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Azithromycin Dose Pack Side Effects

Generic Name: azithromycin

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

For the Consumer

Applies to azithromycin: oral capsule, oral powder for suspension, oral powder for suspension extended release, oral tablet

In addition to its needed effects, some unwanted effects may be caused by azithromycin (the active ingredient contained in Azithromycin Dose Pack). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking azithromycin:

More common:
  • Diarrhea
  • loose stools
Less common:
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • cracked, dry, or scaly skin
  • fever
  • swelling
  • Abdominal or stomach pain
  • blistering, peeling, or loosening of the skin
  • bloody or cloudy urine
  • bloody, black, or tarry stools
  • body aches or pain
  • burning while urinating
  • chest pain
  • chills
  • congestion
  • cough increased
  • cough producing mucus
  • dark urine
  • difficult or labored breathing
  • difficult or painful urination
  • dizziness
  • drowsiness
  • dryness or soreness of the throat
  • earache
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • general feeling of discomfort or illness
  • general feeling of tiredness or weakness
  • headache
  • indigestion
  • irregular or slow heart rate
  • itching
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • muscle aches and pains
  • nausea or vomiting
  • noisy breathing
  • passing of gas
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness or swelling in the ear
  • runny nose
  • shivering
  • shortness of breath
  • sneezing
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain, continuing
  • stomach pain, fullness, or discomfort
  • stuffy nose
  • sweating
  • swelling of the face, ankles, hands, feet, or lower legs
  • tender, swollen glands in the neck
  • tightness in the chest
  • trouble with sleeping
  • trouble with swallowing
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • voice changes
  • vomiting of blood
  • wheezing
  • yellow eyes or skin
Incidence not known:
  • Abdominal or stomach cramps or tenderness
  • bleeding gums
  • bloating
  • blood in the urine or stools
  • blurred vision
  • change in hearing
  • clay-colored stools
  • coma
  • confusion
  • constipation
  • continuing ringing or buzzing or other unexplained noise in the ears
  • decreased urine output
  • depression
  • diarrhea, watery and severe, which may also be bloody
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • greatly decreased frequency of urination or amount of urine
  • hives
  • hostility
  • increased thirst
  • irritability
  • lethargy
  • loss of hearing
  • lower back or side pain
  • muscle twitching
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • seizures
  • stupor
  • unusual weight loss

Minor Side Effects

Some of the side effects that can occur with azithromycin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

  • Acid or sour stomach
  • aggressive or angry
  • bad, unusual, or unpleasant (after) taste
  • belching
  • burning feeling in the chest or stomach
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in taste
  • changes in the color of the tongue
  • crying
  • depersonalization
  • dry mouth
  • dysphoria
  • euphoria
  • excess air or gas in the stomach or intestines
  • feeling of constant movement of self or surroundings
  • full feeling
  • heartburn
  • hyperventilation
  • increase in body movements
  • itching of the vagina or genital area
  • lack or loss of strength
  • mental depression
  • nervousness
  • pain during sexual intercourse
  • paranoia
  • quick to react or overreact emotionally
  • rapidly changing moods
  • rash with flat lesions or small raised lesions on the skin
  • redness of the skin
  • restlessness
  • sensation of spinning
  • shaking
  • shortness of breath
  • sleepiness or unusual drowsiness
  • sleeplessness
  • sore mouth or tongue
  • stomach upset
  • thick, white vaginal discharge with no odor or with a mild odor
  • unable to sleep
  • white patches in the mouth, tongue, or throat
Incidence not known:
  • Difficulty with moving
  • fear or nervousness
  • increased sensitivity of the skin to sunlight
  • muscle pain or stiffness
  • pain in the joints
  • redness or other discoloration of the skin
  • severe sunburn
  • trouble sitting still

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 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.[Ref]


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.[Ref]

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.[Ref]


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.[Ref]


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.[Ref]


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

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.[Ref]


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.[Ref]


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


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.[Ref]


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


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


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


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


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2. Chave J, Munafo A, Chatton JY, Dayer P, Glauser MP, Biollaz J "Once-a-week azithromycin in AIDS patients: tolerability, kinetics, and effects on zidovudine disposition." Antimicrob Agents Chemother 36 (1992): 1013-18

3. "Product Information. Zithromax injection (azithromycin)" Pfizer US Pharmaceuticals, New York, NY.

4. Coates P, Daniel R, Houston A, Antrobus JH, Taylor T "An open study to compare the pharmacokinetics, safety and tolerability of a multiple-dose regimen of azithromycin in young and elderly volunteers." Eur J Clin Microbiol Infect Dis 10 (1991): 850-2

5. Hopkins S "Clinical toleration and safety of azithromycin." Am J Med 91 (1991): s41-5

6. Mertens JC, van Barneveld PW, Asin HR, et al "Double-blind randomized study comparing the efficacies and safeties of a short (3-day) course of azithromycin and a 5-day course of amoxicillin in patients with acute exacerbations of chronic bronchitis." Antimicrob Agents Chemother 36 (1992): 1456-9

7. Handsfield HH, Dalu ZA, Martin DH, Douglas JM, McCarty JM, Schlossberg D "Multicenter trial of single-dose azithromycin vs. ceftriaxone in the treatment of uncomplicated gonorrhea." Sex Transm Dis 21 (1995): 107-11

8. "Product Information. Azithromycin Product Information (azithromycin)." Pfizer US Pharmaceuticals, New York, NY.

9. Zuckerman JM, Kaye KM "The newer macrolides: azithromycin and clarithromycin." Infect Dis Clin North Am 9 (1995): 731-45

10. Trevisi P, Patrizi A, Neri I, Farina P "Toxic pustuloderma associated with azithromycin." Clin Exp Dermatol 19 (1994): 280-1

11. Cascaval RI, Lancaster DJ "Hypersensitivity syndrome associated with azithromycin." Am J Med 110 (2001): 330-1

12. "Product Information. Zithromax (azithromycin)." Pfizer US Pharmaceuticals, New York, NY.

13. Lo SHE, Kotabe S, Mitsunaga L "Azithromycin-induced hearing loss." Am J Health Syst Pharm 56 (1999): 380-3

14. Wallace MR, Miller LK, Nguyen MT, Shields AR "Ototoxicity with azithromycin." Lancet 343 (1994): 241

15. Bizjak ED, Haug MT, Schilz RJ, Sarodia BD, Dresing JM "Intravenous azithromycin-induced ototoxicity." Pharmacotherapy 19 (1999): 245-8

16. Tseng AL, Dolovich L, Salit IE "Azithromycin-related ototoxicity in patients infected with human immunodeficiency virus." Clin Infect Dis 24 (1997): 76-7

17. Mansoor GA, Panner BJ, Ornt DB "Azithromycin-induced acute interstitial nephritis." Ann Intern Med 119 (1993): 636-7

Not all side effects for Azithromycin Dose Pack may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.