hydrochlorothiazide
Pharmaranks rates Hydrochlorothiazide 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Hydrochlorothiazide is a thiazide diuretic used to treat Edema, Heart Failure, Hypertension, Nephrotic Syndrome.
Thiazide Diuretic · by Unichem
Generic of Inzirqo
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Hydrochlorothiazide
- Drug class
- Thiazide Diuretic
- Form
- Capsule, Tablet
- Strength
- Hydrochlorothiazide 12.5MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- edema, heart failure, hypertension
- Manufacturer
- Unichem
- Half-life
- about 6 to 15 hours (the label reports a range, not a single number) (how long it stays in your system)
- What the pharmacy pays
- ~$0.91 for 30 — not your price
- FDA application
- ANDA090510
What is Hydrochlorothiazide?
From the FDA label:Hydrochlorothiazide USP is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C 7 H 8 ClN 3 O 4 S 2 ; its molecular weight is 297.74; and its structural formula is: It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Inactive ingredients : Black iron oxide, colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and titanium dioxide. FDA approved dissolution test specifications differ from USP. Structural Formula
How to use
Hydrochlorothiazide is sold in more than one form (Capsule and Tablet), and each is dosed differently. The instructions below come from the FDA label for application ANDA090510 — follow the label that came with the product you were actually prescribed.
For Control of Hypertension: The adult initial dose of hydrochlorothiazide capsules is one capsule given once daily whether given alone or in combination with other antihypertensives. Total daily doses greater than 50 mg are not recommended.
Side effects
The adverse reactions associated with hydrochlorothiazide have been shown to be dose related. In controlled clinical trials, the adverse events reported with doses of 12.5 mg hydrochlorothiazide once daily were comparable to placebo. The following adverse reactions have been reported for doses of hydrochlorothiazide 25 mg and greater and, within each category, are listed in the 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, paresthesia, dizziness, headache, restlessness. Renal : Renal failure, renal dysfunction, interstitial nephritis (see WARNINGS ). Skin: Erythema multiforme including…
Warnings
Important safety information
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. Diabetes and Hypoglycemia: Latent diabetes mellitus may become manifest and diabetic patients given thiazides may require adjustment of their insulin dose. Renal Disease: Cumulative effects of the thiazides may develop in patients with impaired renal function. In such patients, thiazides may precipitate azotemia.
Who should not take Hydrochlorothiazide
Hydrochlorothiazide capsules are contraindicated in patients with anuria. Hypersensitivity to this product or other sulfonamide derived drugs is also contraindicated.
Overdose — what happens if you take too much
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 gm/kg in the mouse and rat.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
When given concurrently the following drugs may interact with thiazide diuretics: Alcohol, barbiturates, or narcotics – potentiation of orthostatic hypotension may occur. Antidiabetic drugs – (oral agents and insulin) dosage adjustment of the antidiabetic drug may be required. Other antihypertensive drugs – additive effect or potentiation. Cholestyramine and colestipol resins – Cholestyramine and colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. Corticosteroid, ACTH – intensified electrolyte depletion, particularly hypokalemia. Pressor amines (e.g., norepinephrine) – possible decreased response to pressor amines but not sufficient to preclude their use. Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) – possible increased responsiveness to the muscle relaxant. Lithium – generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and greatly increase the risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with hydrochlorothiazide. Non-steroidal anti-inflammatory drugs – In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. When hydrochlorothiazide and non-steroidal anti-inflammatory agents are used concomitantly, the patients should be observed closely to determine if the desired effect of the diuretic is obtained. Drug/Laboratory Test Interactions – Thiazides should be discontinued before carrying out tests for parathyroid function (see PRECAUTIONS , General). Carcinogenesis, Mutagenesis, Impairment of Fertility: Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice. Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in vivo in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene. Positive test results were obtained only in the in vitro CHO Sister Chromatid Exchange (clastogenicity) and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of hydrochlorothiazide from 43 to 1,300 mcg/mL, and in the Aspergillus nidulans non-disjunction assay at an unspecified concentration. Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively, prior to conception and throughout gestation.
How long does Hydrochlorothiazide stay in your body?
The elimination half-life of hydrochlorothiazide is about 6 to 15 hours (the label reports a range, not a single number) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the plasma ELIMINATION half-life. Plasma levels fall bi-exponentially: other FDA labels for hydrochlorothiazide combination products describe a distribution phase of roughly 2 hours before the ~10-hour (6-15 h) elimination phase — the elimination figure is the one given here. Hydrochlorothiazide is NOT a prodrug and is NOT metabolized, so there is no active metabolite that outlasts the parent; more than 95% of the absorbed dose is excreted unchanged in urine. Kidney impairment: the label states plainly that in patients with renal disease plasma concentrations are increased and the elimination half-life is PROLONGED — it does not quantify by how much. The label does not state a different half-life for older adults or for liver impairment, so no number should be assumed for those groups. Absorption (not elimination) is reduced in congestive heart failure. This is a pharmacokinetic figure about how long the drug stays in plasma; it is not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: DailyMed — HYDROCHLOROTHIAZIDE capsule, Clinical Pharmacology (Pharmacokinetics and Metabolism).
Drug class
May treat (source: NIH RxClass)
See how Hydrochlorothiazide ranks — best-rated thiazide diuretic for:
Dosage forms
Capsule and Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Hydrochlorothiazide treat?
- Hydrochlorothiazide (Hydrochlorothiazide) may be used to treat edema, heart failure, hypertension, nephrotic syndrome, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Hydrochlorothiazide rated?
- pharmaranks gives Hydrochlorothiazide a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Hydrochlorothiazide cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.91 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Hydrochlorothiazide?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Hydrochlorothiazide. To pay less, Hydrochlorothiazide is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Hydrochlorothiazide?
- Hydrochlorothiazide is marketed by Unichem. You can see Unichem's full profile, rating, and other products on pharmaranks.
- Is Hydrochlorothiazide a brand-name or generic drug?
- Hydrochlorothiazide is a generic medication; its active ingredient is Hydrochlorothiazide. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Hydrochlorothiazide available over the counter?
- No. Hydrochlorothiazide is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Hydrochlorothiazide come in?
- Hydrochlorothiazide is currently marketed as capsule and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Hydrochlorothiazide?
- Hydrochlorothiazide is classified as thiazide diuretic, per the FDA's Established Pharmacologic Class.
- Is Hydrochlorothiazide FDA-registered?
- Hydrochlorothiazide is on record with the U.S. FDA under application number ANDA090510. You can verify this on its official FDA label.
- Has Hydrochlorothiazide been recalled by the FDA?
- Hydrochlorothiazide has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Hydrochlorothiazide safe?
- There's no single safe-or-not verdict. pharmaranks gives Hydrochlorothiazide a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Hydrochlorothiazide?
- Hydrochlorothiazide's side effects are taken directly from its FDA label. From the label: The adverse reactions associated with hydrochlorothiazide have been shown to be dose related. In controlled clinical trials, the adverse events reported with doses of 12.5 mg hydrochlorothiazide once daily were comparable to placebo.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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hydrochlorothiazide
72/100