Drug information for EMBEDA

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE, EXTENDED RELEASE; ORAL 100MG;4MG Prescription  (Reference Drug) MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE morphine, naltrexone combination ALPHARMA KING 22321
2010-05-25 Review
2009-09-02 Medication Guide
2009-08-19 Letter
2009-08-18 Label
2009-08-18 Summary Review
2009-08-18 Other
CAPSULE, EXTENDED RELEASE; ORAL 20MG;0.8MG Prescription   MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE morphine, naltrexone combination ALPHARMA KING   "
CAPSULE, EXTENDED RELEASE; ORAL 30MG;1.2MG Prescription   MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE morphine, naltrexone combination ALPHARMA KING   "
CAPSULE, EXTENDED RELEASE; ORAL 50MG;2MG Prescription   MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE morphine, naltrexone combination ALPHARMA KING   "
CAPSULE, EXTENDED RELEASE; ORAL 60MG;2.4MG Prescription   MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE morphine, naltrexone combination ALPHARMA KING   "
CAPSULE, EXTENDED RELEASE; ORAL 80MG;3.2MG Prescription   MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE morphine, naltrexone combination ALPHARMA KING   "

Drug Adverse Effects information for EMBEDA

Role code Indications Reaction # Reports
PS ARTHRITIS AMNESIA 2
PS ARTHRITIS BRAIN OEDEMA 2
PS ARTHRITIS CONVULSION 2
PS ARTHRITIS DEPRESSION 2
PS ARTHRITIS DISABILITY 2
PS ARTHRITIS DRUG INEFFECTIVE 2
PS ARTHRITIS EPILEPSY 2
PS ARTHRITIS LOSS OF CONSCIOUSNESS 2
PS ARTHRITIS MIGRAINE 2
PS ARTHRITIS POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 2
PS ARTHRITIS RENAL FAILURE 2
PS ARTHRITIS SPEECH DISORDER 2
PS BACK PAIN AMNESIA 2
PS BACK PAIN BRAIN OEDEMA 2
PS BACK PAIN CHEST DISCOMFORT 1
PS BACK PAIN CONVULSION 2
PS BACK PAIN DEPRESSION 2
PS BACK PAIN DISABILITY 2
PS BACK PAIN DRUG INEFFECTIVE 2
PS BACK PAIN DRY MOUTH 1
PS BACK PAIN DYSPNOEA 1
PS BACK PAIN EPILEPSY 2
PS BACK PAIN HEADACHE 1
PS BACK PAIN HYPERSENSITIVITY 1
PS BACK PAIN INSOMNIA 1
PS BACK PAIN LOSS OF CONSCIOUSNESS 2
PS BACK PAIN MIGRAINE 2
PS BACK PAIN NAUSEA 1
PS BACK PAIN NERVOUS SYSTEM DISORDER 1
PS BACK PAIN POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 2
PS BACK PAIN PRURITUS 1
PS BACK PAIN RASH GENERALISED 1
PS BACK PAIN RENAL FAILURE 2
PS BACK PAIN SPEECH DISORDER 2
PS BACK PAIN TREMOR 1
PS BACK PAIN VISION BLURRED 1
PS DIABETES MELLITUS AMNESIA 4
PS DIABETES MELLITUS BRAIN OEDEMA 4
PS DIABETES MELLITUS CONVULSION 4
PS DIABETES MELLITUS DEPRESSION 4
PS DIABETES MELLITUS DISABILITY 4
PS DIABETES MELLITUS DRUG INEFFECTIVE 4
PS DIABETES MELLITUS EPILEPSY 4
PS DIABETES MELLITUS LOSS OF CONSCIOUSNESS 4
PS DIABETES MELLITUS MIGRAINE 4
PS DIABETES MELLITUS POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 4
PS DIABETES MELLITUS RENAL FAILURE 4
PS DIABETES MELLITUS SPEECH DISORDER 4
PS HEADACHE AMNESIA 2
PS HEADACHE BRAIN OEDEMA 2
PS HEADACHE CHEST DISCOMFORT 1
PS HEADACHE CONVULSION 2
PS HEADACHE DEPRESSION 2
PS HEADACHE DISABILITY 2
PS HEADACHE DRUG INEFFECTIVE 2
PS HEADACHE DRY MOUTH 1
PS HEADACHE DYSPNOEA 1
PS HEADACHE EPILEPSY 2
PS HEADACHE HEADACHE 1
PS HEADACHE HYPERSENSITIVITY 1
PS HEADACHE INSOMNIA 1
PS HEADACHE LOSS OF CONSCIOUSNESS 2
PS HEADACHE MIGRAINE 2
PS HEADACHE NAUSEA 1
PS HEADACHE NERVOUS SYSTEM DISORDER 1
PS HEADACHE POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 2
PS HEADACHE PRURITUS 1
PS HEADACHE RASH GENERALISED 1
PS HEADACHE RENAL FAILURE 2
PS HEADACHE SPEECH DISORDER 2
PS HEADACHE TREMOR 1
PS HEADACHE VISION BLURRED 1
PS HYPERTENSION AMNESIA 6
PS HYPERTENSION BRAIN OEDEMA 6
PS HYPERTENSION CONVULSION 6
PS HYPERTENSION DEPRESSION 6
PS HYPERTENSION DISABILITY 6
PS HYPERTENSION DRUG INEFFECTIVE 6
PS HYPERTENSION EPILEPSY 6
PS HYPERTENSION LOSS OF CONSCIOUSNESS 6
PS HYPERTENSION MIGRAINE 6
PS HYPERTENSION POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 6
PS HYPERTENSION RENAL FAILURE 6
PS HYPERTENSION SPEECH DISORDER 6
PS HYPOTHYROIDISM CHEST DISCOMFORT 1
PS HYPOTHYROIDISM DRY MOUTH 1
PS HYPOTHYROIDISM DYSPNOEA 1
PS HYPOTHYROIDISM HEADACHE 1
PS HYPOTHYROIDISM HYPERSENSITIVITY 1
PS HYPOTHYROIDISM INSOMNIA 1
PS HYPOTHYROIDISM NAUSEA 1
PS HYPOTHYROIDISM NERVOUS SYSTEM DISORDER 1
PS HYPOTHYROIDISM PRURITUS 1
PS HYPOTHYROIDISM RASH GENERALISED 1
PS HYPOTHYROIDISM TREMOR 1
PS HYPOTHYROIDISM VISION BLURRED 1
PS NECK PAIN AMNESIA 2
PS NECK PAIN BRAIN OEDEMA 2
PS NECK PAIN CONVULSION 2
PS NECK PAIN DEPRESSION 2
PS NECK PAIN DISABILITY 2
PS NECK PAIN DRUG INEFFECTIVE 2
PS NECK PAIN EPILEPSY 2
PS NECK PAIN LOSS OF CONSCIOUSNESS 2
PS NECK PAIN MIGRAINE 2
PS NECK PAIN POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 2
PS NECK PAIN RENAL FAILURE 2
PS NECK PAIN SPEECH DISORDER 2
PS PAIN BONE PAIN 1
PS PAIN CRYING 1
PS PAIN FEELING ABNORMAL 1
PS PAIN PAIN 3
PS PAIN SUICIDAL IDEATION 1
PS SPINAL OPERATION BONE PAIN 1
PS SPINAL OPERATION CRYING 1
PS SPINAL OPERATION FEELING ABNORMAL 1
PS SPINAL OPERATION PAIN 2
SS ANXIETY LIBIDO DECREASED 20
SS ARTHRITIS AMNESIA 4
SS ARTHRITIS BRAIN OEDEMA 4
SS ARTHRITIS CONVULSION 4
SS ARTHRITIS DEPRESSION 4
SS ARTHRITIS DISABILITY 4
SS ARTHRITIS DRUG INEFFECTIVE 4
SS ARTHRITIS EPILEPSY 4
SS ARTHRITIS LOSS OF CONSCIOUSNESS 4
SS ARTHRITIS MIGRAINE 4
SS ARTHRITIS POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 4
SS ARTHRITIS RENAL FAILURE 4
SS ARTHRITIS SPEECH DISORDER 4
SS BACK PAIN AMNESIA 4
SS BACK PAIN BRAIN OEDEMA 4
SS BACK PAIN CONVULSION 4
SS BACK PAIN DEPRESSION 4
SS BACK PAIN DISABILITY 4
SS BACK PAIN DRUG INEFFECTIVE 4
SS BACK PAIN EPILEPSY 4
SS BACK PAIN LOSS OF CONSCIOUSNESS 4
SS BACK PAIN MIGRAINE 4
SS BACK PAIN POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 4
SS BACK PAIN RENAL FAILURE 4
SS BACK PAIN SPEECH DISORDER 4
SS BLOOD CHOLESTEROL INCREASED LIBIDO DECREASED 4
SS DEPRESSION LIBIDO DECREASED 20
SS DIABETES MELLITUS AMNESIA 8
SS DIABETES MELLITUS BRAIN OEDEMA 8
SS DIABETES MELLITUS CONVULSION 8
SS DIABETES MELLITUS DEPRESSION 8
SS DIABETES MELLITUS DISABILITY 8
SS DIABETES MELLITUS DRUG INEFFECTIVE 8
SS DIABETES MELLITUS EPILEPSY 8
SS DIABETES MELLITUS LOSS OF CONSCIOUSNESS 8
SS DIABETES MELLITUS MIGRAINE 8
SS DIABETES MELLITUS POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 8
SS DIABETES MELLITUS RENAL FAILURE 8
SS DIABETES MELLITUS SPEECH DISORDER 8
SS HEADACHE AMNESIA 4
SS HEADACHE BRAIN OEDEMA 4
SS HEADACHE CONVULSION 4
SS HEADACHE DEPRESSION 4
SS HEADACHE DISABILITY 4
SS HEADACHE DRUG INEFFECTIVE 4
SS HEADACHE EPILEPSY 4
SS HEADACHE LOSS OF CONSCIOUSNESS 4
SS HEADACHE MIGRAINE 4
SS HEADACHE POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 4
SS HEADACHE RENAL FAILURE 4
SS HEADACHE SPEECH DISORDER 4
SS HYPERTENSION AMNESIA 12
SS HYPERTENSION BLOOD PRESSURE INCREASED 6
SS HYPERTENSION BRAIN OEDEMA 12
SS HYPERTENSION CONVULSION 12
SS HYPERTENSION DEPRESSION 12
SS HYPERTENSION DISABILITY 12
SS HYPERTENSION DRUG INEFFECTIVE 12
SS HYPERTENSION EPILEPSY 12
SS HYPERTENSION LIBIDO DECREASED 4
SS HYPERTENSION LOSS OF CONSCIOUSNESS 12
SS HYPERTENSION MIGRAINE 12
SS HYPERTENSION POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 12
SS HYPERTENSION RENAL FAILURE 12
SS HYPERTENSION SPEECH DISORDER 12
SS NECK PAIN AMNESIA 4
SS NECK PAIN BRAIN OEDEMA 4
SS NECK PAIN CONVULSION 4
SS NECK PAIN DEPRESSION 4
SS NECK PAIN DISABILITY 4
SS NECK PAIN DRUG INEFFECTIVE 4
SS NECK PAIN EPILEPSY 4
SS NECK PAIN LOSS OF CONSCIOUSNESS 4
SS NECK PAIN MIGRAINE 4
SS NECK PAIN POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 4
SS NECK PAIN RENAL FAILURE 4
SS NECK PAIN SPEECH DISORDER 4
SS PAIN BONE PAIN 1
SS PAIN CRYING 1
SS PAIN FEELING ABNORMAL 1
SS PAIN PAIN 2
SS SPINAL OPERATION BONE PAIN 1
SS SPINAL OPERATION CRYING 1
SS SPINAL OPERATION FEELING ABNORMAL 1
SS SPINAL OPERATION PAIN 2
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