Drug Safety Information for NICODERM CQ (Nicotine)
Safety-related Labeling Changes for HABITROL (NICOTINE) Over-the-counter Drug: FDA Link
Safety-related Labeling Changes for NICODERM CQ (NICOTINE) Over-the-counter Drug: FDA Link
Safety-related Labeling Changes for NICOTROL (NICOTINE) Rx Drug: FDA Link
Adverse Drug Reactions for NICODERM CQ* (Nicotine)
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 NICODERM CQ
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Application site erythema | 2449 |
2 | Application site pruritus | 2334 |
3 | Drug ineffective | 2306 |
4 | Nicotine dependence | 1965 |
5 | Nausea | 1961 |
6 | Intentional drug misuse | 1475 |
7 | Dizziness | 1354 |
8 | Drug administration error | 1210 |
9 | Malaise | 973 |
10 | Application site irritation | 881 |
11 | Headache* | 874 |
12 | Vomiting | 821 |
13 | Hypersensitivity | 778 |
14 | Application site reaction | 739 |
15 | Insomnia* | 737 |
16 | Abnormal dreams | 731 |
17 | Application site pain | 693 |
18 | Product quality issue | 660 |
19 | Application site rash | 638 |
20 | Dyspnoea | 615 |
* This side effect also appears in "Top 10 Side Effects of NICODERM CQ " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking NICODERM CQ
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Smoking cessation therapy | 16668 |
2 | Ex-tobacco user | 11175 |
3 | Product used for unknown indication | 6489 |
4 | Nicotine dependence | 762 |
5 | Tobacco user* | 429 |
6 | Tobacco abuse | 234 |
7 | Drug withdrawal maintenance therapy | 208 |
8 | Withdrawal syndrome | 58 |
9 | Therapeutic procedure | 48 |
10 | Chronic obstructive pulmonary disease | 38 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for NICODERM CQ
Total Reports Filed with FDA: 71982
Number of FDA Adverse Event Reports by Patient Age for NICODERM CQ
Total Reports Filed with FDA: 71982*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nicotine (Nicorelief, Care one nicotine, Equaline nicotine, Good sense nicotine, Habitrol patch, Health mart nicotine, Equate nicotine, In control nicotine, Leader nicotine, Nicotine un1654, Nicotinum, Rexall nicotine, Smart sense nicotine, Stop smoking aid, Sunmark nicotine, Topcare nicotine, Careone nicotine, Zonnic nicotine, Habitrol, Up and up nicotine, Nicotine mini, Nicabate, Nicoderm, Nicoderm cq, Nicotine, Nicotrol, Prostep)
Charts are based on 71982 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 NICODERM CQ 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.