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Nicotrol TD Side Effects

Generic Name: nicotine

Note: This page contains side effects data for the generic drug nicotine. It is possible that some of the dosage forms included below may not apply to the brand name Nicotrol TD.

For the Consumer

Applies to nicotine: gum, lozenge/troche

As well as its needed effects, nicotine (the active ingredient contained in Nicotrol TD) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking nicotine, check with your doctor immediately:

Less common:
  • Blurred vision
  • dizziness
  • headache
  • nervousness
  • pounding in the ears
Rare
  • 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
  • Dizziness
  • fast heartbeat
  • nausea or vomiting
  • weakness

Minor Side Effects

Some nicotine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Mouth sores, blisters, or irritation
  • nausea or vomiting
  • sore throat
Less common:
  • Acid or sour stomach
  • belching
  • diarrhea
  • dizziness
  • heartburn
  • hiccups
  • 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

General

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 Nicotrol TD) 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]

References

1. "Product Information. Nicoderm (nicotine)." Hoechst Marion-Roussel Inc, Kansas City, MO.

2. "Product Information. Nicotrol (nicotine)." McNeil Pharmaceutical, Raritan, NJ.

3. "Product Information. NicoDerm CQ (nicotine)." SmithKline Beecham, Philadelphia, PA.

4. "Product Information. Nicorette (nicotine)." SmithKline Beecham, Philadelphia, PA.

5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

6. Cerner Multum, Inc. "Australian Product Information." O 0

7. "Product Information. Nicotrol NS (nicotine)." McNeil Pharmaceutical, Raritan, NJ.

8. "Product Information. Habitrol (nicotine)." Basel Pharmaceuticals, Summit, NJ.

9. "Product Information. Commit (nicotine)." GlaxoSmithKline Healthcare, Pittsburgh, PA.

10. "Product Information. Prostep (nicotine)." Advantus Pharm & Lederle Lab Div, Peral River, NY.

It is possible that some side effects of Nicotrol TD may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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