Side Effects of Tussionex (chlorpheniramine and hydrocodone)

Tussionex (chlorpheniramine and hydrocodone) is a combination of an antihistamine that blocks allergic reactions and reduces the production of mucus, and a narcotic that relieves pain and cough. Tussionex is a liquid that slowly releases the chlorpheniramine and hydrocodone after it is ingested.

Common side effects of Tussionex include

• lightheadedness,
• dizziness,
• sedation,
• nausea,
• vomiting,
• disturbed coordination,
• drying and thickening of oral and other respiratory secretions,
• indigestion,
• constipation,
• difficulty urinating,
• palpitations,
• increased heart rate,
• confusion,
• drowsiness,
• anxiety,
• nervousness,
• irritability,
• blurred vision,
• double vision, and
• tremor.

Serious side effects of Tussionex include

• depressed breathing and impairment of thinking and the physical abilities required for driving or operating machinery.

Hydrocodone may be habit forming. Mental and physical dependence can occur but are unlikely when used for short-term relief of pain.

Drug interactions of Tussionex include alcohol and other drugs that can cause sedation such as benzodiazepines, narcotics, tricyclic antidepressants, antipsychotics, and certain antihypertensive medications (for example, clonidine, propranolol) because chlorpheniramine (although not generally sedating itself) and hydrocodone both add to the sedating effects of these drugs.

• Chlorpheniramine also can intensify the drying effects (due to decreased production of mucus) of other medications with anticholinergic properties. 

Antihistamines are typically not recommended for use in pregnancy, especially during the third trimester, because of a risk of seizures in the fetus. The risk for depressed breathing in the newborn infant when the mother ingests hydrocodone is greatest in premature infants who are particularly sensitive to the effects of hydrocodone.

• Physicians may decide to prescribe Tussionex during pregnancy if the benefits to the mother are deemed to outweigh the risks to the fetus and newborn. 

Chlorpheniramine and hydrocodone both are secreted in breast milk. Owing to the risk in infants of antihistamines causing hyperexcitability and even seizures, particularly in newborns and premature infants, Tussionex is not recommended for use in breastfeeding mothers.

The most frequent side effects of chlorpheniramine and hydrocodone include:

• lightheadedness,
• dizziness,
• sedation,
• nausea,
• vomiting,
• disturbed coordination, and
• drying and thickening of oral and other respiratory secretions.

Other important side effects include:

• dyspepsia (indigestion),
• constipation,
• spasm of the ureter (which can lead to difficulty urinating),
• palpitations,
• increased heart rate,
• confusion,
• drowsiness,
• anxiety,
• nervousness,
• irritability,
• blurred vision,
• double vision, and
• tremor.

Hydrocodone can depress breathing, and should be used with caution in elderly, debilitated patients, and in patients with serious lung disease. Hydrocodone can impair thinking and the physical abilities required for driving or operating machinery.

Hydrocodone may be habit forming. Mental and physical dependence can occur but are unlikely when used for short-term relief of pain.

Gastrointestinal Disorders

• 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.

General Disorders And Administration Site Conditions

• Death

Nervous System Disorders

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

Renal And Urinary Disorders

• Ureteral spasm,
• spasm of vesical sphincters, and
• urinary retention have been reported with opiates.

Respiratory, Thoracic And Mediastinal Disorders

• Dryness of the pharynx, occasional tightness of the chest, and respiratory depression.
• Tussionex Pennkinetic Extended-Release Suspension may produce dose-related respiratory depression by acting directly on brain stem respiratory centers.
• Use of Tussionex Pennkinetic Extended-Release Suspension in children less than 6 years of age has been associated with fatal respiratory depression.
• Overdose with Tussionex Pennkinetic Extended-Release Suspension in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression.

Skin And Subcutaneous Tissue Disorders

• Rash,
•  pruritus.

• The use of benzodiazepines, opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants (including alcohol) concomitantly with Tussionex Pennkinetic Extended-Release Suspension may cause an additive CNS depressant effect, profound sedation, respiratory depression, coma, and death and should be avoided.
• The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.
• The concurrent use of other anticholinergics with hydrocodone may produce paralytic ileus.

Drug Abuse And Dependence

• Tussionex Pennkinetic Extended-Release Suspension is a Schedule II 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.