Drug

Nicotine Transdermal System Patch

75 flagged reaction(s) · 8,321 total co-reports · max PRR 159.8

Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.

	Reaction	Co-reports (a)	PRR	ROR	Signal
1	Product Adhesion Issue	1,196	159.8	215.8	signal
2	Treatment Noncompliance	887	75.9	93.9	signal
3	Macular Degeneration	170	66.2	68.7	signal
4	Application Site Pruritus	207	42.1	44.0	signal
5	Application Site Rash	122	40.8	41.9	signal
6	Vaginal Discharge	86	39.5	40.2	signal
7	Product Quality Issue	944	32.3	40.4	signal
8	Paraesthesia Oral	96	30.8	31.4	signal
9	Oral Candidiasis	86	30.4	31.0	signal
10	Application Site Erythema	167	29.2	30.3	signal
11	Abnormal Dreams	162	26.8	27.8	signal
12	Application Site Irritation	60	22.2	22.4	signal
13	Expired Product Administered	142	19.7	20.3	signal
14	Incorrect Drug Administration Duration	106	17.1	17.4	signal
15	Application Site Pain	80	16.7	17.0	signal
16	Procedural Pain	94	15.6	15.9	signal
17	Frequent Bowel Movements	86	14.7	14.9	signal
18	Underdose	198	12.4	12.9	signal
19	Nightmare	86	11.3	11.5	signal
20	Colitis	87	10.6	10.8	signal
21	Rectal Haemorrhage	86	9.1	9.3	signal
22	Colitis Ulcerative	85	8.7	8.9	signal
23	Overdose	357	7.6	8.1	signal
24	Haematochezia	89	7.4	7.5	signal
25	Infusion Related Reaction	96	6.7	6.8	signal
26	Therapeutic Product Effect Incomplete	98	6.3	6.5	signal
27	Drug Dose Omission	230	6.3	6.6	signal
28	Wrong Technique In Product Usage Process	272	6.2	6.5	signal
29	Product Dose Omission	82	5.7	5.8	signal
30	Dyspepsia	106	4.9	5.0	signal
31	Initial Insomnia	11	4.9	4.9	signal
32	Product Administered At Inappropriate Site	19	4.8	4.8	signal
33	Product Use Issue	191	4.7	4.8	signal
34	Incorrect Product Administration Duration	20	4.5	4.5	signal
35	Inappropriate Schedule Of Drug Administration	65	4.1	4.2	signal
36	Nervousness	44	3.8	3.9	signal
37	Drug Prescribing Error	15	3.5	3.5	signal
38	Irritability	43	3.3	3.3	signal
39	Dermatitis Contact	8	3.2	3.2	signal
40	Feeling Jittery	13	3.1	3.1	signal
41	Drug Toxicity	9	3.0	3.0	signal
42	Incorrect Dose Administered	140	2.8	2.9	signal
43	Pruritus Generalised	13	2.7	2.7	signal
44	Erythema	119	2.7	2.7	signal
45	Product Complaint	14	2.6	2.6	signal
46	Skin Irritation	25	2.5	2.5	signal
47	Product Packaging Issue	5	2.5	2.5	no signal
48	Heart Rate Increased	50	2.3	2.3	signal
49	Drug Ineffective	606	2.1	2.3	signal
50	Cold Sweat	8	2.1	2.1	no signal
51	Heart Rate Irregular	10	2.0	2.0	signal
52	Therapy Cessation	22	2.0	2.0	no signal
53	Rash Pruritic	23	2.0	2.0	no signal
54	Anger	14	1.9	1.9	no signal
55	Restlessness	15	1.9	1.9	no signal
56	Rash Erythematous	19	1.9	1.9	no signal
57	Mood Altered	11	1.9	1.9	no signal
58	Withdrawal Syndrome	17	1.8	1.8	no signal
59	Product Odour Abnormal	4	1.8	1.8	no signal
60	Panic Attack	14	1.8	1.8	no signal
61	Oral Discomfort	5	1.6	1.6	no signal
62	Anosmia	5	1.6	1.6	no signal
63	Dysgeusia	25	1.5	1.5	no signal
64	Drug Dispensing Error	5	1.5	1.5	no signal
65	Increased Appetite	6	1.5	1.5	no signal
66	Inappropriate Schedule Of Product Administration	55	1.4	1.4	no signal
67	Rash Generalised	8	1.4	1.4	no signal
68	Extra Dose Administered	12	1.4	1.4	no signal
69	Product Taste Abnormal	4	1.4	1.4	no signal
70	Product Packaging Quantity Issue	3	1.3	1.3	no signal
71	Blood Glucose Fluctuation	3	1.2	1.2	no signal
72	No Adverse Event	41	1.1	1.1	no signal
73	Lung Neoplasm Malignant	8	0.9	0.9	no signal
74	Intentional Drug Misuse	3	0.6	0.6	no signal
75	Drug Withdrawal Syndrome	8	0.4	0.4	no signal