Drug Safety Information for NULYTELY (Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride)

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 NULYTELY* (Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride)

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 NULYTELY
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Vomiting*123
2Nausea*115
3Dyspnoea88
4Fatigue83
5Diarrhoea*83
6Fall82
7Pneumonia80
8Pain*73
9Confusional state67
10Headache*67
11Pyrexia66
12Asthenia63
13Dizziness62
14Constipation61
15Dehydration60
16Malaise57
17Drug interaction54
18Abdominal pain54
19Anaemia52
20Death50

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

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

Reason # of FDA Reports
1Product used for unknown indication1421
2Constipation1078
3Colonoscopy*305
4Constipation prophylaxis82
5Laxative supportive care55
6Bowel preparation52
7Prophylaxis27
8Infection prophylaxis17
9Diverticulum16
10Gastrointestinal disorder14

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


Types of Adverse Events for NULYTELY

Total Reports Filed with FDA: 8147


Number of FDA Adverse Event Reports by Patient Age for NULYTELY

Total Reports Filed with FDA: 8147*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride (Peg-3350, Nulytely-flavored, Gavilyte - n, Trilyte, Nulytely)

Charts are based on 8147 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 NULYTELY 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.