Experiences with the Use of Varenicline in Daily Practice in the Netherlands: a Prospective

Experiences with the use of varenicline in daily practice in the Netherlands: A prospective, observational cohort study

Ingrid Oosterhuis 1, Linda Härmark1and Eugène van Puijenbroek 1,2

Netherlands Pharmacovigilance Centre Lareb, the Netherlands1

Division of Pharmacotherapy and Pharmaceutical Care, Department of

Pharmacy, University of Groningen, Groningen, the Netherlands2

Drug Safety

Reported ADR / Frequency (n)
Nausea / 437
Abdominalpain / 159
Abnormaldreams / 147
Headache / 141
Sleep disorder / 118
Dizziness / 105
Fatigue / 104
Depressedmood / 78
Insomnia / 75
Flatulence / 59
Constipation / 53
Dry mouth / 52
Somnolence / 45
No adverse event / 38
Diarrhoea / 34
Vomiting / 25
Disturbance in attention / 24
Dyspepsia / 22
Hyperhidrosis / 20
Dyspnoea / 19
Palpitations / 18
Cough / 16
Increasedappetite / 15
Dysgeusia / 14
Eructation / 14
Mood swings / 13
Feeling cold / 11
Decreasedappetite / 11
Myalgia / 11
Feeling abnormal / 10
Pollakiuria / 10
Weightincreased / 10
Chestpain / 9
Visionblurred / 9
Rash / 9
Pruritus / 9
Oropharyngealpain / 8
Memory impairment / 8
Irritability / 8
Influenza likeillness / 7
Menstrual disorder / 7
Musclespasms / 7
Malaise / 7
Dry throat / 6
Gastrointestinalmotility disorder / 6
Agitation / 6
Anxiety / 6
Gastrointestinal disorder / 6
Restlessness / 5
Abnormalfaeces / 5
Arthralgia / 5
Tremor / 5
Hunger / 4
Tension / 4
Nightsweats / 4
Gingivitis / 4
Gingivalbleeding / 4
Panic attack / 4
Feeling jittery / 4
Paraesthesiaoral / 4
Listless / 4
Erythema / 3
Hot flush / 3
Eye irritation / 3
Pain in extremity / 3
Nervousness / 3
Nightmare / 3
Rhinitis / 3
Affect lability / 3
Asthenia / 3
Tinnitus / 3
Chest discomfort / 3
Aggression / 3
Thirst / 3
Pruritus generalised / 2
Suicidalideation / 2
Thinking abnormal / 2
Rashpruritic / 2
Yawning / 2
Glossodynia / 2
Throattightness / 2
Dry skin / 2
Apathy / 2
Therapeutic response unexpected / 2
Daydreaming / 2
Visual acuityreduced / 2
Throatirritation / 2
Oedemaperipheral / 2
Photosensitivityreaction / 2
Feeling hot / 2
Musculoskeletalpain / 2
Paraesthesia / 2
Depression / 2
Flank pain / 2
Fungalinfection / 2
Acne / 2
Ageusia / 1
Erectiledysfunction / 1
Euphoricmood / 1
Epistaxis / 1
Emotional disorder / 1
Eye disorder / 1
Eating disorder / 1
Ear pain / 1
Alopecia / 1
Amenorrhoea / 1
Body temperatureincreased / 1
Conjunctivitis / 1
Confusional state / 1
Contusion / 1
Crying / 1
Chills / 1
Dental plaque / 1
Change of bowelhabit / 1
Derealisation / 1
Bronchialirritation / 1
Dissociation / 1
Aphonia / 1
Bonepain / 1
Amnesia / 1
Drowning / 1
Drug ineffective / 1
Drug interaction / 1
Dry eye / 1
Blood pressureincreased / 1
Aphthous stomatitis / 1
Aphasia / 1
Dysmenorrhoea / 1
Anosmia / 1
Analulcer / 1
Breastpain / 1
Photopsia / 1
Sense of oppression / 1
Salivaryhypersecretion / 1
Rhinorrhoea / 1
Retching / 1
Respiratorytractinfection / 1
Renalpain / 1
Increasedtendencytobruise / 1
Poorquality sleep / 1
Skin burningsensation / 1
Pharyngealoedema / 1
Parosmia / 1
Pain / 1
Oral discomfort / 1
Oesophagealpain / 1
Ocularhyperaemia / 1
Psychomotorhyperactivity / 1
Tongue disorder / 1
Withdrawal syndrome / 1
Visual impairment / 1
VIIthnerveparalysis / 1
Urticaria / 1
Urine output increased / 1
Urine odourabnormal / 1
Sexualdysfunction / 1
Toothloss / 1
Sinus disorder / 1
Tongue blistering / 1
Therapeutic product ineffective / 1
Syncope / 1
Swelling face / 1
Skin irritation / 1
Skin disorder / 1
Nasopharyngitis / 1
Urinaryincontinence / 1
Haemoglobinincreased / 1
Nocturia / 1
Intentionalself-injury / 1
Inflammation / 1
Hyperventilation / 1
Hypersomnia / 1
Heartrateincreased / 1
Lethargy / 1
Haemorrhage / 1
Libido decreased / 1
Haematochezia / 1
Gingivalpain / 1
Gastritis / 1
Flushing / 1
Feeling of relaxation / 1
Eyelid disorder / 1
Eye pruritus / 1
Hallucination / 1
Migraine / 1
Eye movement disorder / 1
Nasaldryness / 1
Nasal disorder / 1
Nasal discomfort / 1
Musculoskeletalstiffness / 1
Muscularweakness / 1
Lacrimationincreased / 1
Moodaltered / 1
Negativethoughts / 1
Micturition disorder / 1
Metrorrhagia / 1
Menstruationirregular / 1
Menorrhagia / 1
Loss of libido / 1
Loss of consciousness / 1
Loosetooth / 1
Musclecontractionsinvoluntary / 1