Azithromycin Side Effects
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).
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For the consumer For the professional
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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:
Seek medical attention right away if any of these SEVERE side effects occur when using Azithromycin:Diarrhea; headache; loose stools; nausea; stomach pain; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; chest pain; dark red raised areas of the skin; hearing loss; pounding in the chest; ringing in the ears; severe diarrhea; stomach cramps/pain; 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 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:
Seek medical attention right away if any of these SEVERE side effects occur when using Azithromycin Suspension:Diarrhea; headache; loose stools; nausea; stomach pain; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; chest pain; dark red raised areas of the skin; hearing loss; pounding in the chest; ringing in the ears; severe diarrhea; stomach cramps/pain; 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:
Seek medical attention right away if any of these SEVERE side effects occur when using Azithromycin Tablets:Diarrhea; headache; loose stools; nausea; stomach pain; vomiting.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; chest pain; dark red raised areas of the skin; hearing loss; pounding in the chest; ringing in the ears; severe diarrhea; stomach cramps/pain; yellowing of the skin or eyes.
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
Multiple-dose regimenOverall, 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.
Chronic therapy with 1200 mg weekly regimenThe 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..
Chronic therapy with 600 mg daily regimen combined with ethambutolThe 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.
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, rare reports of taste perversion.
Laboratory Abnormalities
Significant abnormalities (irrespective of drug relationship) occurring during the clinical trials were reported as follows:
With an incidence of 1-2%, 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.
TopAzithromycin Tablets
In clinical trials, most of the reported side effects were mild to moderate in severity and were reversible upon discontinuation of the drug. Potentially serious side effects of angioedema and cholestatic jaundice were reported rarely. Approximately 0.7% of the patients (adults and pediatric patients) from the 5-day multiple-dose clinical trials discontinued Azithromycin therapy because of treatment-related side effects. In adults given 500 mg/day for 3 days, the discontinuation rate due to treatment-related side effects was 0.6%. In clinical trials in pediatric patients given 30 mg/kg, either as a single dose or over 3 days, discontinuation from the trials due to treatment-related side effects was approximately 1%. Most of the side effects leading to discontinuation were related to the gastrointestinal tract, e.g., nausea, vomiting, diarrhea, or abdominal pain.
Clinical
AdultsMultiple-Dose Regimens
Overall, the most common treatment-related side effects in adult patients receiving multiple-dose regimens of Azithromycin were related to the gastrointestinal system with diarrhea/loose stools (4 to 5%), nausea (3%) and abdominal pain (2 to 3%) being the most frequently reported.
No other treatment-related side effects occurred in patients on the multiple-dose regimens 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, pruritus, photosensitivity and angioedema
Single 1-Gram Dose Regimen
Overall, the most common side effects in patients receiving a single-dose regimen of 1 gram of Azithromycin were related to the gastrointestinal system and were more frequently reported than in patients receiving the multiple-dose regimen.
Side effects that occurred in patients on the single one-gram dosing regimen of Azithromycin with a frequency of 1% or greater included diarrhea/loose stools (7%), nausea (5%), abdominal pain (5%), vomiting (2%), dyspepsia (1%) and vaginitis (1%).
Single 2-Gram Dose Regimen
Overall, the most common side effects in patients receiving a single 2-gram dose of Azithromycin were related to the gastrointestinal system. Side effects that occurred in patients in this study with a frequency of 1% or greater included nausea (18%), diarrhea/loose stools (14%), vomiting (7%), abdominal pain (7%), vaginitis (2%), dyspepsia (1%) and dizziness (1%). The majority of these complaints were mild in nature.
Pediatric PatientsSingle and Multiple-Dose Regimens
The types of side effects in pediatric patients were comparable to those seen in adults, with different incidence rates for the dosage regimens recommended in pediatric patients.
Acute Otitis Media
For the recommended total dosage regimen of 30 mg/kg, the most frequent side effects (≥ 1%) attributed to treatment were diarrhea, abdominal pain, vomiting, nausea and rash.
The incidence, based on dosing regimen, is described in the table below:
| Dosage Regimen | Diarrhea, % | Abdominal Pain, % | Vomiting, % | Nausea, % | Rash, % |
|---|---|---|---|---|---|
| 1-day | 4.3% | 1.4% | 4.9% | 1% | 1% |
| 3-day | 2.6% | 1.7% | 2.3% | 0.4% | 0.6% |
| 5-day | 1.8% | 1.2% | 1.1% | 0.5% | 0.4% |
Community-Acquired Pneumonia
For the recommended dosage regimen of 10 mg/kg on Day 1 followed by 5 mg/kg on Days 2 to 5, the most frequent side effects attributed to treatment were diarrhea/loose stools, abdominal pain, vomiting, nausea and rash.
The incidence is described in the table below:
| Dosage Regimen | Diarrhea/Loose Stools, % | Abdominal Pain, % | Vomiting, % | Nausea, % | Rash, % |
|---|---|---|---|---|---|
| 5-day | 5.8% | 1.9% | 1.9% | 1.9% | 1.6% |
Pharyngitis/Tonsillitis
For the recommended dosage regimen of 12 mg/kg on Days 1 to 5, the most frequent side effects attributed to treatment were diarrhea, vomiting, abdominal pain, nausea and headache.
The incidence is described in the table below:
| Dosage Regimen | Diarrhea, % | Abdominal Pain, % | Vomiting, % | Nausea, % | Rash, % | Headache, % |
|---|---|---|---|---|---|---|
| 5-day | 5.4% | 3.4% | 5.6% | 1.8% | 0.7% | 1.1% |
With any of the treatment regimens, no other treatment-related side effects occurred in pediatric patients treated with Azithromycin with a frequency greater than 1%. Side effects that occurred with a frequency of 1% or less included the following:
Cardiovascular: chest pain
Gastrointestinal: dyspepsia, constipation, anorexia, enteritis, flatulence, gastritis, jaundice, loose stools and oral moniliasis
Hematologic and Lymphatic: anemia and leukopenia
Nervous System: headache (otitis media dosage), hyperkinesia, dizziness, agitation, nervousness and insomnia
General: fever, face edema, fatigue, fungal infection, malaise and pain
Allergic: rash and allergic reaction
Respiratory: cough increased, pharyngitis, pleural effusion and rhinitis
Skin and Appendages: eczema, fungal dermatitis, pruritus, sweating, urticaria and vesiculobullous rash
Special Senses: conjunctivitis
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 and angioedema
Cardiovascular: Arrhythmias including ventricular tachycardia and 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 and 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 and rare reports of taste perversion.
Laboratory Abnormalities
AdultsClinically significant abnormalities (irrespective of drug relationship) occurring during the clinical trials were reported as follows: with an incidence of greater than 1%: decreased hemoglobin, hematocrit, lymphocytes, neutrophils and blood glucose; elevated serum creatine phosphokinase, potassium, ALT, GGT, AST, BUN, creatinine, blood glucose, platelet count, lymphocytes, neutrophils and eosinophils; with an incidence of less than 1%: leukopenia, neutropenia, decreased sodium, potassium, platelet count; elevated monocytes, basophils, bicarbonate, serum alkaline phosphatase, bilirubin, LDH and phosphate. The majority of subjects with elevated serum creatinine also had abnormal values at baseline.
When follow-up was provided, changes in laboratory tests appeared to be reversible.
In multiple-dose clinical trials involving more than 5,000 patients, four patients discontinued therapy because of treatment-related liver enzyme abnormalities and one because of a renal function abnormality.
Pediatric PatientsOne, Three and Five Day Regimens
Laboratory data collected from comparative clinical trials employing two 3-day regimens (30 mg/kg or 60 mg/kg in divided doses over 3 days), or two 5-day regimens (30 mg/kg or 60 mg/kg in divided doses over 5 days) were similar for regimens of Azithromycin and all comparators combined, with most clinically significant laboratory abnormalities occurring at incidences of 1 to 5%. Laboratory data for patients receiving 30 mg/kg as a single dose were collected in one single center trial. In that trial, an absolute neutrophil count between 500 to 1,500 cells/mm3 was observed in 10/64 patients receiving 30 mg/kg as a single dose, 9/62 patients receiving 30 mg/kg given over 3 days, and 8/63 comparator patients. No patient had an absolute neutrophil count < 500 cells/mm3.
In multiple-dose clinical trials involving approximately 4,700 pediatric patients, no patients discontinued therapy because of treatment-related laboratory abnormalities.
TopMore resources:
Azithromycin - Includes detailed dosage instructions.
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