Drug Safety Information for SALAGEN (Pilocarpine hydrochloride)

Safety-related Labeling Changes for VUITY (PILOCARPINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for SALAGEN* (Pilocarpine hydrochloride)

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 SALAGEN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*122
2Drug ineffective122
3Dyspnoea107
4Fatigue101
5Headache92
6Dizziness79
7Asthenia76
8Fall73
9Vomiting71
10Pain*71
11Intraocular pressure increased60
12Diarrhoea60
13Visual acuity reduced58
14Arthralgia56
15Anxiety55
16Pyrexia54
17Pain in extremity51
18Chest pain51
19Malaise50
20Vision blurred49

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

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

Reason # of FDA Reports
1Product used for unknown indication705
2Dry mouth*508
3Sjogren's syndrome*377
4Glaucoma253
5Dry eye214
6Intraocular pressure increased142
7Angle closure glaucoma55
8Miosis47
9Cataract operation35
10Tooth disorder30

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


Types of Adverse Events for SALAGEN

Total Reports Filed with FDA: 9164


Number of FDA Adverse Event Reports by Patient Age for SALAGEN

Total Reports Filed with FDA: 9164*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Pilocarpine hydrochloride (Isopto carpine, Pilopine hs, Pilocarpine, Salagen)

Charts are based on 9164 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 SALAGEN 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.