Drug Safety Information for FERAHEME (Ferumoxytol)

FDA Safety-related Labeling Changes for FERAHEME (FERUMOXYTOL) Rx Drug: Safety Information Link

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Adverse Drug Reactions for FERAHEME* (Ferumoxytol)

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 FERAHEME
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Dyspnoea	174
2	Hypotension	136
3	Nausea	104
4	Unresponsive to stimuli	99
5	Flushing	85
6	Vomiting	82
7	Anaphylactic reaction	74
8	Dizziness	73
9	Back pain	72
10	Chest pain	68
11	Hypersensitivity	68
12	Hyperhidrosis	60
13	Oxygen saturation decreased	53
14	Chest discomfort	49
15	Hypertension	43
16	Infusion related reaction	40
17	Cardio-respiratory arrest	37
18	Cardiac arrest	34
19	Malaise	33
20	Pruritus*	33

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

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

	Reason	# of FDA Reports
1	Iron deficiency anaemia	2545
2	Anaemia	328
3	Iron deficiency	121
4	Nephrogenic anaemia	64
5	Renal failure chronic	45
6	Mineral supplementation	36
7	Blood iron decreased	31
8	Anaemia of chronic disease	21
9	Product used for unknown indication	16
10	Haemoglobin decreased	16

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

Types of Adverse Events for FERAHEME

Total Reports Filed with FDA: 3660

Number of FDA Adverse Event Reports by Patient Age for FERAHEME

Total Reports Filed with FDA: 3660*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ferumoxytol (Ferrosoferric oxide, Feraheme)

Charts are based on 3660 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.