pharmacopeia
GET
/api/v1/drug/hydrochlorothiazide
2D structure
6-chloro-1,1-dioxo-3,4-dihydro-2H-1lambda6,2,4-benzothiadiazine-7-sulfonamide
SMILES C1NC2=CC(=C(C=C2S(=O)(=O)N1)S(=O)(=O)N)Cl
InChIKey JZUFKLXOESDKRF-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Sodium Chloride Symporter Inhibitors.

Sodium Chloride Symporter

Indications

Sourced from openFDA
  • Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.ICD-10: I50.9, R60.9

Contraindications

Sourced from openFDA
  • Anuria. Hypersensitivity to this product or to other sulfonamide-derived drugs.contraindicated

Dosage & administration

Sourced from openFDA

Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response. Adults For Edema - The usual adult dosage is 25 to 100 mg daily as a single or divided dose. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur. For Control Of Hypertension - The usual initial dose in adults is 25 mg daily given as a single dose. The dose may be increased to 50 mg daily, given as a single or two divided doses. Doses above 50 mg are often associated with marked reductions in serum potassium (see also PRECAUTIONS ). Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents. Infants and Children For Diuresis and For Control of Hypertension - The usual pediatric dosage is 0.5 to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required (see PRECAUTIONS , Pediatric Use ).

Warnings & precautions

Sourced from openFDA

Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Thiazides may add to or potentiate the action of other antihypertensive drugs. Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. Lithium generally should not be given with diuretics (see PRECAUTIONS , Drug Interactions ). Acute Myopia and Secondary Angle-Closure Glaucoma Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Adverse reactions

Sourced from openFDA

The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity. Body As A Whole: Weakness. Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs). Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia. Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia. Hypersensitivity: Anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura. Metabolic: Electrolyte imbalance (see PRECAUTIONS ), hyperglycemia, glycosuria, hyperuricemia. Musculoskeletal: Muscle spasm. Nervous System/Psychiatric: Vertigo, paresthesias, dizziness, headache, restlessness. Renal: Renal failure, renal dysfunction, interstitial nephritis. (see WARNINGS .) Skin: Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia. Special Senses: Transient blurred vision, xanthopsia. Urogenital: Impotence. Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn. Postmarketing Experience Non-melanoma Skin Cancer Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects: Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3,000 and 1,000 mg hydrochlorothiazide/kg, respectively, provided no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nonteratogenic Effects: Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Overdosage

Sourced from openFDA

The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. In the event of overdosage, symptomatic and supportive measures should be employed. Emesis should be induced or gastric lavage performed. Correct dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. If required, give oxygen or artificial respiration for respiratory impairment. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD 50 of hydrochlorothiazide is greater than 10 g/kg in the mouse and rat.

Approval history

Sourced from openFDA
  • Jan 27, 1961NDANDA012616Pfizer
  • Jul 20, 1989NDANDA019888Almatica
  • May 19, 1992NDANDA020033Validus Pharms
  • Mar 26, 1993NDANDA020186Teva Branded Pharm
  • Apr 28, 1995NDANDA020387Organon
  • Dec 27, 1996NDANDA020504Teva Branded Pharm
  • Sep 30, 1997NDANDA020758Sanofi Aventis Us
  • Mar 6, 1998NDANDA020818Novartis

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Microzide, Capsule, 12.5 mg (NDC 0591-0347-01)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Microzide, Capsule, 12.5 mg (NDC 0591-0347-05)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Quinapril Hydrochloride And Hydrochlorothiazide, Tablet, 12.5 mg; 10 mg (NDC 65862-161-90)Active
    Sponsor: Aurobindo Pharma USA · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Quinapril Hydrochloride And Hydrochlorothiazide, Tablet, 12.5 mg; 20 mg (NDC 65862-162-90)Active
    Sponsor: Aurobindo Pharma USA · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Quinapril Hydrochloride And Hydrochlorothiazide, Tablet, 25 mg; 20 mg (NDC 65862-163-90)Active
    Sponsor: Aurobindo Pharma USA · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Quinapril/Hydrochlorothiazide, Tablet, 12.5 mg; 10 mg (NDC 62135-667-90)Active
    Sponsor: Chartwell Molecular Holdings LLC
    Updated
  • Quinapril/Hydrochlorothiazide, Tablet, 12.5 mg; 20 mg (NDC 62135-668-90)Active
    Sponsor: Chartwell Molecular Holdings LLC
    Updated
  • Quinapril/Hydrochlorothiazide, Tablet, 25 mg; 20 mg (NDC 62135-669-90)Active
    Sponsor: Chartwell Molecular Holdings LLC
    Updated

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
206,984 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fatigue13,5816.6%
  2. 2Nausea13,5636.6%
  3. 3Drug Ineffective13,1796.4%
  4. 4Diarrhoea11,5825.6%
  5. 5Dizziness11,1105.4%
  6. 6Headache10,6085.1%
  7. 7Dyspnoea10,3785.0%
  8. 8Pain10,1954.9%
  9. 9Arthralgia8,0403.9%
  10. 10Asthenia7,8373.8%
  11. 11Fall7,7483.7%
  12. 12Vomiting7,7053.7%
  13. 13Malaise7,3503.6%
  14. 14Hypertension7,3133.5%
  15. 15Off Label Use7,1143.4%

Literature

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Recent PubMed references pinned to Hydrochlorothiazide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 505 ClinicalTrials.gov registrations naming Hydrochlorothiazide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

View JSON

CPIC-curated drug–gene pairs for Hydrochlorothiazide. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • NEDD4LCPIC D (provisional)ClinPGx 3
  • PRKCACPIC D (provisional)ClinPGx 3
  • YEATS4CPIC D (provisional)ClinPGx 3

Frequently asked questions

How does Hydrochlorothiazide work?
Mechanism-of-action class: Sodium Chloride Symporter Inhibitors.
What is Hydrochlorothiazide used for?
According to FDA labeling, Hydrochlorothiazide carries indications including: Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Hydrochlorothiazide?
Hydrochlorothiazide is classified as Thiazides, plain, Thiazide Diuretic, Sodium Chloride Symporter Inhibitors, Decreased Blood Pressure, Decreased Distal Tubule Ca++ Excretion, Decreased Intravascular Volume, Increased Distal Tubule Cl- Excretion, Increased Distal Tubule H+ Excretion, Increased Distal Tubule K+ Excretion, Increased Distal Tubule Na+ Excretion, Increased Diuresis, Vasodilation.
What are the brand names for Hydrochlorothiazide?
Hydrochlorothiazide is marketed under brand names including Accuretic, Aldactazide, Atacand HCT, Avalide, Benicar HCT, Diovan HCT, Dyazide, Exforge HCT.
What are the contraindications for Hydrochlorothiazide?
Hydrochlorothiazide labeling lists contraindications including: Anuria. Hypersensitivity to this product or to other sulfonamide-derived drugs.. Always consult the full prescribing information and a clinician.
Note. Data for hydrochlorothiazide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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