Drug Safety Information for FORTICAL (Calcitonin salmon recombinant)

Adverse Drug Reactions for FORTICAL* (Calcitonin salmon recombinant)

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 FORTICAL
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Nausea	21
2	Headache	20
3	Pain	17
4	Arthralgia	15
5	Dizziness	15
6	Dehydration	14
7	Vomiting	14
8	Diarrhoea	14
9	Pneumonia	13
10	Asthenia	12
11	Fall	12
12	Back pain	11
13	Nasal discomfort	11
14	Fatigue	10
15	Drug ineffective*	10
16	Chest pain	10
17	Pain in extremity	10
18	Renal failure acute	10
19	Dyspnoea	10
20	Pruritus	10

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

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

	Reason	# of FDA Reports
1	Osteoporosis*	217
2	Osteopenia	86
3	Product used for unknown indication	57
4	Blood calcium decreased	29
5	Bone disorder	22
6	Resorption bone increased	7
7	Osteitis deformans	6
8	Mineral supplementation	5
9	Dyspnoea	4
10	Osteoporosis prophylaxis	4

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

Types of Adverse Events for FORTICAL

Total Reports Filed with FDA: 1543

Number of FDA Adverse Event Reports by Patient Age for FORTICAL

Total Reports Filed with FDA: 1543*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Calcitonin salmon recombinant (Fortical)

Charts are based on 1543 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.