cardura
Pharmaranks rates Cardura 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Cardura (Doxazosin Mesylate) is an alpha-adrenergic blocker used to treat Hypertension, Prostatic Hyperplasia, Urinary Retention.
Doxazosin Mesylate · by Viatris
Available as a generic: Doxazosin Mesylate
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Doxazosin Mesylate
- Drug class
- Alpha-Adrenergic Blocker
- Form
- Tablet
- Strength
- Doxazosin Mesylate EQ 1MG Base · Doxazosin Mesylate EQ 2MG Base · Doxazosin Mesylate EQ 4MG Base · Doxazosin Mesylate EQ 8MG Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- hypertension, prostatic hyperplasia, urinary retention
- Manufacturer
- Viatris
- Half-life
- about 22 hours (terminal/beta phase) (how long it stays in your system)
- What the pharmacy pays
- ~$2.57 for 30 — not your price
- FDA application
- NDA019668
What is Cardura?
From the FDA label:Doxazosin is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of Doxazosin is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for Doxazosin is C 23 H 25 N 5 O 5 • CH 4 O 3 S and the molecular weight is 547.6. It has the following structure: Doxazosin is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin tablet is available as tablets for oral use and contains doxazosin mesylate equivalent to 1 mg (white), 2 mg (white), 4 mg (white) and 8 mg (white) of doxazosin as the free base. The inactive ingredients for all tablets are lactose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate. Doxazosin Structural Formula
How to use
For the treatment of BPH: Initiate therapy at 1 mg once daily. Dose may be titrated at 1 to 2-week intervals, up to 8 mg once daily. ( 2.2 ) • For the treatment of hypertension: Initiate therapy at 1 mg once daily. Dose may be titrated as needed, up to 16 mg once daily. ( 2.3 ) 2.1 Dosing Information Following the initial dose and with each dose increase of Doxazosin, monitor blood pressure for at least 6 hours following administration. If Doxazosin tablet administration is discontinued for several days, therapy should be restarted using the initial dosing regimen. 2.2 Benign Prostatic Hyperplasia The recommended initial dosage of Doxazosin tablet is 1 mg given once daily either in the morning or evening. Depending on the individual patient’s urodynamics and BPH symptomatology, the dose may be titrated at 1 to 2 week intervals to 2 mg, and thereafter to 4 mg and 8 mg once daily. The maximum recommended dose for BPH is 8 mg once daily. Routinely monitor blood pressure in these patients. 2.3 Hypertension The initial dosage of Doxazosin tablet is 1 mg given once daily. Daily dosage may be doubled up 16 mg once daily, as needed, to achieve the desired reduction in blood pressure.
Side effects
The most commonly reported adverse reactions from clinical trials are fatigue, malaise, hypotension, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) 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. Benign Prostatic Hyperplasia (BPH) The incidence of adverse events has been ascertained from worldwide clinical trials in 965 BPH patients. The incidence rates presented below (Table 2) are based on combined data from seven placebo‑controlled trials involving once-daily administration of Doxazosin tablet in doses of 1 to 16 mg in hypertensives and 0.5 to 8 mg in normotensives. Adverse reactions occurring more than 1% more frequently in BPH patients treated with Doxazosin vs. placebo are summarized in Table 1. Table 1. Adverse Reactions Occurring More than 1% More Frequently in BPH Patients Treated with Doxazosin Versus Placebo BODY SYSTEM Doxazosin N=665 Placebo N=300 NERVOUS SYSTEM DISORDERS Dizziness Includes vertigo 15.6% 9.0% Somnolence 3.0% 1.0% CARDIAC DISORDERS Hypotension 1.7% 0% RESPIRATORY, THORACIC AND MEDIASTINAL…
Warnings
Important safety information
Postural hypotension with or without syncope may occur. ( 5.1 ) • Risk of Intraoperative Floppy Iris Syndrome during cataract surgery. ( 5.2 ) • Screen for the presence of prostate cancer prior to treatment for BPH and at regular intervals afterwards. ( 5.3 ) 5.1 Postural Hypotension Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of Doxazosin. However, infrequently, symptomatic postural hypotension has also been reported later than a few hours after dosing. As with other alpha-blockers, there is a potential for syncope, especially after the initial dose or after an increase in dosage strength. Advise patient how to avoid symptoms resulting from postural hypotension and what measures to take should they develop. Concomitant administration of Doxazosin with a PDE-5 inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. 5.2 Cataract Surgery Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with alpha1 blockers. This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. The patient’s surgeon should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances. There does not appear to be a benefit of stopping alpha1 blocker therapy prior to cataract surgery. 5.3 Prostate Cancer Carcinoma of the prostate causes many of the symptoms associated with BPH and the two disorders frequently co‑exist. Carcinoma of the prostate should therefore be ruled out prior to commencing therapy with Doxazosin tablet for the treatment of BPH. 5.4 Priapism Alpha 1 antagonists, including doxazosin, have been associated with priapism (painful penile erection, sustained for hours and unrelieved by sexual intercourse or masturbation). This condition can lead to permanent impotence if not promptly treated.
Who should not take Cardura
The use of Doxazosin tablet is contraindicated in patients with a hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of its components. • Hypersensitivity to doxazosin, other quinazolines, or any other ingredient in Doxazosin. ( 4 )
Overdose — what happens if you take too much
Experience with Doxazosin tablet overdosage is limited. Two adolescents, who each intentionally ingested 40 mg Doxazosin tablet with diclofenac or acetaminophen, were treated with gastric lavage with activated charcoal and made full recoveries. A two‑year‑old child who accidently ingested 4 mg Doxazosin tablet was treated with gastric lavage and remained normotensive during the five‑hour emergency room observation period. A six‑month‑old child accidentally received a crushed 1 mg tablet of Doxazosin tablet and was reported to have been drowsy. A 32‑year‑old female with chronic renal failure, epilepsy, and depression intentionally ingested 60 mg Doxazosin tablet (blood level = 0.9 mcg/mL; normal values in hypertensives = 0.02 mcg/mL); death was attributed to a grand mal seizure resulting from hypotension. A 39‑year‑old female who ingested 70 mg Doxazosin tablet, alcohol, and Dalmane ® (flurazepam) developed hypotension which responded to fluid therapy. The oral LD 50 of doxazosin is greater than 1000 mg/kg in mice and rats. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of fluid. As doxazosin is highly protein bound, dialysis would not be indicated.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Strong cytochrome P450 (CYP) 3A inhibitors may increase exposure to doxazosin and increased risk of hypotension. ( 7.1 ) • Concomitant administration of Doxazosin with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. ( 7.2 ) 7.1 CYP 3A Inhibitors In vitro studies suggest that doxazosin is a substrate of CYP 3A4. Strong CYP3A inhibitors may increase exposure to doxazosin. Monitor blood pressure and for symptoms of hypotension when Doxazosin is used concomitantly with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ]. 7.2 Phosphodiesterase-5 (PDE-5) Inhibitors Concomitant administration of Doxazosin with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. Monitor blood pressure and for symptoms of hypotension [see Warnings and Precautions (5.1) ]. Drug Interactions There are only limited data on the effects of drugs known to influence the hepatic metabolism of doxazosin (e.g., cimetidine). Cimetidine: In healthy volunteers, the administration of a single 1 mg dose of doxazosin on day 1 of a four-day regimen of oral cimetidine (400 mg twice daily) resulted in a 10% increase in mean AUC of doxazosin, and a slight but not significant increase in mean C max and mean half-life of doxazosin. In vitro data in human plasma indicate that Doxazosin has no effect on protein binding of digoxin, warfarin, phenytoin, or indomethacin.
How long does Doxazosin Mesylate stay in your body?
The elimination half-life of doxazosin mesylate is about 22 hours (terminal/beta phase) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The label states plasma elimination is biphasic and reports the terminal (beta) elimination half-life of about 22 hours — not the distribution phase. The parent compound doxazosin is primarily responsible for the drug's activity; several active metabolites exist but circulate at low concentrations and their pharmacokinetics have not been characterized, so no active metabolite is reported to outlast the parent. Populations: half-life is unchanged in older adults (65+ vs under 65 are similar) and in renal impairment (no significant alterations). Hepatic impairment: mild cirrhosis (Child-Pugh A) raises doxazosin exposure ~40%; the effect of moderate-to-severe (Child-Pugh B/C) impairment is not known.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Doxazosin label — DailyMed (Clinical Pharmacology 12.3, Excretion).
Drug class
How this class works, per Alpha-Blockers - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Cardura ranks — best-rated alpha-adrenergic blocker for:
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Cardura treat?
- Cardura (Doxazosin Mesylate) may be used to treat hypertension, prostatic hyperplasia, urinary retention, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Cardura work?
- Cardura is a alpha-adrenergic blocker. Alpha-adrenergic blockers block the alpha-1 receptors that adrenaline-like signals use to tighten muscle in blood vessels and the prostate. This relaxes those muscles, lowering blood pressure and easing urine flow in men with an enlarged prostate.
- How is Cardura rated?
- pharmaranks gives Cardura a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Cardura cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $2.57 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Coreg — about $0.63 on the same basis.
- Is there a coupon or discount for Cardura?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cardura. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cardura?
- Cardura is marketed by Viatris. You can see Viatris's full profile, rating, and other products on pharmaranks.
- Is Cardura a brand-name or generic drug?
- Cardura is a brand-name product with the active ingredient Doxazosin Mesylate. Lower-cost generic equivalents containing Doxazosin Mesylate are available — ask your pharmacist.
- Is Cardura available over the counter?
- No. Cardura is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cardura come in?
- Cardura is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Cardura?
- Cardura is classified as alpha-adrenergic blocker, per the FDA's Established Pharmacologic Class.
- Is Cardura FDA-registered?
- Cardura is on record with the U.S. FDA under application number NDA019668. You can verify this on its official FDA label.
- Has Cardura been recalled by the FDA?
- Cardura has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Cardura safe?
- There's no single safe-or-not verdict. pharmaranks gives Cardura a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Cardura?
- Cardura's side effects are taken directly from its FDA label. From the label: The most commonly reported adverse reactions from clinical trials are fatigue, malaise, hypotension, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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