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Azithromycin Side Effects

In Summary

Commonly reported side effects of azithromycin include: diarrhea, loose stools, and nausea. Other side effects include: abdominal pain, and vomiting. See below for a comprehensive list of adverse effects.

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. 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
Rare
  • 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:

Rare
  • 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

General

The most commonly reported side effects include diarrhea/loose stools, abdominal pain, and nausea.[Ref]

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%), flatulence (up to 10.7%)
Common (1% to 10%): Vomiting, dyspepsia, stomatitis
Uncommon (0.1% to 1%): Gastroenteritis, oral candidiasis, constipation, dysphagia/oral dysphagia, abdominal distension, dry mouth, eructation, mouth ulceration, salivary hypersecretion
Frequency not reported: Pseudomembranous colitis, pancreatitis, tongue discoloration, melena, enteritis, abnormal stools, gastrointestinal disorder
Postmarketing reports: Pyloric stenosis[Ref]

Hematologic

Common (1% to 10%): Decreased lymphocyte, hematocrit, hemoglobin, or neutrophil count, increased eosinophil count, increased platelets, hematocrit, lymphocytes, basophils, monocytes, or neutrophils
Uncommon (0.1% to 1%): Leukopenia, neutropenia/mild neutropenia, eosinophilia
Frequency not reported: Thrombocytopenia, anemia/hemolytic anemia, decreased platelets[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, paresthesia, dysgeusia
Uncommon (0.1% to 1%): Somnolence, hypesthesia
Frequency not reported: Syncope, convulsion, anosmia, ageusia, parosmia, vertigo, myasthenia gravis, taste perversion, hyperkinesia
Postmarketing reports: Hyperactivity[Ref]

Local

Common (1% to 10%): Injection site pain, infection, edema, reactions or inflammation[Ref]

Other

Common (1% to 10%): Deafness, fatigue
Uncommon (0.1% to 1%): Candidiasis, ear disorder, asthenia, malaise, face edema, pyrexia, pain, post procedural complications, hearing disturbances/impairment, tinnitus, laboratory abnormalities, fungal or bacterial infection
Frequency not reported: Psychomotor hyperactivity, mucositis, fever, chills, otitis media
Postmarketing reports: Hearing loss, taste/smell perversion and/or loss[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus
Uncommon (0.1% to 1%): Photosensitivity reaction, Stevens-Johnson syndrome, urticaria, dermatitis, dry skin, hyperhidrosis, eczema
Very rare (less than 0.01%): Drug reaction of eosinophilia and systemic symptoms (DRESS)
Frequency not reported: toxic epidermal necrolysis, erythema multiforme, fungal dermatitis, sweating, vesiculobullous rash, maculopapular rash[Ref]

Metabolic

Common (1% to 10%): Decreased blood bicarbonate, anorexia
Uncommon (0.1% to 1%): Abnormal sodium, increased blood alkaline phosphatase, bicarbonate, or chloride
Frequency not reported: Increased lactate dehydrogenase, decreased sodium or potassium
Postmarketing reports: Dehydration[Ref]

Respiratory

Common (1% to 10%): Dyspnea
Uncommon (0.1% to 1%): Pneumonia, pharyngitis, rhinitis, respiratory disorder, epistaxis
Frequency not reported: Bronchospasm, cough, pleural effusion, asthma, bronchitis[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia
Uncommon (0.1% to 1%): Osteoarthritis, myalgia, back pain, neck pain
Frequency not reported: Increased creatine phosphokinase[Ref]

Genitourinary

Common (1% to 10%): Vaginitis/vaginal infection
Uncommon (0.1% to 1%): Dysuria, metrorrhagia, testicular disorder[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction
Uncommon (0.1% to 1%): Angioedema, hypersensitivity
Frequency not reported: Anaphylactic reaction/anaphylaxis
Postmarketing reports: Fatal anaphylaxis[Ref]

Ocular

Common (1% to 10%): Visual impairment
Frequency not reported: Conjunctivitis[Ref]

Hepatic

Uncommon (0.1% to 1%): Hepatitis, increased AST, ALT, GGT, or blood bilirubin
Rare (0.01% to 0.1%): Abnormal liver function tests, cholestatic jaundice
Frequency not reported: Hepatic failure/fatal hepatic failure, fulminant hepatitis, hepatic necrosis[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Palpitations, hot flush, edema, chest pain, peripheral edema
Frequency not reported: Torsades de pointes, arrhythmia, ECG QT prolonged, hypotension, ventricular tachycardia[Ref]

Psychiatric

Uncommon (0.1% to 1%): Nervousness, insomnia
Rare (0.01% to 0.1%): Agitation
Frequency not reported: Aggression/aggressive reaction, anxiety, delirium, hallucination, emotional lability, irritability, hostility[Ref]

Renal

Uncommon (0.1% to 1%): Renal pain, increased blood urea nitrogen and creatinine
Frequency not reported: Acute renal failure, interstitial nephritis/nephritis[Ref]

Immunologic

Frequency not reported: Moniliasis, flu syndrome[Ref]

References

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

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

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

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

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

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