Axid Side Effects

Generic Name: nizatidine

Please note - some side effects for Axid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Axid - for the Consumer

Axid AR

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Axid AR:

Diarrhea; dizziness; headache.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

Axid

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Axid:

Diarrhea; dizziness; headache.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

Axid Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Axid Solution:

Diarrhea; dizziness; headache.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

Axid Side Effects - for the Professional

Axid

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.

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.

Side Effects by Body System

General

Nizatidine is generally well tolerated.

Endocrine

Endocrine side effects have included rare cases of gynecomastia although the drug is not known to have any antiandrogenic activity. Impotence and decreased libido have also been reported.

Hypersensitivity

Hypersensitivity side effects have included rare cases of anaphylaxis, bronchospasm, laryngeal edema, rash, and eosinophilia.

Hematologic

Hematologic side effects have included eosinophilia, anemia, rare cases of thrombocytopenic purpura, and a fatal case of thrombocytopenia.

Hepatic

Hepatic side effects have included elevations in serum transaminases and rare reports of hepatitis, jaundice, and cholestatic or mixed hepatocellular or cholestatic injury. Abnormalities have been reversible with discontinuation of nizatidine.

Cardiovascular

Cardiovascular side effects have included reports of chest pain (2.3%) and short episodes of asymptomatic ventricular tachycardia, although causality is unknown.

Dermatologic

Dermatologic side effects have included rash (1.9%), pruritus (1.7%), urticaria, exfoliative dermatitis, and sweating.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain (7.5%), diarrhea (4% to 7.2%), nausea (5.4%), flatulence (4.9%), vomiting (3.6% to 4%), dyspepsia (3.6%), constipation (2.5%), dry mouth (1.4%), anorexia (1.2%), GI disorder (1.1%), and tooth disorder (1%).

Nervous system

A 16-year-old female with schizophrenia experienced extrapyramidal symptoms (EPS) coincident with nizatidine therapy. She had been receiving quetiapine and paroxetine for schizophrenia and depression and developed EPS after taking nizatidine 150 mg twice daily for weight loss. Over the ensuing 4 weeks, her weight decreased substantially. Because of these initial positive effects, the nizatidine dosage was increased to 300 mg twice daily. Within 4 days of this dosage increase, the patient started pacing and could not sit still. Examination revealed moderate akithisia and mild parkinsonism. Due to concerns about EPS, the nizatidine dosage was decreased to the original 150 mg twice daily. Over the next five days, the patients EPS resolved .

Nervous system side effects have included headache (16.6%), dizziness (4.6%), pain 4.2%, back pain (2.4%), insomnia (2.7%), abnormal dreams (1.9%), somnolence (1.9%), anxiety (1.6%), and nervousness (1.1%). Rarely, reports of mental confusion, disorientation, agitation, and psychosis have been reported. At least one case of extrapyramidal symptoms has also been reported.

Musculoskeletal

Musculoskeletal side effects including myalgia (1.7%) and hyperuricemia associated with gout have been reported.

Respiratory

Respiratory side effects including rhinitis (9.8%), upper respiratory tract infections (8%), nasopharyngitis (6%), cough (5%), pharyngitis (3.3%), sinusitis (2.4%), and increased cough (2%) have been reported.

Ocular

Ocular side effects including amblyopia (1%) have been reported.

Renal

Renal side effects including nephrolithiasis have been reported.

Other

Other side effects have included otitis media (6%), fever (1.6% to 6%), asthenia (3.1%), infection (1.7%), and, rarely, serum sickness-like reactions.

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