FDA Adverse Events Reports (FAERS) Summary for NICOTINE POLACRILEX

These tables and charts are based on 6,662 total reports for NICOTINE POLACRILEX (NICOTINE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 6,625 pharmaceutical company-submitted and non-U.S. FAERS reports and 37 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

For a separate summary of the 37 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch NICOTINE POLACRILEX summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with NICOTINE POLACRILEX (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	1472
2	NAUSEA	750
3	NICOTINE DEPENDENCE	745
4	MACULAR DEGENERATION	567
5	INTENTIONAL DRUG MISUSE	438
6	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	425
7	ORAL DISCOMFORT	348
8	INDIGESTION	329
9	MALAISE	307
10	DRUG ADMINISTRATION ERROR	289
11	HICCUPS	257
12	HEADACHE	250
13	THROAT IRRITATION	244
14	OFF LABEL USE	225
15	EXPIRED PRODUCT ADMINISTERED	212
16	VOMITING	205
17	ABDOMINAL DISCOMFORT	186
18	DIZZINESS	184
19	DRUG EFFECT INCOMPLETE	175
20	TINGLING MOUTH	168
21	PAIN	166
22	INCORRECT DOSE ADMINISTERED	153
23	DIARRHEA	150
24	PRODUCT QUALITY ISSUE	150
25	STOMATITIS	147
26	WEIGHT DECREASED	139
27	FEVER	136
28	CHRONIC SINUSITIS	125
29	INFUSION RELATED REACTION	125
30	PROCEDURAL PAIN	125
31	METALLIC OR ALTERED TASTE	116
32	ABDOMINAL PAIN UPPER	114
33	THROAT PAIN	114
34	SKIN REDNESS	110
35	CONSTIPATION	108
36	TOOTH DISCOLOURATION	103
37	ABDOMINAL PAIN	102
38	BLOOD GLUCOSE INCREASED	97
39	INCORRECT ROUTE OF PRODUCT ADMINISTRATION	94
40	HYPERSENSITIVITY	91
41	SHORTNESS OF BREATH	90
42	FREQUENT BOWEL MOVEMENTS	87
43	RECTAL BLEEDING	87
44	ACCIDENTAL EXPOSURE TO PRODUCT	86
45	COUGH	86
46	BLOOD IN STOOL	85
47	COLITIS ULCERATIVE	84
48	ORAL THRUSH	84
49	ANEMIA	83
50	COLITIS	83
51	FEMALE GENITAL TRACT FISTULA	83
52	RADICULOPATHY	82
53	VAGINAL DISCHARGE	82
54	VAGINAL FLATULENCE	82
55	PROCTITIS	81
56	ORAL PAIN	79
57	OVERDOSE	77
58	TONGUE DISCOLOURATION	74
59	ANXIETY	73
60	FLATULENCE	68
61	TONGUE DISCOMFORT	63
62	BURNING MOUTH SYNDROME	62
63	PALPITATIONS	62
64	DENTAL CARIES	61
65	FEELING ABNORMAL	56
66	INCORRECT DRUG ADMINISTRATION DURATION	55
67	INCORRECT ROUTE OF DRUG ADMINISTRATION	55
68	RETCHING	55
69	PRODUCT TASTE ABNORMAL	54
70	INSOMNIA	53
71	THROAT TIGHTNESS	53
72	HEART RATE INCREASED	52
73	ORAL MUCOSAL DISCOLOURATION	52
74	UNDERDOSE	52
75	DRY MOUTH	50
76	RASH	50
77	DRUG EFFECT DECREASED	48
78	CHEST PAIN	45
79	FATIGUE	43
80	ITCHING	43
81	CONDITION AGGRAVATED	42
82	HIVES	42
83	BLOOD PRESSURE INCREASED	40
84	LACK OF STRENGTH AND ENERGY (ASTHENIA)	39
85	GASTROOESOPHAGEAL REFLUX DISEASE	37
86	GINGIVAL PAIN	36
87	ORAL MUCOSAL BLISTERING	36
88	BURNING SENSATION	35
89	NERVOUSNESS	35
90	NO ADVERSE EVENT	35
91	THERAPEUTIC PRODUCT EFFECT DECREASED	35
92	TREMOR	35
93	EXPIRED DRUG ADMINISTERED	34
94	PHARYNGEAL OEDEMA	34
95	SALIVARY HYPERSECRETION	34
96	TOOTHACHE	34
97	DEPRESSION	33
98	DRUG DEPENDENCE	31
99	SENSATION OF FOREIGN BODY	29
100	SUICIDAL IDEATION	28

Latest Known Outcomes for Reactions Reported for NICOTINE POLACRILEX

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	3760
2	Patient recovered	1587
3	Patient has not recovered/symtoms have not resolved	974
4	Patient is recovering/symptoms resolving	211
5	Patient died	27
6	Patient has recovered but has consequent health issues	7

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2004	11
2005	10
2006	18
2007	7
2008	29
2009	221
2010	396
2011	216
2012	220
2013	328
2014	35
2015	234
2016	590
2017	519
2018	497
2019	443
2020	480
2021	651
2022	538
2023	348
2024	314
2025	391
2026	166

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	12
11-20	23
21-30	159
31-40	366
41-50	469
51-60	750
61-70	822
71-80	468
81-90	69
91+	5

Based on 3143 reports that included a patient age.

NICOTINE POLACRILEX Total Reports

Male	Female	Unknown	Total
2064	3305	1293	6,662

Top Countries Reporting

	Country	Number of Reports
1	United States	4937
2	Canada	598
3	United Kingdom	17
4	France	8
5	Germany	4
6	Australia	3
7	EU	2
8	Sweden	2
9	Spain	1
10	South Korea	1

Outcomes for Reports

Serious: 1168
Not Serious: 5487
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Product used for unknown indication
Smoking cessation therapy
Ex-tobacco user
Nicotine dependence
Accidental exposure to product

Top Companies Reporting

PL DEVELOPMENTS
Haleon PLC
PERRIGO

Safety-Related FDA Updates

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for NICOTINE POLACRILEX reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through July 30, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.