Pharmacologic class (EPC) · 17 drug pages

Osmotic laxative: adverse event reports filed with FDA

129,514 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

129,514
reports across the class: 0.6% of all reports; 7,110
reports, 12 months to June 2026: 7,301 in the 12 months before; 54.5%
marked serious by the reporter: 57.4% across all reports; 17
drugs with a page: brand and generic names counted separately

Osmotic laxative is a pharmacologic class (an FDA Established Pharmacologic Class) with 17 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 129,514 adverse event reports received by FDA, 0.6% of the database, from January 2004 to June 2026.

7,110 reports arrived in the 12 months to June 2026, close to the 7,301 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 54.5% of the class's reports are marked serious, 15.2% record death among the outcomes and 28.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (9.7%), product use issue (7.5%) and off label use (7.1%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
MiraLAXPolyethylene glycol 3350	brand	38,188	1,721	7.2%	Product use issue
ExtranealIcodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride	brand	30,830	733	83.6%	Death
Sodium chloride	generic	11,044	1,389	92.5%	Myelosuppression
DelflexDextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride	brand	8,765	676	53.8%	Peritonitis
Potassium chloride	generic	8,172	518	86.4%	Drug ineffective
DIANEAL PD-2 with DextroseSodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	brand	7,178	161	88.6%	Death
Polyethylene glycol 3350	generic	5,750	726	17.8%	Drug ineffective
Lactulose	generic	4,133	353	87.1%	Constipation
SUPREP Bowel PrepSodium sulfate, potassium sulfate, magnesium sulfate	brand	3,664	35	9.1%	Vomiting
Sodium bicarbonate	generic	3,342	308	92.1%	Drug ineffective
DulcolaxMagnesium hydroxide	brand	2,893	137	63.8%	Constipation
SutabSodium sulfate, magnesium sulfate, and potassium chloride	brand	1,513	151	12%	Vomiting
BssBalanced salt solution	brand	1,047	41	89.6%	Toxic anterior segment syndrome
DIANEAL Low Calcium with DextroseSodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	brand	970	26	97.4%	Death
Polyethylene glycol	generic	760	58	85.5%	Drug ineffective
Sodium bicarbonate, sodium chloride	generic	675	29	100%	Drug ineffective
Lactated RingersSodium chloride, sodium lactate, potassium chloride, and calcium chloride	brand	590	48	82.5%	Maternal exposure during pregnancy

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected9.7%12,528
Product use issuea problem in how the product was used7.5%9,755
Off label useused for a purpose or in a way not on the label7.1%9,203
Deaththe patient died; cause not stated by this term6.7%8,716
Nauseafeeling sick4.8%6,184
Vomitingbeing sick4.7%6,080
Diarrhoealoose or frequent stools4.6%5,993
Constipationconstipation3.6%4,599
Abdominal painstomach or belly pain3.3%4,230
Product use in unapproved indicationused for a purpose not on the label3.2%4,116
Peritonitis3.1%4,039
Abdominal distensiona bloated abdomen2.9%3,812
Dyspnoeashortness of breath2.9%3,745
Hypotensionlow blood pressure2.8%3,625
Painpain, site not specified2.6%3,376
Malaisegeneral feeling of being unwell2.5%3,235
Incorrect drug administration duration2.2%2,807
Peritonitis bacterial2%2,632
Incorrect dose administeredthe wrong dose was given2%2,631
Falla fall2%2,528
Headachehead pain1.9%2,478
Pyrexiafever1.9%2,411
Incorrect product administration duration1.8%2,340
Astheniaweakness or lack of energy1.7%2,206
Sepsisa severe body-wide response to infection1.6%2,128

Solid bar: share of all class reports. Hollow bar: the median share across the 17 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death15.2%19,646

Life-threatening3.1%3,981

Hospitalisation (initial or prolonged)28.6%37,028

Disability1.5%1,988

Congenital anomaly0.4%566

Other serious27.1%35,060

Not serious45.5%58,868

Patient age

Under 20.6%824

2 to 112.3%2,960

12 to 170.8%1,083

18 to 446.5%8,360

45 to 6416.1%20,819

65 to 7412.2%15,787

75 and over15.2%19,634

Age not given46.4%60,047

Who reported

Physician8.7%11,311

Pharmacist2.2%2,871

Other health professional25.8%33,425

Lawyer0.1%132

Consumer or non-health professional61%78,975

Not given2.2%2,800

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Osmotic laxative reports

Which drugs are in the Osmotic laxative class on this site?

MiraLAX, Extraneal, Sodium chloride, Delflex, Potassium chloride and DIANEAL PD-2 with Dextrose and 11 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

129,514 reports through June 2026, 7,110 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (9.7%), product use issue (7.5%), off label use (7.1%), death (6.7%) and nausea (4.8%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.