DORAL Side Effects

6076498-2 | Eczema, Infection, Pruritus
on Jan 20, 2009 Female patient from JAPAN , 39 years of age, was diagnosed with dysthymic disorder and was treated with Doral (View Usage). Patient experienced the following unwanted or unexpected effects: eczema (What is eczema?), infection (What is infection?), pruritus. Doral dosage: 15 Mg Po. During the same period patient was treated with RIZE (CLOTIAZEPAM) (View Rize (clotiazepam) Review and Rize (clotiazepam) Label ), GOODMIN (BROTIZOLAM) (View Goodmin (brotizolam) Review and Goodmin (brotizolam) Label ), PAXIL (PAREXETINE HYDROCHLORIDE HYDRATE) (View Paxil (parexetine Hydrochloride Hydrate) Review and Paxil (parexetine Hydrochloride Hydrate) Label ).

6055089-3 | Eczema
Patient was taking Doral (View Usage). Patient had the following side effects: eczema (What is eczema?) on Jan 05, 2009 from JAPAN Additional patient health information: Female patient , 39 years of age, was diagnosed with dysthymic disorder and. Doral dosage: .

6024945-4 | Hepatic Function Abnormal, Mucous Membrane Disorder, Stevens-johnson Syndrome
Adverse event was reported on Dec 04, 2008 by a Female patient taking Doral (View Usage) (Dosage: Po) . Location: JAPAN , 18 years of age, After Doral was administered, patient had the following side effects: hepatic function abnormal, mucous membrane disorder, stevens-johnson syndrome. During the same period patient was treated with AMOXAPINE (View Amoxapine Review and Amoxapine Label ), ERISPAN (View Erispan Review and Erispan Label ), LUVOX (View Luvox Review and Luvox Label ), ROHYPNOL (View Rohypnol Review and Rohypnol Label ), SEROQUEL (View Seroquel Review and Seroquel Label ), SOLANEX (View Solanex Review and Solanex Label ). Patient was hospitalized.

5945739-1 | Acute Myocardial Infarction, Blood Pressure Increased, Cyanosis, Electrocardiogram Abnormal, Eyelid Oedema, Face Oedema, Mydriasis, Oedema Peripheral, Peripheral Coldness
on Oct 21, 2008 Female patient from JAPAN , 60 years of age, was diagnosed with insomnia and was treated with Doral (View Usage). Patient experienced the following unwanted or unexpected effects: acute myocardial infarction, blood pressure increased, cyanosis, electrocardiogram abnormal, eyelid oedema, face oedema, mydriasis, oedema peripheral, peripheral coldness. Doral dosage: 15 Mg Po Bid. During the same period patient was treated with FLUNITRAZEPAM (View Flunitrazepam Review and Flunitrazepam Label ), LONASEN (BLONANSERIN) (View Lonasen (blonanserin) Review and Lonasen (blonanserin) Label ), ABILIFY (View Abilify Review and Abilify Label ), ENALAPRIL MALEATE (View Enalapril Maleate Review and Enalapril Maleate Label ), U PAN (LORAZEPAM) (View U Pan (lorazepam) Review and U Pan (lorazepam) Label ), NATEGLINIDE (View Nateglinide Review and Nateglinide Label ).


5914543-2 | Myocardial Infarction
on Oct 03, 2008 Female patient from JAPAN , 60 years of age, was treated with Doral (View Usage). Patient had the following side effects: myocardial infarction. Doral dosage: 15 Mg Po. During the same period patient was treated with FLUNITRAZEPAM (View Flunitrazepam Review and Flunitrazepam Label ), LONASEN (BLONANSERIN) (View Lonasen (blonanserin) Review and Lonasen (blonanserin) Label ), DIOVAN (View Diovan Review and Diovan Label ), ABILIFY (View Abilify Review and Abilify Label ), ENALAPRIL MALEATE (View Enalapril Maleate Review and Enalapril Maleate Label ), U PAN (LORAZEPAM) (View U Pan (lorazepam) Review and U Pan (lorazepam) Label ), NATEGLINIDE (View Nateglinide Review and Nateglinide Label ).

4990882-7 | Blood Alkaline Phosphatase Increased, Delirium, Depressed Level Of Consciousness, Disorientation, Electroencephalogram Abnormal, Euphoric Mood, Mastitis, Pleural Effusion
Patient was taking Doral (View Usage). After Doral was administered, patient had the following side effects: blood alkaline phosphatase increased, delirium, depressed level of consciousness, disorientation, electroencephalogram abnormal, euphoric mood, mastitis, pleural effusion on Apr 17, 2006 from UNITED STATES Additional patient health information: Female patient , 73 years of age, was diagnosed with insomnia, depression (What is depression?) and. Doral dosage: 15 Mg (1 In 1 D) Oral. During the same period patient was treated with PAXIL (View Paxil Review and Paxil Label ), LUVOX (View Luvox Review and Luvox Label ), LENDORM (View Lendorm Review and Lendorm Label ). Patient was hospitalized.

4970870-7 | Coma, Suicide Attempt
Adverse event was reported on Mar 27, 2006 by a Male patient taking Doral (View Usage) (Dosage: Oral) was diagnosed with ill-defined disorder and. Location: JAPAN , 22 years of age, Patient experienced the following unwanted or unexpected effects: coma, suicide attempt. During the same period patient was treated with DEPAS (ETIZOLAM) (View Depas (etizolam) Review and Depas (etizolam) Label ), PAROXETINE (PAROXETINE) (View Paroxetine (paroxetine) Review and Paroxetine (paroxetine) Label ), RISPERIDONE (View Risperidone Review and Risperidone Label ), FLUNITRAZEPAM (FLUNITRAZEPAM) (View Flunitrazepam (flunitrazepam) Review and Flunitrazepam (flunitrazepam) Label ), LORAZEPAM (View Lorazepam Review and Lorazepam Label ), BIPERIDEN (BIPERIDEN) (View Biperiden (biperiden) Review and Biperiden (biperiden) Label ).

4970866-5 | Delirium, Depressed Level Of Consciousness
on Mar 27, 2006 Female patient from JAPAN , 73 years of age, was diagnosed with insomnia, ill-defined disorder and was treated with Doral (View Usage). Patient had the following side effects: delirium, depressed level of consciousness. Doral dosage: 15 M G (1 In 1 D), Oral. During the same period patient was treated with PAXIL (View Paxil Review and Paxil Label ), LUVOX (View Luvox Review and Luvox Label ), LENDORMN (BROTIZOLAM) (View Lendormn (brotizolam) Review and Lendormn (brotizolam) Label ). Patient was hospitalized.

4961237-6 | Depressed Level Of Consciousness, Disorientation
on Mar 15, 2006 Female patient from JAPAN , 69 years of age, was diagnosed with insomnia and was treated with Doral (View Usage). After Doral was administered, patient had the following side effects: depressed level of consciousness, disorientation. Doral dosage: 15 Mg (1 In 1 D), Oral. During the same period patient was treated with LENDORM (0.25 Mg (1 In 1 D)) (View Lendorm Review and Lendorm Label ), ZANTAC (View Zantac Review and Zantac Label ), PREDONINE (PRENISOLONE) (View Predonine (prenisolone) Review and Predonine (prenisolone) Label ), ALFACALCIDOL (ALFACALCIDOL) (View Alfacalcidol (alfacalcidol) Review and Alfacalcidol (alfacalcidol) Label ), MECOBALAMIN (MECOBALAMIN) (View Mecobalamin (mecobalamin) Review and Mecobalamin (mecobalamin) Label ), BLOPRESS (CANDESARTAN CILEXETIL) (View Blopress (candesartan Cilexetil) Review and Blopress (candesartan Cilexetil) Label ), AMLODIPINE BESYLATE (View Amlodipine Besylate Review and Amlodipine Besylate Label ), THEO DUR (View Theo-dur Review and Theo-dur Label ). Patient was hospitalized.

4947920-7 | Coma, Suicide Attempt
Patient was taking Doral (View Usage). Patient experienced the following unwanted or unexpected effects: coma, suicide attempt on Mar 01, 2006 from UNITED STATES Additional patient health information: Male patient , 22 years of age, was diagnosed with ill-defined disorder and. Doral dosage: Oral. During the same period patient was treated with DEPAS (ETIZOLAM) (View Depas (etizolam) Review and Depas (etizolam) Label ), PAROXETINE HCL (View Paroxetine Hcl Review and Paroxetine Hcl Label ), RISPERIDONE (View Risperidone Review and Risperidone Label ), FLUNITRAZEPAM (FLUNITRAZEPAM) (View Flunitrazepam (flunitrazepam) Review and Flunitrazepam (flunitrazepam) Label ), LORAZEPAM (View Lorazepam Review and Lorazepam Label ), BIPERIDEN (BIPERIDEN) (View Biperiden (biperiden) Review and Biperiden (biperiden) Label ).

4936717-X | Oculomucocutaneous Syndrome, Stevens-johnson Syndrome
Adverse event was reported on Feb 17, 2006 by a Female patient taking Doral (View Usage) (Dosage: 15 Mg, 1 In 1 D, Oral) was diagnosed with ill-defined disorder and. Location: JAPAN , 36 years of age, Patient had the following side effects: oculomucocutaneous syndrome, stevens-johnson syndrome.

4929535-X | Abdominal Pain, Diabetes Mellitus
on Feb 14, 2006 Male patient from JAPAN , 44 years of age, was diagnosed with insomnia and was treated with Doral (View Usage). After Doral was administered, patient had the following side effects: abdominal pain (What is abdominal pain?), diabetes mellitus. Doral dosage: 30 Mg. During the same period patient was treated with LEVOTOMIN (LEVOMEPROMAZINE MALEATE) (50 Mg) (View Levotomin (levomepromazine Maleate) Review and Levotomin (levomepromazine Maleate) Label ), PEROSPIRONE (12 Mg) (View Perospirone Review and Perospirone Label ), CHLORPROMAZINE (150 Mg) (View Chlorpromazine Review and Chlorpromazine Label ), TETRAMIDE (MIANSERIN HYDROCHLORIDE) (View Tetramide (mianserin Hydrochloride) Review and Tetramide (mianserin Hydrochloride) Label ), DIAZEPAM (View Diazepam Review and Diazepam Label ), NITRAZEPAM (View Nitrazepam Review and Nitrazepam Label ), ROHYPNOL (FLUNITRAZEPAM) (View Rohypnol (flunitrazepam) Review and Rohypnol (flunitrazepam) Label ), SENNOSIDE (SENNOSIDE A) (View Sennoside (sennoside A) Review and Sennoside (sennoside A) Label ). Patient was hospitalized.

4913506-3 | Bradykinesia, Cheyne-stokes Respiration, Depressed Level Of Consciousness, Fall, Hepatic Congestion, Hypometabolism, Nasopharyngitis
on Jan 27, 2006 Male patient from JAPAN , 81 years of age, was diagnosed with insomnia and was treated with Doral (View Usage). Patient experienced the following unwanted or unexpected effects: bradykinesia, cheyne-stokes respiration, depressed level of consciousness, fall (What is fall?), hepatic congestion, hypometabolism, nasopharyngitis. Doral dosage: 15 Mg, 1 In 1 D, Oral. During the same period patient was treated with ZOLPIDEM TARTRATE (10 Mg, 1 In 1 D,) (View Zolpidem Tartrate Review and Zolpidem Tartrate Label ), ACETYLSALICYLIC ACID SRT (View Acetylsalicylic Acid Srt Review and Acetylsalicylic Acid Srt Label ), SELBEX (TEPRENONE) (View Selbex (teprenone) Review and Selbex (teprenone) Label ), ARICEPT (View Aricept Review and Aricept Label ), EUGLUCON (GLIBENCLAMIDE) (View Euglucon (glibenclamide) Review and Euglucon (glibenclamide) Label ), NICERGOLINE (View Nicergoline Review and Nicergoline Label ). Patient was hospitalized and became disabled.

4913090-4 | Depressed Level Of Consciousness, Disorientation, Haemodialysis
Patient was taking Doral (View Usage). Patient had the following side effects: depressed level of consciousness, disorientation, haemodialysis on Jan 27, 2006 from JAPAN Additional patient health information: Female patient , 69 years of age, was diagnosed with insomnia and. Doral dosage: 15 Mg, 1 In 1 D , Oral. During the same period patient was treated with LENDORM (0.25 Mg 1 In 1 D) (View Lendorm Review and Lendorm Label ), ZANTAC (View Zantac Review and Zantac Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), ALFACALCIDOL (ALFACALICIDOL) (View Alfacalcidol (alfacalicidol) Review and Alfacalcidol (alfacalicidol) Label ), BLOPRESS (CANDESARTAN CILEXETIL) (View Blopress (candesartan Cilexetil) Review and Blopress (candesartan Cilexetil) Label ), AMLODIPINE BESYLATE (View Amlodipine Besylate Review and Amlodipine Besylate Label ), THEO DUR (View Theo-dur Review and Theo-dur Label ). Patient was hospitalized.

4583546-5 | Abdominal Discomfort, Alcohol Use, Aspiration, Body Temperature Fluctuation, Depressed Level Of Consciousness, Emotional Distress, Iatrogenic Injury, Overdose, Vomiting
Adverse event was reported on Feb 02, 2005 by a Male patient taking Doral (View Usage) (Dosage: 75 Mg Qd, Po) was diagnosed with insomnia and. Location: , 29 years of age, After Doral was administered, patient had the following side effects: abdominal discomfort, alcohol use, aspiration, body temperature fluctuation, depressed level of consciousness, emotional distress, iatrogenic injury, overdose, vomiting. During the same period patient was treated with LEVOMEPROMAZINE MALEATE (150 Mg + 600mg, Po) (View Levomepromazine Maleate Review and Levomepromazine Maleate Label ), VALPROATE SODIUM (View Valproate Sodium Review and Valproate Sodium Label ), INSULIN (View Insulin Review and Insulin Label ). Patient was hospitalized.

4563695-8 | Alcohol Use, Body Temperature Decreased, Body Temperature Increased, Depressed Level Of Consciousness, Emotional Distress, Insomnia, Overdose, Vomiting
on Jan 13, 2005 Male patient from , 29 years of age, was diagnosed with insomnia and was treated with Doral (View Usage). Patient experienced the following unwanted or unexpected effects: alcohol use, body temperature decreased, body temperature increased, depressed level of consciousness, emotional distress, insomnia, overdose, vomiting. Doral dosage: 75 Mg + 600mg, Po. During the same period patient was treated with LEVOMEPROMAZINE MALEATE (150 Mg Qd, Po) (View Levomepromazine Maleate Review and Levomepromazine Maleate Label ), VALPROATE SODIUM (View Valproate Sodium Review and Valproate Sodium Label ), INSULIN (View Insulin Review and Insulin Label ). Patient was hospitalized.