Focalin Safety Reports submitted to FDA
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More Rx Information: A B C D E F G H I J K L M N O P Q R S T U V W X Y ZTotal Focalin reports: 79.
Focalin FDA safety alerts: No.
Reported deaths: 1 Reported hospitalizations: 17.
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FDA Reported Focalin Side Effects: heart rate increased, depression, hallucination, visual, agitation, hallucination, auditory, convulsion, dizziness, ventricular hypertrophy, acute myocardial infarction, psychotic disorder, confusional state.
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Focalin Side Effects Report #5196792-7
Physician from UNITED STATES reported FOCALIN problem on Dec 21, 2006. Male patient, child 8 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: deafness bilateral. FOCALIN dosage: 10 MG, QD. Patient recovered.
Focalin Side Effects Report #5287824-6
FOCALIN problem was reported by a Physician from UNITED STATES on Mar 27, 2006. Male patient, 13 years of age, weighting 89.95 lb, was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: aggression, agitation, condition aggravated, depression, pruritus, rash, tic. FOCALIN dosage: 2.5 MG. A.M. AND NOON, ORAL. During the same period patient was treated with ABILIFY, NEURONTIN, LITHIUM CARBONATE. Patient was hospitalized and became disabled. Patient recovered.
Focalin Side Effects Report #5287827-1
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on Mar 20, 2006. Female patient was diagnosed with somnolence and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus, exophthalmos, nervousness, overdose. FOCALIN dosage: 10 MG,QD,ORAL. Patient recovered.
Focalin Side Effects Report #5287830-1
FOCALIN problem was reported by a Physician from UNITED STATES on Mar 24, 2006. Male patient was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: multiple allergies. FOCALIN dosage: unknown. Patient was hospitalized. Patient recovered.
Focalin Side Effects Report #5287835-0
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on Apr 13, 2006. Male patient was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: convulsion. FOCALIN dosage: 10 MG,BID,ORAL. Patient recovered.
Focalin Side Effects Report #5287837-4
FOCALIN problem was reported by a Physician from UNITED STATES on Apr 17, 2006. Male patient, child 11 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: agitation, psychotic disorder. FOCALIN dosage: 20 MG,QD,ORAL. Patient recovered.
Focalin Side Effects Report #5287840-4
Pharmacist from UNITED STATES reported FOCALIN problem on Aug 12, 2006. Female patient, child 7 years of age, was diagnosed with autism and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: convulsion. FOCALIN dosage: 70 MG,QD,ORAL. During the same period patient was treated with ZYPREXA, SEROQUEL. Patient was hospitalized. Patient recovered.
Focalin Side Effects Report #5241464-3
FOCALIN problem was reported by a Physician from UNITED STATES on Feb 15, 2007. Male patient, weighting 52.03 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: agitation, hallucination, visual, mydriasis, psychotic disorder. FOCALIN dosage: 10MG DAILY ORAL. Patient was hospitalized. Patient recovered.
Focalin Side Effects Report #5243899-1
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on Feb 10, 2007. Female patient, 19 years of age, was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: depressed mood, depression, social avoidant behaviour. FOCALIN dosage: unknown. During the same period patient was treated with CYMBALTA. Patient recovered.
Focalin Side Effects Report #5255192-1
FOCALIN problem was reported by a Physician from UNITED STATES on Feb 19, 2007. Male patient, child 6 years of age, weighting 47.62 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: crying, depressed mood, depression, hallucination, musculoskeletal stiffness, social avoidant behaviour. FOCALIN dosage: 30 MG, QD. Patient recovered.
Focalin Side Effects Report #5261812-8
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on Feb 28, 2007. Male patient, child 10 years of age, weighting 83.99 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, acute myocardial infarction, angina pectoris, apnoea, blood creatine phosphokinase increased, carotid artery thrombosis, catheterisation cardiac, chest pain, circulatory collapse. FOCALIN dosage: 5 MG, QD. Patient was hospitalized and became disabled. Patient recovered.
Focalin Side Effects Report #5264756-0
FOCALIN problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 28, 2007. Male patient, child 10 years of age, weighting 83.99 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, acute myocardial infarction, angina pectoris, apnoea, blood creatine phosphokinase increased, carotid artery thrombosis, catheterisation cardiac, chest pain, circulatory collapse. FOCALIN dosage: 5 MG, QD. Patient was hospitalized and became disabled. Patient recovered.
Focalin Side Effects Report #5272272-5
Physician from UNITED STATES reported FOCALIN problem on Mar 08, 2007. Male patient, child 4 years of age, weighting 39.99 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: cyanosis. FOCALIN dosage: 7.5 MG, QD. Patient recovered.
Focalin Side Effects Report #5273813-4
FOCALIN problem was reported by a Physician from UNITED STATES on Mar 21, 2007. Male patient, 18 years of age, weighting 230.0 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: cough, retching, vomiting. FOCALIN dosage: 30MG BID PO. Patient recovered.
Focalin Side Effects Report #5281307-5
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on Oct 05, 2006. Male patient, child 7 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: depressed mood, eating disorder, heart rate increased, insomnia. FOCALIN dosage: 5 MG, QD, ORAL. During the same period patient was treated with SINGULAIR. Patient recovered.
Focalin Side Effects Report #5281309-9
FOCALIN problem was reported by a Physician from UNITED STATES on Nov 01, 2006. Male patient, 15 years of age, was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: depression, irritability. FOCALIN dosage: 20 MG, QD, ORAL. Patient recovered.
Focalin Side Effects Report #5281310-5
Physician from UNITED STATES reported FOCALIN problem on Nov 06, 2006. Male patient, child 5 years of age, weighting 50.04 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: tachycardia. FOCALIN dosage: 40 MG DAILY IN THE A.M., ORAL. During the same period patient was treated with GUANFACINE, ABILIFY. Patient recovered.
Focalin Side Effects Report #5281311-7
FOCALIN problem was reported by a Physician from UNITED STATES on Nov 09, 2006. Female patient, child 6 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: tachycardia. FOCALIN dosage: 20 MG, QD, ORAL. Patient recovered.
Focalin Side Effects Report #5335332-6
Physician from UNITED STATES reported FOCALIN problem on Dec 12, 2006. Male patient, child 6 years of age, weighting 50.93 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: psychotic disorder. FOCALIN dosage: 10 MG QD ORAL. During the same period patient was treated with ZYRTEC, FLOVENT, ALBUTEROL. Patient recovered.
Focalin Side Effects Report #5293234-8
FOCALIN problem was reported by a Physician from UNITED STATES on Mar 28, 2007. Male patient, child 4 years of age, weighting 39.99 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: cyanosis. FOCALIN dosage: 7.5 MG, QD. Patient recovered.
Focalin Side Effects Report #5335333-8
Physician from UNITED STATES reported FOCALIN problem on Dec 14, 2006. Male patient was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: blood pressure increased. FOCALIN dosage: unknown. Patient recovered.
Focalin Side Effects Report #5353708-8
FOCALIN problem was reported by a Consumer or non-health professional from UNITED STATES on May 29, 2007. Female patient, child 6 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: erythema, heart rate increased, incorrect dose administered, tremor. FOCALIN dosage: 10 MG, QD. Patient recovered.
Focalin Side Effects Report #5355739-0
Health Professional from UNITED STATES reported FOCALIN problem on June 11, 2007. Male patient, 36 years of age, weighting 175.0 lb, was diagnosed with crying, nausea, nightmare and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: crying, depression, hyperhidrosis, nausea, sleep terror, weight increased. FOCALIN dosage: 20 MG ONCE DAILY PO. During the same period patient was treated with RISPERDAL. Patient recovered.
Focalin Side Effects Report #5370311-4
FOCALIN problem was reported by a Consumer or non-health professional from UNITED STATES on June 25, 2007. Male patient, child 8 years of age, weighting 48.00 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, attention deficit/hyperactivity disorder, condition aggravated, hyperphagia. FOCALIN dosage: unknown. Patient recovered.
Focalin Side Effects Report #5373324-1
Health Professional from UNITED STATES reported FOCALIN problem on June 26, 2007. Male patient, weighting 52.00 lb, was diagnosed with anxiety, attention deficit/hyperactivity disorder, autism and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: convulsion. FOCALIN dosage: unknown. During the same period patient was treated with PROZAC, RISPERDAL. Patient died on 06/13/2007.
Focalin Side Effects Report #5373544-6
FOCALIN problem was reported by a Pharmacist from UNITED STATES on June 26, 2007. Female patient, weighting 41.89 lb, was diagnosed with autism spectrum disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: convulsion, dystonia. FOCALIN dosage: 20MG 3 OR 4 TIMES DAILY PO. Patient was hospitalized. Patient recovered.
Focalin Side Effects Report #5375211-1
Physician from UNITED STATES reported FOCALIN problem on Mar 05, 2007. Female patient, child 9 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: convulsion. FOCALIN dosage: 10 MG. During the same period patient was treated with LAMICTAL. Patient recovered.
Focalin Side Effects Report #5375237-8
FOCALIN problem was reported by a Physician from UNITED STATES on Mar 06, 2007. Male patient, child 6 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: hallucination, auditory. FOCALIN dosage: 5 MG, QD. Patient recovered.
Focalin Side Effects Report #5375238-X
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on Mar 21, 2007. Male patient, child 8 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: hypertension. FOCALIN dosage: 5 MG, QD. Patient recovered.
Focalin Side Effects Report #5375249-4
FOCALIN problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 30, 2007. Female patient, 38 years of age, was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: anorexia, delusion, insomnia, paranoia. FOCALIN dosage: unknown. Patient recovered.
Focalin Side Effects Report #5375290-1
Physician from UNITED STATES reported FOCALIN problem on Apr 23, 2007. Male patient, child 5 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: hallucination, self injurious behaviour. FOCALIN dosage: 10 MG, QD. Patient recovered.
Focalin Side Effects Report #5375291-3
FOCALIN problem was reported by a Health Professional from UNITED STATES on May 09, 2007. Male patient, child 5 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: anxiety, disturbance in attention, heart rate increased, hyperventilation, respiratory rate increased. FOCALIN dosage: 5 MG, QAM,. Patient recovered.
Focalin Side Effects Report #5375316-5
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on May 11, 2007. Male patient, child 6 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: agitation, confusional state, speech disorder. FOCALIN dosage: 10 MG, QD. Patient recovered.
Focalin Side Effects Report #5044256-3
FOCALIN problem was reported by a Physician from UNITED STATES on June 15, 2006. Female patient, 13 years of age, weighting 110.0 lb, was diagnosed with attention deficit/hyperactivity disorder, bipolar disorder, depression, affective disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: atrioventricular block first degree, electrocardiogram abnormal. FOCALIN dosage: 10 MG, QD IN A.M.. During the same period patient was treated with SEROQUEL, ZOLOFT, DEPAKOTE. Patient recovered.
Focalin Side Effects Report #5076463-8
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on May 01, 2006. Female patient, 46 years of age, was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: confusional state, conversion disorder, suicidal ideation. FOCALIN dosage: 10 MG, QD. During the same period patient was treated with LEXAPRO. Patient was hospitalized. Patient recovered.
Focalin Side Effects Report #5091106-5
FOCALIN problem was reported by a Physician from UNITED STATES on Aug 17, 2006. Female patient, child 6 years of age, weighting 36.99 lb, was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: neutropenia, white blood cell count decreased. FOCALIN dosage: 10 MG, QD. During the same period patient was treated with STRATTERA. Patient was hospitalized. Patient recovered.
Focalin Side Effects Report #5094966-7
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on Aug 09, 2006. Female patient, child 12 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: micturition urgency, pollakiuria, urinary incontinence. FOCALIN dosage: 5 MG, QD. During the same period patient was treated with VITAMIN, DENTAL TREATMENT. Patient recovered.
Focalin Side Effects Report #5095841-4
FOCALIN problem was reported by a Physician from UNITED STATES on Aug 17, 2006. Female patient, weighting 36.99 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: neutropenia, white blood cell count decreased. FOCALIN dosage: 10 MG, QD. During the same period patient was treated with STRATTERA. Patient was hospitalized. Patient recovered.
Focalin Side Effects Report #5103188-2
Pharmacist from UNITED STATES reported FOCALIN problem on Sept 12, 2006. Male patient, weighting 82.67 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, electrocardiogram t wave abnormal, fall. FOCALIN dosage: 5 MG DAILY ORAL. Patient was hospitalized. Patient recovered.
Focalin Side Effects Report #5103803-3
FOCALIN problem was reported by a Physician from UNITED STATES on Sept 06, 2006. Male patient, 14 years of age, weighting 135.0 lb, was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: rash, stevens-johnson syndrome. FOCALIN dosage: 20 MG, BID. Patient was hospitalized. Patient recovered.
Focalin Side Effects Report #5104414-6
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on Sept 08, 2006. Male patient, weighting 65.00 lb, was diagnosed with attention deficit/hyperactivity disorder, anxiety, depression, obsessive-compulsive disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: muscle spasticity. FOCALIN dosage: 7.5 MG -3--2.5 MG BID MORNING, NOON PO. During the same period patient was treated with PAROXETINE. Patient recovered.
Focalin Side Effects Report #5120968-8
FOCALIN problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 22, 2006. Male patient, 14 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: dizziness, heart rate increased, ventricular hypertrophy, visual disturbance. FOCALIN dosage: 5 MG, QD. During the same period patient was treated with ABILIFY, ZOLOFT. Patient recovered.
Focalin Side Effects Report #5121561-3
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on Sept 22, 2006. Male patient, child 12 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: dizziness, dyspnoea, fatigue, ventricular hypertrophy. FOCALIN dosage: 5 MG, QD. Patient recovered.
Focalin Side Effects Report #5122667-5
FOCALIN problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 02, 2006. Male patient, child 10 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, angina pectoris, carotid artery thrombosis, catheterisation cardiac, coronary artery thrombosis, lung disorder. FOCALIN dosage: 5 MG, QD. Patient was hospitalized. Patient recovered.
Focalin Side Effects Report #5124707-6
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on Oct 02, 2006. Male patient, child 10 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, angina pectoris, blood creatine phosphokinase increased, carotid artery thrombosis, catheterisation cardiac, coronary artery thrombosis, lung disorder, troponin increased. FOCALIN dosage: 5 MG, QD. Patient was hospitalized and became disabled. Patient recovered.
Focalin Side Effects Report #5130744-8
FOCALIN problem was reported by a Pharmacist from UNITED STATES on Oct 17, 2006. Male patient, child 4 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: eye rolling, muscle twitching, tachycardia. FOCALIN dosage: 10MG EVERY MORNING PO. Patient was hospitalized. Patient recovered.
Focalin Side Effects Report #5198846-8
Physician from UNITED STATES reported FOCALIN problem on June 27, 2006. Male patient, child 10 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: aggression, psychotic disorder, urticaria. FOCALIN dosage: 5 MG QD IN A.M., ORAL. Patient recovered.
Focalin Side Effects Report #5198847-X
FOCALIN problem was reported by a Physician from UNITED STATES on June 22, 2006. Female patient, child 5 years of age, weighting 48.28 lb, was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: hallucination, sleep disorder. FOCALIN dosage: unknown. Patient recovered.
Focalin Side Effects Report #5198848-1
Physician from UNITED STATES reported FOCALIN problem on June 09, 2006. Female patient, 30 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: convulsion. FOCALIN dosage: 20 MG, QD, ORAL. During the same period patient was treated with DEPAKOTE. Patient recovered.
Focalin Side Effects Report #5198850-X
FOCALIN problem was reported by a Physician from UNITED STATES on June 13, 2006. Female patient, child 10 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: hallucination. FOCALIN dosage: 10 MG, QD, ORAL. Patient recovered.
Focalin Side Effects Report #5198851-1
Physician from UNITED STATES reported FOCALIN problem on June 30, 2006. Male patient, child 5 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: agitation, hallucination, visual. FOCALIN dosage: 20 MG, QD, ORAL. During the same period patient was treated with KLONOPIN. Patient recovered.
Focalin Side Effects Report #5198852-3
FOCALIN problem was reported by a Physician from UNITED STATES on Aug 02, 2006. Female patient, child 10 years of age, was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: hallucination. FOCALIN dosage: unknown. Patient recovered.
Focalin Side Effects Report #5198853-5
Physician from UNITED STATES reported FOCALIN problem on July 21, 2006. Male patient, child 9 years of age, weighting 63.93 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: anxiety disorder, attention deficit/hyperactivity disorder, depression. FOCALIN dosage: unknown. Patient recovered.
Focalin Side Effects Report #5198924-3
FOCALIN problem was reported by a Physician from UNITED STATES on July 21, 2006. Male patient, child 9 years of age, weighting 63.93 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: anxiety disorder, attention deficit/hyperactivity disorder, depression. FOCALIN dosage: unknown. Patient recovered.
Focalin Side Effects Report #5198977-2
Physician from UNITED STATES reported FOCALIN problem on June 27, 2006. Male patient, child 10 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: aggression, psychotic disorder, urticaria. FOCALIN dosage: 5 MG QD IN A.M., ORAL. Patient recovered.
Focalin Side Effects Report #5198979-6
FOCALIN problem was reported by a Physician from UNITED STATES on June 22, 2006. Female patient, child 5 years of age, weighting 54.90 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: hallucination, sleep disorder. FOCALIN dosage: 10 MG, QD, ORAL. During the same period patient was treated with TYLENOL. Patient recovered.
Focalin Side Effects Report #5198980-2
Physician from UNITED STATES reported FOCALIN problem on June 09, 2006. Female patient, 30 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: convulsion. FOCALIN dosage: 20 MG, QD, ORAL. During the same period patient was treated with DEPAKOTE. Patient recovered.
Focalin Side Effects Report #5198982-6
FOCALIN problem was reported by a Physician from UNITED STATES on June 13, 2006. Female patient, child 10 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: hallucination. FOCALIN dosage: 10 MG, QD, ORAL. Patient recovered.
Focalin Side Effects Report #5198988-7
Physician from UNITED STATES reported FOCALIN problem on June 30, 2006. Male patient, child 5 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: agitation, hallucination, visual. FOCALIN dosage: 20 MG, QD, ORAL. During the same period patient was treated with KLONOPIN. Patient recovered.
Focalin Side Effects Report #5198993-0
FOCALIN problem was reported by a Physician from UNITED STATES on Aug 02, 2006. Female patient, child 10 years of age, was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: hallucination. FOCALIN dosage: unknown. Patient recovered.
Focalin Side Effects Report #5146654-6
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on Sept 22, 2006. Male patient, 14 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: dizziness, heart rate increased, ventricular hypertrophy, visual disturbance. FOCALIN dosage: 5 MG, QD. During the same period patient was treated with ABILIFY, ZOLOFT. Patient recovered.
Focalin Side Effects Report #5146655-8
FOCALIN problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 22, 2006. Male patient, child 12 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: dizziness, dyspnoea, fatigue, ventricular hypertrophy. FOCALIN dosage: 5 MG, QD. Patient recovered.
Focalin Side Effects Report #5156079-5
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on Sept 22, 2006. Male patient, 14 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: chest pain, dizziness, dyspnoea, heart rate increased, ventricular hypertrophy, visual disturbance. FOCALIN dosage: 5 MG, QD IN A.M.. During the same period patient was treated with ABILIFY, ZOLOFT. Patient recovered.
Focalin Side Effects Report #5158354-7
FOCALIN problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 16, 2006. Male patient, child 8 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: deafness bilateral. FOCALIN dosage: 10 MG, QD. Patient recovered.
Focalin Side Effects Report #5163359-6
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on Nov 16, 2006. Male patient, child 8 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: deafness bilateral. FOCALIN dosage: 10 MG, QD. Patient recovered.
Focalin Side Effects Report #5180918-5
FOCALIN problem was reported by a Health Professional from UNITED STATES on Dec 18, 2006. Male patient, child 10 years of age, weighting 64.00 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, anger, decreased appetite, feeling abnormal, headache, insomnia, sleep terror. FOCALIN dosage: unknown. Patient recovered.
Focalin Side Effects Report #5376065-X
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on July 02, 2007. Female patient, 14 years of age, weighting 150.0 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, hyperphagia. FOCALIN dosage: unknown. Patient recovered.
Focalin Side Effects Report #5382567-2
FOCALIN problem was reported by a Consumer or non-health professional from UNITED STATES on June 27, 2007. Female patient, child 6 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: erythema, heart rate increased, incorrect dose administered, tremor. FOCALIN dosage: 10 MG, QD. Patient recovered.
Focalin Side Effects Report #5385510-5
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on June 29, 2007. Female patient, child 6 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: erythema, heart rate increased, incorrect dose administered, tremor. FOCALIN dosage: 10 MG, QD. Patient recovered.
Focalin Side Effects Report #5400092-7
FOCALIN problem was reported by a Consumer or non-health professional from UNITED STATES on July 26, 2007. Male patient, 23 years of age, weighting 180.0 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: hallucination, auditory. FOCALIN dosage: 10 MG MANY PO. Patient recovered.
Focalin Side Effects Report #5400108-8
Health Professional from UNITED STATES reported FOCALIN problem on July 26, 2007. Female patient, child 8 years of age, weighting 94.00 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: pain in extremity, purpura. FOCALIN dosage: unknown. Patient recovered.
Focalin Side Effects Report #5409235-2
FOCALIN problem was reported by a Pharmacist from UNITED STATES on July 29, 2007. Male patient, 14 years of age, was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, cyclic vomiting syndrome, weight decreased. FOCALIN dosage: unknown. Patient was hospitalized. Patient recovered.
Focalin Side Effects Report #5476493-8
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on July 19, 2007. Male patient, child 8 years of age, weighting 57.98 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: hypertension. FOCALIN dosage: 5 MG, QD. Patient recovered.
Focalin Side Effects Report #5476494-X
FOCALIN problem was reported by a Physician from UNITED STATES on July 30, 2007. Male patient, child 5 years of age, weighting 44.09 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: hallucination, self injurious behaviour. FOCALIN dosage: 10 MG, QD. Patient recovered.
Focalin Side Effects Report #5476495-1
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on July 16, 2007. Male patient, child 6 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: agitation, confusional state, speech disorder. FOCALIN dosage: 5MG, QD. Patient recovered.
Focalin Side Effects Report #5476496-3
FOCALIN problem was reported by a Consumer or non-health professional from UNITED STATES on July 05, 2007. Male patient, child 6 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: bipolar disorder, confusional state, dehydration, dizziness, hallucination, headache, heart rate increased, nausea. FOCALIN dosage: 5 MG, QD. Patient recovered.
Focalin Side Effects Report #5476497-5
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on July 18, 2007. Female patient, 16 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: agitation, depression, irritability. FOCALIN dosage: 10 MG. Patient recovered.
Focalin Side Effects Report #5476498-7
FOCALIN problem was reported by a Physician from UNITED STATES on July 17, 2007. Female patient, child 8 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: headache. FOCALIN dosage: 30 MG, QD. Patient was hospitalized. Patient recovered.
Focalin Side Effects Report #5476500-2
Consumer or non-health professional from UNITED STATES reported FOCALIN problem on Aug 16, 2007. Female patient was treated with FOCALIN. After drug was administered, patient experienced the following problems/side effects: depression. FOCALIN dosage: 10 MG. Patient recovered.
Drug Information: Dexmethylphenidate
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a603014.html
(dex meth ill fen' i date)IMPORTANT WARNING:
| Dexmethylphenidate can be habit-forming. Do not take a larger dose, take it more often, take it for a longer time, or take it in a different way than prescribed by your doctor. If you take too much dexmethylphenidate, you may find that the medication no longer controls your symptoms, you may feel a need to take large amounts of the medication, and you may experience unusual changes in your behavior or a loss of contact with reality. Tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications.Do not stop taking dexmethylphenidate without talking to your doctor, especially if you have overused the medication. Your doctor will probably decrease your dose gradually and monitor you carefully during this time. You may develop severe depression if you suddenly stop taking dexmethylphenidate after overusing it.Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with dexmethylphenidate and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/cder) or the manufacturer's website to obtain the Medication Guide. |
Why is this medication prescribed?
Dexmethylphenidate is used as part of a treatment program to increase the ability to pay attention and to decrease impulsiveness and hyperactivity in people with Attention Deficit Hyperactivity Disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age). Dexmethylphenidate is in a class of medications called central nervous system (CNS) stimulants. It works by increasing the amounts of certain natural substances in the brain.
How should this medicine be used?
Dexmethylphenidate comes as a tablet and an extended-release (long-acting) capsule to take by mouth. The tablet is usually taken twice a day, at least 4 hours apart, with or without food. The extended-release capsule is usually taken once a day in the morning. The extended-release capsule can be taken with or without food but will start to work faster if it is taken without food. Take dexmethylphenidate at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
Swallow the extended-release capsules whole; do not chew or crush them. If you are unable to swallow the extended-release capsule, you can carefully open the capsule and sprinkle the contents on a spoonful of applesauce. Swallow this mixture immediately, but do not chew it. Do not save this mixture to use at a later time.
Your doctor will probably start you on a low dose of dexmethylphenidate and gradually increase your dose, not more often than once a week.
Your condition should improve during your treatment. Call your doctor if your symptoms worsen at any time during your treatment or do not improve after one month.
Your doctor may tell you to stop taking dexmethylphenidate from time to time to see if the medication is still needed. Follow these directions carefully.
Before taking dexmethylphenidate, ask your pharmacist or doctor for a copy of the manufacturer's information for the patient and read it carefully.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking dexmethylphenidate,
- tell your doctor and pharmacist if you are allergic to dexmethylphenidate, methylphenidate (Concerta, Metadate, Methylin, Ritalin), or any other medications.
- tell your doctor if you are taking monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate), or if you have stopped taking them during the past 14 days. Your doctor will probably tell you not to take dexmethylphenidate until at least 14 days have passed since you last took an MAO inhibitor
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antidepressants (mood elevators) such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); clonidine (Catapres); medications for high blood pressure; medications for seizures such as phenobarbital phenytoin (Dilantin), and primidone (Mysoline); and selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); and venlafaxine (Effexor). If you are taking the extended-release capsules, also tell your doctor if you are taking antacids or other medications for heartburn or ulcers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you or anyone in your family has or has ever had Tourette's syndrome (a condition characterized by the need to perform repeated motions or to repeat sounds or words), facial or motor tics (repeated uncontrollable movements), or verbal tics (repetition of sounds or words that is hard to control), Also tell your doctor if you have glaucoma, or feelings of anxiety, tension, or agitation. Your doctor will probably tell you not to take dexmethylphenidate.
- tell your doctor if anyone in your family has or has ever had an irregular heartbeat or has died suddenly. Also tell your doctor if you have recently had a heart attack and if you have or have ever had a heart defect, high blood pressure, an irregular heartbeat, heart or blood vessel disease, or other heart problems. Your doctor will probably examine you to see if your heart and blood vessels are healthy. Your doctor may tell you not to take dexmethylphenidate if you have a heart condition or if there is a high risk that you may develop a heart condition.
- tell your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), or mania (frenzied, abnormally excited mood), or has thought about or attempted suicide. Also tell your doctor if you ever have abnormal thoughts or visions or hear abnormal sounds.or if you have or have ever had depression; feelings of sadness, hopelessness, helplessness, or worthlessness; mental illness; seizures;an abnormal electroencephalogram (EEG; a test that measures electrical activity in the brain), or thyroid disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking dexmethylphenidate, call your doctor.
- you should know that dexmethylphenidate should be used as part of a total treatment program for ADHD, which may include counseling and special education. Make sure to follow all of your doctor's and/or therapist's instructions.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Dexmethylphenidate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- loss of appetite
- nausea
- vomiting
- heartburn
- weight loss
- dry mouth
- throat pain
- difficulty falling asleep or staying asleep
- dizziness
- drowsiness
- nervousness or jitteriness
- headache
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- fast, pounding, or irregular heartbeat
- chest pain
- shortness of breath
- excessive tiredness
- slow or difficult speech
- dizziness or faintness
- weakness or numbness of an arm or leg
- changes in vision or blurred vision
- seizures
- abnormal thinking
- aggressive behavior
- hallucinations (seeing things or hearing voices that do not exist)
- mood changes
- depression
- motor tics
- verbal tics
- rash
- hives
- itching
- purple blotches under the skin
- fever
- blisters
- joint pain
Dexmethylphenidate may cause sudden death in children and teenagers with heart defects or serious heart problems. This medication also may cause sudden death, heart attack or stroke in adults, especially adults with heart defects or serious heart problems. Talk to your doctor about the risks of taking this medication.
Dexmethylphenidate may slow children's growth or weight gain. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight gain while he or she is taking this medication. Talk to your child's doctor about the risks of giving dexmethylphenidate to your child.
Dexmethylphenidate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
Store dexmethylphenidate in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets or capsules are left so you will know if any are missing.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- vomiting
- agitation
- uncontrollable shaking of a part of the body
- muscle twitching
- seizures
- unconsciousness
- inappropriate happiness
- confusion
- hallucinations (seeing things or hearing voices that do not exist)
- sweating
- flushing
- headache
- fever
- rapid, pounding, or irregular heartbeat
- blurred vision
- dry mouth
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to dexmethylphenidate.
Do not let anyone else take your medication. This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so you do not run out of medication.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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