Axid Pulvules Side Effects

Generic name: nizatidine

Note: This document contains side effect information about nizatidine. Some of the dosage forms listed on this page may not apply to the brand name Axid Pulvules.

Some side effects of Axid Pulvules may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to nizatidine: oral capsule, oral solution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking nizatidine (the active ingredient contained in Axid Pulvules) 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 of nizatidine 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.

For Healthcare Professionals

Applies to nizatidine: oral capsule, oral solution, oral tablet

General

Nizatidine (the active ingredient contained in Axid Pulvules) 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 (the active ingredient contained in Axid Pulvules)

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 (the active ingredient contained in Axid Pulvules) 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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