Generic name
Sodium chloride: adverse event reports filed with FDA
11,044 reports list it as a suspect or interacting product, 2004–2026. Class: Osmotic laxative. Also reported as Sodium Chloride Inj, Sodium Chloride Nasal Spray, Sodium Chloride Solution.
- 11,044
- reports as suspect product
- 0.1% of all reports · about 491 a year
- 1,389
- reports, 12 months to June 2026
- 1,595 in the 12 months before
- 92.5%
- marked serious by the reporter
- 54.5% across the class
- 7.6%
- record death among outcomes, as reported
- 834 reports · not verified by FDA
Between January 2004 and June 2026, 11,044 adverse event reports received by FDA list sodium chloride, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (63,000) are left out of every figure here.
In the 12 months to June 2026, 1,389 reports listed it, down 13% from 1,595 in 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 491 reports a year and 0.1% of the 20,646,523 reports in the database, and 8.5% 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.
Reporters most often recorded myelosuppression (15.1%), drug ineffective (9.7%) and white blood cell count decreased (9.5%). A report can list several reactions, so shares add to more than 100%; 1,442 different terms appear across these reports. Myelosuppression is recorded in 15.1% of these reports, with no counterpart in the median osmotic laxative drug (0%).
92.5% of the reports are marked serious by the reporter (54.5% across the class); 7.6% record death among the outcomes and 41.9% record hospitalisation, as reported. 41.3% of the reports came from physicians, and the largest patient age group is 45 to 64 (29%). 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 Sodium chloride reports recording the termmedian drug in osmotic laxative
- Myelosuppression15.1%1,665
- Drug ineffectivethe medicine did not work as expected9.7%1,072
- White blood cell count decreasedlow white cell count9.5%1,049
- Nauseafeeling sick8.1%895
- Off label useused for a purpose or in a way not on the label7.1%780
- Pyrexiafever7%770
- Dyspnoeashortness of breath5.8%642
- Vomitingbeing sick5.7%629
- Malaisegeneral feeling of being unwell4.5%498
- Neutrophil count decreased4.3%471
- Macular degenerationa disease of the central retina4.2%466
- Painpain, site not specified4.1%449
- Headachehead pain3.6%400
- Condition aggravatedthe condition being treated got worse3.2%349
- Abdominal painstomach or belly pain3%332
- Hypotensionlow blood pressure2.7%303
- Pruritusitching2.5%281
- Erythemaskin redness2.5%276
- Astheniaweakness or lack of energy2.5%273
- Diarrhoealoose or frequent stools2.4%269
- Hypertensionhigh blood pressure2.4%266
- Infusion related reactiona reaction during or soon after an infusion2.4%266
- Agranulocytosis2.4%264
- Anaemialow red blood cells2.4%263
- Fatiguetiredness2.3%251
- Hyponatraemialow blood sodium2.3%249
- Chillschills or shivering2.2%242
- Dizzinesslight-headedness or unsteadiness2.1%234
- Product use in unapproved indicationused for a purpose not on the label2.1%230
Top 30 of 1,442 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. 19.3% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Medication dilution | 3,492 | 31.6% |
| Vehicle solution use | 255 | 2.3% |
| Parenteral nutrition | 204 | 1.8% |
| Hyponatraemia | 172 | 1.6% |
| Fluid replacement | 124 | 1.1% |
| Catheter management | 50 | 0.5% |
The indication field is filled in by the reporter and is often blank; shares are of all 11,044 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Sodium chloride reports |
|---|---|---|
| Cyclophosphamide | 3,136 | 28.4% |
| Dextrose | 1,329 | 12% |
| Potassium chloride | 1,065 | 9.6% |
| Acetaminophen | 1,008 | 9.1% |
| Prednisone | 856 | 7.8% |
| Magnesium sulfate | 730 | 6.6% |
| Pantoprazole | 656 | 5.9% |
| Epirubicin hydrochloride | 597 | 5.4% |
| Metronidazole | 591 | 5.4% |
| Ergocalciferol | 563 | 5.1% |
Other products listed in reports where Sodium chloride is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Sodium chloride | Osmotic laxative | All reports |
|---|---|---|---|
| Reports as suspect product | 11,044 | 129,514 | 20,646,523 |
| Share of that pool | — | 8.5% | 0.1% |
| Reports, latest 12 months | 1,389 | — | 1,332,454 |
| Marked serious | 92.5% | 54.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 76 | 152 | 91 |
| Hospitalisation recorded, per 1,000 reports | 419 | 286 | 213 |
| Consumer-filed share | 12.5% | 61% | 45.8% |
| Top term, share of reports | Myelosuppression 15.1% | median 0% | 0.2% |
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% |
| 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% |
| Sodium bicarbonate, sodium chloride | generic | 675 | 29 | 100% |
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 Sodium chloride reports
How many adverse event reports has FDA received for Sodium chloride?
11,044 reports list Sodium chloride as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 1,389 of them arrived in the latest 12 months. Another 63,000 list it only as a concomitant medication.
What reactions are recorded in Sodium chloride reports?
myelosuppression (15.1%), drug ineffective (9.7%), white blood cell count decreased (9.5%), nausea (8.1%) and off label use (7.1%). 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 Sodium chloride was responsible.
How serious are the reports?
92.5% are marked serious by the reporter. Among the outcomes recorded, 7.6% of reports include death and 41.9% 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?
physician (41.3%), other health professional (35.1%) and consumer or non-health professional (12.5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Sodium chloride rising?
1,389 reports in the 12 months to June 2026, down 13% from 1,595 in 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 Sodium chloride 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 Sodium chloride?
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 Sodium chloride as a suspect or interacting product; reports listing it only as a concomitant medication (63,000) 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.