Tranxene (Clorazepate Dipotassium) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The side effect most frequently reported was drowsiness. Less commonly reported (in descending order of occurrence) were: dizziness, various gastrointestinal complaints, nervousness, blurred vision, dry mouth, headache, and mental confusion. Other side effects included insomnia, transient skin rashes, fatigue, ataxia, genitourinary complaints, irritability, diplopia, depression, tremor, and slurred speech.

There have been reports of abnormal liver and kidney function tests and of decrease in hematocrit.

Decrease in systolic blood pressure has been observed.

To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

REPORTS OF SUSPECTED TRANXENE SIDE EFFECTS / ADVERSE REACTIONS

Possible Tranxene side effects / adverse reactions in 71 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-18

Patient: 71 year old male

Reactions: Muscular Weakness, Gait Disturbance, Fall, Somnolence

Suspect drug(s):
Duragesic-100
    Dosage: 100a?g/72h

Trimeprazine Tartrate
    Dosage: 10 mg daily
    Administration route: Oral
    End date: 2011-07-30

Tranxene
    Dosage: 20 mg daily
    Administration route: Oral
    End date: 2011-07-30

Neurontin
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    End date: 2011-07-30

Morphine Sulfate
    Dosage: 40 mg daily
    Administration route: Oral
    End date: 2011-07-30

Other drugs received by patient: Omeprazole; Tiapridal; Lantus; Vastarel; Lyrica; Doxazosin Mesylate; Alprazolam; Acetaminophen; Glyburide; Cymbalta; Fenofibrate

Possible Tranxene side effects / adverse reactions in 61 year old female

Reported by a pharmacist from United States on 2011-11-10

Patient: 61 year old female

Reactions: OFF Label USE, Respiratory Distress

Adverse event resulted in: life threatening event

Suspect drug(s):
Tranxene
    Dosage: increased from 60 mg to 90 mg oral
    Administration route: Oral
    Indication: Anxiety
    End date: 2011-09-07

Tramadol HCL
    Dosage: 1 dosage form x 1, 2 times per day, oral
    Administration route: Oral
    Indication: Pain
    End date: 2011-09-07

Fentanyl
    Dosage: 1 dosage formx 1 per day sublingual
    Indication: Pain
    End date: 2011-09-26

Other drugs received by patient: Neurontin; Trileptal; Lioresal; Chlorazepate (Chlorazepate); Forlax (Polyethylene Glycol); Depamide (Valpromide) ); Citalopram Hydrobromide

Possible Tranxene side effects / adverse reactions in female

Reported by a health professional (non-physician/pharmacist) from France on 2011-11-14

Patient: female

Reactions: Maternal Drugs Affecting Foetus, Hypoglycaemia Neonatal, Premature Baby, Bradycardia Neonatal, Foetal Malnutrition, Caesarean Section, Malaise, Hypotonia Neonatal, Hypocalcaemia, Foetal Hypokinesia, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Suspect drug(s):
Tranxene
    Indication: Foetal Exposure Timing Unspecified
    End date: 2011-05-17

Levothyroxine Sodium
    Indication: Foetal Exposure Timing Unspecified
    End date: 2011-05-17

Prozac
    Indication: Foetal Exposure Timing Unspecified
    End date: 2011-05-17