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Azithromycin Side Effects

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Common Azithromycin Side Effects


The most commonly reported Azithromycin side effects (click to view or check a box to report):

Diarrhoea (164)
Nausea (131)
Vomiting (123)
Dyspnoea (120)
Dizziness (94)
Rash (90)
Pain (75)
Abdominal Pain Upper (68)
Headache (67)
Pruritus (66)
Abdominal Pain (64)
Asthenia (63)
Pyrexia (59)
Urticaria (56)
Malaise (55)
Anxiety (51)
Tinnitus (42)
Hypotension (42)
Hypersensitivity (42)
Pulmonary Embolism (40)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Azithromycin Side Effects Reported to FDA



Azithromycin Side Effect Report#9999211
Haematochezia
This is a report of a 21-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Azithromycin 250 Mg (dosage: NA, start time:
Mar 04, 2014), combined with: NA. and developed a serious reaction and side effect(s): Haematochezia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Azithromycin 250 Mg treatment in male patients, resulting in Haematochezia side effect.
Azithromycin Side Effect Report#9997680
Pruritus
This report suggests a potential Azithromycin Pruritus side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Azithromycin (dosage: Unk) starting NS. After starting Azithromycin the patient began experiencing various side effects, including: PruritusAdditional drugs used concurrently: NA. Although Azithromycin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pruritus, may still occur.
Azithromycin Side Effect Report#9992525
Abdominal Pain Upper, Bone Pain, Hyperhidrosis, Pyrexia
This Abdominal Pain Upper problem was reported by a pharmacist from IT. A 67-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Feb 05, 2014 this consumer started treatment with Azithromycin (dosage: 500 Mg, Unk). The following drugs were being taken at the same time:
  • Deltacortene (Unk)
  • Plaquenil (Unk)
  • Didrogyl (Unk)
When using Azithromycin, the patient experienced the following unwanted symptoms/side effects: Abdominal Pain Upper, Bone Pain, Hyperhidrosis, PyrexiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abdominal Pain Upper, may become evident only after a product is in use by the general population.
Azithromycin Side Effect Report#9983711
Rash
This Rash side effect was reported by a physician from US. A 35-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Azithromycin (drug dosage: Unk), which was initiated on NS. Concurrently used drugs:
  • Vancomycin Hcl (Unk)
.After starting to take Azithromycin the consumer reported adverse symptoms, such as: RashThese side effects may potentially be related to Azithromycin.
Azithromycin Side Effect Report#9981348
Heart Rate Increased, Panic Reaction
This is a report of a 39-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: upper respiratory tract infection, who was treated with Azithromycin 250 Mg Greenstone Brand (dosage: 2 On Day 1; 1 For Next 4 Days, start time:
Feb 23, 2014), combined with: NA. and developed a serious reaction and side effect(s): Heart Rate Increased, Panic Reaction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Azithromycin 250 Mg Greenstone Brand treatment in female patients, resulting in Heart Rate Increased side effect.
Azithromycin Side Effect Report#9971999
Rash, Pityriasis Rosea, Influenza Like Illness, Unevaluable Event
This report suggests a potential Azithromycin 1 G Rash side effect(s) that can have serious consequences. A 35-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Azithromycin 1 G (dosage: 1 Pill) starting
Aug 17, 2013. After starting Azithromycin 1 G the patient began experiencing various side effects, including: Rash, Pityriasis Rosea, Influenza Like Illness, Unevaluable EventAdditional drugs used concurrently: NA. Although Azithromycin 1 G demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rash, may still occur.
Azithromycin Side Effect Report#9970811
Dysgeusia, Diarrhoea, No Therapeutic Response, Cough, Throat Tightness, Dizziness, Loss Of Consciousness, Hypoaesthesia, Burning Sensation
This Dysgeusia problem was reported by a consumer or non-health professional from US. A 32-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pertussis. On
Feb 24, 2014 this consumer started treatment with Azithromycin (dosage: 2 Pills, 2 Day1,1 Day 2-5). The following drugs were being taken at the same time:
  • Advil
  • Zantac
  • Benedryl
When using Azithromycin, the patient experienced the following unwanted symptoms/side effects: Dysgeusia, Diarrhoea, No Therapeutic Response, Cough, Throat Tightness, Dizziness, Loss Of Consciousness, Hypoaesthesia, Burning SensationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dysgeusia, may become evident only after a product is in use by the general population.
Azithromycin Side Effect Report#9943334
Confusional State, Disorientation
This Confusional State side effect was reported by a health professional from FR. A 82-year-old male patient (weight:NA) experienced the following symptoms/conditions: pneumonia.The patient was prescribed Azithromycin (drug dosage: 1 Df, 1x/day), which was initiated on
Jan 06, 2014. Concurrently used drugs:
  • Lyrica (1 Df, Daily)
  • Oroken (200 Mg, Twice Daily)
  • Surgam (200 Mg, Thrice Daily)
  • Pariet (20 Mg, Once Per Day)
  • Colchimax (Unk)
  • Cortancyl (Unk)
  • Prograf (Unk)
  • Atacand (Unk)
.After starting to take Azithromycin the consumer reported adverse symptoms, such as: Confusional State, DisorientationThese side effects may potentially be related to Azithromycin. The patient was hospitalized.
Azithromycin Side Effect Report#9931803
Tendon Pain, Tendon Rupture
This is a report of a 33-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: cough, who was treated with Azithromycin 250 (dosage: 5 Pills Once Daily, start time:
Feb 22, 2014), combined with: NA. and developed a serious reaction and side effect(s): Tendon Pain, Tendon Rupture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Azithromycin 250 treatment in male patients, resulting in Tendon Pain side effect.
Azithromycin Side Effect Report#9928118
Abdominal Pain Upper
This report suggests a potential Azithromycin 250mg Abdominal Pain Upper side effect(s) that can have serious consequences. A 56-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: sinusitis,bacterial infection and used Azithromycin 250mg (dosage: 6 Pills Once Daily Taken By Mouth) starting NS. After starting Azithromycin 250mg the patient began experiencing various side effects, including: Abdominal Pain UpperAdditional drugs used concurrently: NA. Although Azithromycin 250mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Pain Upper, may still occur.
Azithromycin Side Effect Report#9926042
Hypoglycaemia, Hyperhidrosis, Malaise
This Hypoglycaemia problem was reported by a pharmacist from NL. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Feb 10, 2014 this consumer started treatment with Azithromycin (dosage: 500 Mg, 1x/day). The following drugs were being taken at the same time:
  • Euthyrox (150 Ug, 1x/day)
  • Nitrolingual (1 Df, As Needed)
  • Insulin (Unk)
  • Isosorbide Mononitrate (60 Mg, 1x/day)
  • Perindopril (2 Mg, 1x/day)
  • Calcium (500 Mg, 1x/day)
  • Metoprolol Succinate (200 Mg, 1x/day)
  • Ezetrol (10 Mg, 1x/day)
When using Azithromycin, the patient experienced the following unwanted symptoms/side effects: Hypoglycaemia, Hyperhidrosis, MalaiseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypoglycaemia, may become evident only after a product is in use by the general population.
Azithromycin Side Effect Report#9925149
Nervousness, Anxiety, Tremor, Vagus Nerve Disorder
This Nervousness side effect was reported by a consumer or non-health professional from US. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: sinusitis.The patient was prescribed Azithromycin (drug dosage: NA), which was initiated on
Jan 05, 2013. Concurrently used drugs: NA..After starting to take Azithromycin the consumer reported adverse symptoms, such as: Nervousness, Anxiety, Tremor, Vagus Nerve DisorderThese side effects may potentially be related to Azithromycin.
Azithromycin Side Effect Report#9921469
Delirium, Paranoia
This is a report of a 65-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic obstructive pulmonary disease,prophylaxis, who was treated with Azithromycin (dosage: NA, start time:
Jan 07, 2014), combined with: NA. and developed a serious reaction and side effect(s): Delirium, Paranoia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Azithromycin treatment in male patients, resulting in Delirium side effect. The patient was hospitalized.
Azithromycin Side Effect Report#9918230
Herpes Zoster
This report suggests a potential Azithromycin Herpes Zoster side effect(s) that can have serious consequences. A 48-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Azithromycin (dosage: NA) starting NS. After starting Azithromycin the patient began experiencing various side effects, including: Herpes ZosterAdditional drugs used concurrently:
  • Amoxicillin
  • Gabapentin
  • Estradiol
Although Azithromycin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Herpes Zoster, may still occur.
Azithromycin Side Effect Report#9893561
International Normalised Ratio Increased
This International Normalised Ratio Increased problem was reported by a pharmacist from IT. A 76-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: tonsillitis. On
May 20, 2011 this consumer started treatment with Azithromycin Dihydrate (dosage: 500 Mg Daily). The following drugs were being taken at the same time:
  • Amoxicillin Trihydrate (2 G Daily)
  • Coumadin (10 Mg Weekly)
When using Azithromycin Dihydrate, the patient experienced the following unwanted symptoms/side effects: International Normalised Ratio IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as International Normalised Ratio Increased, may become evident only after a product is in use by the general population.
Azithromycin Side Effect Report#9887863
Hypophagia, Dysphagia, Oral Mucosal Exfoliation, Oral Mucosal Blistering
This Hypophagia side effect was reported by a pharmacist from US. A 43-year-old male patient (weight:NA) experienced the following symptoms/conditions: conjunctivitis chlamydial.The patient was prescribed Azithromycin (drug dosage: NA), which was initiated on
Aug 30, 2012. Concurrently used drugs: NA..After starting to take Azithromycin the consumer reported adverse symptoms, such as: Hypophagia, Dysphagia, Oral Mucosal Exfoliation, Oral Mucosal BlisteringThese side effects may potentially be related to Azithromycin. The patient was hospitalized.
Azithromycin Side Effect Report#9887832
Erythema, Pruritus
This is a report of a 23-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: influenza, who was treated with Azithromycin (dosage: 1 Df Daily, start time:
Dec 22, 2013), combined with:
  • Tachiflu
  • Naproxen (220 Mg Total)
and developed a serious reaction and side effect(s): Erythema, Pruritus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Azithromycin treatment in female patients, resulting in Erythema side effect. The patient was hospitalized.
Azithromycin Side Effect Report#9876980
Hypoacusis
This report suggests a potential Azithromycin Hypoacusis side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Azithromycin (dosage: 250 Mg, Unk) starting
Jan 24, 2014. After starting Azithromycin the patient began experiencing various side effects, including: HypoacusisAdditional drugs used concurrently: NA. Although Azithromycin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypoacusis, may still occur.
Azithromycin Side Effect Report#9868170
Loss Of Consciousness, Malaise, Erythema
This Loss Of Consciousness problem was reported by a health professional from FR. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 10, 2013 this consumer started treatment with Azithromycin Sandoz (dosage: NA). The following drugs were being taken at the same time:
  • Paracetamol Sandoz (1 G, Unk)
When using Azithromycin Sandoz, the patient experienced the following unwanted symptoms/side effects: Loss Of Consciousness, Malaise, ErythemaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Loss Of Consciousness, may become evident only after a product is in use by the general population.
Azithromycin Side Effect Report#9861361
Hypoacusis, Tinnitus, Dizziness
This Hypoacusis side effect was reported by a consumer or non-health professional from US. A 61-year-old female patient (weight:NA) experienced the following symptoms/conditions: bronchitis chronic.The patient was prescribed Azithromycin (drug dosage: NA), which was initiated on
Jan 15, 2014. Concurrently used drugs: NA..After starting to take Azithromycin the consumer reported adverse symptoms, such as: Hypoacusis, Tinnitus, DizzinessThese side effects may potentially be related to Azithromycin.
Azithromycin Side Effect Report#9858713
Erythema, Pruritus
This is a report of a 23-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: influenza, who was treated with Azithromycin (dosage: 1 Df, Daily, start time:
Dec 22, 2013), combined with:
  • Tachiflu (Unk)
  • Naproxen (Unk (220 Mg Tablet))
and developed a serious reaction and side effect(s): Erythema, Pruritus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Azithromycin treatment in female patients, resulting in Erythema side effect. The patient was hospitalized.
Azithromycin Side Effect Report#9858401
Diarrhoea
This report suggests a potential Azithromycin Pak Diarrhoea side effect(s) that can have serious consequences. A 60-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: sinusitis and used Azithromycin Pak (dosage: Taken By Mouth) starting
Jan 29, 2014. After starting Azithromycin Pak the patient began experiencing various side effects, including: DiarrhoeaAdditional drugs used concurrently: NA. Although Azithromycin Pak demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diarrhoea, may still occur.
Azithromycin Side Effect Report#9848849
Palpitations, Dyspnoea, Nausea, Dizziness, Headache, Dyspnoea
This Palpitations problem was reported by a consumer or non-health professional from US. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: upper respiratory tract infection. On
Jan 24, 2014 this consumer started treatment with Azithromycin (dosage: 2 Today Then 1 Each Day Once Daily Taken By Mouth). The following drugs were being taken at the same time: NA. When using Azithromycin, the patient experienced the following unwanted symptoms/side effects: Palpitations, Dyspnoea, Nausea, Dizziness, Headache, DyspnoeaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Palpitations, may become evident only after a product is in use by the general population.
Azithromycin Side Effect Report#9846467
Bronchitis
This Bronchitis side effect was reported by a consumer or non-health professional from US. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: bronchitis.The patient was prescribed Azithromycin 250 Mg Teva Usa (drug dosage: 2 Initial Then 1 Daily Taken By Mouth), which was initiated on
Jan 20, 2014. Concurrently used drugs: NA..After starting to take Azithromycin 250 Mg Teva Usa the consumer reported adverse symptoms, such as: BronchitisThese side effects may potentially be related to Azithromycin 250 Mg Teva Usa.
Azithromycin Side Effect Report#9845027
Tongue Oedema
This is a report of a 62-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Azithromycin (dosage: 500 Mg As Necessary, start time:
Aug 05, 2013), combined with:
  • Bentelan
and developed a serious reaction and side effect(s): Tongue Oedema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Azithromycin treatment in male patients, resulting in Tongue Oedema side effect.


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The appearance of Azithromycin on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Azithromycin Side Effects for Women?

Women Side EffectsReports
Diarrhoea 103
Nausea 100
Dyspnoea 85
Vomiting 81
Dizziness 69
Pain 65
Abdominal Pain Upper 59
Headache 47
Rash 46
Asthenia 42

What are common Azithromycin Side Effects for Men?

Men Side EffectsReports
Diarrhoea 59
Rash 40
Vomiting 39
Dyspnoea 35
Nausea 31
Pyrexia 29
Pruritus 27
Dizziness 24
Abdominal Pain 23
Hypotension 23

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Azithromycin reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Azithromycin Side Effects

    Did You Have a Azithromycin Side Effect?

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    How Effective is Azithromycin for You?

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    Azithromycin Safety Alerts, Active Ingredients, Usage Information

    NDC0093-2026
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameAzithromycin
    NameAzithromycin
    Dosage FormPOWDER, FOR SUSPENSION
    RouteORAL
    On market since20101217
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)AZITHROMYCIN MONOHYDRATE
    Strength(s)200
    Unit(s)mg/5mL
    Pharma ClassMacrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]

    Azithromycin Dosage, Warnings, Usage.

    Side Effects reported to FDA: 1801

    Azithromycin safety alerts: 2014

    Reported deaths: 96

    Reported hospitalizations: 673

    Azithromycin (Zithromax or Zmax): Drug Safety Communication - Risk of Potentially Fatal Heart Rhythms

     

    [Posted 03/12/2013]

    AUDIENCE: Family Practice, Patient, Pharmacy, Health Professional

    ISSUE: FDA is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias.  FDA has issued a Drug Safety Communication today as a result of our review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.

    FDA previously released a Statement on May 17, 2012, about a study that compared the risks of cardiovascular death in patients treated with the antibacterial drugs azithromycin, amoxicillin, ciprofloxacin (Cipro), and levofloxacin (Levaquin), or no antibacterial drug. The study reported an increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.

    BACKGROUND: Azithromycin is marketed under the brand names Zithromax and Zmax. FDA-approved indications for azithromycin include: acute bacterial exacerbations of chronic obstructive pulmonary disease, acute bacterial sinusitis, community-acquired pneumonia, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, urethritis and cervicitis, genital ulcer disease.

    RECOMMENDATION: Health care professionals should consider the risk of torsades de pointes and fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events.  FDA notes that the potential risk of QT prolongation with azithromycin should be placed in appropriate context when choosing an antibacterial drug: Alternative drugs in the macrolide class, or non-macrolides such as the fluoroquinolones, also have the potential for QT prolongation or other significant side effects that should be considered when choosing an antibacterial drug.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [03/12/2013 -Drug Safety Communication - FDA]
    [05/17/2013 - Statement - FDA]  

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