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Review Ramelteon Safety Reports submitted to FDA

Total Ramelteon reports: 2.
Ramelteon FDA safety alerts: 2007 .
   Reported hospitalizations: 1.
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FDA Reported Ramelteon Side Effects: suicidal ideation, depression, weight increased, vomiting, urine output decreased, nausea, gastroenteritis viral, diarrhoea, blood creatinine increased, intentional overdose.
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Ramelteon Side Effects Report #5598243-7
Pharmacist from UNITED STATES reported RAMELTEON problem on Jan 17, 2008. Female patient, 32 years of age, weighting 160.0 lb, was treated with RAMELTEON. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, headache, indifference, memory impairment, mental status changes, thinking abnormal. RAMELTEON dosage: unknown. During the same period patient was treated with TOPIRAMATE. Patient was hospitalized. Patient recovered.

Ramelteon Side Effects Report #5265128-5
RAMELTEON problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 11, 2006. Female patient, 76 years of age, weighting 200.0 lb, was diagnosed with insomnia and was treated with RAMELTEON. After drug was administered, patient experienced the following problems/side effects: intentional overdose. RAMELTEON dosage: unknown. During the same period patient was treated with ACEON, VITAMIN, CALCIUM, FLEXAMINE, VALIUM. Patient recovered.


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abnormal behaviour, headache, indifference, memory impairment, mental status changes, thinking abnormal, , %drugN% %drugN% was diagnosed with insomnia and