Brand name · Sodium chloride, sodium lactate, potassium chloride, and calcium chloride
Lactated Ringers: adverse event reports filed with FDA
590 reports list it as a suspect or interacting product, 2011–2026. Class: Osmotic laxative. Also reported as Lactated Ringers Solution.
- 590
- reports as suspect product
- 0% of all reports · about 38 a year
- 48
- reports, 12 months to June 2026
- 51 in the 12 months before
- 82.5%
- marked serious by the reporter
- 54.5% across the class
- 9.3%
- record death among outcomes, as reported
- 55 reports · not verified by FDA
590 adverse event reports received by FDA list the brand name Lactated Ringers (sodium chloride, sodium lactate, potassium chloride, and calcium chloride) as a suspect or interacting product, from February 2011 to June 2026. A further 1,978 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 48 reports listed it, close to the 51 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 38 reports a year and 0% of the 20,646,523 reports in the database, and 0.5% of the reports for the osmotic laxative class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are maternal exposure during pregnancy (11.5%), exposure during pregnancy (10.2%) and drug ineffective (9.3%). A report can list several reactions, so shares add to more than 100%; 167 different terms appear across these reports. Maternal exposure during pregnancy is recorded in 11.5% of these reports, a larger share than in the median osmotic laxative drug (0.1%).
82.5% of the reports are marked serious by the reporter (54.5% across the class); 9.3% record death among the outcomes and 33.2% record hospitalisation, as reported. 46.1% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (33.2%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Lactated Ringers reports recording the termmedian drug in osmotic laxative
- Maternal exposure during pregnancythe mother took the medicine during pregnancy11.5%68
- Exposure during pregnancythe medicine was taken during pregnancy10.2%60
- Drug ineffectivethe medicine did not work as expected9.3%55
- Dyspnoeashortness of breath8.5%50
- Tachycardiafast heart rate7.5%44
- Hypotensionlow blood pressure6.9%41
- Live birth5.8%34
- Premature babya baby born early5.6%33
- Off label useused for a purpose or in a way not on the label4.9%29
- Anxietyanxiety4.2%25
- Bradycardiaslow heart rate4.2%25
- Premature delivery4.2%25
- Heart rate increaseda fast heart rate reading3.7%22
- Chillschills or shivering3.6%21
- Foetal exposure during pregnancythe unborn baby was exposed to the medicine3.2%19
- Normal newborn2.9%17
- Anaphylactic reactiona severe, sudden allergic reaction2.2%13
- Cardiac arrestthe heart stopped2%12
- Hypersensitivityan allergic-type reaction1.9%11
- Maternal exposure timing unspecified1.9%11
- Rashskin rash1.7%10
- Tremorshaking1.7%10
- Condition aggravatedthe condition being treated got worse1.5%9
- Corneal oedema1.5%9
- Haemorrhagebleeding1.5%9
- Heart rate decreased1.5%9
- Hyponatraemialow blood sodium1.5%9
- No adverse eventno adverse event was reported1.5%9
- Skin reaction1.5%9
- Maternal exposure during delivery1.4%8
Top 30 of 167 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 17 drugs in the osmotic laxative class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 129,514 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 56.6% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Fluid replacement | 29 | 4.9% |
| Septic shock | 8 | 1.4% |
| Laparotomy | 7 | 1.2% |
| Hyperemesis gravidarum | 6 | 1% |
| Eye irrigation | 5 | 0.8% |
| Gastroenteritis | 5 | 0.8% |
The indication field is filled in by the reporter and is often blank; shares are of all 590 reports.
In context
| Measure | Lactated Ringers | Osmotic laxative | All reports |
|---|---|---|---|
| Reports as suspect product | 590 | 129,514 | 20,646,523 |
| Share of that pool | — | 0.5% | 0% |
| Reports, latest 12 months | 48 | — | 1,332,454 |
| Marked serious | 82.5% | 54.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 93 | 152 | 91 |
| Hospitalisation recorded, per 1,000 reports | 332 | 286 | 213 |
| Consumer-filed share | 11% | 61% | 45.8% |
| Top term, share of reports | Maternal exposure during pregnancy 11.5% | median 0.1% | 0.4% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the osmotic laxative class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| MiraLAX | brand | 38,188 | 1,721 | 7.2% |
| Extraneal | brand | 30,830 | 733 | 83.6% |
| Sodium chloride | generic | 11,044 | 1,389 | 92.5% |
| Delflex | brand | 8,765 | 676 | 53.8% |
| Potassium chloride | generic | 8,172 | 518 | 86.4% |
| DIANEAL PD-2 with Dextrose | brand | 7,178 | 161 | 88.6% |
| Polyethylene glycol 3350 | generic | 5,750 | 726 | 17.8% |
| Lactulose | generic | 4,133 | 353 | 87.1% |
| SUPREP Bowel Prep | brand | 3,664 | 35 | 9.1% |
| Sodium bicarbonate | generic | 3,342 | 308 | 92.1% |
| Dulcolax | brand | 2,893 | 137 | 63.8% |
| Sutab | brand | 1,513 | 151 | 12% |
| Bss | brand | 1,047 | 41 | 89.6% |
| DIANEAL Low Calcium with Dextrose | brand | 970 | 26 | 97.4% |
| Polyethylene glycol | generic | 760 | 58 | 85.5% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Lactated Ringers reports
How many adverse event reports has FDA received for Lactated Ringers?
590 reports list Lactated Ringers as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 48 of them arrived in the latest 12 months. Another 1,978 list it only as a concomitant medication.
What reactions are recorded in Lactated Ringers reports?
maternal exposure during pregnancy (11.5%), exposure during pregnancy (10.2%), drug ineffective (9.3%), dyspnoea (8.5%) and tachycardia (7.5%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Lactated Ringers was responsible.
How serious are the reports?
82.5% are marked serious by the reporter. Among the outcomes recorded, 9.3% of reports include death and 33.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (46.1%), physician (28%) and pharmacist (11%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Lactated Ringers rising?
48 reports in the 12 months to June 2026, close to the 51 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Lactated Ringers was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Lactated Ringers?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Lactated Ringers as a suspect or interacting product; reports listing it only as a concomitant medication (1,978) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.