Axid AR Side Effects
Generic Name: nizatidine
Note: This page contains information about the side effects of nizatidine. Some of the dosage forms included on this document may not apply to the brand name Axid AR.
Not all side effects for Axid AR may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to nizatidine: oral capsules, oral tablets for
Side effects include:
For Healthcare Professionals
Applies to nizatidine: oral capsule, oral solution, oral tablet
Nizatidine (the active ingredient contained in Axid AR) is generally well tolerated.
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 side effects have included rare cases of anaphylaxis, bronchospasm, laryngeal edema, rash, and eosinophilia.
Hematologic side effects have included eosinophilia, anemia, rare cases of thrombocytopenic purpura, and a fatal case of thrombocytopenia.
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 AR)
Cardiovascular side effects have included reports of chest pain (2.3%) and short episodes of asymptomatic ventricular tachycardia, although causality is unknown.
Dermatologic side effects have included rash (1.9%), pruritus (1.7%), urticaria, exfoliative dermatitis, and sweating.
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%).
A 16-year-old female with schizophrenia experienced extrapyramidal symptoms (EPS) coincident with nizatidine (the active ingredient contained in Axid AR) 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 side effects including myalgia (1.7%) and hyperuricemia associated with gout have been reported.
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 side effects including amblyopia (1%) have been reported.
Renal side effects including nephrolithiasis have been reported.
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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