Drug Safety Information for HALFLYTELY (Bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride)

Adverse Drug Reactions for HALFLYTELY* (Bisacodyl; 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 HALFLYTELY
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Vomiting216
2Nausea*203
3Asthenia149
4Dyspnoea148
5Constipation140
6Pneumonia139
7Diarrhoea*133
8Abdominal pain130
9Pain*121
10Hypotension119
11Fatigue117
12Pyrexia116
13Anaemia110
14Dehydration105
15Drug interaction102
16Renal failure acute101
17Fall99
18Death92
19Dizziness92
20Oedema peripheral91

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

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

Reason # of FDA Reports
1Product used for unknown indication1530
2Constipation*1422
3Colonoscopy738
4Bowel preparation135
5Laxative supportive care109
6Prophylaxis48
7Adverse event19
8Constipation prophylaxis14
9Weight decreased11
10Faeces hard9

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


Types of Adverse Events for HALFLYTELY

Total Reports Filed with FDA: 16789


Number of FDA Adverse Event Reports by Patient Age for HALFLYTELY

Total Reports Filed with FDA: 16789*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride (Halflytely)

Charts are based on 16789 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 HALFLYTELY 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.