Drug Safety Information for INJECTAFER (Ferric carboxymaltose)

FDA Safety-related Labeling Changes for INJECTAFER (FERRIC CARBOXYMALTOSE) Rx Drug: Safety Information Link

Adverse Drug Reactions for INJECTAFER* (Ferric carboxymaltose)

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 INJECTAFER
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Pruritus	14
2	Dyspnoea	14
3	Chest discomfort	13
4	Urticaria	12
5	Nausea	10
6	Headache	10
7	Dizziness	7
8	Rash	7
9	Hypersensitivity	7
10	Asthenia	6
11	Flushing	5
12	Anaphylactic reaction	5
13	Fatigue	4
14	Infusion related reaction	4
15	Pyrexia	4
16	Blood pressure increased	4
17	Chest pain	4
18	Back pain	4
19	Hyperhidrosis	3
20	Heart rate increased	3

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

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

	Reason	# of FDA Reports
1	Iron deficiency anaemia	94
2	Product used for unknown indication	68
3	Anaemia	24
4	Menorrhagia	11
5	Blood iron decreased	7
6	Iron deficiency	4
7	Uterine leiomyoma	2

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

Types of Adverse Events for INJECTAFER

Total Reports Filed with FDA: 347

Number of FDA Adverse Event Reports by Patient Age for INJECTAFER

Total Reports Filed with FDA: 347*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ferric carboxymaltose (Injectafer)

Charts are based on 347 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 INJECTAFER 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.