Hydrochlorothiazide
Regulatory sources consulted
- AEMPS CIMA FT_90833 (https://cima.aemps.es/cima/dochtml/ft/90833/FT_90833.html)
- CredibleMeds.org
- AEMPS CIMA · nº registro 90833 ↗
Approved indications
- Treatment of edema of cardiac, hepatic, or renal origin.
- Treatment of arterial hypertension, as monotherapy or in combination with other antihypertensives.
- Treatment of nephrogenic diabetes insipidus.
- Prevention of calcium oxalate stone formation in patients with idiopathic hypercalciuria.
Contraindications
Absolute
- Hypersensitivity to hydrochlorothiazide or other sulfonamide-derived drugs.
- Anuria.
- Severe renal impairment (creatinine clearance < 30 ml/min).
- Severe hepatic impairment.
- Refractory hypokalemia, hyponatremia, hypercalcemia.
Clinical warnings
- Major warning · Risk of fluid and electrolyte imbalance (hypokalemia, hyponatremia, hypomagnesemia, hypercalcemia). Monitor electrolytes periodically. — AEMPS
- Major warning · Increased risk of non-melanoma skin cancer with cumulative and prolonged use. Advise sun protection. — AEMPS
- May precipitate gout attacks in susceptible patients due to hyperuricemia. — AEMPS
- May impair glucose tolerance and require dose adjustment of antidiabetic drugs. — AEMPS
Drug interactions
- HighLithiumN05AN01
Mechanism: Thiazide diuretics reduce the renal clearance of lithium, increasing the risk of toxicity.
Recommendation: Concomitant use is generally contraindicated. If necessary, monitor lithium levels closely.
AEMPS CIMA
- ModerateNSAIDs (Nonsteroidal Anti-Inflammatory Drugs)M01A
Mechanism: NSAIDs can attenuate the diuretic, natriuretic, and antihypertensive effect of hydrochlorothiazide.
Recommendation: Monitor blood pressure and renal function, especially when initiating or changing the dose.
AEMPS CIMA
- HighQT-prolonging drugs
Mechanism: Hydrochlorothiazide-induced hypokalemia increases the risk of ventricular arrhythmias (Torsades de Pointes) when combined with QT-prolonging drugs.
Recommendation: Correct hypokalemia before initiating treatment. Monitor electrolytes and ECG periodically.
CredibleMeds.org
Adverse events
Common (≥1%)
hypokalemia · hyperuricemia · hyperglycemia · hyperlipidemia · orthostatic hypotension · dizziness · hyponatremia
Rare but serious
pancreatitis · acute interstitial nephritis · non-melanoma skin cancer · acute angle-closure glaucoma · non-cardiogenic pulmonary edema · necrotizing vasculitis
Pregnancy and lactation
FDA category: B
Contraindicated during the second and third trimesters of pregnancy. It is excreted in breast milk, so a decision should be made whether to discontinue nursing or the drug.