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Vicodin ES (Hydrocodone Bitartrate / Acetaminophen) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The most frequently reported adverse reactions include: lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include:

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

Gastrointestinal System:    Prolonged administration of VICODIN ES Tablets may produce constipation.

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

Respiratory Depression:    Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. (see OVERDOSAGE).

Special Senses:    Very rare cases of hearing impairment or loss have been reported in patients predominantly receiving very high doses of hydrocodone/acetaminophen for long periods of time.

Dermatological:    Skin rash, pruritus.

The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Potential effects of high dosage are listed in the OVERDOSAGE section.

DRUG ABUSE AND DEPENDENCE

Controlled Substance:    VICODIN ES Tablets are classified as a Schedule CIII controlled substance.

Abuse and Dependence:    Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, VICODIN ES Tablets should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when VICODIN ES Tablets are used for a short time for the treatment of pain.

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 narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients.



REPORTS OF SUSPECTED VICODIN ES SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Vicodin ES. The information is not vetted and should not be considered as verified clinical evidence.

Possible Vicodin ES side effects / adverse reactions in 50 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-09

Patient: 50 year old female

Reactions: Dyspnoea, Malaise, Metabolic Acidosis, Pyroglutamate Increased, Asthenia, Hyperchloraemia

Adverse event resulted in: hospitalization

Suspect drug(s):
Ipratropium Bromide and Albuterol Sulfate
    Dosage: ipratropium bromide 18 mcg and albuterol 90 mcg 1 puff every 8 hrs

Vicodin ES
    Dosage: hydrocodone bitartrate 7.5 mg and acetaminophen 750 mg every 8 hours as needed
    Administration route: Oral
    Indication: Pain

Other drugs received by patient: Klonopin; Lopressor



Possible Vicodin ES side effects / adverse reactions in 50 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-06

Patient: 50 year old female

Reactions: Dyspnoea, Metabolic Acidosis, Laboratory Test Abnormal, Anion GAP Increased, Asthenia, Haemodialysis, Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Vicodin ES
    Indication: Product Used FOR Unknown Indication

Clonazepam
    Indication: Product Used FOR Unknown Indication

Albuterol Sulfate and Ipratropium Bromide
    Indication: Product Used FOR Unknown Indication

Metoprolol Succinate
    Indication: Product Used FOR Unknown Indication



Possible Vicodin ES side effects / adverse reactions in 50 year old female

Reported by a physician from United States on 2012-04-17

Patient: 50 year old female

Reactions: Metabolic Acidosis, Dyspnoea, Pyroglutamate Increased, Asthenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Clonazepam
    Indication: Product Used FOR Unknown Indication

Albuterol Sulfate and Ipratropium Bromide
    Indication: Product Used FOR Unknown Indication

Vicodin ES
    Indication: Product Used FOR Unknown Indication

Metoprolol Tartrate
    Indication: Product Used FOR Unknown Indication



See index of all Vicodin ES side effect reports >>

Drug label data at the top of this Page last updated: 2006-01-25

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