Azithromycin Side Effects

Brand Names: Zmax, Zithromax

Please note - some side effects for Azithromycin 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 Azithromycin - for the Consumer

Azithromycin

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 Azithromycin:

Diarrhea; headache; loose stools; nausea; stomach pain; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody stools; changes in hearing or hearing loss; chest pain; eye or vision problems; irregular heartbeat; muscle weakness; pounding in the chest; red, swollen, blistered, or peeling skin; ringing in the ears; seizure; severe diarrhea; stomach cramps/pain; trouble speaking or swallowing; yellowing of the skin or eyes.

Azithromycin Drops

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Azithromycin Drops. Seek medical attention right away if any of these SEVERE side effects occur when using Azithromycin Drops:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); discharge from the eye; red, swollen, blistered, or peeling skin; severe or persistent burning, stinging, or irritation of the eye.

Azithromycin Single-Dose Packet

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 Azithromycin Single-Dose Packet:

Diarrhea; headache; loose stools; nausea; stomach pain; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody stools; changes in hearing or hearing loss; chest pain; eye or vision problems; irregular heartbeat; muscle weakness; pounding in the chest; red, swollen, blistered, or peeling skin; ringing in the ears; seizure; severe diarrhea; stomach cramps/pain; trouble speaking or swallowing; yellowing of the skin or eyes.

Azithromycin Suspension

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 Azithromycin Suspension:

Diarrhea; headache; loose stools; nausea; stomach pain; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody stools; changes in hearing or hearing loss; chest pain; dark, red, raised areas of the skin; eye or vision problems; fainting; irregular heartbeat; muscle weakness; pounding in the chest; red, swollen, or blistered skin; ringing in the ears; seizures; severe diarrhea; severe stomach cramps/pain; trouble speaking or swallowing; unusual vaginal itching, odor, or discharge; yellowing of the skin or eyes.

Azithromycin Tablets

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 Azithromycin Tablets:

Diarrhea; headache; loose stools; nausea; stomach pain; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody stools; changes in hearing or hearing loss; chest pain; eye or vision problems; irregular heartbeat; muscle weakness; pounding in the chest; red, swollen, blistered, or peeling skin; ringing in the ears; seizure; severe diarrhea; stomach cramps/pain; trouble speaking or swallowing; yellowing of the skin or eyes.

Azithromycin Side Effects - for the Professional

Azithromycin

In clinical trials, most of the reported side effects were mild to moderate in severity and were reversible upon discontinuation of the drug. Approximately 0.7% of the patients from the multiple-dose clinical trials discontinued Azithromycin therapy because of treatment-related side effects. Most of the side effects leading to discontinuation were related to the gastrointestinal tract, e.g., nausea, vomiting, diarrhea, or abdominal pain. Rarely but potentially serious side effects were angioedema and cholestatic jaundice.

Clinical

Overall, the most common side effects in adult patients receiving a multiple-dose regimen of Azithromycin were related to the gastrointestinal system with diarrhea/loose stools (5%), nausea (3%), and abdominal pain (3%) being the most frequently reported.

No other side effects occurred in patients on the multiple-dose regimen of Azithromycin with a frequency greater than 1%. Side effects that occurred with a frequency of 1% or less included the following:

Cardiovascular: Palpitations, chest pain.

Gastrointestinal: Dyspepsia, flatulence, vomiting, melena, and cholestatic jaundice.

Genitourinary: Monilia, vaginitis, and nephritis.

Nervous System: Dizziness, headache, vertigo, and somnolence.

General: Fatigue.

Allergic: Rash, photosensitivity, and angioedema.

The nature of side effects seen with the 1200 mg weekly dosing regimen for the prevention of Mycobacterium avium infection in severely immunocompromised HIV-infected patients were similar to those seen with short term dosing regimens..

The nature of side effects seen with the 600 mg daily dosing regimen for the treatment of Mycobacterium avium complex infection in severely immunocompromised HIV-infected patients were similar to those seen with short term dosing regimens. Five percent of patients experienced reversible hearing impairment in the pivotal clinical trial for the treatment of disseminated MAC in patients with AIDS. Hearing impairment has been reported with macrolide antibiotics, especially at higher doses. Other treatment related side effects occurring in >5% of subjects and seen at any time during a median of 87.5 days of therapy include: abdominal pain (14%), nausea (14%), vomiting (13%), diarrhea (12%), flatulence (5%), headache (5%) and abnormal vision (5%). Discontinuations from treatment due to laboratory abnormalities or side effects considered related to study drug occurred in 8/88 (9.1%) of subjects.

Post-Marketing Experience

Adverse events reported with Azithromycin during the post-marketing period in adult and/or pediatric patients for which a causal relationship may not be established include:

Allergic: Arthralgia, edema, urticaria, angioedema.

Cardiovascular: Arrhythmias including ventricular tachycardia, hypotension. There have been rare reports of QT prolongation and torsades de pointes.

Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea rarely resulting in dehydration, pseudomembranous colitis, pancreatitis, oral candidiasis and rare reports of tongue discoloration.

General: Asthenia, paresthesia, fatigue, malaise and anaphylaxis (rarely fatal).

Genitourinary: Interstitial nephritis and acute renal failure, vaginitis.

Hematopoietic: Thrombocytopenia.

Liver/Biliary: Abnormal liver function including hepatitis and cholestatic jaundice, as well as rare cases of hepatic necrosis and hepatic failure, some of which have resulted in death.

Nervous System: Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope.

Psychiatric: Aggressive reaction and anxiety.

Skin/Appendages: Pruritus, rarely serious skin reactions including erythema multiforme, Stevens Johnson Syndrome, and toxic epidermal necrolysis.

Special Senses: Hearing disturbances including hearing loss, deafness, and/or tinnitus, reports of taste/smell perversion and/or loss.

Laboratory Abnormalities

Significant abnormalities (irrespective of drug relationship) occurring during the clinical trials were reported as follows:

With an incidence of 1 to 2%, elevated serum creatine phosphokinase, potassium, ALT (SGPT), GGT, and AST (SGOT).

With an incidence of less than 1%, leukopenia, neutropenia, decreased platelet count, elevated serum alkaline phosphatase, bilirubin, BUN, creatinine, blood glucose, LDH, and phosphate.

When follow-up was provided, changes in laboratory tests appeared to be reversible.

In multiple-dose clinical trials involving more than 3000 patients, 3 patients discontinued therapy because of treatment-related liver enzyme abnormalities and 1 because of a renal function abnormality.

In a phase I drug interaction study performed in normal volunteers, 1 of 6 subjects given the combination of Azithromycin and rifabutin, 1 of 7 given rifabutin alone and 0 of 6 given Azithromycin alone developed a clinically significant neutropenia (<500 cells/mm3).

Laboratory abnormalities seen in clinical trials for the prevention of disseminated Mycobacterium avium disease in severely immunocompromised HIV-infected patients are presented in the CLINICAL STUDIES section.

Chronic therapy (median duration: 87.5 days, range: 1 to 229 days) that resulted in laboratory abnormalities in > 5% subjects with normal baseline values in the pivotal trial for treatment of disseminated MAC in severely immunocompromised HIV infected patients treated with Azithromycin 600 mg daily in combination with ethambutol include: a reduction in absolute neutrophils to < 50% of the lower limit of normal (10/52, 19%) and an increase to five times the upper limit of normal in alkaline phosphatase (3/35, 9%). These findings in subjects with normal baseline values are similar when compared to all subjects for analyses of neutrophil reductions (22/75 [29%]) and elevated alkaline phosphatase (16/80 [20%]). Causality of these laboratory abnormalities due to the use of study drug has not been established.

Side Effects by Body System

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. Anorexia, vomiting/diarrhea rarely resulting in dehydration, pancreatitis, and rare reports of tongue discoloration have been reported during postmarketing experience.

Hypersensitivity

Reappearance of allergic symptoms may occur without further azithromycin 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.

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 monotherapy.

Hematologic

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

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