Drug Safety Information for OSMOPREP (Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate)

FDA Safety-related Labeling Changes for OSMOPREP (SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for OSMOPREP* (Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate)

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 OSMOPREP
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Vomiting	33
2	Nausea	30
3	Renal failure acute	30
4	Dizziness	25
5	Renal failure	21
6	Dehydration	20
7	Diarrhoea	19
8	Asthenia	17
9	Pain	16
10	Dyspnoea	16
11	Nephropathy	14
12	Hypokalaemia	13
13	Malaise	13
14	Tremor	13
15	Paraesthesia	12
16	Hyponatraemia	11
17	Abdominal pain	11
18	Blood creatinine increased	11
19	Back pain	11
20	Chest pain	10

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

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

	Reason	# of FDA Reports
1	Colonoscopy	848
2	Bowel preparation	203
3	Product used for unknown indication	10
4	Pain	6
5	Preoperative care	5
6	Constipation	3
7	Gastrointestinal disorder	3

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

Types of Adverse Events for OSMOPREP

Total Reports Filed with FDA: 1599

Number of FDA Adverse Event Reports by Patient Age for OSMOPREP

Total Reports Filed with FDA: 1599*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate (Osmoprep)

Charts are based on 1599 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.

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.