Terazosin Recall

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Questions & Answers

Side Effects & Adverse Reactions


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 about of severe supraventricular tachycardia with heart rates of 120-160 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, 5 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 2000 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.


Rarely, (probably less than once in every several thousand patients) terazosin and other α1 -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).


Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Terazosin Capsules, USP 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, USP. The long-term effects of Terazosin Capsules, USP on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined.

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



There is currently no drug history available for this drug.

Other Information

Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate.


Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 459.93. Terazosin Capsules, USP for oral ingestion are supplied in four dosage strengths containing terazosin hydrochloride equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin.


The 1 mg, 2 mg, 5 mg and 10 mg capsules contain the following inactive ingredients: lactose monohydrate, starch, stearic acid and talc. The 1 mg, 2 mg, 5 mg and 10 mg capsule imprinting ink contains ammonium hydroxide, black iron oxide, potassium hydroxide, propylene glycol and shellac.

The 1 mg capsule shell contains black iron oxide, gelatin, titanium dioxide and yellow iron oxide. 

The 2 mg capsule shell contains D&C yellow #10, FD&C red #40, gelatin and titanium dioxide. 

The 5 mg capsule shell contains D&C red #28, FD&C red #40, gelatin and titanium dioxide.  

The 10 mg capsule shell contains D&C red #28, D&C yellow #10, FD&C blue #1, gelatin and titanium dioxide.  

USP Dissolution Test 2


Terazosin Manufacturers

  • Remedyrepack Inc.
    Terazosin Capsule [Remedyrepack Inc. ]
  • Proficient Rx Lp
    Terazosin (Terazosin Hydrochloride) Capsule [Proficient Rx Lp]
  • Northwind Pharmaceuticals, Llc
    Terazosin (Terazosin Hydrochloride) Capsule [Northwind Pharmaceuticals, Llc]
  • Northwind Pharmaceuticals, Llc
    Terazosin (Terazosin Hydrochloride) Capsule [Northwind Pharmaceuticals, Llc]
  • Blenheim Pharmacal, Inc.
    Terazosin Capsule [Blenheim Pharmacal, Inc.]
  • State Of Florida Doh Central Pharmacy
    Terazosin (Terazosin Hydrochloride) Capsule [State Of Florida Doh Central Pharmacy]
  • Apotex Corp.
    Terazosin Capsule [Apotex Corp.]
  • Jubilant Cadista Pharmaceuticals Inc.
    Terazosin (Terazosin Hydrochloride) Capsule [Jubilant Cadista Pharmaceuticals Inc.]
  • Remedyrepack Inc.
    Terazosin (Terazosin Hydrochloride) Capsule [Remedyrepack Inc. ]
  • Preferred Pharmaceuticals, Inc.
    Terazosin Capsule [Preferred Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Terazosin Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Terazosin Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Terazosin Capsule [Remedyrepack Inc. ]
  • Aidarex Pharmaceuticals Llc
    Terazosin Capsule [Aidarex Pharmaceuticals Llc]
  • Remedyrepack Inc.
    Terazosin Capsule [Remedyrepack Inc. ]
  • Bryant Ranch Prepack
    Terazosin (Terazosin Hydrochloride) Capsule [Bryant Ranch Prepack]

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