Drug information for EXALGO

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, EXTENDED RELEASE; ORAL 12MG Prescription   HYDROMORPHONE HYDROCHLORIDE Hydromorphone MALLINCKRODT INC 21217
2010-05-23 Review

2010-05-23 Summary Review

2010-04-01 Other

2010-04-01 Other

2010-03-31 Letter

2010-03-03 Letter

2010-03-02 Medication Guide

2010-03-02 Label
TABLET, EXTENDED RELEASE; ORAL 16MG Prescription  (Reference Drug) HYDROMORPHONE HYDROCHLORIDE Hydromorphone MALLINCKRODT INC   "
TABLET, EXTENDED RELEASE; ORAL 8MG Prescription   HYDROMORPHONE HYDROCHLORIDE Hydromorphone MALLINCKRODT INC   "

Drug Adverse Effects information for EXALGO

Role code Indications Reaction # Reports
PS ANALGESIC THERAPY CONSTIPATION 1
PS ANALGESIC THERAPY DISEASE PROGRESSION 3
PS ANALGESIC THERAPY DYSPNOEA 3
PS ANALGESIC THERAPY EYE SWELLING 1
PS ANALGESIC THERAPY FEAR 1
PS ANALGESIC THERAPY HAEMORRHOIDS 1
PS ANALGESIC THERAPY NIGHTMARE 1
PS ANALGESIC THERAPY OEDEMA PERIPHERAL 1
PS ANALGESIC THERAPY PARANOIA 1
PS ANALGESIC THERAPY PSYCHIATRIC SYMPTOM 1
PS ANALGESIC THERAPY SOMNAMBULISM 1
PS ANALGESIC THERAPY WEIGHT INCREASED 1
PS ANXIETY DRUG INTERACTION 1
PS ANXIETY SEROTONIN SYNDROME 1
PS ARRHYTHMIA CONSTIPATION 1
PS ARRHYTHMIA EYE SWELLING 1
PS ARRHYTHMIA FEAR 1
PS ARRHYTHMIA HAEMORRHOIDS 1
PS ARRHYTHMIA NIGHTMARE 1
PS ARRHYTHMIA OEDEMA PERIPHERAL 1
PS ARRHYTHMIA PARANOIA 1
PS ARRHYTHMIA PSYCHIATRIC SYMPTOM 1
PS ARRHYTHMIA SOMNAMBULISM 1
PS ARRHYTHMIA WEIGHT INCREASED 1
PS ARTHRALGIA BLOOD GLUCOSE INCREASED 2
PS ARTHRALGIA BLOOD UREA INCREASED 2
PS ARTHRALGIA CHRONIC OBSTRUCTIVE PULMONARY DISEASE 2
PS ARTHRALGIA DYSPNOEA 2
PS ARTHRALGIA REFUSAL OF TREATMENT BY RELATIVE 2
PS ARTHRALGIA RENAL FUNCTION TEST ABNORMAL 2
PS ARTHRALGIA SEDATION 2
PS ARTHRALGIA SPEECH DISORDER 2
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER PNEUMONIA 1
PS BACK PAIN AGITATION 3
PS BACK PAIN CARDIO-RESPIRATORY ARREST 2
PS BACK PAIN CONFUSIONAL STATE 3
PS BACK PAIN DRUG INEFFECTIVE 1
PS BACK PAIN HYPOCALCAEMIA 1
PS BACK PAIN HYPOKALAEMIA 3
PS BACK PAIN HYPONATRAEMIA 3
PS BACK PAIN SWELLING FACE 1
PS BACK PAIN SYNCOPE 2
PS BACK PAIN URINARY RETENTION 1
PS BONE PAIN CONSTIPATION 1
PS BONE PAIN RECTAL PROLAPSE 2
PS BONE PAIN RESPIRATORY FAILURE 2
PS BONE PAIN RESPIRATORY TRACT INFECTION 2
PS BREAKTHROUGH PAIN ANAEMIA 1
PS BREAKTHROUGH PAIN BILE DUCT OBSTRUCTION 1
PS BREAKTHROUGH PAIN BREAKTHROUGH PAIN 1
PS BREAKTHROUGH PAIN CHOLANGITIS 1
PS BREAKTHROUGH PAIN CONFUSIONAL STATE 1
PS BREAKTHROUGH PAIN DRUG EFFECT DECREASED 2
PS BREAKTHROUGH PAIN DRUG INEFFECTIVE 1
PS BREAKTHROUGH PAIN DYSPHAGIA 1
PS BREAKTHROUGH PAIN GENERAL PHYSICAL HEALTH DETERIORATION 1
PS BREAKTHROUGH PAIN HALLUCINATION 1
PS BREAKTHROUGH PAIN HYPOTENSION 1
PS BREAKTHROUGH PAIN MALAISE 1
PS BREAKTHROUGH PAIN MIDDLE INSOMNIA 1
PS BREAKTHROUGH PAIN MUSCLE SPASMS 1
PS BREAKTHROUGH PAIN NEOPLASM PROGRESSION 1
PS BREAKTHROUGH PAIN SOMNOLENCE 1
PS BREAKTHROUGH PAIN SWELLING FACE 1
PS BREAKTHROUGH PAIN URINARY RETENTION 2
PS BREAKTHROUGH PAIN WEIGHT DECREASED 1
PS CANCER PAIN ABDOMINAL PAIN 2
PS CANCER PAIN ANAEMIA 3
PS CANCER PAIN BILE DUCT OBSTRUCTION 3
PS CANCER PAIN BLOOD GLUCOSE INCREASED 2
PS CANCER PAIN BLOOD UREA INCREASED 2
PS CANCER PAIN BREAKTHROUGH PAIN 2
PS CANCER PAIN CHOLANGITIS 3
PS CANCER PAIN CHRONIC OBSTRUCTIVE PULMONARY DISEASE 2
PS CANCER PAIN CONFUSIONAL STATE 3
PS CANCER PAIN DIZZINESS 1
PS CANCER PAIN DRUG EFFECT DECREASED 3
PS CANCER PAIN DRUG INTOLERANCE 1
PS CANCER PAIN DYSPHAGIA 3
PS CANCER PAIN DYSPNOEA 2
PS CANCER PAIN GAIT DISTURBANCE 2
PS CANCER PAIN GENERAL PHYSICAL HEALTH DETERIORATION 3
PS CANCER PAIN HALLUCINATION 3
PS CANCER PAIN HYPOTENSION 3
PS CANCER PAIN INTESTINAL OBSTRUCTION 2
PS CANCER PAIN LOSS OF CONSCIOUSNESS 1
PS CANCER PAIN MALAISE 3
PS CANCER PAIN MUSCLE SPASMS 3
PS CANCER PAIN MUSCULAR WEAKNESS 2
PS CANCER PAIN NAUSEA 1
PS CANCER PAIN NEOPLASM PROGRESSION 3
PS CANCER PAIN REFUSAL OF TREATMENT BY RELATIVE 2
PS CANCER PAIN RENAL FUNCTION TEST ABNORMAL 2
PS CANCER PAIN RESPIRATORY ARREST 1
PS CANCER PAIN SEDATION 2
PS CANCER PAIN SOMNOLENCE 3
PS CANCER PAIN SPEECH DISORDER 2
PS CANCER PAIN URINARY RETENTION 3
PS CANCER PAIN VOMITING 1
PS CANCER PAIN WEIGHT DECREASED 3
PS CHEMOTHERAPY ANAEMIA 2
PS CHEMOTHERAPY BILE DUCT OBSTRUCTION 2
PS CHEMOTHERAPY CHOLANGITIS 2
PS CHEMOTHERAPY CONFUSIONAL STATE 2
PS CHEMOTHERAPY DRUG EFFECT DECREASED 2
PS CHEMOTHERAPY DYSPHAGIA 2
PS CHEMOTHERAPY GENERAL PHYSICAL HEALTH DETERIORATION 2
PS CHEMOTHERAPY HALLUCINATION 2
PS CHEMOTHERAPY HYPOTENSION 2
PS CHEMOTHERAPY MALAISE 2
PS CHEMOTHERAPY MUSCLE SPASMS 2
PS CHEMOTHERAPY NEOPLASM PROGRESSION 2
PS CHEMOTHERAPY SOMNOLENCE 2
PS CHEMOTHERAPY URINARY RETENTION 2
PS CHEMOTHERAPY WEIGHT DECREASED 2
PS DEPRESSION CONSTIPATION 1
PS DEPRESSION DRUG INTERACTION 1
PS DEPRESSION EYE SWELLING 1
PS DEPRESSION FEAR 1
PS DEPRESSION HAEMORRHOIDS 1
PS DEPRESSION NIGHTMARE 1
PS DEPRESSION OEDEMA PERIPHERAL 1
PS DEPRESSION PARANOIA 1
PS DEPRESSION PSYCHIATRIC SYMPTOM 1
PS DEPRESSION SEROTONIN SYNDROME 1
PS DEPRESSION SOMNAMBULISM 1
PS DEPRESSION WEIGHT INCREASED 1
PS DIABETES MELLITUS BLOOD GLUCOSE INCREASED 1
PS DIABETES MELLITUS BLOOD UREA INCREASED 1
PS DIABETES MELLITUS CHRONIC OBSTRUCTIVE PULMONARY DISEASE 1
PS DIABETES MELLITUS DYSPNOEA 1
PS DIABETES MELLITUS REFUSAL OF TREATMENT BY RELATIVE 1
PS DIABETES MELLITUS RENAL FUNCTION TEST ABNORMAL 1
PS DIABETES MELLITUS SEDATION 1
PS DIABETES MELLITUS SPEECH DISORDER 1
PS DIABETIC NEUROPATHY PNEUMONIA 6
PS EPILEPSY BRONCHIAL DISORDER 1
PS EPILEPSY DEPRESSED LEVEL OF CONSCIOUSNESS 1
PS EPILEPSY FAECAL INCONTINENCE 1
PS EPILEPSY GENERAL PHYSICAL HEALTH DETERIORATION 1
PS EPILEPSY STARING 1
PS EPILEPSY URINARY INCONTINENCE 1
PS HYPERTENSION CONSTIPATION 1
PS HYPERTENSION EYE SWELLING 1
PS HYPERTENSION FEAR 1
PS HYPERTENSION HAEMORRHOIDS 1
PS HYPERTENSION NIGHTMARE 1
PS HYPERTENSION OEDEMA PERIPHERAL 1
PS HYPERTENSION PARANOIA 1
PS HYPERTENSION PSYCHIATRIC SYMPTOM 1
PS HYPERTENSION SOMNAMBULISM 1
PS HYPERTENSION WEIGHT INCREASED 1
PS MUSCLE RELAXANT THERAPY PNEUMONIA 2
PS NEURALGIA BRONCHIAL DISORDER 1
PS NEURALGIA DEPRESSED LEVEL OF CONSCIOUSNESS 1
PS NEURALGIA FAECAL INCONTINENCE 1
PS NEURALGIA GENERAL PHYSICAL HEALTH DETERIORATION 1
PS NEURALGIA PNEUMONIA 1
PS NEURALGIA STARING 1
PS NEURALGIA URINARY INCONTINENCE 1
PS OESOPHAGEAL SPASM AMNESIA 1
PS OESOPHAGEAL SPASM CONFUSIONAL STATE 1
PS OESOPHAGEAL SPASM CONSTIPATION 1
PS OESOPHAGEAL SPASM DYSGEUSIA 1
PS OESOPHAGEAL SPASM FATIGUE 1
PS OESOPHAGEAL SPASM FORMICATION 1
PS OESOPHAGEAL SPASM INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS OESOPHAGEAL SPASM NAUSEA 1
PS OESOPHAGEAL SPASM PAIN 1
PS OESOPHAGEAL SPASM PAROSMIA 1
PS OESOPHAGEAL SPASM PRURITUS 1
PS OESOPHAGEAL SPASM SLUGGISHNESS 1
PS PAIN AMNESIA 1
PS PAIN ANAEMIA 3
PS PAIN BILE DUCT OBSTRUCTION 3
PS PAIN BREAKTHROUGH PAIN 1
PS PAIN BRONCHIAL DISORDER 2
PS PAIN CHOLANGITIS 3
PS PAIN CONDITION AGGRAVATED 3
PS PAIN CONFUSIONAL STATE 5
PS PAIN CONSTIPATION 4
PS PAIN DEATH 3
PS PAIN DEPRESSED LEVEL OF CONSCIOUSNESS 2
PS PAIN DRUG EFFECT DECREASED 4
PS PAIN DRUG INTERACTION 1
PS PAIN DYSGEUSIA 1
PS PAIN DYSPHAGIA 3
PS PAIN EPILEPSY 1
PS PAIN FAECAL INCONTINENCE 1
PS PAIN FATIGUE 1
PS PAIN FORMICATION 1
PS PAIN GENERAL PHYSICAL HEALTH DETERIORATION 4
PS PAIN HALLUCINATION 4
PS PAIN HALLUCINATION, AUDITORY 3
PS PAIN HALLUCINATION, VISUAL 3
PS PAIN HYPOKALAEMIA 1
PS PAIN HYPOTENSION 3
PS PAIN INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS PAIN INCOHERENT 1
PS PAIN LOSS OF CONSCIOUSNESS 4
PS PAIN MALAISE 3
PS PAIN MEDICATION ERROR 6
PS PAIN MIDDLE INSOMNIA 1
PS PAIN MUSCLE CONTRACTIONS INVOLUNTARY 3
PS PAIN MUSCLE SPASMS 3
PS PAIN NAUSEA 1
PS PAIN NEOPLASM PROGRESSION 3
PS PAIN PAIN 4
PS PAIN PAROSMIA 1
PS PAIN PRURITUS 1
PS PAIN RESPIRATION ABNORMAL 4
PS PAIN SEROTONIN SYNDROME 1
PS PAIN SLUGGISHNESS 1
PS PAIN SOMNOLENCE 10
PS PAIN STARING 1
PS PAIN SYNCOPE 1
PS PAIN TOXICITY TO VARIOUS AGENTS 6
PS PAIN URINARY INCONTINENCE 1
PS PAIN URINARY RETENTION 3
PS PAIN WEIGHT DECREASED 3
PS PAIN MANAGEMENT HAEMATEMESIS 1
PS PAIN MANAGEMENT NAUSEA 1
PS PAIN MANAGEMENT PRODUCT SOLUBILITY ABNORMAL 1
PS PRODUCT USED FOR UNKNOWN INDICATION ATAXIA 2
PS PRODUCT USED FOR UNKNOWN INDICATION BLOOD GLUCOSE INCREASED 2
PS PRODUCT USED FOR UNKNOWN INDICATION BREAKTHROUGH PAIN 2
PS PRODUCT USED FOR UNKNOWN INDICATION COMA 1
PS PRODUCT USED FOR UNKNOWN INDICATION COMPLETED SUICIDE 1
PS PRODUCT USED FOR UNKNOWN INDICATION DELIRIUM 1
PS PRODUCT USED FOR UNKNOWN INDICATION DEPENDENCE 1
PS PRODUCT USED FOR UNKNOWN INDICATION DYSARTHRIA 2
PS PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA 1
PS PRODUCT USED FOR UNKNOWN INDICATION GAIT DISTURBANCE 2
PS PRODUCT USED FOR UNKNOWN INDICATION INTENTIONAL OVERDOSE 1
PS PRODUCT USED FOR UNKNOWN INDICATION LOSS OF CONSCIOUSNESS 3
PS PRODUCT USED FOR UNKNOWN INDICATION MIOSIS 2
PS PRODUCT USED FOR UNKNOWN INDICATION MUSCULAR WEAKNESS 2
PS PRODUCT USED FOR UNKNOWN INDICATION OVERDOSE 2
PS PRODUCT USED FOR UNKNOWN INDICATION PRURITUS 2
PS PRODUCT USED FOR UNKNOWN INDICATION RESPIRATION ABNORMAL 3
PS PRODUCT USED FOR UNKNOWN INDICATION RESPIRATORY ARREST 1
PS PRODUCT USED FOR UNKNOWN INDICATION SEDATION 2
PS PRODUCT USED FOR UNKNOWN INDICATION SEROTONIN SYNDROME 1
PS PRODUCT USED FOR UNKNOWN INDICATION SOMNOLENCE 3
PS PRODUCT USED FOR UNKNOWN INDICATION SYNCOPE 2
PS PRURITUS AMNESIA 2
PS PRURITUS CONFUSIONAL STATE 2
PS PRURITUS CONSTIPATION 2
PS PRURITUS DYSGEUSIA 2
PS PRURITUS FATIGUE 2
PS PRURITUS FORMICATION 2
PS PRURITUS INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
PS PRURITUS NAUSEA 2
PS PRURITUS PAIN 2
PS PRURITUS PAROSMIA 2
PS PRURITUS PRURITUS 2
PS PRURITUS SLUGGISHNESS 2
PS THYROID DISORDER CONSTIPATION 1
PS THYROID DISORDER EYE SWELLING 1
PS THYROID DISORDER FEAR 1
PS THYROID DISORDER HAEMORRHOIDS 1
PS THYROID DISORDER NIGHTMARE 1
PS THYROID DISORDER OEDEMA PERIPHERAL 1
PS THYROID DISORDER PARANOIA 1
PS THYROID DISORDER PSYCHIATRIC SYMPTOM 1
PS THYROID DISORDER SOMNAMBULISM 1
PS THYROID DISORDER WEIGHT INCREASED 1
SS ARTHRALGIA BLOOD GLUCOSE INCREASED 2
SS ARTHRALGIA BLOOD UREA INCREASED 2
SS ARTHRALGIA CHRONIC OBSTRUCTIVE PULMONARY DISEASE 2
SS ARTHRALGIA DYSPNOEA 2
SS ARTHRALGIA REFUSAL OF TREATMENT BY RELATIVE 2
SS ARTHRALGIA RENAL FUNCTION TEST ABNORMAL 2
SS ARTHRALGIA SEDATION 2
SS ARTHRALGIA SPEECH DISORDER 2
SS BACK PAIN AGITATION 3
SS BACK PAIN CARDIO-RESPIRATORY ARREST 2
SS BACK PAIN CONFUSIONAL STATE 3
SS BACK PAIN HYPOCALCAEMIA 1
SS BACK PAIN HYPOKALAEMIA 3
SS BACK PAIN HYPONATRAEMIA 3
SS BACK PAIN SYNCOPE 2
SS BONE PAIN CONSTIPATION 2
SS BONE PAIN RECTAL PROLAPSE 3
SS CANCER PAIN BLOOD GLUCOSE INCREASED 2
SS CANCER PAIN BLOOD UREA INCREASED 2
SS CANCER PAIN CHRONIC OBSTRUCTIVE PULMONARY DISEASE 2
SS CANCER PAIN DYSPNOEA 2
SS CANCER PAIN REFUSAL OF TREATMENT BY RELATIVE 2
SS CANCER PAIN RENAL FUNCTION TEST ABNORMAL 2
SS CANCER PAIN SEDATION 2
SS CANCER PAIN SPEECH DISORDER 2
SS DIABETES MELLITUS BLOOD GLUCOSE INCREASED 1
SS DIABETES MELLITUS BLOOD UREA INCREASED 1
SS DIABETES MELLITUS CHRONIC OBSTRUCTIVE PULMONARY DISEASE 1
SS DIABETES MELLITUS DYSPNOEA 1
SS DIABETES MELLITUS REFUSAL OF TREATMENT BY RELATIVE 1
SS DIABETES MELLITUS RENAL FUNCTION TEST ABNORMAL 1
SS DIABETES MELLITUS SEDATION 1
SS DIABETES MELLITUS SPEECH DISORDER 1
SS EPILEPSY BRONCHIAL DISORDER 1
SS EPILEPSY DEPRESSED LEVEL OF CONSCIOUSNESS 1
SS EPILEPSY FAECAL INCONTINENCE 1
SS EPILEPSY GENERAL PHYSICAL HEALTH DETERIORATION 1
SS EPILEPSY STARING 1
SS EPILEPSY URINARY INCONTINENCE 1
SS NEURALGIA BRONCHIAL DISORDER 1
SS NEURALGIA DEPRESSED LEVEL OF CONSCIOUSNESS 1
SS NEURALGIA FAECAL INCONTINENCE 1
SS NEURALGIA GENERAL PHYSICAL HEALTH DETERIORATION 1
SS NEURALGIA STARING 1
SS NEURALGIA URINARY INCONTINENCE 1
SS OESOPHAGEAL SPASM AMNESIA 1
SS OESOPHAGEAL SPASM CONFUSIONAL STATE 1
SS OESOPHAGEAL SPASM CONSTIPATION 1
SS OESOPHAGEAL SPASM DYSGEUSIA 1
SS OESOPHAGEAL SPASM FATIGUE 1
SS OESOPHAGEAL SPASM FORMICATION 1
SS OESOPHAGEAL SPASM INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
SS OESOPHAGEAL SPASM NAUSEA 1
SS OESOPHAGEAL SPASM PAIN 1
SS OESOPHAGEAL SPASM PAROSMIA 1
SS OESOPHAGEAL SPASM PRURITUS 1
SS OESOPHAGEAL SPASM SLUGGISHNESS 1
SS PAIN AMNESIA 1
SS PAIN BRONCHIAL DISORDER 1
SS PAIN CONDITION AGGRAVATED 3
SS PAIN CONFUSIONAL STATE 1
SS PAIN CONSTIPATION 4
SS PAIN DEPRESSED LEVEL OF CONSCIOUSNESS 1
SS PAIN DYSGEUSIA 1
SS PAIN FAECAL INCONTINENCE 1
SS PAIN FATIGUE 1
SS PAIN FORMICATION 1
SS PAIN GENERAL PHYSICAL HEALTH DETERIORATION 1
SS PAIN HALLUCINATION, AUDITORY 3
SS PAIN HALLUCINATION, VISUAL 3
SS PAIN INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
SS PAIN MUSCLE CONTRACTIONS INVOLUNTARY 3
SS PAIN NAUSEA 1
SS PAIN PAIN 4
SS PAIN PAROSMIA 1
SS PAIN PRURITUS 1
SS PAIN SLUGGISHNESS 1
SS PAIN SOMNOLENCE 3
SS PAIN STARING 1
SS PAIN URINARY INCONTINENCE 1
SS PRURITUS AMNESIA 2
SS PRURITUS CONFUSIONAL STATE 2
SS PRURITUS CONSTIPATION 2
SS PRURITUS DYSGEUSIA 2
SS PRURITUS FATIGUE 2
SS PRURITUS FORMICATION 2
SS PRURITUS INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
SS PRURITUS NAUSEA 2
SS PRURITUS PAIN 2
SS PRURITUS PAROSMIA 2
SS PRURITUS PRURITUS 2
SS PRURITUS SLUGGISHNESS 2
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