Drug Safety Information for FERRLECIT (Sodium ferric gluconate complex)

Safety-related Labeling Changes for FERRLECIT (FERRIC SODIUM GLUCONATE) Rx Drug: FDA Link

Adverse Drug Reactions for FERRLECIT* (Sodium ferric gluconate complex)

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 FERRLECIT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Hypothyroidism746
2Nausea*203
3Dyspnoea194
4Vomiting181
5Hypotension147
6Diarrhoea118
7Abdominal pain105
8Oedema peripheral97
9Chest pain93
10Pain*93
11Anaemia92
12Back pain92
13Dizziness*87
14Asthenia86
15Pyrexia83
16Fatigue77
17Arthralgia*75
18Blood pressure decreased72
19Renal failure acute71
20Death70

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

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

Reason # of FDA Reports
1Product used for unknown indication1612
2Iron deficiency anaemia*1186
3Anaemia*745
4Radioactive iodine therapy575
5Iron deficiency306
6Colonoscopy181
7Basedow's disease179
8Constipation171
9Prophylaxis132
10Mineral supplementation100

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


Types of Adverse Events for FERRLECIT

Total Reports Filed with FDA: 11934


Number of FDA Adverse Event Reports by Patient Age for FERRLECIT

Total Reports Filed with FDA: 11934*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Sodium ferric gluconate complex (Nulecit, Ferrlecit)

Charts are based on 11934 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 FERRLECIT 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.