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Review Sominex Safety Reports submitted to FDA

Total Sominex reports: 7.
Sominex FDA safety alerts: No.
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FDA Reported Sominex Side Effects: somnolence, underdose, pain in extremity, joint dislocation, speech disorder, mydriasis, hallucination, loss of consciousness, visual acuity reduced, fatigue, intentional overdose.
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Sominex Side Effects Report #5645306-3
Consumer or non-health professional from UNITED STATES reported SOMINEX problem on Feb 27, 2008. Male patient was diagnosed with intentional overdose and was treated with SOMINEX. After drug was administered, patient experienced the following problems/side effects: intentional overdose, malaise. SOMINEX dosage: unknown. Patient recovered.

Sominex Side Effects Report #5535614-9
SOMINEX problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 05, 2007. Male patient, 45 years of age, was diagnosed with insomnia and was treated with SOMINEX. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, impaired driving ability, incoherent, initial insomnia, muscle twitching, performance status decreased, pruritus, somnolence. SOMINEX dosage: unknown. Patient recovered.

Sominex Side Effects Report #5502887-8
Consumer or non-health professional from UNITED STATES reported SOMINEX problem on Oct 31, 2007. Male patient, 54 years of age, was treated with SOMINEX. After drug was administered, patient experienced the following problems/side effects: hallucination. SOMINEX dosage: unknown. Patient recovered.

Sominex Side Effects Report #5502888-X
SOMINEX problem was reported by a Physician from UNITED STATES on Oct 31, 2007. Male patient was treated with SOMINEX. After drug was administered, patient experienced the following problems/side effects: intentional overdose. SOMINEX dosage: unknown. Patient recovered.


Sominex Side Effects Report #5299481-3
Consumer or non-health professional from UNITED STATES reported SOMINEX problem on Apr 16, 2007. Female patient, 23 years of age, was diagnosed with intentional overdose and was treated with SOMINEX. After drug was administered, patient experienced the following problems/side effects: intentional overdose, somnolence. SOMINEX dosage: unknown. Patient recovered.

Sominex Side Effects Report #5260857-1
SOMINEX problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 09, 2007. Male patient, 45 years of age, was treated with SOMINEX. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, impaired driving ability, incoherent, initial insomnia, muscle twitching, performance status decreased, pruritus, somnolence. SOMINEX dosage: unknown. Patient recovered.

Sominex Side Effects Report #5268543-9
Consumer or non-health professional from UNITED STATES reported SOMINEX problem on Mar 15, 2007. Female patient, 35 years of age, weighting 120.0 lb, was diagnosed with insomnia and was treated with SOMINEX. After drug was administered, patient experienced the following problems/side effects: anxiety, poor quality sleep, somnolence. SOMINEX dosage: unknown. Patient recovered.


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