Hydroxyzine (Hydroxyzine Hydrochloride) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Amoxicillin and clavulanate potassium is generally well tolerated. The majority of side effects observed in clinical trials were of a mild and transient nature and less than 3% of patients discontinued therapy because of drug-related side effects. From the original premarketing studies, where both pediatric and adult patients were enrolled, the most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). The overall incidence of side effects, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported reactions include: Abdominal discomfort, flatulence, and headache.

In pediatric patients (aged 2 months to 12 years), 1 U.S./Canadian clinical trial was conducted which compared amoxicillin and clavulanate potassium 45 mg/6.4 mg/kg/day (divided q12h) for 10 days versus amoxicillin and clavulanate potassium 40 mg/10 mg/kg/day (divided q8h) for 10 days in the treatment of acute otitis media. A total of 575 patients were enrolled, and only the suspension formulations were used in this trial. Overall, the adverse event profile seen was comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes (see CLINICAL STUDIES).

The following adverse reactions have been reported for ampicillin-class antibiotics:

Gastrointestinal: Diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS).

Hypersensitivity Reactions: Skin rashes, pruritus, urticaria, angioedema, serum sickness–like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme (rarely Stevens-Johnson syndrome), acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and an occasional case of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported. These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal hypersensitivity (anaphylactic) reactions can occur with oral penicillin (see WARNINGS).

Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin-class antibiotics, but the significance of these findings is unknown. Hepatic dysfunction, including hepatitis and cholestatic jaundice, (see CONTRAINDICATIONS), increases in serum transaminases (AST and/or ALT), serum bilirubin and/or alkaline phosphatase, has been infrequently reported with amoxicillin and clavulanate potassium. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. On rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications.

Renal: Interstitial nephritis and hematuria have been reported rarely. Crystalluria has also been reported (see OVERDOSAGE).

Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. A slight thrombocytosis was noted in less than 1% of the patients treated with amoxicillin and clavulanate potassium. There have been reports of increased prothrombin time in patients receiving amoxicillin and clavulanate potassium and anticoagulant therapy concomitantly.

Central Nervous System: Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported rarely.

Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

REPORTS OF SUSPECTED HYDROXYZINE SIDE EFFECTS / ADVERSE REACTIONS

Possible Hydroxyzine side effects / adverse reactions in 73 year old female

Reported by a physician from United States on 2011-10-11

Patient: 73 year old female weighing 77.5 kg (170.5 pounds)

Reactions: Multi-Organ Failure, Intentional Overdose, Liver Function Test Abnormal, Vascular Pseudoaneurysm, Intentional Self-Injury

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Acetaminophen

Hydroxyzine
    Indication: Product Used FOR Unknown Indication

Acetaminophen
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Vitamin B Complex CAP; Vitamin A; Ascorbic Acid; Zinc

Possible Hydroxyzine side effects / adverse reactions in 33 year old male

Reported by a health professional (non-physician/pharmacist) on 2011-10-12

Patient: 33 year old male weighing 84.0 kg (184.8 pounds)

Reactions: Rhabdomyolysis, Autonomic Nervous System Imbalance, Mental Disorder, Blood Pressure Abnormal

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Simvastatin
    Dosage: (40 mg),oral
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2010-11-24
    End date: 2010-12-03

Hydroxyzine
    Dosage: 10 mg (10 mg,1 in 1 d)
    Indication: Pruritus
    End date: 2010-12-01

Olanzapine
    Dosage: 20 mg (20 mg,1 in 1 d),oral
    Administration route: Oral
    Indication: Schizophrenia

Trimethoprim
    Dosage: 400 mg (200 mg,2 in 1 d),oral
    Administration route: Oral
    Indication: Acne
    End date: 2010-12-01

Possible Hydroxyzine side effects / adverse reactions in 77 year old male

Reported by a consumer/non-health professional from United States on 2011-10-13

Patient: 77 year old male

Reactions: Drug Ineffective

Suspect drug(s):
Hydroxyzine