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What the label lists and what reports show

Terazosin side effects

Terazosin's FDA label lists its adverse reactions in its own words. FAERS holds 8,843 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (543 reports).

  • Generic listed

Check it at the source: the terazosin FDA label on DailyMed (effective May 5, 2026, Jubilant Cadista Pharmaceuticals Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: 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 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 ≤ 0.05) more common in patients receiving terazosin than in patients receiving placebo. …

TABLE 3. Adverse Reactions During Placebo-Controlled Trials Hypertension

ReactionTerazosin (N = 859) 11.3% Statistically significant at p=0.05 level. 2.4% 16.2% 4.3% 1.3% 1.9%Placebo (N = 506) 4.3% 1.2% 15.8% 1.2% 0.4% 1.2%
DIGESTIVE SYSTEM Nausea4.4%1.4%
MUSCULOSKELETAL SYSTEM Pain – Extremities3.5%3.0%
SPECIAL SENSES Blurred Vision1.6%0.0%
UROGENITAL SYSTEM Impotence1.2%1.4%

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

Source: FDA drug label, Jubilant Cadista Pharmaceuticals Inc., effective May 5, 2026 (SPL set 43e92495-2cf2-46dd-a80c-f0c3c88c7b73), via openFDA; the full label on DailyMed

What do FAERS reports show?

8,843 reports list terazosin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 951 are coded as a death and 3,213 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)549
  • Fatigue (named in the label)543
  • Dyspnoea (named in the label)501
  • Diarrhoea (named in the label)458
  • Dizziness (named in the label)456
  • Asthenia (named in the label)416
  • Death (an outcome recorded in the report)386
  • Acute Kidney Injury375
  • Off Label Use (a use or a product term, not a reaction)365
  • Fall347
  • Nausea (named in the label)347
  • Chronic Kidney Disease333
  • Renal Failure330
  • Pain328
  • Pneumonia321
  • Hypotension (named in the label)304
  • Headache (named in the label)300
  • Constipation (named in the label)248
  • Malaise241
  • Weight Decreased238
  • Blood Pressure Increased231
  • Arthralgia (named in the label)226
  • Rash (named in the label)225
  • Pain In Extremity224
  • Hypertension (a use or a product term, not a reaction)222

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Terazosin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions