Drug Safety Information for PHOSLO (Calcium acetate)

FDA Safety-related Labeling Changes for PHOSLYRA (CALCIUM ACETATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for PHOSLO* (Calcium acetate)

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 PHOSLO
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain309
2Nausea305
3Dyspnoea269
4Nephrogenic systemic fibrosis269
5Vomiting234
6Asthenia209
7Diarrhoea201
8Oedema peripheral200
9Hypotension193
10Anxiety188
11Pruritus184
12Dizziness177
13Pain in extremity176
14Anaemia170
15Fatigue168
16Flushing157
17Arthralgia155
18Renal failure chronic150
19Renal failure146
20Abdominal pain145

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

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

Reason # of FDA Reports
1Product used for unknown indication4476
2Mineral supplementation237
3Blood phosphorus increased216
4Hyperphosphataemia203
5Renal failure chronic153
6Supplementation therapy111
7Renal failure*109
8Renal disorder93
9Osteoporosis67
10Blood phosphorus67

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


Types of Adverse Events for PHOSLO

Total Reports Filed with FDA: 24265


Number of FDA Adverse Event Reports by Patient Age for PHOSLO

Total Reports Filed with FDA: 24265*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Calcium acetate (Phoslyra, Eliphos, Phoslo gelcaps, Calcium acetate, Phoslo)

Charts are based on 24265 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 PHOSLO 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.