Common Fluconazole Side Effects


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

Pyrexia (90)
Headache (69)
Renal Failure Acute (65)
Rhabdomyolysis (61)
Nausea (53)
Torsade De Pointes (52)
Erythema (49)
Vomiting (47)
Pain (47)
Dyspnoea (45)
Dizziness (44)
Renal Impairment (43)
Rash (40)
International Normalised Ratio Increased (39)
Electrocardiogram Qt Prolonged (38)
Fatigue (38)
Pruritus (38)
Malaise (38)
Asthenia (36)
Stevens-johnson Syndrome (35)

➢ 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.

Fluconazole Side Effects Reported to FDA



Fluconazole Side Effect Report#9970442
Lethargy, Dizziness, Asthenia, Loss Of Consciousness, Tachycardia, Hypotension, Hypoxia, Overdose
This is a report of a 45-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: oral candidiasis,back pain, who was treated with Fluconazole (dosage: NA, start time: NS), combined with:
  • Oxycodone
  • Oxycontin
and developed a serious reaction and side effect(s): Lethargy, Dizziness, Asthenia, Loss Of Consciousness, Tachycardia, Hypotension, Hypoxia, Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluconazole treatment in female patients, resulting in Lethargy side effect.
Fluconazole Side Effect Report#9959234
Inflammation, Rash Pruritic, Skin Exfoliation, Chapped Lips, Lip Haemorrhage, Skin Hyperpigmentation, Oral Discomfort
This report suggests a potential Fluconazole Inflammation side effect(s) that can have serious consequences. A 36-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: fungal infection and used Fluconazole (dosage: 1 Pill 1 Time) starting
Feb 22, 2014. After starting Fluconazole the patient began experiencing various side effects, including: Inflammation, Rash Pruritic, Skin Exfoliation, Chapped Lips, Lip Haemorrhage, Skin Hyperpigmentation, Oral DiscomfortAdditional drugs used concurrently:
  • Birth Control Pill
  • Omega Oil
  • Probiotic
Although Fluconazole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Inflammation, may still occur.
Fluconazole Side Effect Report#9925350
Liver Transplant Rejection
This Liver Transplant Rejection problem was reported by a pharmacist from AU. A 39-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: antifungal prophylaxis. On NS this consumer started treatment with Fluconazole (dosage: NA). The following drugs were being taken at the same time: NA. When using Fluconazole, the patient experienced the following unwanted symptoms/side effects: Liver Transplant RejectionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Liver Transplant Rejection, may become evident only after a product is in use by the general population.
Fluconazole Side Effect Report#9916546
Hyperbilirubinaemia, Thrombocytopenia
This Hyperbilirubinaemia side effect was reported by a health professional from ES. A 84-year-old female patient (weight:NA) experienced the following symptoms/conditions: oral candidiasis,respiratory tract infection.The patient was prescribed Fluconazole (fluconazole) (drug dosage: 100 Mg; Cap_hard: Po;qd), which was initiated on
Dec 29, 2013. Concurrently used drugs:
  • Levofloxacin (levofloxacin) (500 Mg; Tab_film;po;qd)
.After starting to take Fluconazole (fluconazole) the consumer reported adverse symptoms, such as: Hyperbilirubinaemia, ThrombocytopeniaThese side effects may potentially be related to Fluconazole (fluconazole).
Fluconazole Side Effect Report#9916402
Lethargy, Dizziness, Asthenia, Loss Of Consciousness, Tachycardia, Hypotension, Hypoxia, Overdose
This is a report of a 45-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: oral candidiasis,back pain, who was treated with Fluconazole (dosage: NA, start time: NS), combined with:
  • Oxycontin
  • Oxycodone
  • Corticosteroids
and developed a serious reaction and side effect(s): Lethargy, Dizziness, Asthenia, Loss Of Consciousness, Tachycardia, Hypotension, Hypoxia, Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluconazole treatment in female patients, resulting in Lethargy side effect. The patient was hospitalized.
Fluconazole Side Effect Report#9915633
Anaemia, Type 2 Diabetes Mellitus, Blood Cholesterol Increased
This report suggests a potential Fluconazole Anaemia side effect(s) that can have serious consequences. A 58-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: vulvovaginal mycotic infection and used Fluconazole (dosage: 1 Pill) starting
Dec 25, 2013. After starting Fluconazole the patient began experiencing various side effects, including: Anaemia, Type 2 Diabetes Mellitus, Blood Cholesterol IncreasedAdditional drugs used concurrently:
  • Lisinopril
  • Ranitidine
  • Nitrouquick
  • Escitalopram
  • Advair Diskus
  • Clonazepam
  • Hydrocodone
  • Gabapentin
Although Fluconazole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anaemia, may still occur.
Fluconazole Side Effect Report#9902308
Thrombosis
This Thrombosis problem was reported by a consumer or non-health professional from US. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Mar 23, 2011 this consumer started treatment with Fluconazole (dosage: Unk). The following drugs were being taken at the same time:
  • Revlimid (5 Mg, 1x/day)
  • Warfarin (Unk)
  • Aspirin (81 Mg, Unk)
When using Fluconazole, the patient experienced the following unwanted symptoms/side effects: ThrombosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Thrombosis, may become evident only after a product is in use by the general population.
Fluconazole Side Effect Report#9891866
Agranulocytosis, Thrombocytopenia, Bone Marrow Failure, Pulmonary Oedema, Pneumonia, Pain In Extremity, Arthralgia, Condition Aggravated, Muscular Weakness
This Agranulocytosis side effect was reported by a health professional from US. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fluconazole (drug dosage: 1 D), which was initiated on NS. Concurrently used drugs: NA..After starting to take Fluconazole the consumer reported adverse symptoms, such as: Agranulocytosis, Thrombocytopenia, Bone Marrow Failure, Pulmonary Oedema, Pneumonia, Pain In Extremity, Arthralgia, Condition Aggravated, Muscular WeaknessThese side effects may potentially be related to Fluconazole.
Fluconazole Side Effect Report#9890782
Electrocardiogram Qt Prolonged, Ventricular Tachycardia, Cardiac Arrest, Blood Potassium Decreased, Blood Magnesium Increased, Long Qt Syndrome
This is a report of a 18-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: electrocardiogram qt prolonged,agitation, who was treated with Fluconazole (dosage: NA, start time: NS), combined with:
  • Neurocil
  • Tacrolimus
  • Lorazepam (lorazepam)
and developed a serious reaction and side effect(s): Electrocardiogram Qt Prolonged, Ventricular Tachycardia, Cardiac Arrest, Blood Potassium Decreased, Blood Magnesium Increased, Long Qt Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluconazole treatment in male patients, resulting in Electrocardiogram Qt Prolonged side effect.
Fluconazole Side Effect Report#9880415
Urticaria, Eyelid Oedema, Eyelids Pruritus, Eyelid Irritation, Skin Exfoliation, Erythema Of Eyelid
This report suggests a potential Fluconazole Urticaria side effect(s) that can have serious consequences. A 41-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: fungal infection and used Fluconazole (dosage: NA) starting
Dec 29, 2013. After starting Fluconazole the patient began experiencing various side effects, including: Urticaria, Eyelid Oedema, Eyelids Pruritus, Eyelid Irritation, Skin Exfoliation, Erythema Of EyelidAdditional drugs used concurrently: NA. Although Fluconazole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Urticaria, may still occur.
Fluconazole Side Effect Report#9867063
Cardiac Arrest, Long Qt Syndrome, Ventricular Tachycardia
This Cardiac Arrest problem was reported by a health professional from Country Not Specified. A 18-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Fluconazole (dosage: NA). The following drugs were being taken at the same time:
  • Lorazepam
  • Levomepromazine
  • Tacrolimus
When using Fluconazole, the patient experienced the following unwanted symptoms/side effects: Cardiac Arrest, Long Qt Syndrome, Ventricular TachycardiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Arrest, may become evident only after a product is in use by the general population.
Fluconazole Side Effect Report#9858359
Hepatic Function Abnormal
This Hepatic Function Abnormal side effect was reported by a pharmacist from US. A 72-year-old male patient (weight:NA) experienced the following symptoms/conditions: infection.The patient was prescribed Fluconazole (drug dosage: NA), which was initiated on
Dec 06, 2013. Concurrently used drugs: NA..After starting to take Fluconazole the consumer reported adverse symptoms, such as: Hepatic Function AbnormalThese side effects may potentially be related to Fluconazole. The patient was hospitalized.
Fluconazole Side Effect Report#9858330
Rash
This is a report of a 82-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: oral candidiasis, who was treated with Fluconazole (dosage: NA, start time:
Dec 16, 2013), combined with: NA. and developed a serious reaction and side effect(s): Rash after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluconazole treatment in male patients, resulting in Rash side effect. The patient was hospitalized.
Fluconazole Side Effect Report#9853249
Treatment Failure, Pathogen Resistance, Bacterial Sepsis
This report suggests a potential Fluconazole (fluconazole) Treatment Failure side effect(s) that can have serious consequences. A 69-year-old male patient (weight: NA) from BE was diagnosed with the following symptoms/conditions: tenosynovitis and used Fluconazole (fluconazole) (dosage: NA) starting NS. After starting Fluconazole (fluconazole) the patient began experiencing various side effects, including: Treatment Failure, Pathogen Resistance, Bacterial SepsisAdditional drugs used concurrently:
  • Voriconazole (voriconazole)
  • Digoxin (digoxin)
  • Molsidomine (molsidomine)
  • Altizide (altizide)
  • Spironolactone (spironolactone)
  • Amitriptyline (amitriptyline)
  • Tramadol (tramadol)
  • Insulin (insulin)
Although Fluconazole (fluconazole) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Treatment Failure, may still occur.
Fluconazole Side Effect Report#9849052
Stevens-johnson Syndrome
This Stevens-johnson Syndrome problem was reported by a physician from IT. A 46-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: onychomycosis. On
Dec 15, 2013 this consumer started treatment with Fluconazole (dosage: 1 D). The following drugs were being taken at the same time:
  • Ciproxin (ciprofloxacin)
When using Fluconazole, the patient experienced the following unwanted symptoms/side effects: Stevens-johnson SyndromeThe 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 Stevens-johnson Syndrome, may become evident only after a product is in use by the general population.
Fluconazole Side Effect Report#9845083
Renal Failure Acute, Shock, Acute Hepatic Failure, Hepatic Encephalopathy, Acinetobacter Infection
This Renal Failure Acute side effect was reported by a health professional from TW. A 66-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fluconazole (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Meropenum
  • Teicoplanin
.After starting to take Fluconazole the consumer reported adverse symptoms, such as: Renal Failure Acute, Shock, Acute Hepatic Failure, Hepatic Encephalopathy, Acinetobacter InfectionThese side effects may potentially be related to Fluconazole.
Fluconazole Side Effect Report#9844990
Hepatic Encephalopathy, Liver Injury, Acute Hepatic Failure
This is a report of a 66-year-old male patient (weight: NA) from TW, suffering from the following health symptoms/conditions: peritonitis, who was treated with Fluconazole (dosage: NA, start time: NS), combined with:
  • Meropenem
  • Teicoplanin
and developed a serious reaction and side effect(s): Hepatic Encephalopathy, Liver Injury, Acute Hepatic Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluconazole treatment in male patients, resulting in Hepatic Encephalopathy side effect. The patient was hospitalized.
Fluconazole Side Effect Report#9844807
Alopecia, Fatigue, Asthenia
This report suggests a potential Fluconazole Alopecia 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: fungal infection,candida infection and used Fluconazole (dosage: NA) starting
Aug 04, 2013. After starting Fluconazole the patient began experiencing various side effects, including: Alopecia, Fatigue, AstheniaAdditional drugs used concurrently: NA. Although Fluconazole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Alopecia, may still occur.
Fluconazole Side Effect Report#9840892
Long Qt Syndrome, Cardiac Arrest, Ventricular Tachycardia, Hypokalaemia, Hypermagnesaemia
This Long Qt Syndrome problem was reported by a health professional from Country Not Specified. A 18-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Fluconazole (dosage: NA). The following drugs were being taken at the same time:
  • Tacrolimus
  • Neurocil
  • Lorazepam
When using Fluconazole, the patient experienced the following unwanted symptoms/side effects: Long Qt Syndrome, Cardiac Arrest, Ventricular Tachycardia, Hypokalaemia, HypermagnesaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Long Qt Syndrome, may become evident only after a product is in use by the general population.
Fluconazole Side Effect Report#9832994
Bacterial Sepsis, Treatment Failure
This Bacterial Sepsis side effect was reported by a health professional from Country Not Specified. A 69-year-old male patient (weight:NA) experienced the following symptoms/conditions: candida infection.The patient was prescribed Fluconazole (drug dosage: 800 Mg), which was initiated on NS. Concurrently used drugs: NA..After starting to take Fluconazole the consumer reported adverse symptoms, such as: Bacterial Sepsis, Treatment FailureThese side effects may potentially be related to Fluconazole.
Fluconazole Side Effect Report#9825562
Abdominal Pain, Nausea, Heart Rate Increased, Headache, Dyspnoea, Vomiting
This is a report of a 80-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: fungal infection, who was treated with Fluconazole (dosage: NA, start time:
Dec 18, 2013), combined with: NA. and developed a serious reaction and side effect(s): Abdominal Pain, Nausea, Heart Rate Increased, Headache, Dyspnoea, Vomiting after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluconazole treatment in female patients, resulting in Abdominal Pain side effect. The patient was hospitalized.
Fluconazole Side Effect Report#9820207
Cough, Dizziness, Cold Sweat, Syncope, Vomiting, Diarrhoea, Blood Pressure Systolic Increased, Chills
This report suggests a potential Fluconazole Cough side effect(s) that can have serious consequences. A 52-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: vulvovaginal mycotic infection,cough and used Fluconazole (dosage: 1 Pill, 1 Every 3 Days) starting
Jan 09, 2014. After starting Fluconazole the patient began experiencing various side effects, including: Cough, Dizziness, Cold Sweat, Syncope, Vomiting, Diarrhoea, Blood Pressure Systolic Increased, ChillsAdditional drugs used concurrently:
  • Promethazine (1 Teaspoon, 4-6 Hours)
  • Pregenolone
  • Uriven
  • Cranberry Extract
  • Vitamin C
  • Glycemic Mgrx Supplement
  • Adr Formula Supplement
Although Fluconazole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cough, may still occur.
Fluconazole Side Effect Report#9815471
Rash, Urticaria
This Rash problem was reported by a consumer or non-health professional from US. A 77-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Fluconazole (dosage: Unk). The following drugs were being taken at the same time: NA. When using Fluconazole, the patient experienced the following unwanted symptoms/side effects: Rash, UrticariaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rash, may become evident only after a product is in use by the general population.
Fluconazole Side Effect Report#9813453
Cardiac Arrest, Anaemia
This Cardiac Arrest side effect was reported by a pharmacist from US. A 64-year-old male patient (weight:NA) experienced the following symptoms/conditions: endocarditis,evidence based treatment,helicobacter infection.The patient was prescribed Fluconazole (drug dosage: 400 Mg Am Po), which was initiated on
Dec 19, 2013. Concurrently used drugs: NA..After starting to take Fluconazole the consumer reported adverse symptoms, such as: Cardiac Arrest, AnaemiaThese side effects may potentially be related to Fluconazole. The patient was hospitalized.
Fluconazole Side Effect Report#9809427
Blood Cholesterol Increased, Weight Decreased, Blood Triglycerides Increased
This is a report of a 64-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: cryptococcosis,lung infection,hypothyroidism,stem cell transplant,benign prostatic hyperplasia,oesophageal irritation, who was treated with Fluconazole (dosage: 400 Mg, Daily, start time: 2013), combined with: NA. and developed a serious reaction and side effect(s): Blood Cholesterol Increased, Weight Decreased, Blood Triglycerides Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluconazole treatment in male patients, resulting in Blood Cholesterol Increased side effect.


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The appearance of Fluconazole 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 Fluconazole Side Effects for Women?

Women Side Effects Reports
Pyrexia 48
Pain 45
Headache 42
Erythema 35
Torsade De Pointes 35
Dizziness 30
Blister 28
Nausea 28
Dyspnoea 27
International Normalised Ratio Increased 27

What are common Fluconazole Side Effects for Men?

Men Side Effects Reports
Renal Failure Acute 52
Rhabdomyolysis 52
Pyrexia 37
Renal Impairment 29
Muscular Weakness 26
Vomiting 26
Thrombocytopenia 24
Nausea 23
Headache 21
Adrenal Insufficiency 19

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.

    Fluconazole 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 Fluconazole Side Effects

    Did You Have a Fluconazole Side Effect?

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    Yes, Minor
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    How Effective is Fluconazole for You?

    Exceeded Expectations
    Effective
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    Fluconazole Safety Alerts, Active Ingredients, Usage Information

    NDC 0054-0002
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Fluconazole
    Name Fluconazole
    Dosage Form POWDER, FOR SUSPENSION
    Route ORAL
    On market since 20040729
    Labeler Roxane Laboratories, Inc
    Active Ingredient(s) FLUCONAZOLE
    Strength(s) 10
    Unit(s) mg/mL
    Pharma Class Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome

    Fluconazole Dosage, Warnings, Usage.

    Side Effects reported to FDA: 1544

    Fluconazole safety alerts: 2011

    Reported deaths: 258

    Reported hospitalizations: 623

    Diflucan (fluconazole): Drug Safety Communication �?? Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects

    [Posted 08/03/2011]

    AUDIENCE: OBGYN, Pharmacy, Infectious Disease

    ISSUE: FDA is informing the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. This risk does not appear to be associated with a single, low dose of fluconazole 150mg to treat vaginal yeast infection (candidiasis). Based on this information, the pregnancy category for fluconazole indications (other than vaginal candidiasis) has been changed from category C to category D. The pregnancy category for a single, low dose of fluconazole has not changed and remains category C.

    BACKGROUND: Diflucan is used to treat yeast infections of the vagina, mouth, throat, esophagus and other organs. It is also used to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before bone marrow transplant. Diflucan is also used to treat meningitis caused by a certain type of fungus. Pregnancy category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite its risks.

    RECOMMENDATION: Healthcare professionals should counsel patients if the drug is used during pregnancy or if a patient becomes pregnant while taking the drug. Patients should notify their healthcare professionals if they are or become pregnant while taking fluconazole. If a patient uses fluconazole during pregnancy, the patient should be informed of the potential risk to the fetus.

    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


    [08/03/2011- Drug Safety Communication - FDA]

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