Drug information for ADDERALL 10

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 2.5MG;2.5MG;2.5MG;2.5MG Discontinued   AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Amphetamine TEVA WOMENS 11522
2007-06-14 Letter

2007-06-12 Label

2007-05-31 Other Important Information from FDA

2006-07-27 Label

2006-07-27 Label

2006-07-27 Letter

2006-07-27 Letter

2005-08-04 Label

2005-08-04 Label

2005-08-04 Letter

2005-08-04 Letter

2004-04-14 Review

2002-11-08 Letter

2000-06-12 Review

Drug Adverse Effects information for ADDERALL 10

Role code Indications Reaction # Reports
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DRUG EFFECT DECREASED 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER PRODUCT SUBSTITUTION ISSUE 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER WEIGHT DECREASED 1
PS DISTURBANCE IN ATTENTION DEPRESSION 1
PS DISTURBANCE IN ATTENTION DISTURBANCE IN SOCIAL BEHAVIOUR 1
PS DISTURBANCE IN ATTENTION DRUG EFFECT DECREASED 1
PS DISTURBANCE IN ATTENTION IMPULSIVE BEHAVIOUR 1
PS DISTURBANCE IN ATTENTION INSOMNIA 1
PS DISTURBANCE IN ATTENTION LOGORRHOEA 1
PS DISTURBANCE IN ATTENTION NEGATIVISM 1
PS PRODUCT USED FOR UNKNOWN INDICATION ANAPHYLACTIC REACTION 1
PS STRESS WEIGHT DECREASED 1
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER AGGRESSION 2
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER CRYING 2
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER INSOMNIA 2
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER IRRITABILITY 2
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER UNDERWEIGHT 2
SS DRUG DEPENDENCE ABDOMINAL PAIN 1
SS DRUG DEPENDENCE AGGRESSION 1
SS DRUG DEPENDENCE DRUG WITHDRAWAL SYNDROME 1
SS DRUG DEPENDENCE RECTAL HAEMORRHAGE 1
SS DRUG DEPENDENCE SUBSTANCE USE 1
SS SUBSTANCE USE ABDOMINAL PAIN 2
SS SUBSTANCE USE AGGRESSION 2
SS SUBSTANCE USE DRUG WITHDRAWAL SYNDROME 2
SS SUBSTANCE USE RECTAL HAEMORRHAGE 2
SS SUBSTANCE USE SUBSTANCE USE 2
C ANTACID THERAPY RESPIRATORY DISTRESS 1
C ANXIETY DISORDER RESPIRATORY DISTRESS 1
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER RESPIRATORY DISTRESS 1
C FATIGUE FATIGUE 1
C FATIGUE PYREXIA 1
C MULTIPLE SCLEROSIS ABDOMINAL DISTENSION 2
C MULTIPLE SCLEROSIS ABDOMINAL PAIN 3
C MULTIPLE SCLEROSIS ABDOMINAL PAIN UPPER 1
C MULTIPLE SCLEROSIS ALANINE AMINOTRANSFERASE INCREASED 1
C MULTIPLE SCLEROSIS ARTHRALGIA 1
C MULTIPLE SCLEROSIS ASPARTATE AMINOTRANSFERASE INCREASED 1
C MULTIPLE SCLEROSIS ASTHENIA 3
C MULTIPLE SCLEROSIS ATRIOVENTRICULAR BLOCK FIRST DEGREE 1
C MULTIPLE SCLEROSIS BALANCE DISORDER 2
C MULTIPLE SCLEROSIS CENTRAL NERVOUS SYSTEM LESION 1
C MULTIPLE SCLEROSIS CHEST DISCOMFORT 1
C MULTIPLE SCLEROSIS CONDUCTION DISORDER 1
C MULTIPLE SCLEROSIS COUGH 2
C MULTIPLE SCLEROSIS DIARRHOEA 2
C MULTIPLE SCLEROSIS DIPLOPIA 2
C MULTIPLE SCLEROSIS DIZZINESS 2
C MULTIPLE SCLEROSIS DYSPEPSIA 1
C MULTIPLE SCLEROSIS DYSPNOEA 2
C MULTIPLE SCLEROSIS ELECTROCARDIOGRAM PR PROLONGATION 1
C MULTIPLE SCLEROSIS ERUCTATION 2
C MULTIPLE SCLEROSIS FATIGUE 8
C MULTIPLE SCLEROSIS FEELING ABNORMAL 2
C MULTIPLE SCLEROSIS GAIT DISTURBANCE 1
C MULTIPLE SCLEROSIS GASTROINTESTINAL PAIN 2
C MULTIPLE SCLEROSIS GASTROOESOPHAGEAL REFLUX DISEASE 2
C MULTIPLE SCLEROSIS HEADACHE 2
C MULTIPLE SCLEROSIS HEART RATE DECREASED 4
C MULTIPLE SCLEROSIS HEART RATE IRREGULAR 1
C MULTIPLE SCLEROSIS HYPOAESTHESIA 1
C MULTIPLE SCLEROSIS INCORRECT DOSE ADMINISTERED 1
C MULTIPLE SCLEROSIS LIVER FUNCTION TEST ABNORMAL 1
C MULTIPLE SCLEROSIS MACULAR OEDEMA 1
C MULTIPLE SCLEROSIS MEMORY IMPAIRMENT 1
C MULTIPLE SCLEROSIS MULTIPLE SCLEROSIS RELAPSE 2
C MULTIPLE SCLEROSIS MUSCULAR WEAKNESS 1
C MULTIPLE SCLEROSIS MUSCULOSKELETAL PAIN 2
C MULTIPLE SCLEROSIS NAUSEA 2
C MULTIPLE SCLEROSIS PAIN IN EXTREMITY 1
C MULTIPLE SCLEROSIS PERIPHERAL SENSORIMOTOR NEUROPATHY 1
C MULTIPLE SCLEROSIS PYREXIA 1
C MULTIPLE SCLEROSIS SALIVARY HYPERSECRETION 1
C MULTIPLE SCLEROSIS SENSATION OF PRESSURE 1
C MULTIPLE SCLEROSIS SINUSITIS 1
C MULTIPLE SCLEROSIS TOXIC ENCEPHALOPATHY 1
C MULTIPLE SCLEROSIS UPPER RESPIRATORY TRACT INFECTION 1
C MULTIPLE SCLEROSIS URINARY TRACT INFECTION 1
C MULTIPLE SCLEROSIS VERTIGO 1
C MULTIPLE SCLEROSIS VISUAL IMPAIRMENT 2
C MULTIPLE SCLEROSIS VITAMIN D INCREASED 1
C MULTIPLE SCLEROSIS VOMITING 1
C MULTIPLE SCLEROSIS WHITE BLOOD CELL COUNT DECREASED 1
C PROPHYLAXIS AGAINST TRANSPLANT REJECTION PANCREATITIS 2
C PSYCHOTIC DISORDER RESPIRATORY DISTRESS 2
C RELAPSING-REMITTING MULTIPLE SCLEROSIS BLOOD PRESSURE INCREASED 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS DIZZINESS 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS HEADACHE 1
C TYPE 2 DIABETES MELLITUS CHOLELITHIASIS 1
C TYPE 2 DIABETES MELLITUS PANCREATITIS 1
C TYPE 2 DIABETES MELLITUS WEIGHT DECREASED 1
C VITAMIN SUPPLEMENTATION RESPIRATORY DISTRESS 1
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