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Nizatidine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Avoid drinking alcohol. It can increase the risk of damage to your stomach.
Avoid taking cimetidine (Tagamet), ranitidine (Zantac), or famotidine (Pepcid) while you are taking nizatidine, unless your doctor has told you to.
Tell your doctor about all other medications you use, especially aspirin.
There may be other drugs that can interact with nizatidine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Is nizatidine safe to take if I'm pregnant or breastfeeding?
There are no adequate studies in pregnant women. Available evidence suggests that there is little risk when used during pregnancy.
Nizatidine is secreted into human breast milk and may pose a potential risk to the infant.
Braintree Laboratories, Inc.
Reliant Pharmaceuticals, Inc.
Side Effects of Axid
Serious side effects have been reported with Axid. See "Drug Precautions" section.
Common side effects of Axid include:
- runny nose
- stomach pain
This is not a complete list of Axid side effects. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
What is Axid (nizatidine)?
Nizatidine is a histamine-2 blocker that works by decreasing the amount of acid produced by the stomach.
Nizatidine is used to treat ulcers in the stomach and intestines. Nizatidine also treats heartburn and erosive esophagitis caused by gastroesophageal reflux disease (GERD), a condition in which acid backs up from the stomach into the esophagus.
Nizatidine may also be used for purposes not listed in this medication guide.
Axid Dosage and Administration
Active Duodenal Ulcer The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.
Maintenance of Healed Duodenal Ulcer The recommended oral dosage for adults is 150 mg once daily at bedtime.
Gastroesophageal Reflux Disease The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.
Active Benign Gastric UlcerThe recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.
Dosage Adjustment for Patients With Moderate to Severe Renal InsufficiencyThe dose for patients with renal dysfunction should be reduced as follows:
Active Duodenal Ulcer, GERD, and Benign Gastric Ulcer
20 – 50 mL/min<20 mL/min
150 mg daily
150 mg every other day
20 – 50 mL/min<20 mL/min
150 mg every other day150 mg every 3 days
Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.
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|
|Percentage of Patients Reporting Event|
|Body System/Adverse Event*||Nizatidine(N=2,694)||Placebo(N=1,729)|
|Body as a Whole|
|Nausea and vomiting||1.2||1.9|
|Skin and Appendages|
|*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 (nizatidine) . 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 (nizatidine) .
Cardiovascular- In clinical pharmacology studies, short episodes of asymptomatic ventricular tachycardia occurred in 2 individuals administered Axid (nizatidine) 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 (nizatidine) . Impotence and decreased libido were reported with similar frequency by patients who received Axid (nizatidine) 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 (nizatidine) 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.
Read the entire FDA prescribing information for Axid (Nizatidine)Read More »
For the Consumer
Applies to nizatidine: oral capsules, oral tablets for
Side effects include:
Nizatidine Pregnancy Warnings
Nizatidine has been assigned to pregnancy category B by the FDA. Animal studies have revealed no evidence of impaired fertility or harm to the fetus. There are no controlled data in human pregnancy. Nizatidine should only be given during pregnancy when benefit outweighs risk.
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