Drug information for HORIZANT

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, EXTENDED RELEASE; ORAL 300MG Prescription   GABAPENTIN ENACARBIL 1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid GLAXO GRP LTD 22399
2012-04-23 Letter

2012-04-20 Label

2011-05-16 Review

2011-05-16 Summary Review

2011-04-11 Letter

2011-04-07 Label

2011-04-07 Medication Guide
TABLET, EXTENDED RELEASE; ORAL 600MG Prescription  (Reference Drug) GABAPENTIN ENACARBIL 1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid GLAXO GRP LTD   "

Drug Adverse Effects information for HORIZANT

Role code Indications Reaction # Reports
PS NEUROPATHY PERIPHERAL LIP SWELLING 1
PS NEUROPATHY PERIPHERAL OROPHARYNGEAL DISCOMFORT 1
PS NEUROPATHY PERIPHERAL PARAESTHESIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPOMANIA 1
PS RESTLESS LEGS SYNDROME ABNORMAL DREAMS 1
PS RESTLESS LEGS SYNDROME AGITATION 1
PS RESTLESS LEGS SYNDROME ANXIETY 1
PS RESTLESS LEGS SYNDROME ASTHENIA 1
PS RESTLESS LEGS SYNDROME BALANCE DISORDER 1
PS RESTLESS LEGS SYNDROME CONDITION AGGRAVATED 1
PS RESTLESS LEGS SYNDROME CONFUSIONAL STATE 1
PS RESTLESS LEGS SYNDROME CYSTITIS 1
PS RESTLESS LEGS SYNDROME DEPRESSION 1
PS RESTLESS LEGS SYNDROME DIZZINESS 6
PS RESTLESS LEGS SYNDROME DRUG INEFFECTIVE 11
PS RESTLESS LEGS SYNDROME EPISTAXIS 1
PS RESTLESS LEGS SYNDROME EXCORIATION 1
PS RESTLESS LEGS SYNDROME FACE INJURY 1
PS RESTLESS LEGS SYNDROME FALL 2
PS RESTLESS LEGS SYNDROME FEELING ABNORMAL 1
PS RESTLESS LEGS SYNDROME HALLUCINATION 1
PS RESTLESS LEGS SYNDROME HEADACHE 1
PS RESTLESS LEGS SYNDROME HYPERSOMNIA 2
PS RESTLESS LEGS SYNDROME ILL-DEFINED DISORDER 1
PS RESTLESS LEGS SYNDROME INSOMNIA 5
PS RESTLESS LEGS SYNDROME INTESTINAL OBSTRUCTION 1
PS RESTLESS LEGS SYNDROME JOINT INJURY 1
PS RESTLESS LEGS SYNDROME LIMB INJURY 1
PS RESTLESS LEGS SYNDROME NAUSEA 2
PS RESTLESS LEGS SYNDROME OBSESSIVE-COMPULSIVE DISORDER 2
PS RESTLESS LEGS SYNDROME PELVIC FRACTURE 1
PS RESTLESS LEGS SYNDROME PSYCHOMOTOR HYPERACTIVITY 1
PS RESTLESS LEGS SYNDROME RASH 1
PS RESTLESS LEGS SYNDROME SEDATION 2
PS RESTLESS LEGS SYNDROME SLEEP TERROR 1
PS RESTLESS LEGS SYNDROME SLUGGISHNESS 2
PS RESTLESS LEGS SYNDROME SOMNAMBULISM 1
PS RESTLESS LEGS SYNDROME VOMITING 2
SS DEPRESSION FEELING JITTERY 2
SS DEPRESSION INITIAL INSOMNIA 2
SS DEPRESSION SLEEP DISORDER 2
SS FEELING JITTERY FEELING JITTERY 1
SS FEELING JITTERY INITIAL INSOMNIA 1
SS FEELING JITTERY SLEEP DISORDER 1
SS RESTLESS LEGS SYNDROME FEELING JITTERY 3
SS RESTLESS LEGS SYNDROME INITIAL INSOMNIA 3
SS RESTLESS LEGS SYNDROME SLEEP DISORDER 3
SS RHINITIS ALLERGIC FEELING JITTERY 2
SS RHINITIS ALLERGIC INITIAL INSOMNIA 2
SS RHINITIS ALLERGIC SLEEP DISORDER 2
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