{
 "query": "acyclovir",
 "ingredient": "acyclovir",
 "slug": "acyclovir",
 "rxcui": "281",
 "brands": [
  "Zovirax",
  "Avaclyr",
  "Sitavig"
 ],
 "names": [
  "acyclovir",
  "acyclovir sodium"
 ],
 "classes": [
  {
   "id": "D06BB",
   "name": "Antivirals"
  },
  {
   "id": "J05AB",
   "name": "Nucleosides and nucleotides excl. reverse transcriptase inhibitors"
  },
  {
   "id": "S01AD",
   "name": "Antivirals"
  }
 ],
 "alternatives": [
  "berdazimer sodium",
  "brincidofovir",
  "brivudine",
  "cidofovir",
  "docosanol",
  "edoxudine",
  "famciclovir",
  "fomivirsen",
  "ganciclovir",
  "idoxuridine",
  "imiquimod",
  "inosine",
  "lysozyme",
  "molnupiravir",
  "penciclovir",
  "podofilox",
  "remdesivir",
  "sinecatechins",
  "trifluridine",
  "tromantadine",
  "valacyclovir",
  "valganciclovir",
  "vidarabine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 135,
   "TOPICAL": 31,
   "INTRAVENOUS": 10,
   "CUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Herpes Zoster Infections Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox Acyclovir is indicated for the treatment of chickenpox (varicella).",
  "contraindications": "CONTRAINDICATIONS Acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Acyclovir Tablets and Capsules are intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS: Observed During Clinical Practice and OVERDOSAGE ). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.",
  "adverse_reactions": "ADVERSE REACTIONS Herpes Simplex Short-Term Administration The most frequent adverse events reported during clinical trials of treatment of genital herpes with acyclovir 200 mg administered orally 5 times daily every 4 hours for 10 days were nausea and/or vomiting in 8 of 298 patient treatments (2.7%). Nausea and/or vomiting occurred in 2 of 287 (0.7%) patients who received placebo. Long-Term Administration The most frequent adverse events reported in a clinical trial for the prevention of recurrences with continuous administration of 400 mg (two 200 mg capsules) 2 times daily for 1 year in 586 patients treated with acyclovir were nausea (4.8%) and diarrhea (2.4%). The 589 control patients receiving intermittent treatment of recurrences with acyclovir for 1 year reported diarrhea (2.7%), nausea (2.4%), and headache (2.2%). Herpes Zoster The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster (shingles) with 800 mg of oral acyclovir 5 times daily for 7 to 10 days in 323 patients was malaise (11.5%). The 323 placebo recipients reported malaise (11.1%). Chickenpox The most frequent adverse event reported during 3 clinical trials of treatment of ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients are instructed to consult with their physician if they experience severe or troublesome adverse reactions, they become pregnant or intend to become pregnant, they intend to breastfeed while taking orally administered acyclovir, or they have any other questions. Patients should be advised to maintain adequate hydration. Herpes Zoster There are no data on treatment initiated more than 72 hours after onset of the zoster rash. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster. Genital Herpes Infections Patients should be informed that acyclovir is not a cure for genital herpes. There are no data evaluating whether acyclovir will prevent transmission of infection to others. Because genital herpes is a sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital herpes can also be transmitted in the absence of symptoms through asymptomatic viral shedding. If medical mangement of a genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of ...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Acyclovir",
  "manufacturer": "Redpharm Drug",
  "application_number": "ANDA210401",
  "pharm_class_epc": [
   "Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]",
   "Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]",
   "Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251213",
  "set_id": "37453bcd-e34e-5902-e063-6294a90a0245",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 123878,
  "serious": 91088,
  "death": 14963,
  "hospitalization": 47325,
  "primary_suspect": 123628,
  "top_reactions": [
   [
    "Fatigue",
    8795
   ],
   [
    "Off Label Use",
    7808
   ],
   [
    "Diarrhoea",
    7770
   ],
   [
    "Nausea",
    6180
   ],
   [
    "Pneumonia",
    6051
   ],
   [
    "Pyrexia",
    5519
   ],
   [
    "Drug Ineffective",
    5106
   ],
   [
    "Death",
    4978
   ],
   [
    "Rash",
    4714
   ],
   [
    "Headache",
    3941
   ],
   [
    "Dyspnoea",
    3788
   ],
   [
    "Acute Kidney Injury",
    3660
   ],
   [
    "Asthenia",
    3536
   ],
   [
    "White Blood Cell Count Decreased",
    3494
   ],
   [
    "Neutropenia",
    3450
   ]
  ],
  "by_year": {
   "2019": 13529,
   "2020": 14689,
   "2021": 14276,
   "2022": 10689,
   "2023": 8857,
   "2024": 8250,
   "2025": 8375,
   "2026": 3542
  },
  "by_year_primary": {
   "2019": 13525,
   "2020": 14688,
   "2021": 14273,
   "2022": 10656,
   "2023": 8758,
   "2024": 8207,
   "2025": 8340,
   "2026": 3518
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20221228",
   "reason": "Presence of Particulate Matter: Customer complaint of dark particles found inside the vial",
   "firm": "Eugia US LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220926",
   "reason": "Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.",
   "firm": "AuroMedics Pharma LLC",
   "status": "Completed"
  },
  {
   "class": "Class III",
   "date": "20210421",
   "reason": "Labeling: Incorrect or Missing Lot and/or Exp Date",
   "firm": "Heritage Pharmaceuticals Inc",
   "status": "Terminated"
  },
  {
   "class": "Class I",
   "date": "20210218",
   "reason": "Crystallization: customer complaints for crystallization in finished product.",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Terminated"
  },
  {
   "class": "Class I",
   "date": "20210218",
   "reason": "Crystallization: customer complaints for crystallization in finished product.",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190425",
   "reason": "Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20180209",
   "reason": "Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.",
   "firm": "Apace KY LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20170427",
   "reason": "Presence of Foreign Substance:  human hair melded into tablet.",
   "firm": "Hetero USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130717",
   "reason": "Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.",
   "firm": "Apotex Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 9,
 "drugsfda": {
  "applications": 99,
  "nda": 8,
  "anda": 88,
  "first_approval": "19820329",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 64,
  "labeling_recent": 4,
  "sponsors": [
   "ABBVIE",
   "ACTAVIS ELIZABETH",
   "ACTAVIS MID ATLANTIC",
   "ADAPTIS",
   "ALEMBIC",
   "AMNEAL",
   "AMNEAL PHARMS",
   "APOTEX"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/29/1982"
 },
 "trials": {
  "total": 436,
  "completed": 295,
  "terminated": 47,
  "with_results": 94,
  "industry": 188,
  "phase3": 92,
  "results_share": 0.31864406779661014,
  "terminated_share": 0.10779816513761468
 },
 "pubmed": {
  "rct": 379,
  "meta": 26,
  "recent_rct": 10,
  "cochrane": [
   {
    "pmid": "27841441",
    "title": "Valacyclovir versus acyclovir for the treatment of herpes zoster ophthalmicus in immunocompetent patients",
    "year": "2016"
   },
   {
    "pmid": "26784280",
    "title": "WITHDRAWN: Acyclovir for treating primary herpetic gingivostomatitis",
    "year": "2016"
   },
   {
    "pmid": "18843726",
    "title": "Acyclovir for treating primary herpetic gingivostomatitis",
    "year": "2008"
   },
   {
    "pmid": "16235308",
    "title": "Acyclovir for treating varicella in otherwise healthy children and adolescents",
    "year": "2005"
   },
   {
    "pmid": "15106185",
    "title": "Acyclovir for treating varicella in otherwise healthy children and adolescents",
    "year": "2004"
   },
   {
    "pmid": "12519581",
    "title": "Acyclovir for treating varicella in otherwise healthy children and adolescents",
    "year": "2002"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "acyclovir",
   "Zovirax",
   "Avaclyr",
   "Sitavig"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2010416,
  "beneficiaries": 696544,
  "spend": 36995271.81,
  "by_brand": [
   {
    "brand": "Acyclovir",
    "claims": 2009620,
    "per_claim": 18.30703111,
    "is_generic": true
   },
   {
    "brand": "Zovirax",
    "claims": 600,
    "per_claim": 283.22445,
    "is_generic": false
   },
   {
    "brand": "Acyclovir Sodium",
    "claims": 196,
    "per_claim": 179.39428571,
    "is_generic": true
   }
  ],
  "per_claim": 18.401799334068173
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 20065,
  "fills": 2010416,
  "per_million": 9980.521444317992,
  "ratio": 3.6044429591600804,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 64,
   "letter": "C",
   "why": [
    "9,981 FDA reports naming it as the suspect drug per million Medicare fills, 3.6x the median drug on this site (-11)",
    "Death share in reports is near or below the FAERS average (1.3x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)",
    "2 Class I recall(s): reasonable probability of serious harm (-20)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 61,
   "letter": "D",
   "why": [
    "379 randomized trials and 26 systematic reviews/meta-analyses indexed in PubMed",
    "6 independent Cochrane review(s) exist",
    "Only 32% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 66,
   "letter": "C",
   "why": [
    "Recalls since 2016: 2 Class I, 4 Class II, 2 Class III across 88 generic makers (-30)",
    "4 label changes approved since 2021 (-4)"
   ],
   "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": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (88 applications)",
    "23 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 73,
 "grade": "C",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, diarrhoea, 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 berdazimer sodium, brincidofovir, brivudine? 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.)"
 ]
}