Drug Safety Information for HYDERGINE (Ergoloid mesylates)

Adverse Drug Reactions for HYDERGINE* (Ergoloid mesylates)

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 HYDERGINE
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Dizziness*	25
2	Dyspnoea	14
3	Cerebrovascular accident	14
4	Hypertension	13
5	Fall	12
6	Somnolence	10
7	Blood pressure increased	10
8	Asthenia	10
9	Memory impairment	10
10	Drug ineffective	9
11	Confusional state	9
12	Anaemia	8
13	Pain	8
14	Malaise	8
15	Nervousness	8
16	Balance disorder	7
17	Fatigue	7
18	Loss of consciousness	7
19	Syncope	7
20	Cardiac arrest	7

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

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

	Reason	# of FDA Reports
1	Dizziness	44
2	Memory impairment	40
3	Cardiovascular disorder	27
4	Labyrinthitis	24
5	Amnesia	23
6	Oxygen supplementation	22
7	Depression	20
8	Confusional state	18
9	Hypertension	17
10	Infarction	13

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

Types of Adverse Events for HYDERGINE

Total Reports Filed with FDA: 906

Number of FDA Adverse Event Reports by Patient Age for HYDERGINE

Total Reports Filed with FDA: 906*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ergoloid mesylates (Circanol, Gerimal, Deapril-st, Alkergot, Hydergine lc, Hydergine, Ergoloid mesylates)

Charts are based on 906 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.