Azithromycin Dose Pack Side Effects

Generic name: azithromycin

Note: This document contains side effect information about azithromycin. Some of the dosage forms listed on this page may not apply to the brand name Azithromycin Dose Pack.

Some side effects of Azithromycin Dose Pack 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 azithromycin: oral powder for reconstitution, oral powder for reconstitution extended release, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking azithromycin (the active ingredient contained in Azithromycin Dose Pack) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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

• diarrhea that is watery or bloody;

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of azithromycin may include:

• mild diarrhea, vomiting, constipation;

• stomach pain or upset;

• dizziness, tired feeling, mild headache;

• nervous feeling, sleep problems (insomnia);

• vaginal itching or discharge;

• mild rash or itching;

• ringing in your ears, problems with hearing; or

• decreased sense of taste or smell.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to azithromycin: intravenous powder for injection, oral capsule, oral powder for reconstitution, oral powder for reconstitution extended release, oral tablet

Gastrointestinal

Gastrointestinal side effects have included nausea, abdominal discomfort, vomiting, and diarrhea in up to 10% of patients. However, patients rarely (less than 1%) discontinued therapy due to these side effects. Dyspepsia, flatulence, mucositis, oral moniliasis, constipation, melena, and gastritis have been reported with a frequency of 1% or less. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of azithromycin (the active ingredient contained in Azithromycin Dose Pack) Anorexia, vomiting/diarrhea rarely resulting in dehydration, pancreatitis, oral candidiasis, pyloric stenosis, and rare cases of tongue discoloration have been reported during postmarketing experience.

Hypersensitivity

Reappearance of allergic symptoms may occur without further azithromycin (the active ingredient contained in Azithromycin Dose Pack) exposure when symptomatic therapy is discontinued. This phenomenon may be related to the long tissue half-life of the drug. Patients experiencing allergic symptoms may require prolonged periods of observation and symptomatic treatment.

Hypersensitivity side effects have rarely included angioedema, anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Toxic pustuloderma with fever has been reported in at least one patient receiving azithromycin. There is also an isolated report of azithromycin-induced hypersensitivity syndrome. Allergic reactions (including arthralgia, edema, urticaria, and angioedema) and anaphylaxis (rarely fatal) have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have rarely included arrhythmias (including ventricular tachycardia), prolongation of the QT interval, torsades de pointes, palpitations, hypotension, and chest pain in postmarketing experience. A causal relationship has not been established.

Hepatic

Hepatic side effects have infrequently included transient elevations of liver function tests (including AST and ALT) and elevated bilirubin. Hepatitis and cholestatic jaundice, as well as rare cases of hepatic necrosis and hepatic failure (some resulting in death), have been reported during postmarketing experience.

Local

Local side effects associated with intravenous administration of the drug have included pain at injection site (6.5%) and local inflammation (3.1%).

Nervous system

Nervous system side effects have included headache, somnolence, vertigo, and dizziness in approximately 1% of patients. Hearing disturbances including hearing loss, deafness, and/or tinnitus have been reported rarely. Paresthesia, convulsions, hyperactivity, nervousness, agitation, and syncope have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash, pruritus, and urticaria. Photosensitivity and, rarely, serious skin reactions (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) have been reported during postmarketing experience.

Other

Other side effects have included asthenia. Taste/smell perversion and/or loss (rare), fatigue, and malaise have been reported during postmarketing experience.

Renal

Renal side effects have rarely included elevations in serum creatinine and blood urea nitrogen. Interstitial nephritis and acute renal failure have been reported during postmarketing experience. Interstitial nephritis resulting in permanent renal failure has been reported in a patient receiving azithromycin (the active ingredient contained in Azithromycin Dose Pack) monotherapy.

Hematologic

Hematologic side effects have included decreased lymphocytes, increased eosinophils, leukopenia, and neutropenia. Thrombocytopenia has been reported during postmarketing experience.

Metabolic

Metabolic side effects have included reduced bicarbonate and alterations in potassium.

Psychiatric

Psychiatric side effects have included aggressive reaction and anxiety during postmarketing experience.

Genitourinary

Genitourinary side effects have included vaginitis. Moniliasis has been reported during postmarketing experience.