Trade Names:
Status: Approved
Entry Type: Small molecule
Molecule Category: Parent
ATC: N03AX18

Pharmacology

Primary Target
Nav1.7

Indications

Mesh Heading Maximum Phase Reference
Epilepsy; Seizures Phase 2 ClinicalTrials
Epilepsies, Partial Phase 3 ClinicalTrials
Neuralgia Phase 2 ClinicalTrials
Epilepsy Phase 3 ClinicalTrials
Epilepsy Phase 2/Phase 3 ClinicalTrials
Epilepsy; Seizures Phase 3 ClinicalTrials
Peripheral Nervous System Diseases; Small Fiber Neuropathy Phase 3 ClinicalTrials
Necrosis; Osteoarthritis Phase 2 ClinicalTrials
Epilepsy Phase 3 ClinicalTrials
Acute Kidney Injury; Renal Insufficiency Phase 4 ClinicalTrials
Epilepsy Phase 1 ClinicalTrials
Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Sclerosis Phase 1/Phase 2 ClinicalTrials
Epilepsy; Seizures Phase 3 ClinicalTrials
Epilepsies, Partial; Seizures Phase 2 ClinicalTrials
Epilepsy Phase 3 ClinicalTrials
Epilepsy; Seizures Phase 3 ClinicalTrials
Seizures Phase 4 ClinicalTrials
Epilepsy; Epileptic Syndromes; Seizures Phase 2 ClinicalTrials
Epilepsies, Partial; Epilepsy; Seizures Phase 3 ClinicalTrials
Epilepsies, Partial; Epilepsy Phase 4 ClinicalTrials
Diabetic Neuropathies; Neuralgia; Peripheral Nervous System Diseases Phase 2 ClinicalTrials
Epilepsy; Seizures Phase 2 ClinicalTrials
Epilepsy; Seizures Phase 3 ClinicalTrials
Epilepsy Phase 2 ClinicalTrials
Seizures Phase 3 ClinicalTrials
Epilepsies, Partial; Epilepsy; Seizures Phase 4 ClinicalTrials
Diabetic Neuropathies; Peripheral Nervous System Diseases Phase 2/Phase 3 ClinicalTrials
Alcohol Drinking; Alcoholism; Disease Phase 2 ClinicalTrials
Migraine Disorders Phase 2 ClinicalTrials
Epilepsy Phase 3 ClinicalTrials
Diabetic Neuropathies; Pain Phase 3 ClinicalTrials
Epilepsy; Seizures Phase 3 ClinicalTrials
Epilepsies, Partial; Epilepsy Phase 2 ClinicalTrials
Epilepsy; Seizures Phase 3 ClinicalTrials
Epilepsy Phase 4 ClinicalTrials
Epilepsy Phase 3 ClinicalTrials
Epilepsies, Partial; Epilepsy Phase 4 ClinicalTrials
Epilepsy; Seizures Phase 3 ClinicalTrials
Epilepsy; Seizures Phase 2 ClinicalTrials
Epilepsies, Partial; Epilepsy; Seizures Phase 3 ClinicalTrials
Anxiety Disorders; Disease; Psychophysiologic Disorders; Schizophrenia; Somatoform Disorders Phase 3 ClinicalTrials
Status Epilepticus Phase 3 ClinicalTrials
Fibromyalgia; Myofascial Pain Syndromes; Signs and Symptoms; Syndrome Phase 2 ClinicalTrials
Epilepsies, Partial; Epilepsy; Seizures Phase 3 ClinicalTrials
Alcoholic Intoxication; Alcoholism Phase 1 ClinicalTrials
Glioma; Seizures Phase 2 ClinicalTrials
Osteoarthritis; Osteoarthritis, Knee Phase 2 ClinicalTrials
Diabetic Neuropathies; Pain Phase 3 ClinicalTrials
Epilepsy Phase 4 ClinicalTrials

Side Effects from Label

Side effects Relative Frequency (%) Labels
Cardiac disorders Dizziness 60.0
Cardiac disorders Dizziness 53.0
Cardiac disorders Dizziness 46.0
Cardiac disorders Dizziness 43.0
Nervous system disorders Somnolence 36.0
Nervous system disorders Somnolence 34.0
Cardiac disorders Dizziness 31.0
Cardiac disorders Dizziness 30.0
Nervous system disorders Somnolence 26.0
Gastrointestinal disorders Nausea 24.0
Eye disorders Diplopia 20.0
Cardiac disorders Dizziness 20.0
General disorders and administration site conditions Asthenia 18.0
General disorders and administration site conditions Fatigue 18.0
Gastrointestinal disorders Nausea 17.0
Eye disorders Diplopia 16.0
Cardiac disorders Dizziness 16.0
Nervous system disorders Headache 16.0
Gastrointestinal disorders Nausea 16.0
Eye disorders Vision blurred 16.0
Gastrointestinal disorders Vomiting 16.0
General disorders and administration site conditions Asthenia 15.0
Nervous system disorders Ataxia 15.0
General disorders and administration site conditions Fatigue 15.0
Nervous system disorders Headache 14.0
Gastrointestinal disorders Nausea 14.0
Nervous system disorders Headache 13.0
General disorders and administration site conditions Asthenia 12.0
Cardiac disorders Chest pain 12.0
Gastrointestinal disorders Dry mouth 12.0
General disorders and administration site conditions Fatigue 12.0
Nervous system disorders Headache 12.0
Nervous system disorders Tremor 12.0
Eye disorders Vision blurred 12.0
Gastrointestinal disorders Vomiting 12.0
Eye disorders Diplopia 11.0
Nervous system disorders Headache 11.0
Gastrointestinal disorders Nausea 11.0
Eye disorders Diplopia 10.0
Eye disorders Nystagmus 10.0
General disorders and administration site conditions Asthenia 9.0
Eye disorders Diplopia 9.0
General disorders and administration site conditions Fatigue 9.0
Nervous system disorders Headache
Eye disorders Vision blurred 9.0
Gastrointestinal disorders Vomiting 9.0
Nervous system disorders Ataxia 8.0
Gastrointestinal disorders Diarrhoea 8.0
Cardiac disorders Dizziness
General disorders and administration site conditions Gait disturbance 8.0
Nervous system disorders Headache 8.0
General disorders and administration site conditions Hyperhidrosis 8.0
Gastrointestinal disorders Hypoaesthesia oral 8.0
Nervous system disorders Paraesthesia 8.0
Gastrointestinal disorders Paraesthesia oral 8.0
Nervous system disorders Somnolence 8.0
Eye disorders Vision blurred 8.0
General disorders and administration site conditions Asthenia 7.0
Nervous system disorders Ataxia 7.0
General disorders and administration site conditions Fatigue 7.0
Gastrointestinal disorders Nausea 7.0
Nervous system disorders Somnolence 7.0
Nervous system disorders Tremor 7.0
General disorders and administration site conditions Asthenia
General disorders and administration site conditions Balance disorder 6.0
Nervous system disorders Coordination abnormal 6.0
Eye disorders Diplopia 6.0
Gastrointestinal disorders Dry mouth 6.0
General disorders and administration site conditions Fatigue
Gastrointestinal disorders Hypoaesthesia oral 6.0
Nervous system disorders Memory impairment 6.0
Nervous system disorders Paraesthesia 6.0
Skin and subcutaneous tissue disorders Pruritus 6.0
Nervous system disorders Tremor 6.0
Gastrointestinal disorders Vomiting 6.0
General disorders and administration site conditions Balance disorder 5.0
Gastrointestinal disorders Diarrhoea 5.0
Gastrointestinal disorders Hypoaesthesia oral 5.0
Eye disorders Nystagmus 5.0
Gastrointestinal disorders Paraesthesia oral 5.0
Nervous system disorders Somnolence
Nervous system disorders Somnolence 5.0
Ear and labyrinth disorders Vertigo 5.0
Eye disorders Vision blurred 5.0
Gastrointestinal disorders Vomiting 5.0
General disorders and administration site conditions Asthenia 4.0
Nervous system disorders Ataxia 4.0
General disorders and administration site conditions Balance disorder 4.0
Injury, poisoning and procedural complications Contusion 4.0
Gastrointestinal disorders Diarrhoea 4.0
Eye disorders Diplopia 4.0
General disorders and administration site conditions Gait disturbance 4.0
Nervous system disorders Headache 4.0
Gastrointestinal disorders Nausea
Eye disorders Nystagmus
Nervous system disorders Paraesthesia 4.0
Gastrointestinal disorders Paraesthesia oral 4.0
Skin and subcutaneous tissue disorders Pruritus 4.0
Nervous system disorders Tremor
Nervous system disorders Tremor 4.0
Ear and labyrinth disorders Vertigo 4.0
Eye disorders Vision blurred 4.0
Gastrointestinal disorders Vomiting 4.0
Cardiac disorders Chest pain 3.0
Injury, poisoning and procedural complications Contusion
Injury, poisoning and procedural complications Contusion 3.0
Nervous system disorders Coordination abnormal 3.0
Gastrointestinal disorders Diarrhoea
Gastrointestinal disorders Diarrhoea 3.0
General disorders and administration site conditions Gait disturbance 3.0
Laceration 3.0
Skin and subcutaneous tissue disorders Pruritus 3.0
Ear and labyrinth disorders Vertigo 3.0
Eye disorders Vision blurred
Gastrointestinal disorders Vomiting
General disorders and administration site conditions Discomfort 2.5
General disorders and administration site conditions Asthenia 2.0
Nervous system disorders Ataxia
Injury, poisoning and procedural complications Contusion 2.0
Psychiatric disorders Depression 2.0
Eye disorders Diplopia
General disorders and administration site conditions Gait disturbance 2.0
General disorders and administration site conditions Hyperhidrosis 2.0
Laceration
Laceration 2.0
Nervous system disorders Memory impairment
Nervous system disorders Memory impairment 2.0
Eye disorders Nystagmus 2.0
Skin and subcutaneous tissue disorders Pruritus 2.0
Eye disorders Vision blurred 2.0
General disorders and administration site conditions Asthenia
General disorders and administration site conditions Balance disorder 1.0
Psychiatric disorders Depression
General disorders and administration site conditions Gait disturbance
General disorders and administration site conditions Gait disturbance 1.0
Nervous system disorders Memory impairment 1.0
Skin and subcutaneous tissue disorders Pruritus
Ear and labyrinth disorders Vertigo
Skin and subcutaneous tissue disorders Erythema 0.5

Adverse Reactions

System Organ Classification (SOC)
Relative Frequency (%)
Nervous system disorders
27.71
Injury, poisoning and procedural complications
12.47
Psychiatric disorders
11.02
General disorders and administration site conditions
9.67
Cardiac disorders
5.34
Vascular disorders
4.34
Gastrointestinal disorders
3.93
Respiratory, thoracic and mediastinal disorders
3.17
Musculoskeletal and connective tissue disorders
2.9
Skin and subcutaneous tissue disorders
2.72
Investigations
2.46
Infections and infestations
2.4