Central Nervous System

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

Gastrointestinal System

Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of HYCODAN (hydrocodone bitartrate and homatropine methylbromide) may produce constipation.

Genitourinary System

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

Respiratory Depression

HYCODAN (hydrocodone bitartrate and homatropine methylbromide) may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSE). Use of HYCODAN (hydrocodone bitartrate and homatropine methylbromide) in children less than 6 years of age has been associated with fatal respiratory depression.

Overdose with HYCODAN (hydrocodone bitartrate and homatropine methylbromide) in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression.

Postmarketing events seen in children under 6 years of age include accidental overdose, bronchopneumonia, coma, cyanosis, death, death neonatal, dyspnea, pulmonary edema, respiratory arrest, and respiratory depression.

Postmarketing events seen in patients older than 6 years of age include accidental overdose, cardio-respiratory arrest, death due to drug toxicity, non-accidental overdose, and overdose.

Dermatological

Skin rash, pruritus.

Drug Abuse And Dependence

HYCODAN (hydrocodone bitartrate and homatropine methylbromide) is a Schedule III opioid. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of opioids; therefore, HYCODAN (hydrocodone bitartrate and homatropine methylbromide) should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when HYCODAN (hydrocodone bitartrate and homatropine methylbromide) 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 opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy.

Read the Hycodan (hydrocodone bitartrate and homatropine methylbromide) Side Effects Center for a complete guide to possible side effects »

Patients receiving opioids, antihistamines, antipsychotics, antianxiety agents or other CNS depressants (including alcohol) concomitantly with HYCODAN (hydrocodone bitartrate and homatropine methylbromide) may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

Last reviewed on RxList: 3/19/2009
This monograph has been modified to include the generic and brand name in many instances.