Does Axid (nizatidine) cause side effects?
Axid blocks the action of histamine on stomach cells and reduces their production of acid. Histamine is a naturally-occurring chemical that stimulates stomach cells to produce acid. H2-blockers inhibit the action of histamine on stomach cells, thus reducing the production of acid by the stomach.
Since excessive stomach acid can cause or worsen stomach and duodenal ulcers, reducing stomach acid prevents ulcer formation and helps ulcers to heal.
Common side effects of Axid include
- muscle pain,
- depression, and
Drug interactions of Axid include drugs that require acid for adequate absorption such as iron salts, itraconazole, ketoconazole, atazanavir, dasatinib, indinavir, and dapsone, because Axid may interfere with the absorption of these drugs.
Available evidence suggests there is little risk when Axid is used during pregnancy.
What are the side effects of Axid (nizatidine)?
Common side effects are:
- muscle pain,
- depression, and
Axid (nizatidine) side effects list for healthcare professionals
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*|
|Body as a Whole|
|Nausea and vomiting|
|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.
What drugs interact with Axid (nizatidine)?
Axid (nizatidine) does not inhibit the cytochrome P-450-linked drug-metabolizing enzyme system; therefore, drug interactions mediated by inhibition of hepatic metabolism are not expected to occur.
In patients given very high doses (3,900 mg) of aspirin daily, increases in serum salicylate levels were seen when nizatidine, 150 mg b.i.d., was administered concurrently.
Axid (nizatidine) is an H2 blocker used to treat and prevent duodenal and gastric ulcers (peptic, stomach), GERD, and heartburn. Common side effects of Axid include constipation, diarrhea, fatigue, headache, insomnia, muscle pain, nausea, vomiting, dizziness, confusion, depression, and agitation. Available evidence suggests there is little risk when Axid is used during pregnancy. Axid is secreted into human breast milk and may pose a potential risk to the infant.
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Related Disease Conditions
Peptic Ulcer (Stomach Ulcer)
Peptic or stomach ulcers are ulcers are an ulcer in the lining of the stomach, duodenum, or esophagus. Ulcer formation is related to H. pylori bacteria in the stomach, use of anti-inflammatory medications, and cigarette smoking. Symptoms of peptic or stomach ulcers include abdominal burning or hunger pain, indigestion, and abdominal discomfort after meals. Treatment for stomach ulcers depends upon the cause.
Heartburn is a burning sensation experienced from acid reflux (GERD). Symptoms of heartburn include chest pain, burning in the throat, difficulty swallowing, the feeling of food sticking in the throat, and a burning feeling in the chest. Causes of heartburn include dietary habits, lifestyle habits, and medical causes. Treatments for heartburn include lifestyle changes, OTC medication,prescription medication, and surgery.
GERD (Acid Reflux, Heartburn)
GERD (gastroesophageal reflux disease) is a condition in which the acidified liquid contents of the stomach backs up into the esophagus. The symptoms of uncomplicated GERD are: heartburn, regurgitation, and nausea. Effective treatment is available for most patients with GERD.
Heartburn during Pregnancy
Heartburn during pregnancy is quite common. During pregnancy the lower esophageal sphincter muscle becomes weakened , which likely occurs due to the effect of the high levels of the hormones estrogen and progesterone during pregnancy. Fortunately, this resolves after pregnancy. Management of heartburn during pregnancy are generally involves lifestyle changes and avoiding foods that promote heartburn, for example, don't smoke, avoid tight clothing, eat small, frequent meals, chew gum, or sip liquids. The effect of heartburn medications on the fetus is unknown, so it is best to check with your OB/GYN if you feel you need medication to treat heartburn.
Heartburn vs. Acid Reflux (Differences and Similarities)
Heartburn and acid reflux are not the same thing. Heartburn is actually a symptom of acid reflux. Heartburn gets its name because it feels like a burning sensation around the heart. Another symptom that occurs with heartburn is a bitter or sour taste in the mouth, usually when you eat or lye down. Heartburn affects more than 60 million people in the US at least once a month. Acid reflux, or GERD, occurs when stomach acid backs up into the esophagus, which irritates it. Heartburn is just one symptom of acid reflux. Other symptoms of acid reflux include: Belching Nausea after eating A feeling of fullness during or after eating Abdominal bloating Upset stomach Belching Wheezing Reflux laryngitis A tightness in the throat Problems swallowing Indigestion In some people, vomiting Causes of acid reflux and heartburn include: Being obese Slouching (poor posture) Medications like calcium channel blockers, theophylline, nitrates, and antihistamines Foods and drinks like caffeine, citrus fruits and vegetables, alcohol, and chocolate Pregnancy Diabetes Increase in stomach acid Eating a heavy meal Eating before bed The treatment for heartburn and acid reflux is to treat the underlying cause, for example, GERD, with over-the-counter (OTC) medicine, prescription medicine, natural remedies, and lifestyle changes like a eating a healthy, less fatty, spicy diet, not eating big meals, not eating before bed, and getting regular exercise to improve your posture.Sometimes a heart attack can mimic heartburn and acid reflux because they feel very similar. If you have symptoms of chest pain, tightness in the chest, heartburn, acid reflux, jaw, tooth, or head pain; shortness of breath, nausea, vomiting, sweating, discomfort in the upper middle of the abdomen, arm or upper back pain, or the general feeling of being ill, go to the nearest Emergency Department immediately because these are the symptoms of a heart attack.REFERENCES:American College of Gastroenterology. "Acid Reflux." 2017.<http://patients.gi.org/topics/acid-reflux/> familydoctor.org. "Heartburn." Updated: Mar 2014.<https://familydoctor.org/condition/heartburn/> National Library of Medicine; PubMed Health. "Heartburn and GERD: Treatment options for GERD." Updated: Nov 18, 2015.<https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0072436/>
Heart Attack vs. Heartburn (Differences between Symptoms and Signs)
Heartburn is a symptom of another disease or medical problem and can be described as a feeling of burning in the chest accompanied by symptoms of nausea, vomiting, or a sour taste or food stuck in the back of the throat. Heart attack occurs when an artery in the heart is completely blocked by a blood clot, which causes that portion of heart muscle to die. Heart attack also has symptoms of chest pain, nausea, and vomiting, however, other warning signs and symptoms of a heart attack are unusual weakness or fatigue, and persistent and/or increased severity of symptoms over a few minutes. Heart attack is a life threatening emergency. If you think you or someone you are with is having a heart attack, call 911 immediately for urgent medical treatment. It may save your life.
Gastroesophageal Reflux Disease (GERD)
Second Source article from Government
Gastroesophageal Reflux Disease (GERD)
Second Source article from The Cleveland Clinic
GERD and GER (Acid Reflux) in Infants and Children
GERD (gastroesophageal reflux disease) is the upward movement of stomach content, including acid, into the esophagus and sometimes into or out of the mouth. Common symptoms of GERD in children include colic, feeding problems, poor growth, frequent vomiting or coughing, heartburn, regurgitation, recurrent wheezing, pneumonia, choking, or gagging. Treatment may involve elevating the child's bed, keeping the child upright after eating, limiting foods that seem to make the reflux worse, encouraging your child to exercise, and serving several small meals a day.
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.