{ "query": "hydralazine", "ingredient": "hydralazine", "slug": "hydralazine", "rxcui": "5470", "brands": [], "names": [ "hydralazine", "hydralazine hydrochloride" ], "classes": [ { "id": "C02DB", "name": "Hydrazinophthalazine derivatives" } ], "alternatives": [ "dihydralazine" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 74, "INTRAMUSCULAR": 23, "INTRAVENOUS": 23 }, "boxed_warning": "", "indications_and_usage": "INDICATIONS & USAGE Essential hypertension, alone or as an adjunct.", "contraindications": "CONTRAINDICATIONS Hypersensitivity to hydrALAZINE; coronary artery disease; mitral valvular rheumatic heart disease.", "warnings_and_cautions": "", "warnings": "WARNINGS In a few patients hydrALAZINE may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydrALAZINE should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary. (See PRECAUTIONS, Laboratory Tests .)", "adverse_reactions": "ADVERSE REACTIONS Adverse reactions with hydrALAZINE are usually reversible when dosage is reduced. However, in some cases it may be necessary to discontinue the drug. The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency. Common headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris. Less Frequent Digestive: constipation, paralytic ileus. Cardiovascular hypotension, paradoxical pressor response, edema. Respiratory dyspnea. Neurologic peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety. Genitourinary difficulty in urination. Hematologic blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly. Hypersensitive Reactions rash, urticaria, pruritus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis. Other nasal congestion, flushing, lacrimation, conjunctivitis.", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "Information for Patients Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed.", "spl_medguide": "", "clinical_studies": "", "brand_name": "HYDRALAZINE HYDROCHLORIDE", "manufacturer": "Coupler LLC", "application_number": "ANDA203845", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20250212", "set_id": "2df51a19-a39a-0ec8-e063-6394a90a147c", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 32992, "serious": 24782, "death": 3887, "hospitalization": 13807, "primary_suspect": 32948, "top_reactions": [ [ "Chronic Kidney Disease", 3012 ], [ "Acute Kidney Injury", 2913 ], [ "Renal Failure", 2233 ], [ "Fatigue", 1937 ], [ "Dyspnoea", 1818 ], [ "Diarrhoea", 1745 ], [ "End Stage Renal Disease", 1702 ], [ "Death", 1543 ], [ "Nausea", 1529 ], [ "Drug Ineffective", 1500 ], [ "Hypertension", 1468 ], [ "Off Label Use", 1454 ], [ "Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis", 1276 ], [ "Headache", 1133 ], [ "Asthenia", 1129 ] ], "by_year": { "2019": 3991, "2020": 3137, "2021": 2921, "2022": 2129, "2023": 2192, "2024": 2455, "2025": 2511, "2026": 1254 }, "by_year_primary": { "2019": 3991, "2020": 3137, "2021": 2918, "2022": 2118, "2023": 2184, "2024": 2448, "2025": 2499, "2026": 1252 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20170308", "reason": "Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.", "firm": "Mckesson Medical Surgical", "status": "Terminated" }, { "class": "Class III", "date": "20150728", "reason": "Incorrect Expiration Date: The \"11/06\" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)", "firm": "Fresenius Kabi USA, LLC", "status": "Terminated" } ], "recall_total": 2, "drugsfda": { "applications": 87, "nda": 1, "anda": 62, "first_approval": "19530115", "rems": false, "rems_last": "", "labeling_supplements": 12, "labeling_recent": 0, "sponsors": [ "ABRAXIS PHARM", "ACTAVIS ELIZABETH", "ACTAVIS GRP PTC", "ALKEM LABS LTD", "AM REGENT", "ASCOT", "BAXTER HLTHCARE CORP", "CADILA PHARMS LTD" ], "unapproved": false, "first_approval_fmt": "01/15/1953" }, "trials": { "total": 76, "completed": 45, "terminated": 11, "with_results": 12, "industry": 20, "phase3": 14, "results_share": 0.26666666666666666, "terminated_share": 0.14473684210526316 }, "pubmed": { "rct": 109, "meta": 10, "recent_rct": 4, "cochrane": [ { "pmid": "23450605", "title": "Hydralazine in infants with persistent hypoxemic respiratory failure", "year": "2013" }, { "pmid": "22071816", "title": "Hydralazine for essential hypertension", "year": "2011" }, { "pmid": "20687078", "title": "Hydralazine for essential hypertension", "year": "2010" } ] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "hydralazine" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 6074425, "beneficiaries": 1472549, "spend": 81689817.39, "by_brand": [ { "brand": "Hydralazine HCl", "claims": 6074425, "per_claim": 13.448156392, "is_generic": true } ], "per_claim": 13.448156391757244 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": true, "status": "AddedToEml", "name": "hydralazine", "matched": "hydralazine", "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 6199, "fills": 6074425, "per_million": 1020.5081139367102, "ratio": 0.3685542189921385, "median": 2768.949753790441 }, "scores": { "safety": { "score": 100, "letter": "A", "why": [ "1,021 FDA reports naming it as the suspect drug per million Medicare fills, 0.4x the median drug on this site", "Death share in reports is near or below the FAERS average (1.3x)" ], "weight": 0.35 }, "evidence": { "score": 46, "letter": "F", "why": [ "109 randomized trials and 10 systematic reviews/meta-analyses indexed in PubMed", "On the WHO Model List of Essential Medicines (shown for context; no score effect)", "3 independent Cochrane review(s) exist", "Only 27% of completed registered trials posted results (-15)" ], "weight": 0.25 }, "regulatory": { "score": 99, "letter": "A", "why": [ "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 62 generic makers (-1)" ], "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 (62 applications)", "1 same-class alternative(s) (-10)" ], "weight": 0.1 } }, "total": 85, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are chronic kidney disease, acute kidney injury, renal failure, fatigue. How would we recognize and handle those?", "Why this one over dihydralazine? 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.)" ] }