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Axid (Nizatidine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Worldwide, controlled clinical trials of nizatidine included over 6,000 patients given nizatidine in studies of varying durations. Placebo-controlled trials in the United States and Canada included over 2,600 patients given nizatidine and over 1,700 given placebo. Among the adverse events in these placebo-controlled trials, anemia (0.2% vs 0%) and urticaria (0.5% vs 0.1%) were significantly more common in the nizatidine group.

Incidence in Placebo-Controlled Clinical Trials in the United States and Canada— Table 5 lists adverse events that occurred at a frequency of 1% or more among nizatidine-treated patients who participated in placebo-controlled trials. The cited figures provide some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.

Table 5 Incidence of Treatment-Emergent Adverse Events in Placebo-Controlled Clinical Trials in the United States and Canada

Body System/

Adverse Event*

Percentage of

Patients Reporting Event

NizatidinePlacebo
(N=2,694)(N=1,729)
Body as a Whole
Headache16.615.6
Abdominal Pain7.512.5
Pain4.23.8
Asthenia3.12.9
Back Pain2.42.6
Chest pain2.32.1
Infection1.71.1
Fever1.62.3
Surgical Procedure1.41.5
Injury, accident1.20.9
Digestive
Diarrhea7.26.9
Nausea5.47.4
Flatulence4.95.4
Vomiting3.65.6
Dyspepsia3.64.4
Constipation2.53.8
Dry mouth1.41.3
Nausea and Vomiting1.21.9
Anorexia1.21.6
Gastrointestinal Disorder1.11.2
Tooth disorder1.00.8
Musculoskeletal
Myalgia1.71.5
Nervous
Dizziness4.63.8
Insomnia2.73.4
Abnormal dreams1.91.9
Somnolence1.91.6
Anxiety1.61.4
Nervousness1.10.8
Respiratory
Rhinitis9.89.6
Pharyngitis3.33.1
Sinusitis2.42.1
Cough, increased2.02.0
Skin and Appendages
Rash1.92.1
Pruritis1.71.3
Special Senses
Amblyopia1.00.9

*Events reported by at least 1% of nizatidine-treated patients are included.

A variety of less common events were also reported; it was not possible to determine whether these were caused by nizatidine.

Hepatic— Hepatocellular injury, evidenced by elevated liver enzyme tests (SGOT [AST], SGPT [ALT], or alkaline phosphatase), occurred in some patients and was possibly or probably related to nizatidine. In some cases, there was marked elevation of SGOT, SGPT enzymes (greater than 500 IU/L) and, in a single instance, SGPT was greater than 2,000 IU/L. The overall rate of occurrences of elevated liver enzymes and elevations to 3 times the upper limit of normal, however, did not significantly differ from the rate of liver enzyme abnormalities in placebo-treated patients. All abnormalities were reversible after discontinuation of Axid. Since market introduction, hepatitis and jaundice have been reported. Rare cases of cholestatic or mixed hepatocellular and cholestatic injury with jaundice have been reported with reversal of the abnormalities after discontinuation of Axid.

Cardiovascular—In clinical pharmacology studies, short episodes of asymptomatic ventricular tachycardia occurred in 2 individuals administered Axid and in 3 untreated subjects.

CNS— Rare cases of reversible mental confusion have been reported.

Endocrine— Clinical pharmacology studies and controlled clinical trials showed no evidence of antiandrogenic activity due to Axid. Impotence and decreased libido were reported with similar frequency by patients who received Axid and by those given placebo. Rare reports of gynecomastia occurred.

Hematologic— Anemia was reported significantly more frequently in nizatidine- than in placebo-treated patients. Fatal thrombocytopenia was reported in a patient who was treated with Axid and another H2-receptor antagonist. On previous occasions, this patient had experienced thrombocytopenia while taking other drugs. Rare cases of thrombocytopenic purpura have been reported.

Integumental— Sweating and urticaria were reported significantly more frequently in nizatidine- than in placebo-treated patients. Rash and exfoliative dermatitis were also reported. Vasculitis has been reported rarely.

Hypersensitivity— As with other H2-receptor antagonists, rare cases of anaphylaxis following administration of nizatidine have been reported. Rare episodes of hypersensitivity reactions (eg, bronchospasm, laryngeal edema, rash, and eosinophilia) have been reported.

Body as a Whole— Serum sickness-like reactions have occurred rarely in conjunction with nizatidine use.

Genitourinary— Reports of impotence have occurred.

Other— Hyperuricemia unassociated with gout or nephrolithiasis was reported. Eosinophilia, fever, and nausea related to nizatidine administration have been reported.

Drug label data at the top of this Page last updated: 2007-01-09

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