Diuretic Adverse Events in FAERS: 763,000 Reports Across Three Sub-Classes

Diuretics are among the oldest and most broadly prescribed drug classes in cardiovascular and renal medicine. From the loop diuretics that anchor acute decompensated heart failure management to the thiazides that remain first-line therapy for essential hypertension and the potassium-sparing agents that modulate aldosterone-driven remodeling, these drugs touch virtually every high-acuity patient population that a health system manages. Because the treated population skews older, multimorbid, and cardiorenal-comorbid, the adverse-event reporting profile captured in the FDA Adverse Event Reporting System (FAERS) is large, serious, and structurally distinct from newer therapeutic classes. Across the public openFDA FAERS extract (aggregating over 20.3 million reports, export dated June 8, 2026), diuretics accumulate a cumulative total of 763,189 reports — one of the largest class footprints in the cardiovascular pharmacovigilance landscape. This analysis provides clinical safety directors, pharmacy and therapeutics (P&T) committees, and medical-affairs teams with a detailed, data-driven baseline across all major diuretic sub-classes: loop, thiazide and thiazide-like, potassium-sparing (mineralocorticoid receptor antagonists and epithelial sodium channel blockers), carbonic anhydrase inhibitors, aquaretics, and osmotic diuretics.

Quick answer

What is the scenario question? If I want the population-level adverse-event footprint of diuretics (not a mechanism recap), what does FAERS show, and how do furosemide, HCTZ, and spironolactone compare across the loop, thiazide, and potassium-sparing sub-classes?

Direct Answer: Across the public openFDA FAERS extract (20,328,575 total reports, export dated June 8, 2026), diuretics (any-role named, 1986–2026) account for 763,189 reports — 76.6% serious (584,310) and 11.8% fatal (90,436) — peaking in 2019 (55,271 reports). This seriousness and death share is higher than most cardiovascular classes, reflecting an older, cardiorenal-comorbid population rather than intrinsic lethality. Furosemide (353,027 reports) dominates, contributing roughly 46% of the class, followed by hydrochlorothiazide (187,362) and spironolactone (95,546). Acute kidney injury (28,188) and hypotension (23,062) are the cleanest hemodynamic and renal signals. Hypertension (133,902) and atrial fibrillation (38,093) are the leading indications, and the reporter mix is clinician-heavy (physician 208,111; other HCP 160,824), consistent with a hospital-and-clinic-monitored class.

---

Who this is for

• Pharmacovigilance and Safety Teams: Establishing a quantitative class-wide baseline for diuretics across all sub-classes to distinguish true emerging signals from chronic background noise in a high-volume, high-seriousness reporting environment.
• P&T Committee Members and Formulary Managers: Reviewing real-world safety data to structure evidence-based monitoring requirements for loop-diuretic dosing in heart failure, thiazide-based hypertension management, and MRA-related hyperkalemia surveillance.
• Medical Affairs and Medical Information Specialists: Preparing AMCP dossiers, clinical safety briefs, and field medical responses that contextualize diuretic safety signals against the cardiorenal comorbidity burden of the treated population.
• Specialty Pharmacists and Clinical Directors: Building renal-function and electrolyte monitoring workflows for high-risk diuretic combinations, including loop-thiazide sequential nephron blockade and MRA-ACE inhibitor/ARB stacking.

---

Methodology, in one paragraph

The statistics presented in this analysis are computed directly from the public openFDA FAERS extract (export dated June 8, 2026), representing 20,328,575 total reports. Diuretics are identified when the drug substance name matches generic identifiers for agents across six pharmacologic sub-classes: loop diuretics (furosemide, torsemide, bumetanide, ethacrynic acid), thiazide and thiazide-like diuretics (hydrochlorothiazide, chlorthalidone, indapamide, metolazone), potassium-sparing diuretics (spironolactone, eplerenone, amiloride, triamterene), carbonic anhydrase inhibitors (acetazolamide, methazolamide), aquaretics (tolvaptan), and osmotic diuretics (mannitol). Report counts follow the any-role-named convention: a report is included if the substance appears in any role — primary suspect, secondary suspect, concomitant, or interacting — and are normalized by unique safety report IDs. Seriousness categories are derived from the FDA's standardized flags. Adverse events are mapped to MedDRA Preferred Terms (PTs). Because FAERS is a spontaneous-reporting system, these figures represent raw reporting frequencies rather than incidence rates; they lack an exposure denominator (total patient-years), are subject to reporting biases (stimulated reporting, notoriety bias, Weber effect), and do not establish direct clinical causality. Substance-level analysis is used throughout; route-level separation (oral vs. IV furosemide, for example) is not reliably available in the FAERS extract. For broader database methodology, see our companion inside 20 million FAERS reports; for cardiovascular comparisons, see our analyses of calcium channel blocker adverse events by the numbers, beta-blocker adverse events by the numbers, and ACE inhibitor and ARB adverse events by the numbers.

---

How big is the diuretic adverse-event footprint in FAERS, and why is it so serious?

Over the full span of the FAERS database (1986 through mid-2026), diuretics in any reporting role have accumulated 763,189 reports. Of these, 584,310 reports (76.6%) carry the FDA's serious flag (resulting in death, hospitalization, a life-threatening event, disability, or requiring significant medical intervention), and 90,436 reports (11.8%) carry a fatal outcome flag. Both the seriousness share and the death share exceed the corresponding figures for most other cardiovascular drug classes — calcium channel blockers (75.0% serious, 11.0% fatal), beta-blockers, and RAAS inhibitors — positioning diuretics at the upper end of the cardiovascular pharmacovigilance severity spectrum.

The annual trend over the last decade shows a peak in 2019 at 55,271 reports, followed by a gradual moderation that tracks the broader FAERS database-wide trend rather than any diuretic-specific safety event:

Annual Named Reports (2015–2025):
2015: 40,116
2016: 44,217
2017: 47,633
2018: 52,889
2019: 55,271 (Peak)
2020: 51,504
2021: 47,152
2022: 45,830
2023: 43,689
2024: 41,202
2025: 41,877

The critical interpretive point for pharmacovigilance teams is that the elevated seriousness and death figures are a population-level signal, not a drug-level signal. Diuretics are administered predominantly to older adults with severe cardiovascular disease, chronic kidney disease, decompensated heart failure, hepatic cirrhosis with ascites, and nephrotic syndrome. These patients carry an intrinsically high baseline risk of hospitalization and death from cardiovascular events (stroke, acute coronary syndrome, sudden cardiac death), renal failure progression, and sepsis — events that populate the FAERS database because the patient was taking a diuretic at the time, not because the diuretic caused the event.

Several structural features of the database reinforce this framing:

• Heart failure dominance: The loop diuretics (furosemide, bumetanide, torsemide) that generate the majority of reports are prescribed almost exclusively to patients with NYHA Class II–IV heart failure, a population with annual mortality rates of 5–75% depending on class and ejection fraction. Every background death in this population is a candidate for a FAERS report naming the diuretic.
• Hospital-based reporting: The reporter mix (see below) is heavily weighted toward physicians and healthcare professionals, indicating that reports are generated during inpatient encounters — emergency departments, ICUs, heart failure units — where death and hospitalization are common outcomes regardless of drug exposure.
• Combination therapy confounding: Diuretics are rarely used as monotherapy in heart failure or advanced renal disease. They are co-prescribed with ACE inhibitors, ARBs, beta-blockers, MRAs, SGLT2 inhibitors, and vasopressors — any of which may be the true driver of a reported event.

The 76.6% seriousness figure and 11.8% death share should therefore be communicated to P&T committees and safety boards as a marker of the treated population's baseline acuity, not as evidence that diuretics are intrinsically more dangerous than other cardiovascular agents.

---

Which diuretics drive the most reports across loop, thiazide, and potassium-sparing sub-classes?

The distribution of reports among individual diuretic substances is heavily skewed toward furosemide, reflecting its status as the most prescribed loop diuretic globally and its near-universal use in acute and chronic heart failure management. The following table presents the top 12 diuretic substances by cumulative report count:

(Note: Reports use the any-role-named convention. A single report can name multiple diuretics — for example, furosemide + metolazone in a sequential nephron blockade regimen — so substance-level counts must not be summed to derive the class total.)

Sub-class composition

The following table discloses the full sub-class assignment used in this analysis. This disclosure is important because some agents — tolvaptan, acetazolamide, mannitol — are pharmacologically distinct from the classical loop/thiazide/K-sparing framework and are included only because they share the "diuretic" regulatory label:

Interpreting the top three substances

Furosemide (353,027 reports, ~46% of class): Furosemide's dominance is a prescribing-volume artifact, not a safety signal. As the most prescribed loop diuretic in the US and globally — used in acute decompensated heart failure, chronic heart failure, nephrotic syndrome, hepatic cirrhosis, acute pulmonary edema, and hypertensive emergencies — furosemide has the largest exposure denominator in the class. This aligns with a 2025 loop-diuretic FAERS analysis published in BMC Pharmacology & Toxicology (Springer, s40360-025-00890-7), which identified furosemide as the primary suspect in 22,187 of 24,880 primary-suspect loop-diuretic reports (89.18%), reflecting "overwhelming clinical use rather than a disproportionate safety signal."

Hydrochlorothiazide (187,362 reports): HCTZ is the second-largest substance and the dominant thiazide in the database, consistent with its status as the most prescribed thiazide-type diuretic in the US (present in dozens of combination antihypertensive products, including losartan-HCTZ, lisinopril-HCTZ, valsartan-HCTZ, amlodipine-HCTZ, and olmesartan-HCTZ). Because HCTZ is frequently co-formulated, a significant proportion of reports naming HCTZ are actually driven by the co-administered RAAS inhibitor (the primary suspect), with HCTZ appearing as a concomitant. Safety teams must disclose this combination-product conflation when interpreting HCTZ signal counts.

Spironolactone (95,546 reports): Spironolactone's large footprint reflects both its long clinical history (approved 1960) and its expanding indications: heart failure (RALES trial), resistant hypertension, primary aldosteronism, hepatic ascites, and off-label use in acne and hirsutism. Its safety profile in FAERS is characterized by hormonal and electrolyte signals (gynecomastia, hyperkalemia, hyponatremia) that distinguish it from loop and thiazide agents.

---

What do the renal, hemodynamic, and electrolyte signals look like?

Analyzing the overall reaction terms for reports naming a diuretic highlights a mixture of clinical side effects, markers of disease progression, and hemodynamic/renal signals that align with the pharmacologic mechanisms of volume depletion and electrolyte disturbance:

Within these class-wide aggregates, pharmacovigilance teams must apply pathophysiological reasoning to identify the signals that are mechanistically attributable to diuretic pharmacology versus those that represent background disease progression in a cardiorenal-comorbid population.

1. Renal signals: Acute kidney injury (28,188 reports)

Acute kidney injury (AKI) is the cleanest mechanistic renal signal in the diuretic class. AKI from diuretics occurs through two primary pathways:

• Pre-renal azotemia from volume depletion: Loop diuretics and thiazides reduce intravascular volume by blocking sodium reabsorption. In patients with marginal renal perfusion (heart failure with low cardiac output, hepatorenal syndrome, sepsis), this volume contraction reduces renal blood flow below the autoregulatory threshold, causing pre-renal AKI. This is the dominant mechanism driving the 28,188 AKI reports.
• Interstitial nephritis: Rarely, thiazide and loop diuretics can cause allergic interstitial nephritis, an immunologically-mediated tubular injury that presents as AKI with eosinophilia, rash, and pyuria. This mechanism accounts for a small minority of AKI reports but is clinically important because it requires drug discontinuation.

A 2022 study published in Frontiers in Pharmacology (PMID: 35935854, article 924173) specifically analyzed diuretic-associated AKI signals in FAERS, confirming that loop diuretics — particularly furosemide — generate the strongest disproportionality signal for AKI among all diuretic sub-classes, consistent with their potent natriuretic effect and use in volume-depleted patients.

2. Hemodynamic signals: Hypotension (23,062 reports) and dizziness (31,311 reports)

Hypotension is the second major mechanistic signal. Diuretics reduce blood pressure through two mechanisms: acute intravascular volume reduction (loop diuretics, thiazides) and chronic reduction in peripheral vascular resistance (thiazides, through a mechanism that is incompletely understood but involves reduced vascular smooth muscle calcium responsiveness). Hypotension reports are concentrated in two clinical scenarios:

• Acute over-diuresis: Aggressive IV furosemide dosing in acute heart failure can precipitate severe hypotension, particularly when combined with vasodilators (nitroglycerin, nitroprusside) or RAAS inhibitors.
• Orthostatic hypotension in older adults: Chronic thiazide or loop diuretic use in older patients causes intravascular volume contraction that impairs baroreceptor-mediated compensation for postural changes, leading to orthostatic hypotension, dizziness, syncope, and falls. The 31,311 dizziness reports and the 23,062 hypotension reports share significant overlap with fall-related adverse events.

3. Electrolyte signals

While specific electrolyte MedDRA PTs (hyponatremia, hypokalemia, hyperkalemia, hypomagnesemia) do not appear in the class-wide top 9 reactions, they are critically important sub-class-specific signals:

• Loop diuretics: Hypokalemia, hyponatremia, hypomagnesemia, and metabolic alkalosis from massive urinary electrolyte losses.
• Thiazides: Hyponatremia (particularly dangerous in elderly women, where thiazide-induced hyponatremia can cause seizures, obtundation, and death), hypokalemia, and hyperuricemia (precipitating gout attacks).
• K-sparing (MRA/ENaC): Hyperkalemia — the signature safety concern for spironolactone and eplerenone — particularly when co-prescribed with ACE inhibitors, ARBs, or potassium supplements in patients with chronic kidney disease.

A published FAERS analysis of spironolactone (PMC12443299) confirmed the electrolyte and hormonal signal profile, reporting hyponatremia at 2.4% and dehydration at 3.4% of spironolactone reports, alongside the well-known hormonal signal of gynecomastia.

4. Background disease signals

Several of the top reactions — dyspnoea (45,034), fatigue (37,837), drug ineffective (33,792), and death (27,466) — are not mechanistic diuretic adverse effects but rather markers of the underlying disease burden:

• Dyspnoea reflects heart failure progression (pulmonary congestion) and pulmonary arterial hypertension (PAH), both of which are leading indications for diuretics.
• Drug ineffective reflects diuretic resistance in advanced heart failure, where cardiorenal syndrome impairs the kidney's ability to respond to loop diuretics, often prompting dose escalation, IV conversion, or sequential nephron blockade with metolazone.
• Death reflects background mortality in a population with severe heart failure, advanced CKD, and hepatic cirrhosis.

These signals must not be attributed to diuretic pharmacology; they are confounders arising from indication bias (channeling of sicker patients toward diuretics).

---

How do the top indications and reporters frame the diuretic safety profile?

Indications

The top indications reported in the diuretic class illustrate the cardiorenal-comorbid population that drives the safety profile:

Several features of this indication profile deserve analysis:

• Hypertension (133,902): The dominant indication, reflecting the massive prescribing of hydrochlorothiazide and chlorthalidone as first-line antihypertensive therapy. This aligns with JNC/ACC guidelines that recommend thiazide-type diuretics as initial therapy for essential hypertension.
• Atrial fibrillation (38,093): A co-morbidity rather than a primary indication for diuretics. Patients with AF frequently have hypertensive heart disease and heart failure with preserved ejection fraction (HFpEF), both of which require diuretic therapy for volume management.
• Diabetes mellitus (37,312): Another co-morbidity. Diabetic patients are disproportionately represented in the hypertension and heart failure populations, and thiazides are known to modestly impair glucose tolerance (a labeled adverse effect).
• Pulmonary arterial hypertension (32,377): Loop diuretics are used for volume management in right heart failure secondary to PAH. This indication signal is enriched by tolvaptan (aquaretic) reports, which are generated in clinical trials and post-approval use for ADPKD and SIADH — conditions that overlap with pulmonary hypertension registries.
• Cardiac failure (22,116): The clinical core of loop-diuretic use. Despite being the fifth-ranked indication by report count, heart failure is the indication most tightly coupled to the hemodynamic and renal signals (AKI, hypotension, electrolyte disturbance) that define the diuretic safety profile.

Reporter mix

The reporter profile for diuretics is heavily clinical, reflecting hospital-based and clinic-based surveillance:

The combined physician + other-HCP share (48.4%) exceeds consumer reporting (34.7%), a pattern that distinguishes diuretics from consumer-driven classes (such as GLP-1 receptor agonists, where consumer reporting dominates). The low lawyer share (1.2%) confirms that the diuretic FAERS footprint is not inflated by litigation-driven reporting waves, which have historically distorted signal profiles in classes like fluoroquinolones and opioids.

Outcomes

The outcome distribution provides further context for the seriousness profile:

The largest single category is "recovered" (194,858), indicating that the majority of reported events are self-limited or resolve with dose adjustment, drug discontinuation, or electrolyte repletion. The "not recovered" category (144,199) reflects the chronic, non-resolving nature of many background conditions (progressive heart failure, CKD progression) rather than irreversible drug toxicity. The 63,006 fatal outcomes in the outcome field are a narrower count than the 90,436 reports flagged with a seriousness death criterion cited earlier — the two FAERS fields do not always coincide, because a report can carry a seriousness death flag without a recorded "Fatal" outcome (or vice versa). Under either measure, the elevated fatal count aligns with the high baseline mortality of the treated population — predominantly patients with advanced heart failure, decompensated cirrhosis, and end-stage renal disease.

---

How does this compare to the published loop-diuretic and spironolactone FAERS literature?

Cross-validation against published FAERS analyses confirms the patterns observed in this class-wide analysis and provides additional granularity:

Loop-diuretic FAERS analysis (Springer, BMC Pharmacology & Toxicology, 2025)

A 2025 study published in BMC Pharmacology & Toxicology (Springer, s40360-025-00890-7) analyzed loop-diuretic adverse events in the FAERS database using a primary-suspect-only convention. Key findings:

The difference in absolute numbers (86,635 primary-suspect vs. our 353,027 any-role furosemide reports) reflects the convention difference: primary-suspect counts capture only reports where the loop diuretic is flagged as the suspected cause, while any-role-named counts capture all reports where the diuretic appears in any capacity. The 46.72% hospitalization rate in the primary-suspect cut is notably higher than the class-wide hospitalization share, confirming that reports where the diuretic is suspected as causal are enriched for acute clinical events.

Spironolactone FAERS analysis (PMC12443299)

A published analysis of spironolactone-specific FAERS data (PMC12443299) reported the following signal profile:

• Hyponatremia: 2.4% of spironolactone reports
• Dehydration: 3.4% of spironolactone reports
• Gynecomastia: A well-documented hormonal adverse effect unique to the MRA sub-class, resulting from spironolactone's non-selective binding to androgen and progesterone receptors

These findings are consistent with the FDA-approved Aldactazide label (2025 revision), which lists gynecomastia, hyperkalemia, hyponatremia, and dehydration as established adverse effects. Eplerenone (11,938 reports), the selective MRA, was developed specifically to reduce the gynecomastia signal by improving mineralocorticoid receptor selectivity.

AKI diuretic signal (Frontiers in Pharmacology, 2022)

A 2022 FAERS-based disproportionality analysis published in Frontiers in Pharmacology (article 924173) confirmed that loop diuretics generate a statistically significant disproportionality signal for acute kidney injury, with furosemide producing the strongest signal among all diuretic agents analyzed. The study reinforced that the AKI mechanism is predominantly pre-renal (volume-depletion mediated) and is exacerbated by co-administration of RAAS inhibitors and NSAIDs — a "triple whammy" combination that is well-established in nephrology guidelines as a high-risk prescribing pattern.

---

What FAERS limitations and sub-class caveats apply?

Standard FAERS limitations

All figures in this analysis are subject to the fundamental limitations of spontaneous adverse-event reporting:

1. No causality: A FAERS report documents a temporal association between a drug exposure and an adverse event. It does not prove that the drug caused the event. The majority of diuretic-named reports likely reflect background clinical events in a high-risk population.
2. No denominator: FAERS lacks a prescribing denominator (total patient-years of exposure). Because furosemide has an enormously larger prescribing base than bumetanide or torsemide, raw report counts cannot be used to compare safety across substances. Disproportionality analyses (such as Reporting Odds Ratios) partially address this, but they too are subject to confounding.
3. Reporting biases: Serious events (death, hospitalization) are over-reported relative to minor events (mild dizziness, transient nausea). Newly marketed drugs experience stimulated reporting due to the Weber effect. Well-known adverse effects (hypokalemia with thiazides) may be under-reported because clinicians consider them expected.
4. Duplicate and incomplete reports: Despite FDA deduplication efforts, some reports may be duplicated, and many reports contain incomplete data (missing indication, missing dose, missing outcome).
5. No route-level separation: The FAERS substance field does not reliably distinguish oral furosemide (outpatient heart failure maintenance) from IV furosemide (acute decompensated heart failure in the ICU). These two clinical contexts have vastly different risk profiles.

Sub-class-specific caveats

Beyond the standard FAERS caveats, several diuretic-specific limitations must be disclosed:

• Multi-sub-class inclusion: This analysis includes agents — tolvaptan (a vasopressin V2 receptor antagonist), acetazolamide (a carbonic anhydrase inhibitor), and mannitol (an osmotic diuretic) — that are pharmacologically distinct from classical loop/thiazide/K-sparing diuretics. They share the "diuretic" label in regulatory databases and clinical nomenclature, but their mechanisms, indications, and safety profiles are fundamentally different. Tolvaptan is primarily used for SIADH and ADPKD; acetazolamide for glaucoma, altitude sickness, and idiopathic intracranial hypertension; mannitol for cerebral edema and acute glaucoma. Their inclusion inflates the class total and introduces non-cardiovascular signals.
• Combination-product conflation: Hydrochlorothiazide is extensively co-formulated with ACE inhibitors, ARBs, and calcium channel blockers (losartan-HCTZ, valsartan-HCTZ, amlodipine-HCTZ, etc.). Reports naming these combination products increment the HCTZ count even when the adverse event is clearly driven by the co-administered agent (e.g., angioedema from the ACE inhibitor component). Safety teams must disclose this combination-product conflation when interpreting HCTZ signal counts.
• Spironolactone indication breadth: Spironolactone's reports span cardiology (heart failure, hypertension), hepatology (ascites), nephrology (proteinuric CKD), endocrinology (primary aldosteronism), and dermatology (acne, hirsutism). The safety profile of a 25 mg daily dose for heart failure in an elderly male is fundamentally different from a 100 mg daily dose for acne in a young female. Aggregate spironolactone counts blur these population-specific risk profiles.
• Metolazone co-prescribing: Metolazone (7,398 reports) is almost exclusively used in combination with a loop diuretic for sequential nephron blockade in diuretic-resistant heart failure. Its reports are therefore nearly always co-named with furosemide or bumetanide, and the adverse events (profound diuresis, AKI, electrolyte derangement) reflect the synergistic pharmacology of the combination rather than metolazone alone.

---

FAQs

How many FAERS reports name diuretics?

The diuretic class accumulates 763,189 any-role-named reports in the public openFDA FAERS extract (export June 8, 2026). Of these, 76.6% are classified as serious and 11.8% carry a fatal outcome flag. This makes diuretics one of the largest and most serious class footprints in the cardiovascular pharmacovigilance landscape.

Which diuretic has the largest FAERS footprint?

Furosemide leads with 353,027 reports, accounting for approximately 46% of the class total. This dominance reflects furosemide's status as the most widely prescribed loop diuretic globally — it is the first-line agent for volume management in heart failure, nephrotic syndrome, and hepatic cirrhosis — and mirrors the "denominator effect" observed with amlodipine in the calcium channel blocker class and metoprolol in the beta-blocker class.

Why is the death share high for diuretics?

The 11.8% fatal outcome share (90,436 reports) reflects the baseline mortality risk of the treated population, not intrinsic drug lethality. Diuretics are prescribed to patients with advanced heart failure (NYHA III–IV), decompensated cirrhosis, end-stage renal disease, and severe cardiovascular comorbidities (atrial fibrillation, coronary artery disease, stroke). These patients have high annual mortality rates independent of diuretic therapy. In the spontaneous reporting system, deaths occurring during drug exposure are reportable regardless of whether the drug contributed to the outcome. The elevated death share is a population acuity marker, not a comparative safety signal.

Does the diuretic FAERS cut include tolvaptan, acetazolamide, and mannitol?

Yes. The analysis includes agents from six pharmacologic sub-classes: loop, thiazide/thiazide-like, potassium-sparing (MRA and ENaC), carbonic anhydrase inhibitor, aquaretic, and osmotic. Tolvaptan (12,993 reports), acetazolamide (5,782 reports), and mannitol are included because they carry the "diuretic" classification in regulatory databases. However, their mechanisms, indications, and safety profiles are pharmacologically distinct from classical loop/thiazide/K-sparing diuretics, and this is disclosed throughout the analysis. Route-level and sub-class-level separation beyond substance identification is not reliably possible in the FAERS extract.

---

Sources

• US FDA. openFDA FAERS (Adverse Event Reporting System) extract, export dated June 8, 2026. Per-drug, class-union, and reaction aggregates computed by PharmaDossier from the public FAERS extract. openFDA Data
• Wang Y, et al. "Adverse events associated with loop diuretics: a pharmacovigilance study using the FAERS database." BMC Pharmacology & Toxicology. 2025;26:890. Springer
• Spironolactone FAERS pharmacovigilance analysis. PubMed Central. 2025. PMC12443299
• US FDA. Aldactazide (spironolactone and hydrochlorothiazide) prescribing information, revised 2025. Drugs@FDA
• Chen Y, et al. "Diuretic-associated acute kidney injury: a FAERS-based disproportionality analysis." Frontiers in Pharmacology. 2022;13:924173. Frontiers
• CV Pharmacology. Diuretics: mechanism of action, pharmacology, and clinical pharmacology reference. CVPharmacology