Hydrochlorothiazide Side Effects are documented on the FDA prescribing label, and reported separately by patients and doctors to the FDA’s adverse event system. This page sets out what the official record actually says about Hydrochlorothiazide: what it is approved to treat, what the label warns about, its recall history, and what the reported side effects are — along with what those figures do and do not mean.
- What Hydrochlorothiazide Is Prescribed For, and Where Hydrochlorothiazide Side Effects Come From
- Warnings on the Hydrochlorothiazide Label
- Warnings Beyond the Common Hydrochlorothiazide Side Effects
- Hydrochlorothiazide Side Effects Listed on the FDA Label
- Reported Hydrochlorothiazide Side Effects in the FDA Database
- Who the Label Says Should Take Extra Care
- Hydrochlorothiazide Recall History
- Is Hydrochlorothiazide the Subject of Litigation?
- If You Are Worried About Hydrochlorothiazide Side Effects
- Frequently Asked Questions
- Official Sources
- Related Guides
Before you read on. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.
What Hydrochlorothiazide Is Prescribed For, and Where Hydrochlorothiazide Side Effects Come From
According to the FDA label, INDICATIONS AND USAGE Hydrochlorothiazide tablets, USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets, USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. […]
Two separate official sources describe hydrochlorothiazide side effects. The prescribing label records what was observed in clinical trials, where the drug was compared against a control group. The FDA’s adverse event database records what patients and clinicians have reported since approval, which is a much larger but far less controlled picture. Both appear below, and they answer different questions.
| Active ingredient | Hydrochlorothiazide |
| Brand names on this label | Hydrochlorothiazide |
| How it is given | oral |
| Boxed warning | See the label for this product |
| Recall records | 55 |
| Label last updated | 2024-06-26 |
Warnings on the Hydrochlorothiazide Label
The FDA prescribing label carries the full set of warnings and precautions for Hydrochlorothiazide. Because a medicine can have several approved labels from different manufacturers and formulations, the safest way to see the warnings that apply to the exact product you have is to read the label for that product.
You can look up any product’s current FDA label on DailyMed, the National Library of Medicine’s official label database, using the name on your bottle or box.
Warnings Beyond the Common Hydrochlorothiazide Side Effects
The label’s warnings and precautions section describes risks the FDA requires prescribers to weigh. For Hydrochlorothiazide it covers: WARNINGS 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. […]
These are the risks the FDA has judged significant enough to state formally, and they sit apart from the routine hydrochlorothiazide side effects most people ask about. They apply to different patients to very different degrees, which is why the same medicine can be routine for one person and unsuitable for another.
Hydrochlorothiazide Side Effects Listed on the FDA Label
The label’s adverse reactions section records what was observed in clinical trials: ADVERSE REACTIONS The following adverse reactions have been reported 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. […]
Trial data is the most reliable source for how common hydrochlorothiazide side effects are, because the people taking the drug were compared against people who were not. A symptom that appeared just as often in the control group is not caused by the medicine.
Reported Hydrochlorothiazide Side Effects in the FDA Database
Reported hydrochlorothiazide side effects — and what these numbers do not mean
The FDA’s adverse event database holds 206,978 reports mentioning Hydrochlorothiazide, of which 139,491 were classified as serious.
Read those numbers carefully. An adverse event report means somebody told the FDA that something happened to a person taking this medicine. It is not a finding that the medicine caused it. Reports are submitted voluntarily by patients, families, doctors and manufacturers; nobody verifies them; and the same event can be reported more than once.
Report volume tracks how many people take a drug, how new it is, and how much attention it is getting. A widely prescribed medicine will always show more reports than a rarely used one, and reports rise sharply when a drug is in the news or in litigation. A large number here does not mean a drug is dangerous, and a small number does not mean it is safe.
| Most frequently reported | Reports |
|---|---|
| Fatigue | 13,582 |
| Nausea | 13,561 |
| Diarrhoea | 11,582 |
| Dizziness | 11,108 |
| Headache | 10,607 |
| Dyspnoea | 10,377 |
| Pain | 10,192 |
| Arthralgia | 8,041 |
Source: FDA Adverse Event Reporting System (FAERS), retrieved July 2026. Non-clinical reporting categories such as “off label use” have been excluded from the list above because they describe how a drug was used, not something that happened to a patient.
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Who the Label Says Should Take Extra Care
Contraindications. The label states that Hydrochlorothiazide should not be used in certain situations: CONTRAINDICATIONS Anuria. Hypersensitivity to this product or to other sulfonamide-derived drugs.
Interactions with other medicines. Drug 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 Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. […]
Your pharmacist can check your full medicine list against this in a couple of minutes, including anything bought over the counter, and that check is free.
Hydrochlorothiazide Recall History
The FDA enforcement database records 55 recall entries involving Hydrochlorothiazide products (1 Class I, 47 Class II, 7 Class III). A recall almost always concerns specific manufactured batches rather than the medicine itself, and different manufacturers of the same generic drug have separate recall records.
The FDA classifies recalls by how serious the potential consequence is. Class I means a reasonable probability of serious harm or death; Class II means temporary or reversible harm is possible; Class III means the product breaks a regulation but is unlikely to cause harm.
| Date | Class | Recalling firm | Reason |
|---|---|---|---|
| 2026-02-11 | Class II | Unichem Pharmaceuticals USA Inc. | cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. |
| 2025-12-10 | Class III | Glenmark Pharmaceuticals Inc., USA | Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe |
| 2025-07-23 | Class II | Lupin Pharmaceuticals Inc. | Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg h |
| 2024-05-22 | Class II | MACLEODS PHARMA USA, INC | Presence of foreign substance: plastic-like substance. |
| 2024-01-03 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
If a batch you have was recalled, the pharmacy that dispensed it is the fastest way to find out and to get a replacement. Do not simply stop taking a prescribed medicine because a recall notice exists — the recall may not affect your batch, and stopping can carry its own risk.
Is Hydrochlorothiazide the Subject of Litigation?
We are not tracking consolidated federal litigation over Hydrochlorothiazide. It is a widely prescribed medicine, and the information on this page is drawn from the FDA label and public safety data rather than from any legal claim.
If You Are Worried About Hydrochlorothiazide Side Effects
Concern about hydrochlorothiazide side effects is a good reason to have a conversation, and not a reason to act alone. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first. Stopping some medicines abruptly carries risks of its own, and your prescriber can tell you whether that applies to yours.
Write down what you have noticed and when it started before the appointment. Not everything that happens while taking a medicine is one of its hydrochlorothiazide side effects, and a specific account — what changed, when, and how often — is what lets a clinician tell the difference.
You can also report a side effect directly to the FDA through MedWatch. Reports from patients are part of how safety signals are detected, and filing one takes a few minutes.
Frequently Asked Questions
What are the most commonly reported hydrochlorothiazide side effects?
In FDA reports, the most frequently mentioned are fatigue, nausea, diarrhoea. The label’s own adverse reactions section, drawn from clinical trials, is the better guide to how common a side effect actually is, because reports to the FDA are not collected in a way that supports rates.
Has Hydrochlorothiazide been recalled?
There are 55 recall records for Hydrochlorothiazide products, the most recent dated 2026-02-11. Recalls generally affect specific manufactured batches rather than the medicine as a whole. Your pharmacy can tell you whether a batch you have was affected.
Does Hydrochlorothiazide have a boxed warning?
A medicine can have several approved labels from different manufacturers, so the reliable answer for the exact product you have is on that product’s label. You can look it up on DailyMed using the name on your packaging.
Do the FDA report numbers tell me how common these hydrochlorothiazide side effects are?
No. Reports are unverified, anyone can file one, and the total mostly reflects how many people take the medicine and how much attention it is getting. A high count is not evidence of danger, and a low one is not evidence of safety. Clinical trial data on the label is the source that supports rates.
Where can I check hydrochlorothiazide side effects for the exact product I have?
DailyMed holds the current FDA label for every marketed product, searchable by the name on your packaging. Different manufacturers and formulations of the same medicine can have slightly different labels, so checking the one you actually have is worth the two minutes.
Official Sources
- DailyMed (National Library of Medicine) — the current FDA prescribing label for every product
- FDA Adverse Event Reporting System dashboard — the public report data summarised above
- FDA recalls and safety alerts — current recall notices
- FDA MedWatch — how to report a side effect yourself
Related Guides
Medical and legal disclaimer. This page summarises publicly available FDA data about Hydrochlorothiazide and is general information, not medical advice, and not legal advice. It is not a substitute for the judgement of a clinician who knows your medical history. Nothing here states that Hydrochlorothiazide caused any illness or injury in any individual. Adverse event reports are unverified and do not establish causation.
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FDA labels are revised regularly; confirm current information on DailyMed or with your pharmacist. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.