Leader Nicotine Polacrilex Side Effects
Generic Name: nicotine
Note: This page contains information about the side effects of nicotine. Some of the dosage forms included on this document may not apply to the brand name Leader Nicotine Polacrilex.
For the Consumer
Applies to nicotine: gum, lozenge/troche
Other dosage forms:
In addition to its needed effects, some unwanted effects may be caused by nicotine (the active ingredient contained in Leader Nicotine Polacrilex). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking nicotine:Less common:
- Blurred vision
- pounding in the ears
- Fast or irregular heartbeat
- hives, itching, rash, redness, or swelling of the skin
If any of the following symptoms of overdose occur while taking nicotine, get emergency help immediately:Symptoms of overdose
- fast heartbeat
- nausea or vomiting
Minor Side Effects
Some of the side effects that can occur with nicotine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common:
- Mouth sores, blisters, or irritation
- nausea or vomiting
- sore throat
- Acid or sour stomach
- mouth, tooth, jaw, or neck pain
- problems with teeth
- unusual tiredness or weakness
For Healthcare Professionals
Applies to nicotine: compounding powder, inhalation device, nasal spray, oral transmucosal gum, oral transmucosal lozenge, transdermal film extended release
Cardiovascular effects have included increases in heart rate and blood pressure. New ventricular and supraventricular tachycardia, increase in PVC frequency, less supraventricular arrhythmia, less arrhythmia and lower heart rate, new ST segment depression, and an improvement in ST- or T-wave changes have been reported in patients with coronary artery disease given transdermal nicotine (the active ingredient contained in Leader Nicotine Polacrilex) for smoking cessation. The average heart rate and incidence of arrhythmias or angina has not been shown to be significantly different from baseline while smoking and during transdermal nicotine therapy in patients with coronary artery disease. In patients with coronary artery disease, nicotine may cause coronary artery vasoconstriction. Myocardial infarction has been rarely associated with the use of nicotine patches. Some of these patients were also smoking (receiving a greater than recommended dose of nicotine) and some may have had underlying coronary artery disease. At least one case of intracerebral hematoma has also been reported.[Ref]
In patients with coronary artery disease, nicotine may cause coronary artery vasoconstriction. This can be important to patients with ischemic heart disease.
In patients with coronary artery disease given transdermal nicotine for smoking cessation, the following have been reported: new ventricular and supraventricular tachycardia, increase in PVC frequency, less supraventricular arrhythmia, less arrhythmia and lower heart rate, new ST segment depression, and an improvement in ST- or T-wave changes. The average heart rate and incidence of arrhythmias or angina has not been shown to be significantly different from baseline while smoking and during transdermal nicotine therapy in patients with coronary artery disease.
Myocardial infarction has been rarely associated with the use of nicotine patches. Some of these patients were also smoking (receiving a greater than recommended dose of nicotine) and some may have had underlying coronary artery disease.[Ref]
Respiratory side effects have included bronchospasm in patients with preexisting asthma. It has been associated with the use of nicotine (the active ingredient contained in Leader Nicotine Polacrilex) nasal spray and inhaler. Sore throat reported in at least two patients has been associated with the use of the nicotine gums.[Ref]
Dermatologic side effects have included itching and local erythema at the patch site in up to half of patients treated. Skin irritation rarely required drug discontinuation. Contact dermatitis due to nicotine (the active ingredient contained in Leader Nicotine Polacrilex) or the contents of the nicotine transdermal patch has been reported. Nicotine gum has been associated with increased sweating.[Ref]
Gastrointestinal side effects have included nausea, dry mouth, dyspepsia, and diarrhea with the patch and gum formulations in approximately 6% of patients. Use of nicotine (the active ingredient contained in Leader Nicotine Polacrilex) gum may also cause hiccups, flatulence, increased salivation, stomatitis, tooth disorder, glossitis, and unpleasant taste. The use of nicotine has been shown to decrease lower esophageal sphincter pressure. Heartburn has been associated with nicotine lozenges in 5% to 5.8% of patients. Gastrointestinal side effects associated with nicotine gum reported postmarketing have included oral blistering.[Ref]
Nervous system side effects have been reported in 3% to 12% of patients. These have included lightheadedness, headache, sleep disturbances, abnormal dreams, irritability, dizziness, and tremor. Stroke due to severe cerebral artery vasospasm has been reported in a patient with a recent history of subarachnoid hemorrhage shortly after applying a 10 mg nicotine (the active ingredient contained in Leader Nicotine Polacrilex) patch.[Ref]
Musculoskeletal side effects have rarely included arthralgias and myalgias. Jaw pain has been associated with the use of nicotine (the active ingredient contained in Leader Nicotine Polacrilex) gum.[Ref]
Hematologic side effects have included increases in platelet aggregation and enhanced thrombus formation.[Ref]
Local side effects have been reported most frequently with the use of nicotine (the active ingredient contained in Leader Nicotine Polacrilex) nasal spray. Nicotine inhaler also produced local irritant effects including coughing and rhinitis in 40% of patients.[Ref]
Endocrine side effects have included hyperinsulinemia and insulin resistance during the long-term use of nicotine (the active ingredient contained in Leader Nicotine Polacrilex) gum.[Ref]
Metabolic side effects including at least one case of hyponatremia and syndrome of inappropriate antidiuretic hormone (SIADH) have been reported.[Ref]
A 39-year-old male in good health experienced hyponatremia and syndrome of inappropriate antidiuretic hormone (SIADH) after being administered a nicotine patch. The patient presented complaining of a worsening cough that had progressed over the past month. A chest radiograph showed pneumonia with bilateral lower lobe infiltrates. He was administered a nicotine patch (21 mg/d), ticarcillin/clavulanate, tobramycin, nebulized albuterol, and ipratropium. His urine sodium and osmolarity were 156 mmol/L and 550 mOsm/kg, respectively, confirming the diagnosis of SIADH. On day 12, his serum sodium was 130 mmol/L. The serum sodium continued to decrease despite fluid restriction to 128 mmol/L and 126 mmol/L on Day 14 and 15, respectively. The nicotine patch was reduced to 14 mg/d on Day 16. The patient continued the same fluid restriction and regular diet while the serum sodium remained low at 129 mmol/L. The nicotine patch was further reduced to 7 mg/d on Day 17. The patient was discharged after 18 days of hospitalization with a sodium level of 131 mmol/L.[Ref]
Ocular side effects including vision problems reported in at least two patients have been associated with the use of the nicotine (the active ingredient contained in Leader Nicotine Polacrilex) gums.[Ref]
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2. Warner JG, Little WC "Myocardial infarction in a patient who smoked while wearing a nicotine patch." Ann Intern Med 120 (1994): 695
3. Dale LC, Hurt RD, Offord KP, Lawson GM, Croghan IT, Schroeder DR "High-dose nicotine patch therapy: percentage of replacement and smoking cessation." JAMA 274 (1995): 1353-8
4. Sandborn WJ, Tremaine WJ, Offord KP, Lawson GM, Petersen BT, Batts KP, Croghan IT, Dale LC, Schroeder DR, Hurt RD "Transdermal nicotine for mildly to moderately active ulcerative colitis - A randomized, double-blind, placebo-controlled trial." Ann Intern Med 126 (1997): 364
5. Joseph AM, Norman SM, Feerry LH, et al. "The safety of transdermal nicotine as an aid to smoking cessation in patients with cardiac disease." N Engl J Med 335 (1996): 1792-8
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12. Dwyer CM, Forsyth A "Allergic contact dermatitis from methacrylates in a nicotine transdermal patch." Contact Dermatitis 30 (1994): 309-10
13. Hilleman DE, Mohiuddin SM, Delcore MG "Comparison of fixed-dose transdermal nicotine, tapered-dose transdermal nicotine, and buspirone in smoking cessation." J Clin Pharmacol 34 (1994): 222-4
14. Jorenby DE, Smith SS, Fiore MC, Hurt RD, Offord KP, Croghan IT, Hays JT, Lewis SF, Baker TB "Varying nicotine patch dose and type of smoking cessation counseling." JAMA 274 (1995): 1347-52
15. Fiore MC, Kenford SL, Jorenby DE, Wetter DW, Smith SS, Baker TB "Two studies of the clinical effectiveness of the nicotine patch with different counseling treatments." Chest 105 (1994): 524-33
16. Rahal PS, Wright RA "Transdermal nicotine and gastroesophageal reflux." Am J Gastroenterol 90 (1995): 919-21
17. Shiffman S, Dresler CM, Hajek P, Gilburt SJ, Targett DA, Strahs KR "Efficacy of a nicotine lozenge for smoking cessation." Arch Intern Med 162 (2002): 1267-76
18. Einarson TR, Einarson A "Hiccups following nicotine gum use." Ann Pharmacother 31 (1997): 1263-4
19. Hjalmarson A, Nilsson F, Sjostrom L, Wikland O "The nicotine inhaler in smoking cessation." Arch Intern Med 157 (1997): 1721-8
20. Kadakia SC, Delabaume HR, Shaffer RT "Effects of transdermal nicotine on lower esophageal sphincter and esophageal motility." Dig Dis Sci 41 (1996): 2130-4
21. Silagy C, Mant D, Fowler G, Lodge M "The effectiveness of nicotine replacement therapies in smoking cessation." Online J Curr Clin Trials Jan 14 (Do (1994): w7906ords
22. Pullen RD, Rhodes J, Ganesh S, et al. "Transdermal nicotine for active ulcerative colitis." N Engl J Med 330 (1994): 811-5
23. Pierce JR "Stroke following application of a nicotine patch." Ann Pharmacother 28 (1994): 402
24. Riche G, Nighoghossian N, Trouillas P "Intracerebral haematoma after application of nicotine patch." Lancet 346 (1995): 777-8
25. Mundal HH, Hjemdahl P, Gjesdal K "Acute effects of low dose nicotine gum on platelet function in non-smoking hypertensive and normotensive men." Eur J Clin Pharmacol 47 (1995): 411-6
26. Eliasson B, Taskinen MR, Smith U "Long-term use of nicotine gum is associated with hyperinsulinemia and insulin resistance." Circulation 94 (1996): 878-81
27. Finch CK, Andrus MR, Curry WA "Nicotine replacement therapy-associated syndrome of inappropriate antidiuretic hormone." South Med J 97 (2004): 322-4
Not all side effects for Leader Nicotine Polacrilex may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
More about Leader Nicotine Polacrilex (nicotine)
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