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Review Dextromethorphan Safety Reports submitted to FDA

Total Dextromethorphan reports: 33.
Dextromethorphan FDA safety alerts: 2004 2005 .
Reported deaths: 36    Reported hospitalizations: 8.
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FDA Reported Dextromethorphan Side Effects: depressed level of consciousness, coordination abnormal, nystagmus, impaired driving ability, hallucination, convulsion, flushing, fatigue, dysarthria, dizziness postural, disturbance in attention.
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Dextromethorphan Side Effects Report #5584214-3
Health Professional from UNITED STATES reported DEXTROMETHORPHAN problem on Dec 18, 2007. Male patient, child 6 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: accidental overdose, lethargy, serotonin syndrome. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with SERTRALINE. Patient was hospitalized. Patient recovered.

Dextromethorphan Side Effects Report #5585360-0
DEXTROMETHORPHAN problem was reported by a Health Professional from UNITED STATES on Dec 28, 2007. Male patient, 20 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: overdose, serotonin syndrome. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with ESCITALOPRAM, ARIPIPRAZOLE, BENZTROPINE MESYLATE, CHLORPHENIRAMINE MALEATE, NICOTINE. Patient was hospitalized. Patient recovered.

Dextromethorphan Side Effects Report #5585361-2
Health Professional from UNITED STATES reported DEXTROMETHORPHAN problem on Dec 28, 2007. Male patient, child 6 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: overdose, serotonin syndrome. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with SERTRALINE, CAFFEINE CITRATE. Patient was hospitalized. Patient recovered.

Dextromethorphan Side Effects Report #5591673-9
DEXTROMETHORPHAN problem was reported by a Physician from UNITED STATES on Jan 04, 2008. Male patient, 18 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: completed suicide. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with QUETIAPINE. Patient died.

Dextromethorphan Side Effects Report #5594371-0
Consumer or non-health professional from BRAZIL reported DEXTROMETHORPHAN problem on Jan 07, 2008. Male patient, child 5 years of age, weighting 50.71 lb, was diagnosed with cough and was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, incorrect dose administered. DEXTROMETHORPHAN dosage: unknown. Patient recovered.

Dextromethorphan Side Effects Report #5595155-X
DEXTROMETHORPHAN problem was reported by a Health Professional from UNITED STATES on Jan 07, 2008. Female patient, 16 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: overdose. DEXTROMETHORPHAN dosage: unknown. Patient died on 01/01/2006.

Dextromethorphan Side Effects Report #5595189-5
Health Professional from UNITED STATES reported DEXTROMETHORPHAN problem on Jan 07, 2008. Female patient, 35 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: intentional overdose. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with DIPHENHYDRAMINE, PSEUDOEPHEDRINE HYDROCHLORIDE. Patient died on 01/01/2006.

Dextromethorphan Side Effects Report #5595384-5
DEXTROMETHORPHAN problem was reported by a Health Professional from UNITED STATES on Jan 07, 2008. Male patient, 18 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: intentional overdose. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with QUETIAPINE. Patient died on 01/01/2006.

Dextromethorphan Side Effects Report #5595386-9
Health Professional from UNITED STATES reported DEXTROMETHORPHAN problem on Jan 07, 2008. Male patient, 50 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: intentional overdose. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with OXYCODONE AND ACETAMINOPHEN. Patient died on 01/01/2006.

Dextromethorphan Side Effects Report #5595419-X
DEXTROMETHORPHAN problem was reported by a Health Professional from UNITED STATES on Jan 07, 2008. Female patient, 62 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: intentional overdose. DEXTROMETHORPHAN dosage: unknown. Patient died on 01/01/2006.

Dextromethorphan Side Effects Report #5595803-4
Physician from UNITED STATES reported DEXTROMETHORPHAN problem on Jan 04, 2008. Female patient, 62 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: completed suicide. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with ACETAMINOPHEN. Patient died.

Dextromethorphan Side Effects Report #5595804-6
DEXTROMETHORPHAN problem was reported by a Physician from UNITED STATES on Jan 04, 2008. Female patient, 62 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: completed suicide. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with ACETAMINOPHEN. Patient died.

Dextromethorphan Side Effects Report #5597085-6
Health Professional from UNITED STATES reported DEXTROMETHORPHAN problem on Jan 07, 2008. Male patient, 21 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: intentional overdose. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with AMFEBUTAMONE. Patient died on 01/01/2006.

Dextromethorphan Side Effects Report #5597129-1
DEXTROMETHORPHAN problem was reported by a Health Professional from UNITED STATES on Jan 07, 2008. Male patient, 23 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: intentional overdose. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with ESCITALOPRAM. Patient died on 01/01/2006.

Dextromethorphan Side Effects Report #5597147-3
Health Professional from UNITED STATES reported DEXTROMETHORPHAN problem on Jan 07, 2008. Male patient, 31 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: intentional overdose. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with ETHANOL, ALPRAZOLAM. Patient died on 01/01/2006.

Dextromethorphan Side Effects Report #5597169-2
DEXTROMETHORPHAN problem was reported by a Health Professional from UNITED STATES on Jan 07, 2008. Female patient, 39 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: intentional overdose. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with AMFEBUTAMONE, DIPHENHYDRAMINE, MEPROBAMATE. Patient died on 01/01/2006.

Dextromethorphan Side Effects Report #5597171-0
Health Professional from UNITED STATES reported DEXTROMETHORPHAN problem on Jan 07, 2008. Female patient, 29 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: overdose. DEXTROMETHORPHAN dosage: unknown. Patient died on 01/01/2006.

Dextromethorphan Side Effects Report #5600982-6
DEXTROMETHORPHAN problem was reported by a Physician from UNITED STATES on Jan 04, 2008. Male patient, 31 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, respiratory arrest. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with ALPRAZOLAM, ETHANOL. Patient died.

Dextromethorphan Side Effects Report #5600983-8
Physician from UNITED STATES reported DEXTROMETHORPHAN problem on Jan 04, 2008. Male patient, 23 years of age, was diagnosed with suicide attempt and was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, completed suicide, respiratory arrest. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with ESCITALOPRAM OXALATE. Patient died.

Dextromethorphan Side Effects Report #5602293-1
DEXTROMETHORPHAN problem was reported by a Physician from UNITED STATES on Jan 04, 2008. Female patient, 39 years of age, was diagnosed with suicide attempt and was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, respiratory arrest, suicide attempt. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with DECONGESTANTS AND ANTIALLERGICS, MEPROBAMATE, BUPROPION. Patient died.

Dextromethorphan Side Effects Report #5602342-0
Physician from UNITED STATES reported DEXTROMETHORPHAN problem on Jan 04, 2008. Male patient, 18 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: completed suicide. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with QUETIAPINE FUMARATE. Patient died.

Dextromethorphan Side Effects Report #5603156-8
DEXTROMETHORPHAN problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 11, 2008. Male patient, 75 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: dyspnoea, hyperhidrosis, incorrect dose administered. DEXTROMETHORPHAN dosage: unknown. Patient recovered.

Dextromethorphan Side Effects Report #5563190-3
Physician from UNITED STATES reported DEXTROMETHORPHAN problem on Dec 12, 2007. Male patient, weighting 13.23 lb, was diagnosed with cough and was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: agitation, heart rate increased, respiratory rate increased, somnolence. DEXTROMETHORPHAN dosage: 0.3ML TID PO. Patient was hospitalized. Patient recovered.

Dextromethorphan Side Effects Report #5582815-X
DEXTROMETHORPHAN problem was reported by a Pharmacist from CANADA on Dec 21, 2007. Male patient, child 6 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: dyspnoea, rash. DEXTROMETHORPHAN dosage: unknown. Patient recovered.

Dextromethorphan Side Effects Report #5507654-7
Health Professional from GERMANY reported DEXTROMETHORPHAN problem on Oct 25, 2007. Female patient, 17 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness. DEXTROMETHORPHAN dosage: unknown. Patient recovered.

Dextromethorphan Side Effects Report #5552557-5
DEXTROMETHORPHAN problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 20, 2007. Male patient, child 6 years of age, weighting 41.89 lb, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: respiration abnormal. DEXTROMETHORPHAN dosage: unknown. Patient recovered.

Dextromethorphan Side Effects Report #5485306-X
Pharmacist from UNITED STATES reported DEXTROMETHORPHAN problem on Oct 10, 2007. Male patient, 22 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: lethargy, respiratory depression, suicide attempt. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with PSEUDOEPHEDRINE. Patient was hospitalized. Patient recovered.

Dextromethorphan Side Effects Report #5505223-6
DEXTROMETHORPHAN problem was reported by a Health Professional from UNITED STATES on Oct 18, 2007. Female patient, child 3 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: hallucination, visual. DEXTROMETHORPHAN dosage: unknown. Patient recovered.

Dextromethorphan Side Effects Report #5449138-0
Consumer or non-health professional from reported DEXTROMETHORPHAN problem on Sept 05, 2007. Female patient, 22 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: convulsion, fall, hallucination, head injury, limb injury. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with COCAINE HYDROCHLORIDE. Patient died.

Dextromethorphan Side Effects Report #5470024-4
DEXTROMETHORPHAN problem was reported by a Consumer or non-health professional from on Sept 24, 2007. Male patient, 19 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: confusional state, impaired driving ability, incoherent, movement disorder, mydriasis, nystagmus, paranoia. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with SERTRALINE, ATOMOXETINE. Patient recovered.

Dextromethorphan Side Effects Report #5470025-6
Consumer or non-health professional from reported DEXTROMETHORPHAN problem on Sept 26, 2007. Male patient, 51 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: cerebellar syndrome, coordination abnormal, dysarthria, hip fracture, impaired driving ability, muscle spasms, nystagmus, road traffic accident. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with LORAZEPAM. Patient was hospitalized. Patient recovered.

Dextromethorphan Side Effects Report #5413928-0
DEXTROMETHORPHAN problem was reported by a Consumer or non-health professional from on Aug 14, 2007. Female patient, 22 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: convulsion, hallucination. DEXTROMETHORPHAN dosage: unknown. During the same period patient was treated with COCAINE HYDROCHLORIDE. Patient died.

Dextromethorphan Side Effects Report #5425853-X
Physician from UNITED STATES reported DEXTROMETHORPHAN problem on June 21, 2007. Male patient, 20 years of age, was treated with DEXTROMETHORPHAN. After drug was administered, patient experienced the following problems/side effects: agitation, depressed level of consciousness, dry skin, flushing, gastrointestinal sounds abnormal, hypertension. DEXTROMETHORPHAN dosage: unknown. Patient recovered.


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