Azithromycin Dose Pack Side Effects
Generic name: azithromycin
Medically reviewed by Drugs.com. Last updated on Nov 13, 2023.
Note: This document contains side effect information about azithromycin. Some dosage forms listed on this page may not apply to the brand name Azithromycin Dose Pack.
For Healthcare Professionals
Applies to azithromycin: intravenous powder for injection, oral capsule, oral powder for reconstitution, oral powder for reconstitution extended release, oral tablet.
General
The most commonly reported side effects were diarrhea/loose stools, nausea, abdominal pain, and vomiting.[Ref]
Cardiovascular
Uncommon (0.1% to 1%): Palpitations, chest pain
Postmarketing reports: Torsades de pointes, arrhythmia (including ventricular tachycardia), ECG QT prolonged, hypotension, cardiovascular death
Dermatologic
Common (1% to 10%): Rash, pruritus
Uncommon (0.1% to 1%): Angioedema, photosensitivity reaction, Stevens-Johnson syndrome, urticaria, dermatitis, dry skin, hyperhidrosis/sweating
Rare (0.01% to 0.1%): Acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS)
Frequency not reported: Eczema, fungal dermatitis, vesiculobullous rash
Postmarketing reports: Toxic epidermal necrolysis, erythema multiforme, serious skin reactions
Gastrointestinal
Very common (10% or more): Diarrhea (up to 52.8%), nausea (up to 32.6%), abdominal pain (up to 32.2%), loose stools (up to 19.1%), vomiting (up to 13%), flatulence (up to 10.7%), abdominal discomfort
Common (1% to 10%): Dyspepsia, stomatitis
Uncommon (0.1% to 1%): Gastritis, gastroenteritis, oral candidiasis/moniliasis, constipation, dysphagia, abdominal distension, dry mouth, eructation, mouth ulceration, salivary hypersecretion
Frequency not reported: Clostridioides difficile-associated diarrhea, melena, infantile hypertrophic pyloric stenosis, mucositis, enteritis
Postmarketing reports: Pyloric stenosis, pseudomembranous colitis, pancreatitis, tongue discoloration
Genitourinary
Common (1% to 10%): Vaginitis/vaginal infection
Uncommon (0.1% to 1%): Dysuria, metrorrhagia, testicular disorder
Hematologic
Very common (10% or more): Decreased neutrophils (up to 29%)
Common (1% to 10%): Decreased lymphocyte count, decreased hematocrit, decreased hemoglobin, increased eosinophil count, increased platelet count, increased lymphocytes, increased basophils, increased monocytes, increased neutrophils
Uncommon (0.1% to 1%): Leukopenia, neutropenia, eosinophilia
Frequency not reported: Decreased white cell count, decreased platelet count, anemia
Postmarketing reports: Thrombocytopenia, hemolytic anemia
Hepatic
Hepatic failure has rarely resulted in death.
Common (1% to 10%): Increased AST, increased ALT, increased GGT, increased blood bilirubin
Uncommon (0.1% to 1%): Hepatitis, abnormal liver function tests
Rare (0.01% to 0.1%): Abnormal hepatic function, cholestatic jaundice
Frequency not reported: Liver enzyme abnormalities, increased transaminase levels, jaundice
Postmarketing reports: Hepatic failure, fulminant hepatitis, hepatic necrosis
Hypersensitivity
Severe (rarely fatal) anaphylactic reaction has been reported.
Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Anaphylactic reaction/anaphylaxis (e.g., anaphylactic shock), allergic reactions
Local
Common (1% to 10%): IV site pain, injection site inflammation (with IV administration), IV site disorders (infection/inflammation/edema/pain reactions), local inflammation, infusion site reaction
Frequency not reported: Local inflammation at infusion site
Metabolic
Common (1% to 10%): Decreased blood bicarbonate, anorexia, decreased blood glucose, increased blood glucose
Uncommon (0.1% to 1%): Increased bicarbonate
Postmarketing reports: Dehydration
Musculoskeletal
Common (1% to 10%): Arthralgia, increased creatine phosphokinase
Uncommon (0.1% to 1%): Osteoarthritis, myalgia, back pain, neck pain
Nervous system
Common (1% to 10%): Headache, dizziness, paresthesia, dysgeusia
Uncommon (0.1% to 1%): Somnolence, hypesthesia, tinnitus, vertigo
Frequency not reported: Hyperkinesia
Postmarketing reports: Syncope, convulsion, psychomotor hyperactivity, anosmia, ageusia, parosmia, myasthenia gravis, hyperactivity
Ocular
Common (1% to 10%): Visual impairment, abnormal vision
Frequency not reported: Conjunctivitis, blurred vision
Other
Very common (10% or more): Increased blood alkaline phosphatase (up to 20%)
Common (1% to 10%): Deafness, fatigue, increased potassium, increased lactate dehydrogenase, reversible hearing impairment
Uncommon (0.1% to 1%): Candidiasis/moniliasis, ear disorder, asthenia, malaise, chest pain, edema, hearing impaired, abnormal blood potassium, fungal infection, bacterial infection, hot flush, face edema, pyrexia/fever, pain, peripheral edema, increased chloride, abnormal sodium, postprocedural complications
Frequency not reported: Increased phosphate, decreased sodium, decreased potassium
Postmarketing reports: Hearing disturbances (including hearing loss, deafness, tinnitus)
Psychiatric
Uncommon (0.1% to 1%): Nervousness, insomnia
Rare (0.01% to 0.1%): Agitation, depersonalization
Frequency not reported: Delirium, hallucination
Postmarketing reports: Aggression/aggressive reaction, anxiety
Renal
Common (1% to 10%): Increased blood urea/BUN, increased blood creatinine
Uncommon (0.1% to 1%): Renal pain
Frequency not reported: Nephritis, renal function abnormality
Postmarketing reports: Acute renal failure, interstitial nephritis
Respiratory
Common (1% to 10%): Dyspnea
Uncommon (0.1% to 1%): Pneumonia, pharyngitis, rhinitis, respiratory disorder, epistaxis
Frequency not reported: Bronchospasm, cough, pleural effusion
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References
1. (2022) "Product Information. Zithromax IV (azithromycin)." Pfizer U.S. Pharmaceuticals Group, LAB-0024-23.0
2. (2021) "Product Information. Zithromax (azithromycin)." Pfizer U.S. Pharmaceuticals Group, LAB-0372-7.0
3. (2022) "Product Information. Zithromax (aziTHROMYCIN)." Pfizer Australia Pty Ltd, pfpzithb10122
4. (2019) "Product Information. Zithromax IV (aziTHROMYCIN)." Pfizer Australia Pty Ltd, pfpzithv10619
5. (2022) "Product Information. AziTHROMYCIN (Mylan) (aziTHROMYCIN)." Alphapharm Pty Ltd
6. (2022) "Product Information. Zedbac (azithromycin)." Aspire Pharma Ltd
7. (2022) "Product Information. Zithromax (azithromycin)." Pfizer Ltd
8. (2022) "Product Information. Azithromycin (azithromycin)." Sandoz Ltd
9. (2022) "Product Information. Azithromycin (azithromycin)." Accord-UK Ltd
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.