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Review Endep Safety Reports submitted to FDA

Total Endep reports: 11.
Endep FDA safety alerts: 2008 .
   Reported hospitalizations: 2.
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FDA Reported Endep Side Effects:
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Endep Side Effects Report #5670150-0
Consumer or non-health professional from AUSTRALIA reported ENDEP problem on Feb 25, 2008. Female patient, 55 years of age, was diagnosed with depression and was treated with ENDEP. After drug was administered, patient experienced the following problems/side effects: dry mouth, dysuria, eye pain, hallucination, auditory, insomnia, paraesthesia, sensation of heaviness. ENDEP dosage: 20 MG; AT BEDTIME; ORAL. During the same period patient was treated with LIPITOR. Patient recovered.

Endep Side Effects Report #5671085-X
ENDEP problem was reported by a Physician from AUSTRALIA on Mar 06, 2008. Male patient was diagnosed with insomnia and was treated with ENDEP. After drug was administered, patient experienced the following problems/side effects: abnormal dreams, aggression, agitation, amnesia, anger, anxiety, apathy, confusional state, depression. ENDEP dosage: unknown. During the same period patient was treated with NEURONTIN, STILNOX, VIOXX. Patient recovered.

Endep Side Effects Report #5677566-7
Physician from AUSTRALIA reported ENDEP problem on Feb 28, 2008. Female patient was treated with ENDEP. After drug was administered, patient experienced the following problems/side effects: blood electrolytes abnormal, fall, upper limb fracture. ENDEP dosage: 50 MG; AT BEDTIME; ORAL. Patient was hospitalized. Patient recovered.

Endep Side Effects Report #5614060-3
ENDEP problem was reported by a Consumer or non-health professional from AUSTRALIA on Jan 15, 2008. Female patient, 75 years of age, was diagnosed with fibromyalgia and was treated with ENDEP. After drug was administered, patient experienced the following problems/side effects: dry mouth, tardive dyskinesia, trismus, vision blurred. ENDEP dosage: 25 MG;NOCTE;ORAL. Patient recovered.

Endep Side Effects Report #5500099-5
Consumer or non-health professional from reported ENDEP problem on Oct 09, 2007. Female patient, 57 years of age, was diagnosed with burning sensation and was treated with ENDEP. After drug was administered, patient experienced the following problems/side effects: aggression, dry mouth, fatigue, self-injurious ideation, tearfulness. ENDEP dosage: 25 MG. Patient recovered.

Endep Side Effects Report #5503568-7
ENDEP problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 12, 2007. Male patient, 33 years of age, was diagnosed with bone pain, neuralgia and was treated with ENDEP. After drug was administered, patient experienced the following problems/side effects: agitation, anxiety, delusion, nightmare, paranoia, urinary retention. ENDEP dosage: 50 MG; HD; ORAL; 10 MG; HD; ORAL. During the same period patient was treated with PANADEINE, BRUFEN. Patient recovered.

Endep Side Effects Report #5753052-0
Consumer or non-health professional from AUSTRALIA reported ENDEP problem on May 08, 2008. Female patient, 69 years of age, was diagnosed with anxiety and was treated with ENDEP. After drug was administered, patient experienced the following problems/side effects: condition aggravated, dry mouth, dysgeusia, hallucination, hyperhidrosis, lip dry. ENDEP dosage: 50 MG; AT BEDTIME; ORAL. During the same period patient was treated with PROTOS, BRUFEN, ARATAC, AVAPRO, WARFARIN, ZOCOR. Patient recovered.

Endep Side Effects Report #5754127-2
ENDEP problem was reported by a Consumer or non-health professional from AUSTRALIA on May 07, 2008. Female patient, 43 years of age, was diagnosed with neuralgia and was treated with ENDEP. After drug was administered, patient experienced the following problems/side effects: bladder disorder, dry mouth, dysuria, gingivitis, oral candidiasis, sensitivity of teeth, sleep disorder, urinary retention. ENDEP dosage: 150 MG; AT BEDTIME; ORAL. During the same period patient was treated with TRIFEME, LYRICA, NEURONTIN, DITROPAN, PANADEINE, VESICARE, COLOXYL WITH SENNA, AVANZA. Patient recovered.

Endep Side Effects Report #5694191-2
Physician from AUSTRALIA reported ENDEP problem on Mar 18, 2008. Female patient, 76 years of age, was diagnosed with depression and was treated with ENDEP. After drug was administered, patient experienced the following problems/side effects: blood electrolytes abnormal, dizziness, fall, somnolence, transient ischaemic attack, upper limb fracture. ENDEP dosage: 50 MG;AT BEDTIME;ORAL. Patient was hospitalized. Patient recovered.

Endep Side Effects Report #5706342-1
ENDEP problem was reported by a Consumer or non-health professional from AUSTRALIA on Mar 28, 2008. Female patient, 29 years of age, was diagnosed with depression and was treated with ENDEP. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, anorexia, anxiety, convulsion, mood altered, spousal abuse, stress, suicidal ideation. ENDEP dosage: unknown. During the same period patient was treated with TRAMADOL, RESTAVIT, DIGESIC. Patient recovered.

Endep Side Effects Report #5725069-3
Physician from AUSTRALIA reported ENDEP problem on Apr 14, 2008. Male patient, 64 years of age, was diagnosed with depression and was treated with ENDEP. After drug was administered, patient experienced the following problems/side effects: anorexia, chills, dry mouth, gait disturbance, influenza, myalgia, nausea, pharyngolaryngeal pain, pyrexia. ENDEP dosage: 50 MG; DAILY; ORAL. During the same period patient was treated with METFORMIN, PREDNISONE, ZOCOR, PANTOPRAZOLE, MYOCRISIN. Patient recovered.


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dry mouth, dysuria, eye pain, hallucination, auditory, insomnia, paraesthesia, sensation of heaviness, , was diagnosed with depression and was diagnosed with insomnia and was diagnosed with fibromyalgia and