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

ADVERSE REACTIONS

The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory 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 Lortab 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 brain stem respiratory centers (see OVERDOSAGE).

Special Senses:    Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.

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:    Lortab Tablets are classified as Schedule III controlled substances.

Abuse and Dependence:    Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, this product should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen 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 SIDE EFFECTS / ADVERSE REACTIONS RELATED TO LORTAB

Possible Lortab side effects / adverse reactions in 56 year old female

Reported by a individual with unspecified qualification from United States on 2007-01-17

Patient: 56 year old female weighing 66.1 kg (145.5 pounds)

Reactions: Pco2 Decreased, Blood PH Increased, Tachycardia, Mental Status Changes, Pyrexia, Pericardial Effusion, Delusion, PO2 Decreased, Pleural Effusion, Multiple Drug Overdose, Hallucination, Lethargy, Cardiac Failure Congestive, Oxygen Saturation Decreased, Pneumonia, Paranoia, Delirium, Pericarditis, Memory Impairment

Adverse event resulted in: hospitalization

Suspect drug(s):
Lexapro
    Dosage: 10 mg qd po
    Administration route: Oral
    Indication: Depression
    Start date: 2005-10-28

Oravescent Fentanyl Citrate
    Dosage: 600 mg prn po
    Administration route: Oral
    Indication: Breakthrough Pain
    Start date: 2005-09-23
    End date: 2006-06-19

Oravescent Fentanyl Citrate
    Dosage: 400 mg prn po
    Administration route: Oral
    Indication: Breakthrough Pain
    Start date: 2006-06-20
    End date: 2006-07-20

Oxycontin
    Dosage: 160 mg qd po
    Administration route: Oral
    Start date: 2004-01-01

Lortab
    Start date: 2005-08-29

Tylenol

Flexeril

Other drugs received by patient: Synthroid; Lyrica; Combivent; Seroquel; Albuterol; Aspirin; Nexium

Possible Lortab side effects / adverse reactions in 65 year old female

Reported by a pharmacist from United States on 2007-01-24

Patient: 65 year old female

Reactions: Cardio-Respiratory Arrest, Hypotension, Unresponsive TO Stimuli, Hypoxia, Bradycardia

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Fentanyl

Lortab

Possible Lortab side effects / adverse reactions in 32 year old male

Reported by a individual with unspecified qualification from United States on 2007-01-25

Patient: 32 year old male

Reactions: Confusional State, Head Injury, Intentional Self-Injury, Fall, Loss of Consciousness, Abnormal Dreams, Mood Altered, Completed Suicide, Pulmonary Oedema, Brain Oedema, Depression, Adrenal Haemorrhage, Pupil Fixed, Hallucination, Nervousness, Oxygen Saturation Decreased, Mydriasis, Partner Stress, Amnesia, Anxiety, Emotional Distress, Visceral Congestion, Pneumoconiosis, Hypotonia, Heart Rate Increased, Bradycardia, GUN Shot Wound, Blood Pressure Decreased, Face Injury

Adverse event resulted in: death

Suspect drug(s):
Lorcet Plus Tablets 7.5/650 (Hydrocodone Bitartrate and Acetaminophen)
    Indication: Pain

Talwin NX
    Indication: Pain

Norco
    Indication: Pain

Vicodin
    Indication: Pain

Lortab
    Indication: Pain

Ambien
    Indication: Pain

Temazepam
    Indication: Pain

Dalmane
    Indication: Pain

Restoril
    Indication: Pain

Lidoderm
    Indication: Pain

Lidopain (Lidocaine)
    Indication: Pain

Other drugs received by patient: Zonegran; Proponapat (Nos)