The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list below by class and frequency (very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<10,000) and not known (cannot be estimated from the available data)). Where an adverse reaction was seen at different frequencies in clinical studies, it was assigned to the highest frequency reported.
Additional reactions reported from post-marketing experience are included as frequency Not known (cannot be estimated from the available data) in italics in the list below.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Infections and infestations
Very Common: Viral infection
Common: Pneumonia, respiratory infection, urinary tract infection, infection, otitis media
Blood and the lymphatic system disorders
Common:Leucopenia
Not known: Thrombocytopenia
Immune system disorders
Uncommon:Allergic reactions (e.g. urticaria)
Not known: Hypersensitivity syndrome (a systemic reaction with a variable presentation that can include fever, rash, hepatitis, lymphadenopathy, eosinophilia, and sometimes other signs and symptoms), anaphylaxis (see section 4.4)
Metabolism and nutrition disorders
Common:Anorexia, increased appetite
Uncommon:hyperglycaemia (most often observed in patients with diabetes)
Rare:hypoglycaemia (most often observed in patients with diabetes)
Not known: hyponatraemia
Psychiatric disorders
Common:Hostility, confusion and emotional lability, depression, anxiety, nervousness, thinking abnormal
Uncommon:agitation
Not known: Hallucinations
Nervous system disorders
Very Common:Somnolence, dizziness, ataxia
Common:Convulsions, hyperkinesias, dysarthria, amnesia, tremor, insomnia, headache, sensations such as paresthesia, hypoesthesia, coordination abnormal, nystagmus, increased, decreased, or absent reflexes
Uncommon:Hypokinesia, mental impairment
Rare:Loss of consciousness
Not known: Other movement disorders (e.g. choreoathetosis, dyskinesia, dystonia)
Eye disorders
Common:Visual disturbances such as amblyopia, diplopia
Ear and labyrinth disorders
Common:Vertigo
Not known: Tinnitus
Cardiac disorders
Uncommon: Palpitations
Vascular disorder
Common: Hypertension, vasodilatation
Respiratory, thoracic and mediastinal disorders
Common: Dyspnoea, bronchitis, pharyngitis, cough, rhinitis
Gastrointestinal disorders
Common:Vomiting, nausea, dental abnormalities, gingivitis, diarrhoea, abdominal pain, dyspepsia, constipation, dry mouth or throat, flatulence
Not known: Pancreatitis
Hepatobiliary disorders
Not known: Hepatitis, jaundice
Skin and subcutaneous tissue disorders
Common:Facial oedema, purpura most often described as bruises resulting from physical trauma, rash, pruritus, acne
Not known: Stevens-Johnson syndrome, angioedema, erythema multiforme, alopecia, drug rash with eosinophilia and systemic symptoms (see section 4.4)
Musculoskeletal and connective tissue disorders
Common:Arthralgia, myalgia, back pain, twitching
Not known: Rhabdomyolysis, myoclonus
Renal and urinary disorder
Not known: Acute renal failure, incontinence
Reproductive system and breast disorders
Common:Impotence
Not known: Breast hypertrophy, gynaecomastia, sexual dysfunction (including changes in libido, ejaculation disorders and anorgasmia)
General disorders and administration site conditions
Very Common:Fatigue, fever
Common:Peripheral oedema, abnormal gait, asthenia, pain, malaise, flu syndrome
Uncommon:Generalised oedema
Not known: Withdrawal reactions (mostly anxiety, insomnia, nausea, pains, sweating), chest pain. Sudden unexplained deaths have been reported where a causal relationship to treatment with gabapentin has not been established.
Investigations
Common:WBC (white blood cell count) decreased, weight gain
Uncommon:Elevated liver function tests SGOT (AST), SGPT (ALT) and bilirubin
Not known: blood creatine phosphokinase increased
Injury, poisoning and procedural complications
Common: Accidental injury, fracture, abrasion
Uncommon: Fall
Under treatment with gabapentin cases of acute pancreatitis were reported. Causality with gabapentin is unclear (see section 4.4).
In patients on haemodialysis due to end-stage renal failure, myopathy with elevated creatine kinase levels has been reported.
Paediatric population
Respiratory tract infections, otitis media, convulsions and bronchitis were reported only in clinical studies in children. Additionally, in clinical studies in children, aggressive behaviour and hyperkinesias were reported commonly.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;E-mail: medsafety@hpra.ie.
The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list below by class and frequency (very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<10,000) and not known (cannot be estimated from the available data)). Where an adverse reaction was seen at different frequencies in clinical studies, it was assigned to the highest frequency reported.
Additional reactions reported from post-marketing experience are included as frequency Not known (cannot be estimated from the available data) in italics in the list below.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Infections and infestations
Very Common: Viral infection
Common: Pneumonia, respiratory infection, urinary tract infection, infection, otitis media
Blood and the lymphatic system disorders
Common:Leucopenia
Not known: Thrombocytopenia
Immune system disorders
Uncommon:Allergic reactions (e.g. urticaria)
Not known: Hypersensitivity syndrome (a systemic reaction with a variable presentation that can include fever, rash, hepatitis, lymphadenopathy, eosinophilia, and sometimes other signs and symptoms), anaphylaxis (see section 4.4)
Metabolism and nutrition disorders
Common: Anorexia, increased appetite
Uncommon: hyperglycaemia (most often observed in patients with diabetes)
Rare:hypoglycaemia (most often observed in patients with diabetes)
Not known: hyponatraemia
Psychiatric disorders
Common:Hostility, confusion and emotional lability, depression, anxiety, nervousness, thinking abnormal
Uncommon:agitation
Not known: Hallucinations
Nervous system disorders
Very Common:Somnolence, dizziness, ataxia
Common:Convulsions, hyperkinesias, dysarthria, amnesia, tremor, insomnia, headache, sensations such as paresthesia, hypoesthesia, coordination abnormal, nystagmus, increased, decreased, or absent reflexes
Uncommon:Hypokinesia, mental impairment
Rare:Loss of consciousness
Not known: Other movement disorders (e.g. choreoathetosis, dyskinesia, dystonia)
Eye disorders
Common:Visual disturbances such as amblyopia, diplopia
Ear and labyrinth disorders
Common:Vertigo
Not known: Tinnitus
Cardiac disorders
Uncommon: Palpitations
Vascular disorder
Common: Hypertension, vasodilatation
Respiratory, thoracic and mediastinal disorders
Common: Dyspnoea, bronchitis, pharyngitis, cough, rhinitis
Rare: Respiratory depression
Gastrointestinal disorders
Common:Vomiting, nausea, dental abnormalities, gingivitis, diarrhoea, abdominal pain, dyspepsia, constipation, dry mouth or throat, flatulence
Not known: Pancreatitis
Hepatobiliary disorders
Not known: Hepatitis, jaundice
Skin and subcutaneous tissue disorders
Common:Facial oedema, purpura most often described as bruises resulting from physical trauma, rash, pruritus, acne
Not known: Stevens-Johnson syndrome, angioedema, erythema multiforme, alopecia, drug rash with eosinophilia
and systemic symptoms (see section 4.4)
Musculoskeletal and connective tissue disorders
Common:Arthralgia, myalgia, back pain, twitching
Not known: Rhabdomyolysis, myoclonus
Renal and urinary disorder
Not known: Acute renal failure, incontinence
Reproductive system and breast disorders
Common:Impotence
Not known: Breast hypertrophy, gynaecomastia, sexual dysfunction (including changes in libido, ejaculation disorders and anorgasmia)
General disorders and administration site conditions
Very Common:Fatigue, fever
Common:Peripheral oedema, abnormal gait, asthenia, pain, malaise, flu syndrome
Uncommon:Generalised oedema
Not known: Withdrawal reactions (mostly anxiety, insomnia, nausea, pains, sweating), chest pain. Sudden unexplained deaths have been reported where a causal relationship to treatment with gabapentin has not been established.
Investigations
Common:WBC (white blood cell count) decreased, weight gain
Uncommon:Elevated liver function tests SGOT (AST), SGPT (ALT) and bilirubin
Not known: blood creatine phosphokinase increased
Injury, poisoning and procedural complications
Common: Accidental injury, fracture, abrasion
Uncommon: Fall
Under treatment with gabapentin cases of acute pancreatitis were reported. Causality with gabapentin is unclear (see section 4.4).
In patients on haemodialysis due to end-stage renal failure, myopathy with elevated creatine kinase levels has been reported.
Paediatric population
Respiratory tract infections, otitis media, convulsions and bronchitis were reported only in clinical studies in children. Additionally, in clinical studies in children, aggressive behaviour and hyperkinesias were reported commonly.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: http://www.hpra.ie/;E-mail: medsafety@hpra.ie.