Zithromax
- Generic Name: azithromycin
- Brand Name: Zithromax
- Drug Class: Macrolides
Zithromax (Azithromycin) side effects drug center
Zithromax Side Effects Center
What Is Zithromax Z-PAK?
Zithromax Z-PAK (azithromycin) is a semi-synthetic macrolide antibiotic used for treating:
- otitis media (middle ear infection),
- tonsillitis,
- laryngitis,
- bronchitis,
- pneumonia,
- and sinusitis caused by susceptible bacteria.
What Are Side Effects of Zithromax Z-PAK?
Common side effects of Zithromax include:
- diarrhea or loose stools,
- nausea,
- abdominal pain,
- stomach upset,
- vomiting,
- constipation,
- dizziness,
- tiredness,
- headache,
- vaginal itching or discharge,
- nervousness,
- sleep problems (insomnia),
- skin rash or itching,
- ringing in the ears,
- hearing problems,
- or decreased sense of taste or smell.
Dosage for Zithromax Z-PAK
A typical oral dose of Zithromax consists of 500 mg for 1 day then 250 mg for 4 days. A typical intravenous dose consists of 500 mg for 2 days followed by 500 mg orally daily for an additional 5-8 days.
What Drugs, Substances, or Supplements Interact with Zithromax Z-PAK?
Zithromax may interact with:
- Aresenic trioxide,
- cyclosporine,
- pimozide,
- tacrolimus,
- theophylline,
- warfarin,
- other antibiotics,
- antidepressants,
- anti-malaria medications,
- cholesterol-lowering medicines,
- ergot medicines,
- heart or blood pressure medications,
- heart rhythm medicines,
- HIV medicines,
- medicine to prevent or treat nausea and vomiting,
- medicines to treat psychiatric disorders,
- migraine headache medicines,
- narcotics,
- sedatives,
- tranquilizers, or
- seizure medicines
Tell your doctor all medications and supplements you use.
Zithromax Z-PAK During Pregnancy and Breastfeeding
There are no adequate studies of Zithromax in pregnant women and it is not known whether Zithromax is excreted in breast milk. Only use Zithromax in pregnant or nursing mothers when absolutely necessary.
Additional Information
Our Zithromax Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Zithromax Consumer Information
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Call your doctor at once if you have:
- severe stomach pain, diarrhea that is watery or bloody;
- fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); or
- liver problems--nausea, vomiting, loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
Call your doctor right away if a baby taking azithromycin becomes irritable or vomits while eating or nursing.
Older adults may be more likely to have side effects on heart rhythm, including a life-threatening fast heart rate.
Common side effects may include:
- nausea, vomiting; or
- stomach pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Zithromax (Azithromycin)
Zithromax Professional Information
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials of intravenous azithromycin for community-acquired pneumonia, in which 2 to 5 IV doses were given, the reported adverse reactions were mild to moderate in severity and were reversible upon discontinuation of the drug. The majority of patients in these trials had one or more comorbid diseases and were receiving concomitant medications. Approximately 1.2% of the patients discontinued intravenous ZITHROMAX therapy, and a total of 2.4% discontinued azithromycin therapy by either the intravenous or oral route because of clinical or laboratory side effects.
In clinical trials conducted in patients with pelvic inflammatory disease, in which 1 to 2 IV doses were given, 2% of women who received monotherapy with azithromycin and 4% who received azithromycin plus metronidazole discontinued therapy due to clinical side effects.
Clinical adverse reactions leading to discontinuations from these studies were gastrointestinal (abdominal pain, nausea, vomiting, diarrhea), and rashes; laboratory side effects leading to discontinuation were increases in transaminase levels and/or alkaline phosphatase levels.
Overall, the most common adverse reactions associated with treatment in adult patients who received IV/Oral ZITHROMAX in studies of community-acquired pneumonia were related to the gastrointestinal system with diarrhea/loose stools (4.3%), nausea (3.9%), abdominal pain (2.7%), and vomiting (1.4%) being the most frequently reported.
Approximately 12% of patients experienced a side effect related to the intravenous infusion; most common were pain at the injection site (6.5%) and local inflammation (3.1%).
The most common adverse reactions associated with treatment in adult women who received IV/Oral ZITHROMAX in trials of pelvic inflammatory disease were related to the gastrointestinal system. Diarrhea (8.5%) and nausea (6.6%) were most commonly reported, followed by vaginitis (2.8%), abdominal pain (1.9%), anorexia (1.9%), rash and pruritus (1.9%). When azithromycin was coadministered with metronidazole in these trials, a higher proportion of women experienced adverse reactions of nausea (10.3%), abdominal pain (3.7%), vomiting (2.8%), infusion site reaction, stomatitis, dizziness, or dyspnea (all at 1.9%).
Adverse reactions that occurred with a frequency of 1% or less included the following:
Gastrointestinal: Dyspepsia, flatulence, mucositis, oral moniliasis, and gastritis.
Nervous system: Headache, somnolence.
Allergic: Bronchospasm.
Special senses: Taste perversion.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of azithromycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions 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 reports of QT prolongation and torsades de pointes.
Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and reports of tongue discoloration.
General: Asthenia, paresthesia, fatigue, malaise and anaphylaxis (including fatalities).
Genitourinary: Interstitial nephritis and acute renal failure and vaginitis.
Hematopoietic: Thrombocytopenia.
Liver/biliary: Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure. [see WARNINGS AND PRECAUTIONS]
Nervous system: Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope.
Psychiatric: Aggressive reaction and anxiety.
Skin/appendages: Pruritus, serious skin reactions including, erythema multiforme, AGEP, Stevens- Johnson syndrome, toxic epidermal necrolysis, and DRESS.
Special senses: Hearing disturbances including hearing loss, deafness and/or tinnitus and 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:
- elevated ALT (SGPT), AST (SGOT), creatinine (4 to 6%)
- elevated LDH, bilirubin (1 to 3%)
- leukopenia, neutropenia, decreased platelet count, and elevated serum alkaline phosphatase (less than 1%)
When follow-up was provided, changes in laboratory tests appeared to be reversible.
In multiple-dose clinical trials involving more than 750 patients treated with ZITHROMAX (IV/Oral), less than 2% of patients discontinued azithromycin therapy because of treatment-related liver enzyme abnormalities.
Read the entire FDA prescribing information for Zithromax (Azithromycin)
&Copy; Zithromax Patient Information is supplied by Cerner Multum, Inc. and Zithromax Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.