Drug information for AMRIX

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE, EXTENDED RELEASE; ORAL 15MG Prescription AB  CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine ANESTA AG 21777
2008-05-06 Review

2008-03-26 Letter

2007-02-12 Letter

2007-02-02 Label
CAPSULE, EXTENDED RELEASE; ORAL 30MG Prescription AB (Reference Drug) CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine ANESTA AG   "

Drug Adverse Effects information for AMRIX

Role code Indications Reaction # Reports
C ANALGESIC THERAPY ABDOMINAL DISCOMFORT 2
C ANALGESIC THERAPY DIARRHOEA 2
C ANALGESIC THERAPY DISCOMFORT 2
C ANALGESIC THERAPY FATIGUE 2
C ANALGESIC THERAPY INTERVERTEBRAL DISC OPERATION 2
C ANALGESIC THERAPY MALAISE 2
C ANALGESIC THERAPY NASAL SEPTUM DEVIATION 2
C ANALGESIC THERAPY NAUSEA 2
C ANALGESIC THERAPY PAIN 2
C ANALGESIC THERAPY VOMITING 2
C ANKYLOSING SPONDYLITIS ABDOMINAL DISCOMFORT 2
C ANKYLOSING SPONDYLITIS DIARRHOEA 2
C ANKYLOSING SPONDYLITIS DISCOMFORT 2
C ANKYLOSING SPONDYLITIS FATIGUE 2
C ANKYLOSING SPONDYLITIS INTERVERTEBRAL DISC OPERATION 2
C ANKYLOSING SPONDYLITIS MALAISE 2
C ANKYLOSING SPONDYLITIS NASAL SEPTUM DEVIATION 2
C ANKYLOSING SPONDYLITIS NAUSEA 2
C ANKYLOSING SPONDYLITIS PAIN 2
C ANKYLOSING SPONDYLITIS VOMITING 2
C ANTICOAGULANT THERAPY ABDOMINAL RIGIDITY 1
C ANTICOAGULANT THERAPY ANAEMIA 1
C ANTICOAGULANT THERAPY APPLICATION SITE ERYTHEMA 1
C ANTICOAGULANT THERAPY APPLICATION SITE RASH 1
C ANTICOAGULANT THERAPY BLOOD THYROID STIMULATING HORMONE DECREASED 1
C ANTICOAGULANT THERAPY CEREBRAL HAEMORRHAGE 1
C ANTICOAGULANT THERAPY CEREBROVASCULAR ACCIDENT 1
C ANTICOAGULANT THERAPY FEELING ABNORMAL 1
C ANTICOAGULANT THERAPY FUNGAL INFECTION 1
C ANTICOAGULANT THERAPY GASTROINTESTINAL INFECTION 1
C ANTICOAGULANT THERAPY INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 3
C ANTICOAGULANT THERAPY INCORRECT DOSE ADMINISTERED 1
C ANTICOAGULANT THERAPY INJECTION SITE ERYTHEMA 1
C ANTICOAGULANT THERAPY INJECTION SITE HAEMATOMA 1
C ANTICOAGULANT THERAPY INJECTION SITE MASS 1
C ANTICOAGULANT THERAPY INJECTION SITE PAIN 1
C ANTICOAGULANT THERAPY MALAISE 1
C ANTICOAGULANT THERAPY MULTIPLE SCLEROSIS RELAPSE 1
C ANTICOAGULANT THERAPY NAUSEA 1
C ANTICOAGULANT THERAPY PAIN 1
C ANTICOAGULANT THERAPY PNEUMONIA 1
C ANTICOAGULANT THERAPY PRODUCT ADHESION ISSUE 1
C ANTICOAGULANT THERAPY PRODUCT QUALITY ISSUE 1
C ANTICOAGULANT THERAPY PROTHROMBIN TIME ABNORMAL 1
C ANTICOAGULANT THERAPY RAYNAUD'S PHENOMENON 1
C ANTICOAGULANT THERAPY THERAPEUTIC RESPONSE UNEXPECTED 1
C ANTICOAGULANT THERAPY WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
C ANTIINFLAMMATORY THERAPY ABDOMINAL RIGIDITY 1
C ANTIINFLAMMATORY THERAPY FEELING ABNORMAL 1
C ANTIINFLAMMATORY THERAPY GASTROINTESTINAL INFECTION 1
C ANTIINFLAMMATORY THERAPY INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
C ANTIINFLAMMATORY THERAPY INCORRECT DOSE ADMINISTERED 1
C ANTIINFLAMMATORY THERAPY MALAISE 1
C ANTIINFLAMMATORY THERAPY NAUSEA 1
C ANTIINFLAMMATORY THERAPY PAIN 1
C ANTIINFLAMMATORY THERAPY PRODUCT QUALITY ISSUE 1
C BLOOD CHOLESTEROL ABDOMINAL RIGIDITY 1
C BLOOD CHOLESTEROL APPLICATION SITE ERYTHEMA 1
C BLOOD CHOLESTEROL APPLICATION SITE RASH 1
C BLOOD CHOLESTEROL FEELING ABNORMAL 1
C BLOOD CHOLESTEROL FUNGAL INFECTION 1
C BLOOD CHOLESTEROL GASTROINTESTINAL INFECTION 1
C BLOOD CHOLESTEROL INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
C BLOOD CHOLESTEROL INCORRECT DOSE ADMINISTERED 1
C BLOOD CHOLESTEROL MALAISE 1
C BLOOD CHOLESTEROL NAUSEA 1
C BLOOD CHOLESTEROL PAIN 1
C BLOOD CHOLESTEROL PRODUCT ADHESION ISSUE 1
C BLOOD CHOLESTEROL PRODUCT QUALITY ISSUE 1
C BLOOD CHOLESTEROL RAYNAUD'S PHENOMENON 1
C BLOOD CHOLESTEROL WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
C BLOOD PRESSURE ABDOMINAL RIGIDITY 1
C BLOOD PRESSURE APPLICATION SITE ERYTHEMA 1
C BLOOD PRESSURE APPLICATION SITE RASH 1
C BLOOD PRESSURE FEELING ABNORMAL 1
C BLOOD PRESSURE FUNGAL INFECTION 1
C BLOOD PRESSURE GASTROINTESTINAL INFECTION 1
C BLOOD PRESSURE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
C BLOOD PRESSURE INCORRECT DOSE ADMINISTERED 1
C BLOOD PRESSURE MALAISE 1
C BLOOD PRESSURE NAUSEA 1
C BLOOD PRESSURE PAIN 1
C BLOOD PRESSURE PRODUCT ADHESION ISSUE 1
C BLOOD PRESSURE PRODUCT QUALITY ISSUE 1
C BLOOD PRESSURE RAYNAUD'S PHENOMENON 1
C BLOOD PRESSURE WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
C BREAKTHROUGH PAIN ABDOMINAL RIGIDITY 1
C BREAKTHROUGH PAIN APPLICATION SITE ERYTHEMA 1
C BREAKTHROUGH PAIN APPLICATION SITE RASH 1
C BREAKTHROUGH PAIN FEELING ABNORMAL 1
C BREAKTHROUGH PAIN FUNGAL INFECTION 1
C BREAKTHROUGH PAIN GASTROINTESTINAL INFECTION 1
C BREAKTHROUGH PAIN INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
C BREAKTHROUGH PAIN INCORRECT DOSE ADMINISTERED 1
C BREAKTHROUGH PAIN MALAISE 1
C BREAKTHROUGH PAIN NAUSEA 1
C BREAKTHROUGH PAIN PAIN 1
C BREAKTHROUGH PAIN PRODUCT ADHESION ISSUE 1
C BREAKTHROUGH PAIN PRODUCT QUALITY ISSUE 1
C BREAKTHROUGH PAIN RAYNAUD'S PHENOMENON 1
C BREAKTHROUGH PAIN WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
C CONVULSION ABDOMINAL RIGIDITY 1
C CONVULSION APPLICATION SITE ERYTHEMA 1
C CONVULSION APPLICATION SITE RASH 1
C CONVULSION FEELING ABNORMAL 1
C CONVULSION FUNGAL INFECTION 1
C CONVULSION GASTROINTESTINAL INFECTION 1
C CONVULSION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
C CONVULSION INCORRECT DOSE ADMINISTERED 1
C CONVULSION MALAISE 1
C CONVULSION NAUSEA 1
C CONVULSION PAIN 1
C CONVULSION PRODUCT ADHESION ISSUE 1
C CONVULSION PRODUCT QUALITY ISSUE 1
C CONVULSION RAYNAUD'S PHENOMENON 1
C CONVULSION WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
C DYSTONIA AGITATION 1
C DYSTONIA ANXIETY 1
C DYSTONIA COUGH 1
C DYSTONIA DEPRESSION 1
C DYSTONIA DYSPNOEA 1
C DYSTONIA FRUSTRATION 1
C DYSTONIA HEADACHE 1
C DYSTONIA HYPERHIDROSIS 1
C DYSTONIA IRRITABILITY 1
C DYSTONIA MOOD SWINGS 1
C DYSTONIA NAUSEA 1
C DYSTONIA PSYCHOMOTOR HYPERACTIVITY 1
C DYSTONIA VISION BLURRED 1
C DYSTONIA VOMITING 1
C EPILEPSY ABDOMINAL RIGIDITY 1
C EPILEPSY FEELING ABNORMAL 1
C EPILEPSY GASTROINTESTINAL INFECTION 1
C EPILEPSY INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
C EPILEPSY INCORRECT DOSE ADMINISTERED 1
C EPILEPSY MALAISE 1
C EPILEPSY NAUSEA 1
C EPILEPSY PAIN 1
C EPILEPSY PRODUCT QUALITY ISSUE 1
C FIBROMYALGIA ABDOMINAL RIGIDITY 1
C FIBROMYALGIA APPLICATION SITE ERYTHEMA 3
C FIBROMYALGIA APPLICATION SITE RASH 3
C FIBROMYALGIA FEELING ABNORMAL 1
C FIBROMYALGIA FUNGAL INFECTION 3
C FIBROMYALGIA GASTROINTESTINAL INFECTION 1
C FIBROMYALGIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 4
C FIBROMYALGIA INCORRECT DOSE ADMINISTERED 1
C FIBROMYALGIA MALAISE 1
C FIBROMYALGIA NAUSEA 1
C FIBROMYALGIA PAIN 1
C FIBROMYALGIA PRODUCT ADHESION ISSUE 3
C FIBROMYALGIA PRODUCT QUALITY ISSUE 1
C FIBROMYALGIA RAYNAUD'S PHENOMENON 3
C FIBROMYALGIA WRONG TECHNIQUE IN DRUG USAGE PROCESS 3
C GASTROINTESTINAL DISORDER THERAPY ABDOMINAL RIGIDITY 1
C GASTROINTESTINAL DISORDER THERAPY APPLICATION SITE ERYTHEMA 1
C GASTROINTESTINAL DISORDER THERAPY APPLICATION SITE RASH 1
C GASTROINTESTINAL DISORDER THERAPY FEELING ABNORMAL 1
C GASTROINTESTINAL DISORDER THERAPY FUNGAL INFECTION 1
C GASTROINTESTINAL DISORDER THERAPY GASTROINTESTINAL INFECTION 1
C GASTROINTESTINAL DISORDER THERAPY INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
C GASTROINTESTINAL DISORDER THERAPY INCORRECT DOSE ADMINISTERED 1
C GASTROINTESTINAL DISORDER THERAPY MALAISE 1
C GASTROINTESTINAL DISORDER THERAPY NAUSEA 1
C GASTROINTESTINAL DISORDER THERAPY PAIN 1
C GASTROINTESTINAL DISORDER THERAPY PRODUCT ADHESION ISSUE 1
C GASTROINTESTINAL DISORDER THERAPY PRODUCT QUALITY ISSUE 1
C GASTROINTESTINAL DISORDER THERAPY RAYNAUD'S PHENOMENON 1
C GASTROINTESTINAL DISORDER THERAPY WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
C ILL-DEFINED DISORDER ABDOMINAL RIGIDITY 1
C ILL-DEFINED DISORDER FEELING ABNORMAL 1
C ILL-DEFINED DISORDER GASTROINTESTINAL INFECTION 1
C ILL-DEFINED DISORDER INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
C ILL-DEFINED DISORDER INCORRECT DOSE ADMINISTERED 1
C ILL-DEFINED DISORDER MALAISE 1
C ILL-DEFINED DISORDER NAUSEA 1
C ILL-DEFINED DISORDER PAIN 1
C ILL-DEFINED DISORDER PRODUCT QUALITY ISSUE 1
C MIGRAINE APPLICATION SITE ERYTHEMA 1
C MIGRAINE APPLICATION SITE RASH 1
C MIGRAINE FUNGAL INFECTION 1
C MIGRAINE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
C MIGRAINE PRODUCT ADHESION ISSUE 1
C MIGRAINE RAYNAUD'S PHENOMENON 1
C MIGRAINE WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
C MULTIPLE SCLEROSIS ANAEMIA 1
C MULTIPLE SCLEROSIS BLOOD THYROID STIMULATING HORMONE DECREASED 1
C MULTIPLE SCLEROSIS CARPAL TUNNEL SYNDROME 1
C MULTIPLE SCLEROSIS CEREBRAL HAEMORRHAGE 1
C MULTIPLE SCLEROSIS CEREBROVASCULAR ACCIDENT 1
C MULTIPLE SCLEROSIS DIARRHOEA 1
C MULTIPLE SCLEROSIS HEADACHE 1
C MULTIPLE SCLEROSIS HYPERTENSION 1
C MULTIPLE SCLEROSIS INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
C MULTIPLE SCLEROSIS INJECTION SITE ERYTHEMA 1
C MULTIPLE SCLEROSIS INJECTION SITE HAEMATOMA 1
C MULTIPLE SCLEROSIS INJECTION SITE MASS 1
C MULTIPLE SCLEROSIS INJECTION SITE PAIN 1
C MULTIPLE SCLEROSIS MULTIPLE SCLEROSIS RELAPSE 1
C MULTIPLE SCLEROSIS MUSCLE SPASMS 1
C MULTIPLE SCLEROSIS PNEUMONIA 1
C MULTIPLE SCLEROSIS PROTHROMBIN TIME ABNORMAL 1
C MULTIPLE SCLEROSIS THERAPEUTIC RESPONSE UNEXPECTED 1
C MUSCLE RELAXANT THERAPY ABDOMINAL DISCOMFORT 2
C MUSCLE RELAXANT THERAPY ABDOMINAL RIGIDITY 1
C MUSCLE RELAXANT THERAPY DIARRHOEA 2
C MUSCLE RELAXANT THERAPY DISCOMFORT 2
C MUSCLE RELAXANT THERAPY FATIGUE 2
C MUSCLE RELAXANT THERAPY FEELING ABNORMAL 1
C MUSCLE RELAXANT THERAPY GASTROINTESTINAL INFECTION 1
C MUSCLE RELAXANT THERAPY INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
C MUSCLE RELAXANT THERAPY INCORRECT DOSE ADMINISTERED 1
C MUSCLE RELAXANT THERAPY INTERVERTEBRAL DISC OPERATION 2
C MUSCLE RELAXANT THERAPY MALAISE 3
C MUSCLE RELAXANT THERAPY NASAL SEPTUM DEVIATION 2
C MUSCLE RELAXANT THERAPY NAUSEA 3
C MUSCLE RELAXANT THERAPY PAIN 3
C MUSCLE RELAXANT THERAPY PRODUCT QUALITY ISSUE 1
C MUSCLE RELAXANT THERAPY VOMITING 2
C MUSCLE SPASMS ABDOMINAL DISCOMFORT 2
C MUSCLE SPASMS DIARRHOEA 2
C MUSCLE SPASMS DISCOMFORT 2
C MUSCLE SPASMS FATIGUE 2
C MUSCLE SPASMS INTERVERTEBRAL DISC OPERATION 2
C MUSCLE SPASMS MALAISE 2
C MUSCLE SPASMS NASAL SEPTUM DEVIATION 2
C MUSCLE SPASMS NAUSEA 2
C MUSCLE SPASMS PAIN 2
C MUSCLE SPASMS VOMITING 2
C NAUSEA ABDOMINAL RIGIDITY 1
C NAUSEA FEELING ABNORMAL 1
C NAUSEA GASTROINTESTINAL INFECTION 1
C NAUSEA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
C NAUSEA INCORRECT DOSE ADMINISTERED 1
C NAUSEA MALAISE 1
C NAUSEA NAUSEA 1
C NAUSEA PAIN 1
C NAUSEA PRODUCT QUALITY ISSUE 1
C OSTEOPOROSIS ABDOMINAL RIGIDITY 1
C OSTEOPOROSIS APPLICATION SITE ERYTHEMA 1
C OSTEOPOROSIS APPLICATION SITE RASH 1
C OSTEOPOROSIS FEELING ABNORMAL 1
C OSTEOPOROSIS FUNGAL INFECTION 1
C OSTEOPOROSIS GASTROINTESTINAL INFECTION 1
C OSTEOPOROSIS INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
C OSTEOPOROSIS INCORRECT DOSE ADMINISTERED 1
C OSTEOPOROSIS MALAISE 1
C OSTEOPOROSIS NAUSEA 1
C OSTEOPOROSIS PAIN 1
C OSTEOPOROSIS PRODUCT ADHESION ISSUE 1
C OSTEOPOROSIS PRODUCT QUALITY ISSUE 1
C OSTEOPOROSIS RAYNAUD'S PHENOMENON 1
C OSTEOPOROSIS WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
C PAIN ABDOMINAL DISCOMFORT 4
C PAIN ABDOMINAL RIGIDITY 1
C PAIN APPLICATION SITE ERYTHEMA 3
C PAIN APPLICATION SITE RASH 3
C PAIN DIARRHOEA 4
C PAIN DISCOMFORT 4
C PAIN FATIGUE 4
C PAIN FEELING ABNORMAL 1
C PAIN FUNGAL INFECTION 3
C PAIN GASTROINTESTINAL INFECTION 1
C PAIN INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 4
C PAIN INCORRECT DOSE ADMINISTERED 1
C PAIN INTERVERTEBRAL DISC OPERATION 4
C PAIN MALAISE 5
C PAIN NASAL SEPTUM DEVIATION 4
C PAIN NAUSEA 5
C PAIN PAIN 5
C PAIN PRODUCT ADHESION ISSUE 3
C PAIN PRODUCT QUALITY ISSUE 1
C PAIN RAYNAUD'S PHENOMENON 3
C PAIN VOMITING 4
C PAIN WRONG TECHNIQUE IN DRUG USAGE PROCESS 3
C PREMEDICATION ANAEMIA 1
C PREMEDICATION BLOOD THYROID STIMULATING HORMONE DECREASED 1
C PREMEDICATION CEREBRAL HAEMORRHAGE 1
C PREMEDICATION CEREBROVASCULAR ACCIDENT 1
C PREMEDICATION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
C PREMEDICATION INJECTION SITE ERYTHEMA 1
C PREMEDICATION INJECTION SITE HAEMATOMA 1
C PREMEDICATION INJECTION SITE MASS 1
C PREMEDICATION INJECTION SITE PAIN 1
C PREMEDICATION MULTIPLE SCLEROSIS RELAPSE 1
C PREMEDICATION PNEUMONIA 1
C PREMEDICATION PROTHROMBIN TIME ABNORMAL 1
C PREMEDICATION THERAPEUTIC RESPONSE UNEXPECTED 1
C PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL DISCOMFORT 4
C PRODUCT USED FOR UNKNOWN INDICATION DIARRHOEA 4
C PRODUCT USED FOR UNKNOWN INDICATION DISCOMFORT 4
C PRODUCT USED FOR UNKNOWN INDICATION FATIGUE 4
C PRODUCT USED FOR UNKNOWN INDICATION INTERVERTEBRAL DISC OPERATION 4
C PRODUCT USED FOR UNKNOWN INDICATION MALAISE 4
C PRODUCT USED FOR UNKNOWN INDICATION NASAL SEPTUM DEVIATION 4
C PRODUCT USED FOR UNKNOWN INDICATION NAUSEA 4
C PRODUCT USED FOR UNKNOWN INDICATION PAIN 4
C PRODUCT USED FOR UNKNOWN INDICATION VOMITING 4
C SLEEP DISORDER APPLICATION SITE ERYTHEMA 2
C SLEEP DISORDER APPLICATION SITE RASH 2
C SLEEP DISORDER FUNGAL INFECTION 2
C SLEEP DISORDER INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
C SLEEP DISORDER PRODUCT ADHESION ISSUE 2
C SLEEP DISORDER RAYNAUD'S PHENOMENON 2
C SLEEP DISORDER WRONG TECHNIQUE IN DRUG USAGE PROCESS 2
C SLEEP DISORDER THERAPY ABDOMINAL RIGIDITY 2
C SLEEP DISORDER THERAPY FEELING ABNORMAL 2
C SLEEP DISORDER THERAPY GASTROINTESTINAL INFECTION 2
C SLEEP DISORDER THERAPY INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
C SLEEP DISORDER THERAPY INCORRECT DOSE ADMINISTERED 2
C SLEEP DISORDER THERAPY MALAISE 2
C SLEEP DISORDER THERAPY NAUSEA 2
C SLEEP DISORDER THERAPY PAIN 2
C SLEEP DISORDER THERAPY PRODUCT QUALITY ISSUE 2
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