{ "query": "amiodarone", "ingredient": "amiodarone", "slug": "amiodarone", "rxcui": "703", "brands": [ "Pacerone", "Nexterone" ], "names": [ "amiodarone", "amiodarone hydrochloride" ], "classes": [ { "id": "C01BD", "name": "Antiarrhythmics, class III" } ], "alternatives": [ "bretylium tosylate", "dofetilide", "dronedarone", "ibutilide" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 29, "INTRAVENOUS": 22 }, "boxed_warning": "WARNING: PULMONARY, HEPATIC and CARDIAC TOXICITY Pacerone is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity [see Indications and Usage (1) ] . Pacerone can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. Pulmonary toxicity has been fatal about 10% of the time . Obtain a baseline chest X-ray and pulmonary-function tests, including diffusion capacity, when Pacerone therapy is initiated. Repeat history, physical exam, and chest X-ray every 3 to 6 months [see Warnings and Precautions 5.2) ] . Pacerone can cause hepatoxicity, which can be fatal. Obtain baseline and periodic liver transaminases and discontinue or reduce dose if the increase exceeds three times normal, or doubles in a patient with an elevated baseline. Discontinue Pacerone if the patient experiences signs or symptoms of clinical liver injury [see Warnings and Precautions (5.3) ] . Pacerone can exacerbate arrhythmias. Initiate amiodarone hydrochloride in a clinical setting where continuous e...", "indications_and_usage": "Pacerone is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. Pacerone is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1 ) Recurrent hemodynamically unstable ventricular tachycardia. ( 1 )", "contraindications": "Cardiogenic shock. Sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia leading to syncope without a functioning pacemaker. Known hypersensitivity to the drug or to any of its components, including iodine. Pacerone is contraindicated in patients with ( 4 ): Cardiogenic shock. Sick sinus syndrome, second- or third-degree AV block, bradycardia leading to syncope without a functioning pacemaker. Known hypersensitivity to the drug or any of its components.", "warnings_and_cautions": "Persistence of Adverse Effects: Adverse reactions and drug interaction can persist for several weeks following discontinuation. ( 5.1 ) Impaired Vision: Corneal microdeposits (common; reversible), optic neuropathy/neuritis (rare; may lead to blindness). ( 5.5 ) Thyroid Abnormalities: Hyperthyroidism or hypothyroidism. ( 5.6 ) 5.1 Persistence of Adverse Effects Because of the long half-life of amiodarone (15 to 142 days) and its active metabolite desethylamiodarone (14 to 75 days), adverse reactions and drug interactions can persist for several weeks following amiodarone discontinuation [see Clinical Pharmacology (12.3) ] . 5.2 Pulmonary Toxicity Pacerone may cause a clinical syndrome of cough and progressive dyspnea accompanied by functional, radiographic, gallium-scan, and pathological data consistent with pulmonary toxicity. Pulmonary toxicity secondary to Pacerone may result from either indirect or direct toxicity as represented by hypersensitivity pneumonitis (including eosinophilic pneumonia) or interstitial/alveolar pneumonitis, respectively. Rates of pulmonary toxicity have been reported to be as high as 17% and is fatal in about 10% of cases. Obtain a baseline chest X-ray a...", "warnings": "", "adverse_reactions": "The following serious adverse reactions are described in more detail in other sections of the prescribing information: Pulmonary Toxicity [see Warnings and Precautions (5.2) ] Hepatic Injury [see Warnings and Precautions (5.3) ] Worsened Arrhythmia [see Warnings and Precautions (5.4) ] Visual Impairment and Loss of Vision [see Warnings and Precautions (5.5) ] Thyroid Abnormalities [see Warnings and Precautions (5.6) ] Bradycardia [see Warnings and Precautions (5.7) ] Peripheral Neuropathy [see Warnings and Precautions (5.10) ] Photosensitivity and Skin Discoloration [see Warnings and Precautions (5.11) ] The most common reactions (>1%) leading to discontinuation of amiodarone include pulmonary toxicity, paroxysmal ventricular tachycardia, congestive heart failure, and elevation of liver enzymes. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 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 dru...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1) ] . Advise women that breastfeeding is not recommended during treatment with Pacerone [see Use in Specific Populations (8.2) ] . Advise patients to avoid grapefruit juice and St. John's Wort. Advise patients to seek medical attention if they experience the signs and symptoms of pulmonary toxicity, worsening arrhythmia, bradycardia, visual impairment, or hypo- and hyperthyroidism. This product's label may have been updated. For full prescribing information, please visit www.upsher-smith.com.", "spl_medguide": "MEDICATION GUIDE Pacerone \u00ae (P\u0100S-\u0259r-\u014dn) Tablets (Amiodarone Hydrochloride) What is the most important information I should know about Pacerone tablets? Pacerone tablets can cause serious side effects that can lead to death, including: lung problems liver problems worsening of heartbeat problems Call your healthcare provider or get medical help right away if you have any of the following symptoms during treatment with Pacerone tablets: trouble breathing, wheezing, shortness of breath, coughing chest pain, spitting up of blood, or fever nausea or vomiting, brown or dark-colored urine, feel more tired than usual, yellowing of your skin or the whites of your eyes (jaundice), or right upper stomach-area pain heart pounding, skipping a beat, beating fast or slowly, feel light-headed, or if you faint vision problems, including blurred vision, see halos, or your eyes become sensitive to light. You should have regular eye exams before and during treatment with Pacerone tablets. Pacerone tablets should be started in a hospital so that your medical condition can be carefully monitored. Pacerone tablets should only be used to treat people who have been diagnosed with life-threatening heartbeat...", "clinical_studies": "", "brand_name": "Pacerone", "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC", "application_number": "ANDA075135", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20240202", "set_id": "02f4a736-63ed-4ad4-a1f1-b21a71e928bd", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 61945, "serious": 55468, "death": 10379, "hospitalization": 34167, "primary_suspect": 61208, "top_reactions": [ [ "Dyspnoea", 4024 ], [ "Drug Ineffective", 3489 ], [ "Drug Interaction", 3471 ], [ "Off Label Use", 3287 ], [ "Atrial Fibrillation", 3141 ], [ "Acute Kidney Injury", 3022 ], [ "Fatigue", 2805 ], [ "Asthenia", 2793 ], [ "Hypotension", 2475 ], [ "Death", 2435 ], [ "Dizziness", 2214 ], [ "Fall", 2167 ], [ "Nausea", 2072 ], [ "Pneumonia", 2054 ], [ "Anaemia", 1922 ] ], "by_year": { "2019": 6942, "2020": 6134, "2021": 4943, "2022": 4176, "2023": 4283, "2024": 4518, "2025": 4067, "2026": 1850 }, "by_year_primary": { "2019": 6928, "2020": 6123, "2021": 4887, "2022": 4020, "2023": 4169, "2024": 4358, "2025": 3937, "2026": 1774 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20260806", "reason": "CGMP Deviations", "firm": "Baxter Healthcare Corporation", "status": "Ongoing" }, { "class": "Class I", "date": "20200817", "reason": "Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, US", "firm": "Mylan Institutional LLC", "status": "Terminated" }, { "class": "Class III", "date": "20191111", "reason": "Crystallization: Presence of visible particulate matter.", "firm": "AuroMedics Pharma LLC", "status": "Terminated" }, { "class": "Class III", "date": "20191111", "reason": "Crystallization: Presence of visible particulate matter.", "firm": "AuroMedics Pharma LLC", "status": "Terminated" }, { "class": "Class III", "date": "20191111", "reason": "Crystallization: Presence of visible particulate matter.", "firm": "AuroMedics Pharma LLC", "status": "Terminated" }, { "class": "Class I", "date": "20171110", "reason": "Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged", "firm": "Baxter Healthcare Corporation", "status": "Terminated" }, { "class": "Class II", "date": "20140912", "reason": "Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.", "firm": "Mckesson", "status": "Terminated" } ], "recall_total": 7, "drugsfda": { "applications": 35, "nda": 4, "anda": 31, "first_approval": "19851224", "rems": false, "rems_last": "", "labeling_supplements": 65, "labeling_recent": 2, "sponsors": [ "ACELLA", "AUROBINDO PHARMA LTD", "BAXTER HLTHCARE", "BEDFORD", "BEDFORD LABS", "BEN VENUE", "CHARTWELL RX", "DR REDDYS" ], "unapproved": false, "first_approval_fmt": "12/24/1985" }, "trials": { "total": 236, "completed": 101, "terminated": 38, "with_results": 38, "industry": 71, "phase3": 54, "results_share": 0.37623762376237624, "terminated_share": 0.16101694915254236 }, "pubmed": { "rct": 330, "meta": 69, "recent_rct": 18, "cochrane": [ { "pmid": "26646017", "title": "Amiodarone versus other pharmacological interventions for prevention of sudden cardiac death", "year": "2015" } ] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "amiodarone", "Pacerone", "Nexterone" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 3133867, "beneficiaries": 880448, "spend": 77834781.06, "by_brand": [ { "brand": "Amiodarone HCl", "claims": 3102724, "per_claim": 23.88874137, "is_generic": true }, { "brand": "Pacerone", "claims": 31143, "per_claim": 119.2759169, "is_generic": false } ], "per_claim": 24.836657413987258 }, "mdl": [], "dsc": [ { "date": "20150324", "title": "FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir (Harvoni) or Sovaldi in combination with another Direct Acting Antiviral drug", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm439484.htm", "kind": "drug", "matched": "amiodarone" }, { "date": "20111215", "title": "Zocor (simvastatin) - Revised dose limitation for Zocor (simvastatin) when taken with amiodarone", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm283137.htm", "kind": "drug", "matched": "amiodarone" }, { "date": "20110506", "title": "Glass Syringe - Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm254215.htm", "kind": "drug", "matched": "amiodarone" } ], "settlements": [], "prescrire": null, "eml": { "listed": true, "status": "AddedToEml", "name": "amiodarone", "matched": "amiodarone", "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 10069, "fills": 3133867, "per_million": 3212.9634091044704, "ratio": 1.1603545368442367, "median": 2768.949753790441 }, "scores": { "safety": { "score": 21, "letter": "F", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "FDA issued 3 Drug Safety Communication(s) naming this drug since 2010, most recently 2015 (-20)", "3,213 FDA reports naming it as the suspect drug per million Medicare fills, 1.2x the median drug on this site", "Death appears in 1.8x the share of reports seen across all of FAERS (-4)", "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": 73, "letter": "C", "why": [ "330 randomized trials and 69 systematic reviews/meta-analyses indexed in PubMed", "On the WHO Model List of Essential Medicines (shown for context; no score effect)", "1 independent Cochrane review(s) exist", "Only 38% of completed registered trials posted results (-8)" ], "weight": 0.25 }, "regulatory": { "score": 66, "letter": "C", "why": [ "Recalls since 2016: 2 Class I, 1 Class II, 3 Class III across 31 generic makers (-30)", "2 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 (31 applications)", "4 same-class alternatives exist" ], "weight": 0.1 } }, "total": 60, "grade": "D", "questions": [ "In 2015 the FDA issued a safety communication about this drug (FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C tr). Does that risk apply to me?", "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?", "The most-reported problems in FDA's adverse event data are dyspnoea, drug interaction. 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 bretylium tosylate, dofetilide, dronedarone? 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.)" ] }