Leader Nicotine Polacrilex Side Effects

Generic name: nicotine

Medically reviewed by Drugs.com. Last updated on Aug 31, 2024.

Note: This document provides detailed information about Leader Nicotine Polacrilex Side Effects associated with nicotine. Some dosage forms listed on this page may not apply specifically to the brand name Leader Nicotine Polacrilex.

Applies to nicotine: gum, lozenge/troche.

Other dosage forms:

• inhalation device
• nasal spray
• transdermal patch extended release

Other side effects

Some side effects of nicotine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• mouth sores, blisters, or irritation
• nausea or vomiting
• sore throat

Less common side effects

• acid or sour stomach
• belching
• diarrhea
• dizziness
• heartburn
• hiccups
• mouth, tooth, jaw, or neck pain
• problems with teeth
• unusual tiredness or weakness

Serious side effects

Along with its needed effects, nicotine (the active ingredient contained in Leader Nicotine Polacrilex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nicotine:

Less common side effects

• blurred vision
• dizziness
• headache
• nervousness
• pounding in the ears

Rare side effects

• fast or irregular heartbeat
• hives, itching, rash, redness, or swelling of the skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking nicotine:

Symptoms of overdose

• dizziness
• fast heartbeat
• nausea or vomiting
• weakness

For healthcare professionals

Applies to nicotine: compounding powder, inhalation device, nasal spray, oral transmucosal gum, oral transmucosal lozenge, transdermal film extended release.

General adverse events

Oral Formulations: The most commonly reported side effects were cough and irritation of the throat and mouth.

Nasal Spray: The most commonly reported side effects included nasal irritation, watering eyes, and cough.

Transdermal Patch: The most commonly reported side effects included local skin reactions (e.g., burning, edema, erythema, irritation, urticaria).^[Ref]

Respiratory

• Very common (10% or more): Throat irritation (up to 40%), cough (up to 32%)
• Common (1% to 10%): Hiccups, nasal congestion, pharyngitis, pharyngolaryngeal pain
• Uncommon (0.1% to 1%): Bronchospasm, dysphonia, dyspnea, sneezing, throat tightness, oropharyngeal pain, rhinorrhea

INHALATOR/INHALER:

• Very common (10% oR more): Cough (up to 32%), rhinitis (up to 23%)
• Common (1% to 10%): Sinusitis, bronchitis, hiccup

MOUTH SPRAY:

• Frequency not reported: Cough, nasopharyngitis, hiccups

NASAL SPRAY:

• Common (1% to 10%): Cough, throat irritation, dyspnea, epistaxis
• Frequency not reported: Hiccup, sneezing, transient epistaxis, pharyngitis, hoarseness, bronchitis, bronchospasm, increased sputum oropharyngeal discomfort and pain

NICOTINE BITARTRATE LOZENGE:

• Common (1% to 10%): Hiccups

TRANSDERMAL PATCH:

• Common (1% to 10%): Cough
• Uncommon (0.1% to 1%): Dyspnea, upper respiratory tract infections^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 26%)
• Common (1% to 10%): Burning sensation, dizziness, dysgeusia, paresthesia
• Frequency not reported: Poor concentration
• Postmarketing reports: Tremor, seizures

INHALATOR/INHALER:

• Very common (10% or more): Headache (up to 26%)
• Common (1% to 10%): Paresthesia, dizziness

MOUTH SPRAY:

• Frequency not reported: Dizziness

NASAL SPRAY:

• Very common (10% or more): Headache (up to 18%)
• Common (1% to 10%): Dizziness, paresthesia or mouth/head/limb paresthesia
• Frequency not reported: Aphasia, numbness, amnesia, migraines, impaired/poor concentration, somnolence, tremor, incoordination, transient changes in taste

NICOTINE BITARTRATE LOZENGE:

• Common (1% to 10%): Dizziness, headache

TRANSDERMAL PATCH:

• Common (1% to 10%): Dizziness, headache, motor dysfunction
• Uncommon (0.1% to 1%): Paresthesia, dysgeusia, somnolence
• Rare (0.01% to 0.1%): Tremor^[Ref]

Local

NASAL SPRAY:

• Very common (10% or more): Rhinorrhea/nasal irritation or discomfort (up to 94%)
• Frequency not reported: Nasal congestion, sinus irritation, transient changes in the sense of smell, runny nose, nasal paresthesia, numbness of nose, nasal ulcer/blister, burning of nose or eyes

TRANSDERMAL PATCH:

• Very common (10% or more): Local skin/application site reactions (up to 20%)
• Uncommon (0.1% to 1%): Localized myalgia, irritation, burning, edema, pain and discomfort^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, abdominal pain/upper abdominal pain, diarrhea, dry mouth, dyspepsia, flatulence, salivary hypersecretion, constipation, vomiting, oral discomfort, stomatitis, toothache
• Uncommon (0.1% to 1%): Eructation, glossitis, oral paresthesia, gingivitis, oral mucosal blistering and exfoliation
• Rare (0.01% to 0.1%): Dysphagia, oral hypoesthesia, retching
• Frequency not reported: Dry throat, gastrointestinal discomfort, lip pain
• Postmarketing reports: Ulcerative/aphthous stomatitis

GUM:

• Frequency not reported: Indigestion and heartburn

INHALATOR/INHALER:

• Very common (10% or more): Dyspepsia (up to 18%)
• Common (1% to 10%): Tooth disorders, taste disturbances, nausea, diarrhea, flatulence, mouth and throat irritation
• Frequency not reported: Aphthous stomatitis

MOUTH SPRAY:

• Frequency not reported: Constipation, mouth ulceration, gingival bleeding, mouth or throat irritation

NASAL SPRAY:

• Common (1% to 10%): Nausea, vomiting, dyspepsia, constipation, stomatitis, flatulence, tooth disorder, gum problems
• Frequency not reported: Gastrointestinal discomfort, abdominal pain, nausea, dry mouth, diarrhea, aphthous ulcer

NICOTINE BITARTRATE LOZENGE:

• Common (1% to 10%): Nausea, flatulence, gastritis, dry mouth, stomatitis, esophagitis

TRANSDERMAL PATCH:

• Common (1% to 10%): Nausea, vomiting, abdominal pain, dyspepsia
• Rare (0.01% to 0.1%): Gastrointestinal discomfort, constipation, diarrhea, flatulence, dry mouth
• Frequency not reported: Aphthous stomatitis^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia
• Uncommon (0.1% to 1%): Abnormal dreams
• Frequency not reported: Dysphoria, depression/depressed mood, irritability, aggression, frustration/anger, restlessness/impatience, anxiety, cravings/urges to smoke, nighttime awakenings/sleep disturbances
• Postmarketing reports: Nervousness

INHALATOR/INHALER:

• Common (1% to 10%): Withdrawal symptoms/syndrome, anxiety, sleep disorder, depression, drug dependence

MOUTH SPRAY:

• Frequency not reported: Dysphoria, depression/depressed mood, irritability, frustration/anger, difficulty concentrating, restlessness/impatience, insomnia, anxiety

NASAL SPRAY:

• Common (1% to 10%): Anxiety, irritability, restlessness, emotional lability, insomnia, withdrawal symptoms, cravings/urges to smoke
• Frequency not reported: Confusion, aggression, dysphoria, depression, apathy, nighttime awakenings/sleep disturbances, increased dreaming, feelings of dependence

NICOTINE BITARTRATE LOZENGE:

• Frequency not reported: Insomnia, nicotine (the active ingredient contained in Leader Nicotine Polacrilex) dependence, withdrawal symptoms

TRANSDERMAL PATCH:

• Common (1% to 10%): Agitation, anxiety, nervousness, insomnia, abnormal dreams
• Uncommon (0.1% to 1%): Attention disturbance, affect lability, irritability, depressed mood, confusion
• Frequency not reported: Sleep disturbances^[Ref]

Hypersensitivity

• Common (1% to 10%): Hypersensitivity reactions
• Rare (0.01% to 0.1%): Allergic reactions and angioedema
• Frequency not reported: Anaphylactic reactions

NASAL SPRAY:

• Uncommon (0.1% to 1%): Hypersensitivity
• Frequency not reported: Angioedema, anaphylactic reactions

NICOTINE BITARTRATE LOZENGE:

• Rare (0.01% to 0.1%): Hypersensitivity, anaphylactic reactions

TRANSDERMAL PATCH:

• Uncommon (0.1% to 1%): Hypersensitivity reaction
• Rare (0.01% to 0.1%): Anaphylactic reaction, angioedema^[Ref]

Other

• Common (1% to 10%): Fatigue
• Uncommon (0.1% to 1%): Asthenia, malaise
• Postmarketing reports: Influenza-type illness

GUM:

• Frequency not reported: Denture damage

INHALATOR/INHALER:

• Common (1% to 10%): Influenza-like symptoms, fatigue, pain, fever

NASAL SPRAY:

• Uncommon (0.1% to 1%): Fatigue, malaise
• Frequency not reported: Asthenia, pain, earache, calming sensation, abnormal taste or use of dosage form

TRANSDERMAL PATCH:

• Uncommon (0.1% to 1%): Asthenia/asthenic conditions, malaise, fatigue^[Ref]

Ocular

• Frequency not reported: Blurred vision, increased lacrimation

NASAL SPRAY:

• Common (1% to 10%): Increased lacrimation/watering eyes
• Frequency not reported: Eye irritation, abnormal vision

TRANSDERMAL PATCH:

• Uncommon (0.1% to 1%): Blurred vision^[Ref]

Genitourinary

NASAL SPRAY:

• Common (1% to 10%): Dysmenorrhea
• Frequency not reported: Menstrual disorder^[Ref]

Immunologic

INHALATOR/INHALER:

• Common (1% to 10%): Allergy

NASAL SPRAY:

• Frequency not reported: Allergy^[Ref]

Dermatologic

• Uncommon (0.1% to 1%): Flushing, hyperhidrosis, pruritus, rash, urticaria, dry skin
• Frequency not reported: Erythema

NASAL SPRAY:

• Common (1% to 10%): Hyperhidrosis/increased sweating, pruritus, rash, acne
• Uncommon (0.1% to 1%): Flushing/facial flushing
• Frequency not reported: Erythema, urticaria

NICOTINE BITARTRATE LOZENGE:

• Rare (0.01% to 0.1%): Angioneurotic edema

TRANSDERMAL PATCH:

• Common (1% to 10%): Pruritus, rash, urticaria with/without vesicles
• Uncommon (0.1% to 1%): Flushing/hot flush, hyperhidrosis
• Rare (0.01% to 0.1%): Erythema, skin discoloration, cutaneous vasculitis
• Frequency not reported: Angioneurotic edema^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Palpitations, tachycardia, hypertension, chest discomfort and pain
• Very rare (less than 0.01%): Reversible atrial fibrillation
• Frequency not reported: Bradycardia/decreased heart rate, atrial fibrillation

INHALATOR/INHALER:

• Common (1% to 10%): Chest discomfort, hypertension

NICOTINE BITARTRATE LOZENGE:

• Uncommon (0.1% to 1%): Palpitations
• Rare (0.01% to 0.1%): Atrial arrhythmia

MOUTH SPRAY:

• Frequency not reported: Presyncopal symptoms

NASAL SPRAY:

• Common (1% to 10%): Palpitations, chest discomfort/tightness and pain
• Uncommon (0.1% to 1%): Hypertension
• Very rare (less than 0.01%): Reversible atrial fibrillation
• Frequency not reported: Tachycardia, peripheral edema, decreased heart rate/bradycardia

TRANSDERMAL PATCH:

• Uncommon (0.1% to 1%): Palpitations, tachycardia, hypertension, chest discomfort and pain
• Very rare (less than 0.01%): Reversible atrial fibrillation^[Ref]

Musculoskeletal

• Uncommon (0.1% to 1%): Jaw pain, musculoskeletal pain
• Frequency not reported: Muscle tightness

INHALATOR/INHALER:

• Common (1% to 10%): Myalgia, back pain, jaw and neck pain

NASAL SPRAY:

• Common (1% to 10%): Back pain, arthralgia
• Frequency not reported: Myalgia

TRANSDERMAL PATCH:

• Common (1% to 10%): Myalgia, arthritis
• Uncommon (0.1% to 1%): Arthralgia, muscle cramp, back pain
• Rare (0.01% to 0.1%): Pain in extremity^[Ref]

Metabolic

• Frequency not reported: Increased appetite, weight gain

MOUTH SPRAY:

• Frequency not reported: Increased appetite, weight gain

NASAL SPRAY:

• Frequency not reported: Weight gain, increased appetite^[Ref]

Hematologic

NASAL SPRAY:

• Frequency not reported: Purpura^[Ref]

Frequently asked questions

• How long does nicotine withdrawal last?
• How long does nicotine stay in your system?
• What are the side effects of vaping?

Further information

Leader Nicotine Polacrilex side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer