999"
 },
 "trials": {
  "total": 173,
  "completed": 104,
  "terminated": 26,
  "with_results": 47,
  "industry": 89,
  "phase3": 45,
  "results_share": 0.4519230769230769,
  "terminated_share": 0.15028901734104047
 },
 "pubmed": {
  "rct": 109,
  "meta": 27,
  "recent_rct": 19,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "oseltamivir",
   "Tamiflu"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 639302,
  "beneficiaries": 606029,
  "spend": 18804202.68,
  "by_brand": [
   {
    "brand": "Oseltamivir Phosphate",
    "claims": 638709,
    "per_claim": 29.352554043,
    "is_generic": true
   },
   {
    "brand": "Tamiflu",
    "claims": 593,
    "per_claim": 95.214569983,
    "is_generic": false
   }
  ],
  "per_claim": 29.413645945108883
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20110711",
   "title": "Tamiflu - Important safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm261686.htm",
   "kind": "drug",
   "matched": "oseltamivir phosphate"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "oseltamivir",
  "matched": "oseltamivir",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3421,
  "fills": 639302,
  "per_million": 5351.14859643799,
  "ratio": 1.932555326839266,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 81,
   "letter": "B",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2011 (-8)",
    "5,351 FDA reports naming it as the suspect drug per million Medicare fills, 1.9x the median drug on this site (-6)",
    "Death share in reports is near or below the FAERS average (1.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 54,
   "letter": "D",
   "why": [
    "109 randomized trials and 27 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 45% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 98,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 1 Class III across 37 generic makers (-2)"
   ],
   "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": 90,
   "letter": "A",
   "why": [
    "Generic versions approved (37 applications)",
    "2 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 81,
 "grade": "B",
 "questions": [
  "In 2011 the FDA issued a safety communication about this drug (Tamiflu - Important safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are vomiting, 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?",
  "Why this one over peramivir, zanamivir? 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.)"
 ]
}