Drug Safety Information for MIRALAX (Polyethylene glycol 3350)

Safety-related Labeling Changes for COLYTE (POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, A) Rx Drug: FDA Link

Safety-related Labeling Changes for COLYTE WITH FLAVOR PACKS (POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, A) Rx Drug: FDA Link

Safety-related Labeling Changes for COLYTE-FLAVORED (POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, A) Rx Drug: FDA Link

Safety-related Labeling Changes for GOLYTELY (POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, A) Rx Drug: FDA Link

Safety-related Labeling Changes for NULYTELY (POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for NULYTELY-FLAVORED (POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for MIRALAX* (Polyethylene glycol 3350)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with MIRALAX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective*2370
2Incorrect drug administration duration1539
3Off label use1378
4Diarrhoea*1315
5Nausea*1206
6Constipation973
7Fatigue872
8Vomiting*828
9Pain*820
10Overdose809
11Dyspnoea763
12Inappropriate schedule of drug administration724
13Asthenia695
14Drug administered to patient of inappropriate age688
15Abdominal pain*686
16Dizziness594
17Headache536
18Pyrexia521
19Abdominal distension*516
20Fall483

* This side effect also appears in "Top 10 Side Effects of MIRALAX " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking MIRALAX
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication16148
2Constipation*12164
3Medical observation1157
4Colonoscopy*873
5Bowel preparation393
6Bowel movement irregularity341
7Irritable bowel syndrome*301
8Constipation prophylaxis229
9Laxative supportive care215
10Gastrointestinal motility disorder193

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for MIRALAX

Total Reports Filed with FDA: 85220


Number of FDA Adverse Event Reports by Patient Age for MIRALAX

Total Reports Filed with FDA: 85220*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Polyethylene glycol 3350 (Clear lax, Peg 3350, Clearlax, Care one clearlax, Dg health clearlax, Equaline clearlax, Gentle lax, Good sense clear lax, Healtylax, Leader clear lax, Smart sense clearlax, Sunmark clearlax, Topcare clearlax, Up and up powderlax, Dulcolax balance, Clear laxative, Ez2go, Health mart clearlax, Healthylax, Leader clearlax, Gavilax, Natura-lax, Equate clear lax, Purelax, Smooth lax, Glycolax, Miralax)

Charts are based on 85220 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and MIRALAX Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.