Drug Safety Information for NICOTINE POLACRILEX (Nicotine polacrilex)

Adverse Drug Reactions for NICOTINE POLACRILEX* (Nicotine polacrilex)

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 NICOTINE POLACRILEX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Intentional drug misuse4058
2Nicotine dependence1955
3Nausea1641
4Drug ineffective1062
5Malaise919
6Drug administration error896
7Product quality issue890
8Vomiting642
9Oral discomfort635
10Dizziness576
11Throat irritation557
12Hiccups540
13Dyspepsia*469
14Drug abuser451
15Abdominal discomfort410
16Headache*389
17Dependence367
18Oropharyngeal pain*353
19Hypersensitivity291
20Diarrhoea274

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

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

Reason # of FDA Reports
1Smoking cessation therapy5380
2Product used for unknown indication3389
3Ex-tobacco user3201
4Nicotine dependence217
5Tobacco abuse185
6Drug withdrawal maintenance therapy160
7Tobacco user*130
8Ill-defined disorder50
9Intentional self-injury22
10Tobacco withdrawal symptoms22

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


Types of Adverse Events for NICOTINE POLACRILEX

Total Reports Filed with FDA: 35014


Number of FDA Adverse Event Reports by Patient Age for NICOTINE POLACRILEX

Total Reports Filed with FDA: 35014*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nicotine polacrilex (Thrive, Commit, Nicorette (mint), Nicorette, Nicotine polacrilex)

Charts are based on 35014 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.

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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.

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