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What the label lists and what reports show

Triamterene side effects

Triamterene's FDA label lists its adverse reactions in its own words. FAERS holds 7,263 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 chronic kidney disease (479 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the triamterene FDA label on DailyMed (effective December 5, 2024, Advanz Pharma (US) Corp.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Adverse effects are listed in decreasing order of frequency; however, the most serious adverse effects are listed first, regardless of frequency. All adverse effects occur rarely (that is, 1 in 1000, or less). Hypersensitivity: anaphylaxis, rash, photosensitivity. Metabolic: hyperkalemia, hypokalemia. Renal: azotemia, elevated BUN and creatinine, renal stones, acute interstitial nephritis (rare), acute renal failure (one case of irreversible renal failure has been reported). Gastrointestinal: jaundice and/or liver enzyme abnormalities, nausea and vomiting, diarrhea. Hematologic: thrombocytopenia, megaloblastic anemia. Central Nervous System: weakness, fatigue, dizziness, headache, dry mouth. To report SUSPECTED ADVERSE REACTIONS, contact Advanz Pharma (US) Corp. at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Source: FDA drug label, Advanz Pharma (US) Corp., effective December 5, 2024 (SPL set ebb177c0-d45d-4443-a85a-e76bd9931a42), via openFDA; the full label on DailyMed

What do FAERS reports show?

7,263 reports list triamterene among the medicines taken, each a report of something that happened, not proof the medicine caused it; 413 are coded as a death and 1,801 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 23 reactions below, 8 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

  • Chronic Kidney Disease479
  • Fatigue (named in the label)474
  • Drug Ineffective (a use or a product term, not a reaction)448
  • Pain435
  • Nausea (named in the label)420
  • Diarrhoea (named in the label)400
  • Dyspnoea348
  • Dizziness (named in the label)341
  • Renal Failure (named in the label)329
  • Headache (named in the label)321
  • Acute Kidney Injury308
  • Arthralgia308
  • Off Label Use (a use or a product term, not a reaction)267
  • Asthenia260
  • Fall255
  • Pain In Extremity252
  • Alopecia247
  • Pruritus239
  • Anxiety229
  • Insomnia214
  • Rash (named in the label)214
  • Vomiting (named in the label)212
  • Back Pain209
  • Malaise208
  • Gastrooesophageal Reflux Disease193

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

What next?

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