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Terazosin 2 mg Capsule, 100-count — NDC 27241-0289-01 package photo

Terazosin 2 mg Capsule, 100-count

by Ajanta Pharma USA Inc. · 100 CAPSULE in 1 BOTTLE (27241-289-01)
NDC 27241-0289-01
🏷️ FDA NDC (as labeled) 27241-289-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.1055 NADAC Per package$10.55 / 100 capsules Pack sizes2 compare ↓
Also priced by: Part D plans $0.2378/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 27241-289-01
Product NDC 27241-289
11-digit billing NDC 27241028901
NCPDP billing unit EA — each (per item)
UNII D32S14F082
UPC 0327241289019, 0327241291012, 0327241290015, 0327241288012
Application # ANDA219482
SPL Set ID bed99c2a-4266-4a2c-bb0f-7643fdafff78
Established class (EPC) alpha-Adrenergic Blocker
Mechanism of action Adrenergic alpha-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-12
Route ORAL
Dosage form CAPSULE
Substance TERAZOSIN HYDROCHLORIDE
GPI-14 36202040100110
GCN Seq No 022650
GCN 47125
HICL code 000094
Ingredient (HICL) Terazosin Hcl
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J7
Therapeutic class — intermediate (HIC2) Antiadrenergics
HIC3 code J7B
Therapeutic class — specific (HIC3) Alpha-Adrenergic Blocking Agents
AHFS code 24:16.00.00
AHFS class Alpha-Adrenergic Blocking Agents (24:16)
FDB label name TERAZOSIN 2 MG CAPSULE
FDB brand name Terazosin Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 27241-289-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 27241-0289-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the alpha-Adrenergic Blocker class.

Pharmacologic class alpha-Adrenergic Blocker
Drug family (ATC) Alpha-adrenoreceptor antagonists
How it works Adrenergic alpha-Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAjanta Pharma USA Inc.
Application holderAJANTA PHARMA LTD
FDA applicationANDA219482 (ANDA)
Labeler code27241
First marketedMay 2025
Product typeHuman Prescription Drug
Portfolio168 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name TERAZOSIN 2 MG CAPSULE Ingredient Terazosin Hcl
📖 What it is MedlinePlus · NLM

Terazosin is used to: treat benign prostatic hyperplasia (BPH; enlarged prostate that can cause difficulty urinating, painful urination or increased urinary frequency or urgency). treat high blood pressure. Terazosin is in a class of medications called alpha-blockers. It relieves the symptoms of BPH by relaxing the muscles of the bladder and prostate. It lowers blood pressure by relaxing the blood vessels so that blood can flow more easily through the body. High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys and oth...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It can actually be used for both. Terazosin relaxes smooth muscle in the prostate and bladder neck, which helps urine flow more easily if you have an enlarged prostate (BPH). That...
  • What exactly does terazosin do — is it for my prostate or my blood pressure?
  • The first dose — and doses after any break or increase — can cause a significant drop in blood pressure, especially when you stand up. That can make you dizzy or even faint. Taking...
  • Why do I have to take the first dose at bedtime? Can't I just take it in the morning?
📖 Read our full Terazosin guide →
1
Nutrient depletion considerations

Terazosin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Gray / Yellow / Orange / Green
ShapeCapsule
Imprintap;TE10
Size3 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

13 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.106 $10.55 / 100 capsules
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2378 $23.78 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
May 2026 Jun 2026 Jul 2026 Sep 2026 $0.113 $0.103
▼ Down 6% over the last 5 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
terazosin 2 mg 23155-0736-01 Heritage 100 capsules $0.106 AB Availability likely —
Terazosin 2 mgthis 27241-0289-01 Ajanta 100 capsules $0.106 AB Availability likely —
Terazosin 2 mg 50268-0765-15 AvPAK 50 capsules $0.106 AB Availability likely —
Terazosin 2 mg 59746-0384-06 Jubilant 100 capsules $0.106 AB Availability likely —
Terazosin 2 mg 62135-0459-90 Chartwell 90 capsules $0.106 AB Availability likely —
Terazosin 2 mg 69452-0331-20 Bionpharma 100 capsules $0.106 AB Availability likely —
Terazosin 2 mg 42291-0821-10 AvKARE 1000 capsules — AB FDA listed —
Terazosin 2 mg 50090-2623-00 A-S 30 capsules — AB FDA listed —
terazosin 2 mg 51655-0915-52 Northwind 30 capsules — AB FDA listed —
Terazosin 2 mg 66267-0389-90 NuCare 90 capsules — AB FDA listed —
Terazosin 2 mg 68788-4064-01 Preferred 100 capsules — AB FDA listed —
terazosin 2 mg 68788-8171-03 Preferred 30 capsules — AB FDA listed —
Terazosin hydrochloride 2 mg 68788-9816-01 Preferred 100 capsules — AB FDA listed —
Terazosin Hydrochloride 2 mg 69292-0202-01 Amici 100 capsules — AB FDA listed —
Terazosin 2 mg 70518-0074-01 REMEDYREPACK 30 capsules — AB FDA listed —
Terazosin 2 mg 70518-4545-00 REMEDYREPACK 30 capsules — AB FDA listed —
Terazosin 2 mg 71335-3059-01 Bryant 30 capsules — AB FDA listed —
Terazosin 2 mg 71610-0510-30 Aphena 30 capsules — AB FDA listed —
Terazosin Hydrochloride 2 mg 71610-0698-30 Aphena 30 capsules — AB FDA listed —
Terazosin 2 mg 71610-0720-30 Aphena 30 capsules — AB FDA listed —
Terazosin 2 mg 72162-2182-00 Bryant 1000 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Terazosin — the ingredient across all brands.

Top reported reactions

Fatigue543
Dyspnoea502
Diarrhoea458
Dizziness457
Asthenia418
Death387
Acute Kidney Injury375

Age at onset

Neonate5
Infant1
Child1
Adolescent1
Adult341
Elderly959

Reporter sex

8,843 reports
Male · 85%
Female · 15%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 719 158
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
27241-0289-01 You're viewing this 100 CAPSULE in 1 BOTTLE (27241-289-01) $0.1055 / ea $10.55 2025-05-12 Active
27241-0289-10 1000 CAPSULE in 1 BOTTLE (27241-289-10) — — 2025-05-12 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 27241-0289-01?
NDC 27241-0289-01 is a 100-count package — 100 capsule in 1 bottle.
What is the difference between NDC 27241-0289-01 and NDC 27241-0289-10?
Both are Terazosin 2 mg Capsule — the drug itself is identical. NDC 27241-0289-01 is the 100-count package, while NDC 27241-0289-10 is the 1000 capsules package.
What NDC number is used to bill for this package of Terazosin 2 mg Capsule?
Bill NDC 27241-0289-01 — the 11-digit billing format is 27241028901. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 97 words ▾

INDICATIONS AND USAGE Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined.

Terazosin capsules are also indicated for the treatment of hypertension. Terazosin capsules can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION If terazosin capsules administration is discontinued for several days, therapy should be reinstituted using the initial dosing regimen. Benign Prostatic Hyperplasia Initial Dose: 1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded as an initial dose. Patients should be closely followed during initial administration in order to minimize the risk of severe hypotensive response.

Subsequent Doses: The dose should be increased in a stepwise fashion to 2 mg, 5 mg, or 10 mg once daily to achieve the desired improvement of symptoms and/or flow rates. Doses of 10 mg once daily are generally required for the clinical response. Therefore, treatment with 10 mg for a minimum of 4 weeks to 6 weeks may be required to assess whether a beneficial response has been achieved.

Some patients may not achieve a clinical response despite appropriate titration. Although some additional patients responded at a 20 mg daily dose, there was an insufficient number of patients studied to draw definitive conclusions about this dose. There are insufficient data to support the use of higher doses for those patients who show inadequate or no response to 20 mg daily.

If terazosin administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen. Use With Other Drugs: Caution should be observed when terazosin capsules are administered concomitantly with other antihypertensive agents, especially the calcium channel blocker verapamil, to avoid the possibility of developing significant hypotension. When using terazosin and other antihypertensive agents concomitantly, dosage reduction and retitration of either agent may be necessary(see PRECAUTIONS ).

Hypotension has been reported when terazosin capsules have been used with phosphodiesterase-5 (PDE-5) inhibitors. Hypertension The dose of terazosin capsules and the dose interval (12 hours or 24 hours) should be adjusted according to the patient’s individual blood pressure response. The following is a guide to its administration.

Initial Dose 1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded. This initial dosing regimen should be strictly observed to minimize the potential for severe hypotensive effects. Subsequent Doses The dose may be slowly increased to achieve the desired blood pressure response.

The usual recommended dose range is 1 mg to 5 mg administered once a day; however, some patients may benefit from doses as high as 20 mg per day. Doses over 20 mg do not appear to provide further blood pressure effect and doses over 40 mg have not been studied. Blood pressure should be monitored at the end of the dosing interval to be sure control is maintained throughout the interval.

It may also be helpful to measure blood pressure 2 hours to 3 hours after dosing to see if the maximum and minimum responses are similar, and to evaluate symptoms such as dizziness or palpitations which can result from excessive hypotensive response. If response is substantially diminished at 24 hours an increased dose or use of a twice daily regimen can be considered. If terazosin administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen.

In clinical trials, except for the initial dose, the dose was given in the morning. Use With Other Drugs (See above.)

⛔ Contraindications 14 words ▾

CONTRAINDICATIONS Terazosin capsules are contraindicated in patients known to be hypersensitive to terazosin hydrochloride.

⚠️ Warnings ~2 min read ▾

WARNINGS Syncope and ‘‘First-dose’’ Effect Terazosin capsules, like other alpha-adrenergic blocking agents, can cause marked lowering of blood pressure, especially postural hypotension, and syncope in association with the first dose or first few days of therapy. A similar effect can be anticipated if therapy is interrupted for several days and then restarted. Syncope has also been reported with other alpha-adrenergic blocking agents in association with rapid dosage increases or the introduction of another antihypertensive drug.

Syncope is believed to be due to an excessive postural hypotensive effect, although occasionally the syncopal episode has been preceded by a bout of severe supraventricular tachycardia with heart rates of 120 beats per minute to 160 beats per minute. Additionally, the possibility of the contribution of hemodilution to the symptoms of postural hypotension should be considered. To decrease the likelihood of syncope or excessive hypotension, treatment should always be initiated with a 1 mg dose of terazosin, given at bedtime.

The 2 mg, 5 mg and 10 mg capsules are not indicated as initial therapy. Dosage should then be increased slowly, according to recommendations in the Dosage and Administration section and additional antihypertensive agents should be added with caution. The patient should be cautioned to avoid situations, such as driving or hazardous tasks, where injury could result should syncope occur during initiation of therapy.

In early investigational studies, where increasing single doses up to 7.5 mg were given at 3 day intervals, tolerance to the first dose phenomenon did not necessarily develop and the ‘‘first-dose” effect could be observed at all doses. Syncopal episodes occurred in 3 of the 14 subjects given terazosin at doses of 2.5 mg, 5 mg and 7.5 mg, which are higher than the recommended initial dose; in addition, severe orthostatic hypotension (blood pressure falling to 50/0 mmHg) was seen in two others and dizziness, tachycardia, and lightheadedness occurred in most subjects.

These adverse effects all occurred within 90 minutes of dosing. In three placebo-controlled BPH studies 1, 2, and 3 (see CLINICAL PHARMACOLOGY ), the incidence of postural hypotension in the terazosin treated patients was 5.1%, 5.2%, and 3.7% respectively. In multiple dose clinical trials involving nearly 2,000 hypertensive patients treated with terazosin, syncope was reported in about 1% of patients.

Syncope was not necessarily associated only with the first dose. If syncope occurs, the patient should be placed in a recumbent position and treated supportively as necessary. There is evidence that the orthostatic effect of terazosin is greater, even in chronic use, shortly after dosing.

The risk of the events is greatest during the initial seven days of treatment, but continues at all time intervals. Priapism Rarely, (probably less than once in every several thousand patients) terazosin and other α 1 -antagonists have been associated with priapism (painful penile erection, sustained for hours and unrelieved by sexual intercourse or masturbation). Two or three dozen cases have been reported.

Because this condition can lead to permanent impotence if not promptly treated, patients must be advised about the seriousness of the condition (see PRECAUTIONS: Information for Patients ).

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS Benign Prostatic Hyperplasia The incidence of treatment-emergent adverse events has been ascertained from clinical trials conducted worldwide. All adverse events reported during these trials were recorded as adverse reactions. The incidence rates presented below are based on combined data from six placebo-controlled trials involving once-a-day administration of terazosin at doses ranging from 1 mg to 20 mg.

Table 1 summarizes those adverse events reported for patients in these trials when the incidence rate in the terazosin group was at least 1%, and was greater than that for the placebo group, or where the reaction is of clinical interest. Asthenia, postural hypotension, dizziness, somnolence, nasal congestion/rhinitis, and impotence were the only events that were significantly (p less than or equal to 0.05) more common in patients receiving terazosin than in patients receiving placebo. The incidence of urinary tract infection was significantly lower in the patients receiving terazosin than in patients receiving placebo.

An analysis of the incidence rate of hypotensive adverse events (see PRECAUTIONS ) adjusted for the length of drug treatment has shown that the risk of the events is greatest during the initial seven days of treatment, but continues at all time intervals. TABLE 1. Adverse Reactions During Placebo-Controlled Trials Benign Prostatic Hyperplasia * Includes weakness, tiredness, lassitude, and fatigue. † p less than or equal to 0.05 comparison between groups.

Body System Terazosin (N=636) Placebo (N=360) BODY AS A WHOLE *Asthenia 7.4% † 3.3% Flu Syndrome 2.4% 1.7% Headache 4.9% 5.8% CARDIOVASCULAR SYSTEM Hypotension 0.6% 0.6% Palpitations 0.9% 1.1% Postural Hypotension 3.9% † 0.8% Syncope 0.6% 0.0% DIGESTIVE SYSTEM Nausea 1.7% 1.1% METABOLIC AND NUTRITIONAL DISORDERS Peripheral Edema 0.9% 0.3% Weight Gain 0.5% 0.0% NERVOUS SYSTEM Dizziness 9.1% † 4.2% Somnolence 3.6% † 1.9% Vertigo 1.4% 0.3% RESPIRATORY SYSTEM Dyspnea 1.7% 0.8% Nasal Congestion/Rhinitis 1.9% † 0.0% SPECIAL SENSES Blurred Vision/Amblyopia 1.3% 0.6% UROGENITAL SYSTEM Impotence 1.6% † 0.6% Urinary Tract Infection 1.3% 3.9% † Additional adverse events have been reported, but these are, in general, not distinguishable from symptoms that might have occurred in the absence of exposure to terazosin.

The safety profile of patients treated in the long-term open-label study was similar to that observed in the controlled studies. The adverse events were usually transient and mild or moderate in intensity, but sometimes were serious enough to interrupt treatment. In the placebo-controlled clinical trials, the rates of premature termination due to adverse events were not statistically different between the placebo and terazosin groups.

The adverse events that were bothersome, as judged by their being reported as reasons for discontinuation of therapy by at least 0.5% of the terazosin group and being reported more often than in the placebo group, are shown in Table 2. TABLE 2. Discontinuation During Placebo-Controlled Trials Benign Prostatic Hyperplasia Body System Terazosin (N=636) Placebo (N=360) BODY AS A WHOLE Fever 0.5% 0.0% Headache 1.1% 0.8% CARDIOVASCULAR SYSTEM Postural Hypotension 0.5% 0.0% Syncope 0.5% 0.0% DIGESTIVE SYSTEM Nausea 0.5% 0.3% NERVOUS SYSTEM Dizziness 2.0% 1.1% Vertigo 0.5% 0.0% RESPIRATORY SYSTEM Dyspnea 0.5% 0.3% SPECIAL SENSES Blurred Vision/Amblyopia 0.6% 0.0% UROGENITAL SYSTEM Urinary Tract Infection 0.5% 0.3% Hypertension The prevalence of adverse reactions has been ascertained from clinical trials conducted primarily in the United States.

All adverse experiences (events) reported during these trials were recorded as adverse reactions. The prevalence rates presented below are based on combined data from fourteen placebo-controlled trials involving once-a-day administration of terazosin, as monotherapy or in combination with other antihypertensive agents, at doses ranging from 1 mg to 40 mg. Table 3 summarizes thos…

🆘 Overdosage 85 words ▾

OVERDOSAGE Should overdosage of terazosin lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, shock should first be treated with volume expanders.

If necessary, vasopressors should then be used and renal function should be monitored and supported as needed. Laboratory data indicate that terazosin is 90% to 94% protein bound; therefore, dialysis may not be of benefit.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pharmacodynamics: A . Benign Prostatic Hyperplasia (BPH) The symptoms associated with BPH are related to bladder outlet obstruction, which is comprised of two underlying components: a static component and a dynamic component. The static component is a consequence of an increase in prostate size.

Over time, the prostate will continue to enlarge. However, clinical studies have demonstrated that the size of the prostate does not correlate with the severity of BPH symptoms or the degree of urinary obstruction. The dynamic component is a function of an increase in smooth muscle tone in the prostate and bladder neck, leading to constriction of the bladder outlet.

Smooth muscle tone is mediated by sympathetic nervous stimulation of alpha-l adrenoceptors, which are abundant in the prostate, prostatic capsule and bladder neck. The reduction in symptoms and improvement in urine flow rates following administration of terazosin is related to relaxation of smooth muscle produced by blockade of alpha-l adrenoceptors in the bladder neck and prostate. Because there are relatively few alpha-l adrenoceptors in the bladder body, terazosin is able to reduce the bladder outlet obstruction without affecting bladder contractility.

Terazosin has been studied in 1,222 men with symptomatic BPH. In three placebo-controlled studies, symptom evaluation and uroflowmetric measurements were performed approximately 24 hours following dosing. Symptoms were quantified using the Boyarsky Index.

The questionnaire evaluated both obstructive (hesitancy, intermittency, terminal dribbling, impairment of size and force of stream, sensation of incomplete bladder emptying) and irritative (nocturia, daytime frequency, urgency, dysuria) symptoms by rating each of the 9 symptoms from 0 to 3, for a total score of 27 points. Results from these studies indicated that terazosin statistically significantly improved symptoms and peak urine flow rates over placebo as follows: a Highest dose 10 mg shown. b 23% of patients on 10 mg, 41% of patients on 20 mg. c 67% of patients on 10 mg. * Significantly (p less than or equal to 0.05) more improvement than placebo.

Symptom Score Change (%) Peak Flow Rate Change (%) (Range 0 -27) (mL/sec) Mean Mean Mean Mean N Baseline N B aseline Study 1 (10mg) a Titration to fixed dose (12 wks) Placebo 55 9.7 -2.3 (24) 54 10.1 +1.0 (10) Terazosin 54 10.1 -4.5 (45)* 52 8.8 +3.0 (34)* Study 2 (2, 5, 10, 20 mg) b Titration to Response (24 wks) Placebo 89 12.5 -3.8 (30) 88 8.8 +1.4 (16) Terazosin 85 12.2 -5.3 (43)* 84 8.4 +2.9 (35)* Study 3 (1, 2, 5, 10 mg) c Titration to response (24 wks) Placebo 74 10.4 -1.1 (11) 74 8.8 +1.2 (14) Terazosin 73 10.9 -4.6 (42)* 73 8.6 +2.6 (30)* In all three studies, both symptom scores and peak urine flow rates showed statistically significant improvement from baseline in patients treated with terazosin from week 2 (or the first clinic visit) and throughout the study duration.

Analysis of the effect of terazosin on individual urinary symptoms demonstrated that compared to placebo, terazosin significantly improved the symptoms of hesitancy, intermittency, impairment in size and force of urinary stream, sensation of incomplete emptying, terminal dribbling, daytime frequency and nocturia. Global assessments of overall urinary function and symptoms were also performed by investigators who were blinded to patient treatment assignment. In studies 1 and 3, patients treated with terazosin had a significantly (p less than or equal to 0.001) greater overall improvement compared to placebo treated patients.

In a short term study (Study 1), patients were randomized to either 2 mg, 5 mg or 10 mg of terazosin or placebo. Patients randomized to the 10 mg group achieved a statistically significant response in both symptoms and peak flow rate compared to placebo (Figure 1). FIGURE 1., STUDY 1 † for baseline values see above table * p less than or equal to 0.05, compared to placebo group In a long-term, open-label, n…

📦 How Supplied / Storage and Handling ~1 min read ▾

HOW SUPPLIED Terazosin Capsules, USP are available in four dosage strengths: 1 mg : Grey opaque/ Grey opaque hard gelatin size “3” capsules imprinted with “ap” logo on cap and “TE1” on body in black ink containing white to off-white powder. Bottles of 100 capsules with child resistant closure NDC 27241-288-01 Bottles of 1000 capsules NDC 27241-288-10 2 mg: Yellow opaque/ Yellow opaque hard gelatin size “3” capsules imprinted with “ap” logo on cap and “TE2” on body in black ink containing white to off-white powder. Bottles of 100 capsules with child resistant closure NDC 27241-289-01 Bottles of 1000 capsules NDC 27241-289-10 5 mg: Orange opaque/ Orange opaque hard gelatin size “3” capsules imprinted with “ap” logo on cap and “TE5” on body in black ink containing white to off-white powder.

Bottles of 100 capsules with child resistant closure NDC 27241-290-01 Bottles of 1000 capsules NDC 27241-290-10 10 mg: Light green opaque/ Light green opaque hard gelatin size “3” capsules imprinted with “ap” logo on cap and “TE10” on body in black ink containing white to off-white powder. Bottles of 100 capsules with child resistant closure NDC 27241-291-01 Bottles of 1000 capsules NDC 27241-291-10 Dispense in a tight, light-resistant container as defined in the USP. Recommended storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).

Protect from light and moisture. Rx only Product of Italy Manufactured by: Ajanta Pharma Limited, India Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807.

Revised: 11/2025

📋 Description 191 words ▾

DESCRIPTION Terazosin hydrochloride USP, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name, molecular formula and structural formula: Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. C 19 H 25 N 5 O 4 HCl 2H 2 O. Terazosin hydrochloride, USP is a white to pale yellow, crystalline powder.

Soluble in methanol, sparingly soluble in water, slightly soluble in alcohol and in

0.1N hydrochloric acid, very slightly soluble in isotonic saline solution and in chloroform and practically insoluble in acetone and in hexanes and has a molecular weight of 459.93. Each capsule, for oral administration, contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The gelatin capsule contains gelatin, sodium lauryl sulfate, and titanium dioxide.

The 1 mg shell also contains ferric oxide black; the 2 mg capsule shell also contains D&C Yellow-10; the 5 mg capsule shell also contains D&C Yellow-10, D&C Red-28 and FD&C Red-40; the 10 mg capsule shell also contains D&C Yellow-10 and FD&C Green-3. Imprinting ink contains shellac, propylene glycol, butyl alcohol, potassium hydroxide and black iron oxide. FDA approved dissolution test specifications differ from USP. structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.