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Axid

Last reviewed on RxList: 12/5/2016
Axid Side Effects Center

Last reviewed on RxList 11/29/2016

Axid (nizatidine) Capsules are a histamine antagonist indicated for up to 8 weeks treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Axid is available in generic form. Side effects of Axid include:

Contact your doctor if you experience serious side effects of Axid including:

Axid is available in pulvules in strengths of 150 and 300mg; dosage is determined by the severity of the disease being treated. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration. Axid may interact with aspirin, alcohol, cimetidine, ranitidine, or famotidine. Tell your doctor all medications and supplements you use. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Axid can pass into breast milk and may harm a nursing baby. Breastfeeding while taking Axid is not recommended. The safety and effectiveness of Axid has not been determined for the pediatric population.

Our Axid (nizatidine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Axid Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using nizatidine and call your doctor at once if you have a serious side effect such as:

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • unusual bleeding, purple or red pinpoint spots under your skin;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • fever, confusion; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache, dizziness;
  • mild rash;
  • diarrhea; or
  • runny or stuffy nose, sore throat, cough.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Axid (Nizatidine)

Axid Professional Information

SIDE EFFECTS

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    
Headache
16.6
15.6
Abdominal pain
7.5
12.5
Pain
4.2
3.8
Asthenia
3.1
2.9
Back pain
2.4
2.6
Chest pain
2.3
2.1
Infection
1.7
1.1
Fever
1.6
2.3
Surgical procedure
1.4
1.5
Injury, accident
1.2
0.9
Digestive    
Diarrhea
7.2
6.9
Nausea
5.4
7.4
Flatulence
4.9
5.4
Vomiting
3.6
5.6
Dyspepsia
3.6
4.4
Constipation
2.5
3.8
Dry mouth
1.4
1.3
Nausea and vomiting
1.2
1.9
Anorexia
1.2
1.6
Gastrointestinal disorder
1.1
1.2
Tooth disorder
1
0.8
Musculoskeletal    
Myalgia
1.7
1.5
Nervous    
Dizziness
4.6
3.8
Insomnia
2.7
3.4
Abnormal dreams
1.9
1.9
Somnolence
1.9
1.6
Anxiety
1.6
1.4
Nervousness
1.1
0.8
Respiratory    
Rhinitis
9.8
9.6
Pharyngitis
3.3
3.1
Sinusitis
2.4
2.1
Cough, increased
2
2
Skin and Appendages    
Rash
1.9
2.1
Pruritus
1.7
1.3
Special Senses    
Amblyopia
1
0.9
*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 (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)

Related Resources for Axid

Read the Axid User Reviews »

© Axid Patient Information is supplied by Cerner Multum, Inc. and Axid Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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