Tussionex (Hydrocodone Polistirex / Chlorpheniramine Polistirex) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Central Nervous System:    Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, euphoria, dizziness, psychic dependence, mood changes.

Dermatologic System:    Rash, pruritus.

Gastrointestinal System:    Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of TUSSIONEX Pennkinetic Extended-Release Suspension may produce constipation.

Genitourinary System:    Ureteral spasm, spasm of vesicle sphincters and urinary retention have been reported with opiates.

Respiratory Depression:    TUSSIONEX Pennkinetic Extended-Release Suspension may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE).

Respiratory System:    Dryness of the pharynx, occasional tightness of the chest.

DRUG ABUSE AND DEPENDENCE

TUSSIONEX Pennkinetic Extended-Release Suspension is a Schedule III narcotic. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore, TUSSIONEX Pennkinetic Extended-Release Suspension should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when TUSSIONEX Pennkinetic Extended-Release Suspension is used for a short time for the treatment of cough. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO TUSSIONEX

Possible Tussionex side effects / adverse reactions in 23 year old male

Reported by a individual with unspecified qualification from United States on 2007-05-07

Patient: 23 year old male

Reactions: Pulmonary Congestion, Pulmonary Oedema, Brain Oedema, Accidental Overdose

Adverse event resulted in: death

Suspect drug(s):
Tussionex

Possible Tussionex side effects / adverse reactions in 21 year old male

Reported by a individual with unspecified qualification from United States on 2007-05-07

Patient: 21 year old male

Reactions: Alcohol USE, Bronchopneumonia, Choking, Pulmonary Congestion, Pulmonary Oedema, Accidental Overdose

Adverse event resulted in: death

Suspect drug(s):
Tussionex

Possible Tussionex side effects / adverse reactions in 3 year old female

Reported by a physician from United States on 2007-10-11

Patient: 3 year old female

Reactions: Brain Death, Brain Stem Infarction, Blood PH Decreased, Coma, Blood Bicarbonate Decreased, Cerebral Infarction, Cyanosis, Heart Rate Increased, Multiple Drug Overdose, Accidental Drug Intake by Child

Adverse event resulted in: death

Suspect drug(s):
Ibuprofen
    Administration route: Oral

Ibuprofen
    Dosage: unknown
    Administration route: Oral
    Indication: Accidental Exposure

Tussionex
    Dosage: unknown
    Administration route: Oral
    Indication: Accidental Exposure