Loop Diuretic · Brand: Lasix Onyu, Lasix + 1 more
Furosemide Side Effects: Common, Serious & FDA Warnings
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Quick answer
Based on 393,000+ FDA adverse event reports, the most-reported furosemide reactions include dyspnoea, fatigue, and diarrhoea. FDA reports 2 active Class II recalls of furosemide, primarily for failed dissolution specifications. The FDA-approved label does not carry a boxed warning.
For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.
Common Side Effects of Furosemide
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for furosemide. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Dyspnoea | 29,501 | 7.5% |
| Fatigue | 20,725 | 5.3% |
| Diarrhoea | 20,256 | 5.2% |
| Acute Kidney Injury | 18,758 | 4.8% |
| Nausea | 18,971 | 4.8% |
| Pneumonia | 16,249 | 4.1% |
| Asthenia | 15,338 | 3.9% |
| Dizziness | 14,963 | 3.8% |
| Hypotension | 14,929 | 3.8% |
| Pain | 13,712 | 3.5% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
| Death reported as outcome FAERS outcome flag, not a reaction term. The patient was on the drug when the report was filed; causation is not established. | 18,541 | 4.7% |
Furosemide Recalls
FDA enforcement actions matched to furosemide via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2026-04-29 | CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. Leading Pharma, LLC | Class II | 9384 bottles | Ongoing |
| 2026-01-28 | Presence of Foreign Substance Graviti Pharmaceuticals Private Limited | Class II | 4212 bottles | Ongoing |
Show 5 closed recalls (2013 to 2017)
Includes resolved and terminated recalls matched to furosemide. Most recent first.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2017-02-01 | Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint. Roxane Laboratories, Inc. | Class II | 6493 bottles | Terminated |
| 2015-10-21 | CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP. Boehringer Ingelheim Roxane Inc | Class III | 11,110 bottles | Terminated |
| 2015-10-21 | CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP. Boehringer Ingelheim Roxane Inc | Class III | 5,160 bottles | Terminated |
| 2013-05-15 | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Hospira Inc. | Class II | 259,050 vials | Terminated |
| 2013-03-06 | Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial Hospira, Inc. | Class II | 63,900 vials | Terminated |
Furosemide Shortages
FDA-listed shortages of furosemide products. Strength and dosage-form level detail.
| Strength | Reason | Resolved | Status |
|---|---|---|---|
| Furosemide, Injection, 10 mg/1 mL (NDC 36000-283-25) | — | — | Resolved |
| Furosemide, Injection, 20 mg/2 mL (NDC 55150-322-25) | Demand increase for the drug | — | Resolved |
| Furosemide, Injection, 10 mg/1 mL (NDC 25021-311-02) | Discontinuation of the manufacture of the drug | — | Resolved |
| Furosemide, Injection, 10 mg/1 mL; 4mL vial (NDC 83634-302-04) | — | — | Resolved |
| Furosemide, Injection, 10 mg/1 mL (NDC 63323-280-02) | — | — | Resolved |
| Furosemide, Injection, 100 mg/10 mL (NDC 55150-324-25) | — | — | Resolved |
| Furosemide, Oral Solution, 40 mg/5 mL (NDC 0054-3298-63) | Shortage of an inactive ingredient component | — | Resolved |
| Furosemide, Injection, 10 mg/1 mL (NDC 71288-203-05) | — | — | Resolved |
| Furosemide, Injection, 10 mg/1 mL (NDC 83634-302-10) | — | — | Resolved |
| Furosemide, Injection, 10 mg/1 mL (NDC 25021-311-10) | — | — | Discontinued |
| Furosemide, Injection, 10 mg/1 mL (NDC 63323-280-04) | — | — | Resolved |
| Furosemide, Injection, 40 mg/4 mL (NDC 55150-323-25) | Demand increase for the drug | — | Resolved |
| Furosemide, Injection, 10 mg/1 mL (NDC 25021-311-02) | — | — | Discontinued |
| Furosemide, Injection, 10 mg/1 mL (NDC 63323-280-10) | — | — | Resolved |
| Furosemide, Injection, 10 mg/1 mL (NDC 71288-203-11) | — | — | Resolved |
| Furosemide, Injection, 10 mg/1 mL (NDC 36000-282-25) | — | — | Resolved |
| Furosemide, Injection, 10 mg/1 mL (NDC 25021-311-10) | Discontinuation of the manufacture of the drug | — | Resolved |
| Furosemide, Injection, 10 mg/1 mL (NDC 25021-311-04) | — | — | Discontinued |
| Furosemide, Injection, 10 mg/1 mL (NDC 36000-284-25) | — | — | Resolved |
| Furosemide, Injection, 10 mg/1 mL; 2mL vial (NDC 83634-302-02) | — | — | Resolved |
Is Furosemide Safe?
Furosemide is FDA-approved and the label does not carry a boxed warning.
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Furosemide is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
INDICATIONS AND USAGE Edema Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide tablets are particularly useful when an agent with greater diuretic potential is desired. Hypertension Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents.Show full Indications and Usage
Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone. Edema Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide tablets are particularly useful when an agent with greater diuretic potential is desired. Hypertension Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.
Frequently Asked Questions
What are the most-reported side effects of furosemide?
Dyspnoea, fatigue, and diarrhoea are among the most-reported reactions in FDA FAERS data for furosemide. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.
Is furosemide the same as Lasix Onyu?
Furosemide is the generic name; Lasix Onyu is a brand name for the same active ingredient. Other brand names include Lasix and Furoscix. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.
Has furosemide been recalled?
Yes. Furosemide has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by CGMP deviations and contamination or foreign material. See the recalls table on this page for current counts, firm names, dates, and lot quantities.
What are furosemide's current ongoing recalls about?
Active furosemide recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reasons across these recalls are CGMP deviations and contamination or foreign material. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.
What do FDA recall classes mean?
Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.
Is there a current shortage of furosemide?
No active shortages of furosemide are listed by the FDA. Historical shortage records appear in the shortages table on this page.
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.