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Review Cesamet Safety Reports submitted to FDA

Total Cesamet reports: 11.
Cesamet FDA safety alerts: No.
Reported deaths: 1    .
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FDA Reported Cesamet Side Effects: injury asphyxiation, euphoric mood, completed suicide, sepsis, catheter related infection, blood pressure increased, bacteraemia, hallucination, depression.
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Cesamet Side Effects Report #5626383-2
Health Professional from CANADA reported CESAMET problem on Jan 30, 2008. Female patient, 65 years of age, weighting 175.0 lb, was diagnosed with migraine and was treated with CESAMET. After drug was administered, patient experienced the following problems/side effects: amnesia, ataxia, disturbance in attention, dry mouth, fatigue, hypoaesthesia, immunoglobulins decreased, loss of consciousness, orthostatic hypotension. CESAMET dosage: 1.5 MG;HS;PO; 0.5 MG;HS;PO. During the same period patient was treated with NEXIUM, DICETEL. Patient recovered.

Cesamet Side Effects Report #5605660-5
CESAMET problem was reported by a Consumer or non-health professional from CANADA on Jan 10, 2008. Female patient, 65 years of age, weighting 175.0 lb, was diagnosed with migraine and was treated with CESAMET. After drug was administered, patient experienced the following problems/side effects: amnesia, ataxia, dry mouth, fatigue, immunoglobulins decreased, loss of consciousness, orthostatic hypotension, somnolence, vertigo. CESAMET dosage: 1.5 MG; HS; PO, 0.5 MG; HS; PO. During the same period patient was treated with NEXIUM, DICETEL. Patient recovered.

Cesamet Side Effects Report #5578507-3
Physician from CANADA reported CESAMET problem on Oct 05, 2006. Male patient, 43 years of age, was treated with CESAMET. After drug was administered, patient experienced the following problems/side effects: amnesia, apnoea, confusional state, convulsion, fall, impulsive behaviour, insomnia, loss of consciousness, rib fracture. CESAMET dosage: 1 MG; PO. During the same period patient was treated with MARIJUANA, BETASERON, NEURONTIN, MINOCYCLINE, SIMVASTATIN, TOPAMAX, EFFEXOR, BACLOFEN. Patient recovered.

Cesamet Side Effects Report #5578511-5
CESAMET problem was reported by a Health Professional from CANADA on Dec 15, 1982. Male patient, 59 years of age, was diagnosed with apnoea and was treated with CESAMET. After drug was administered, patient experienced the following problems/side effects: apnoea, dizziness, syncope. CESAMET dosage: 3.00 MG;QD;PO. During the same period patient was treated with MAXERAN, SERAX, PEPTOL. Patient recovered.

Cesamet Side Effects Report #5578512-7
Consumer or non-health professional from CANADA reported CESAMET problem on May 11, 2006. Female patient, child 12 years of age, was treated with CESAMET. CESAMET dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, VINCRISTINE, DACTINOMYCIN, DAUNORUBICIN. Patient died on 04/15/1982.

Cesamet Side Effects Report #5578522-X
CESAMET problem was reported by a Pharmacist from CANADA on May 11, 2006. Female patient, 44 years of age, weighting 216.1 lb, was treated with CESAMET. After drug was administered, patient experienced the following problems/side effects: asthenia, burning sensation, convulsion, loss of consciousness, myoclonus, tremor. CESAMET dosage: 0.5 MG; FIRST DOSE; PO. During the same period patient was treated with CI PRALEX, TRAZODONE, NASONEX, PRAVASTATIN, RANITIDINE. Patient recovered.

Cesamet Side Effects Report #5578523-1
Health Professional from CANADA reported CESAMET problem on Oct 04, 2006. Female patient, 78 years of age, weighting 160.9 lb, was treated with CESAMET. After drug was administered, patient experienced the following problems/side effects: condition aggravated, confusional state, gait disturbance, pain, spinal cord compression, tachycardia. CESAMET dosage: unknown. During the same period patient was treated with REMICADE. Patient recovered.

Cesamet Side Effects Report #5578524-3
CESAMET problem was reported by a Health Professional from CANADA on May 11, 2007. Male patient, child 9 years of age, weighting 57.32 lb, was treated with CESAMET. After drug was administered, patient experienced the following problems/side effects: agitation, anaphylactic reaction, confusional state, cough, cyanosis, dyspnoea. CESAMET dosage: 0.50 MG; QD; PO. During the same period patient was treated with CHLORPROMAZINE, METHOTREXATE, CYTOSAR, PROLOPRIM. Patient recovered.

Cesamet Side Effects Report #5578525-5
Health Professional from CANADA reported CESAMET problem on Oct 03, 2006. Male patient, 61 years of age, weighting 147.7 lb, was treated with CESAMET. After drug was administered, patient experienced the following problems/side effects: bradycardia, dizziness, hypotension, somnolence. CESAMET dosage: 2.00 MG; QD; PO. Patient recovered.

Cesamet Side Effects Report #5699767-4
CESAMET problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 08, 2008. Female patient, weighting 115.0 lb, was diagnosed with decreased appetite and was treated with CESAMET. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, cold sweat, fear, heart rate increased, tremor. CESAMET dosage: unknown. Patient recovered.

Cesamet Side Effects Report #5713147-4
Consumer or non-health professional from CANADA reported CESAMET problem on Apr 02, 2008. Female patient, 45 years of age, weighting 194.0 lb, was treated with CESAMET. After drug was administered, patient experienced the following problems/side effects: rectal haemorrhage. CESAMET dosage: unknown. During the same period patient was treated with DURAGESIC, ATIVAN, HYDROXYZINE, GRAVOL, EFFEXOR, METOPROLOL SUCCINATE, PANTOPRAZOLE, MARIJUANA. Patient recovered.


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amnesia, ataxia, disturbance in attention, dry mouth, fatigue, hypoaesthesia, immunoglobulins decreased, loss of consciousness, orthostatic hypotension, , was diagnosed with migraine and was diagnosed with migraine and was diagnosed with apnoea and