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Dexa Side Effects

Common Dexa Side Effects


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

Pneumonia (155)
Dyspnoea (153)
Pyrexia (142)
Thrombocytopenia (132)
Diarrhoea (123)
Neutropenia (114)
Nausea (114)
Febrile Neutropenia (105)
Vomiting (98)
Sepsis (96)
Anaemia (94)
Asthenia (88)
Dehydration (86)
Multiple Myeloma (84)
Death (82)
Fatigue (80)
Constipation (79)
Abdominal Pain (78)
Osteonecrosis (73)
Hypotension (72)

➢ 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.

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.

Dexa Side Effects Reported to FDA

The following Dexa 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.


The appearance of Dexa 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.
Blood Lactic Acid Increased, Hyperglycaemia
This is a report of a 54-year-old male patient (weight: NA) from COUNTRY NOT SPECIFIED, suffering from the following symptoms/conditions: prophylaxis of nausea and vomiting,pancreatic carcinoma,type 2 diabetes mellitus, who was treated with Dexamethasone (dosage: NA, start time: NS), combined with:
  • Oxaliplatin
  • Metformin
  • Glimepiride
  • Exenatide
  • Fluorouracil
  • Leucovorin
and developed a serious reaction and side effect(s). The consumer presented with:
  • Blood Lactic Acid Increased
  • Hyperglycaemia
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dexamethasone treatment in male patients, resulting in blood lactic acid increased side effect. The patient was hospitalized.

Blood Creatinine Increased
This report suggests a potential Dexamethasone Blood Creatinine Increased side effect(s) that can have serious consequences. A 73-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Dexamethasone (dosage: 40 Mg, Unk) starting Oct 08, 2013. Soon after starting Dexamethasone the patient began experiencing various side effects, including:
  • Blood Creatinine Increased
Drugs used concurrently:
  • Temsirolimus (25 Mg, Unk)
  • Cisplatin (188 Mg, Unk)
  • Cytarabine (3760 Mg)
  • Rituximab (705 Mg, Unk)
  • Pantozol (40 Mg, Unk)
  • Lyrica (150 Mg, Unk)
  • Rulid (300 Mg, Unk)
  • Cotrim Forte (560 Mg, Monday, Wednesday And Friday)
The patient was hospitalized. Although Dexamethasone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as blood creatinine increased, may still occur.

Pancreatitis Acute, Lipase Increased, Renal Failure Acute, Ileus, Food Intolerance, Vomiting, Abdominal Pain
This Pancreatitis Acute, Lipase Increased, Renal Failure Acute, Ileus, Food Intolerance, Vomiting, Abdominal Pain problem was reported by a health professional from FR. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Sep 30, 0201 this consumer started treatment with Dexamethasone (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Dexamethasone, the patient experienced the following unwanted symptoms/side effects:
  • Pancreatitis Acute
  • Lipase Increased
  • Renal Failure Acute
  • Ileus
  • Food Intolerance
  • Vomiting
  • Abdominal Pain
The 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 pancreatitis acute, may become evident only after a product is in use by the general population.

Abdominal Pain, Hypophagia, Vomiting, Syncope, Unresponsive To Stimuli, Blood Pressure Immeasurable, White Blood Cell Count Decreased, Haemoglobin Decreased, Platelet Count Decreased
This is a report of a 4.-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Dexamethasone (dosage: NA) starting NS. Concurrently used drugs:
  • Methotrexate
  • Peg-l-asparaginase (pegaspargase, Oncospar)
  • Vincristine Sulfate
Soon after that, the consumer experienced the following side effects:
  • Abdominal Pain
  • Hypophagia
  • Vomiting
  • Syncope
  • Unresponsive To Stimuli
  • Blood Pressure Immeasurable
  • White Blood Cell Count Decreased
  • Haemoglobin Decreased
  • Platelet Count Decreased
The patient was hospitalized. This opens a possibility that Dexamethasone treatment could cause the above reactions, including abdominal pain, and some male subjects may be more susceptible.


Castleman^s Disease
A 65-year-old male patient (weight: NA) from GB with the following symptoms/conditions: castleman^s disease started Dexamethasone treatment (dosage: NA) on NS. Soon after starting Dexamethasone treatment, the subject experienced various side effects, including:
  • Castleman^s Disease
Concurrently used drugs:
  • Prednisone
  • Cisplatin
  • Cyclophosphamide
  • Cytarabine
  • Doxorubicin Hydrochloride
  • Rituximab
  • Vincristine
This finding indicates that some male patients could be more vulnerable to Dexamethasone.

Posterior Reversible Encephalopathy Syndrome
A 10-year-old female patient from JP (weight: NA) experienced symptoms, such as: t-cell type acute leukaemia and was treated with Dexamethasone(dosage: 10 Mg/m2/d Daily For 3w, Then Tapered). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Posterior Reversible Encephalopathy Syndrome
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Dexamethasone efficacy:
  • Cytarabine (On D5)
  • Vincristine (4 Doses Of 1.5 Mg/m2 Every Week)
  • Daunorubicin (4 Doses Of 30 Mg/m2 Every Week)
  • Asparaginase (8 Doses Of 5000 Units/m2 Every 3rd Day)
  • Methotrexate (On D5)
  • Prednisolone (On D5)


Liver Function Test Abnormal
In this report, Dexamethasone Tablets Bp 500mcg was administered for the following condition: plasma cell myeloma.A 79-year-old male consumer from GB (weight: NA) started Dexamethasone Tablets Bp 500mcg treatment (dosage: 20 Mg, Days One, Two, Four, Five, Eight, Nine, 11, 12 Every 21 Days) on Jun 11, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Liver Function Test Abnormal
A possible interaction with other drugs could have contributed to this reaction:
  • Velcade (1.2 Mg/kg, Days One, Four, Eight 11 Every 21 Day)
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Dexamethasone Tablets Bp 500mcg treatment could be related to the listed above side effect(s).

Cerebrovascular Accident
This is a report of the following Dexamethasone side effect(s):
  • Cerebrovascular Accident
A 80-year-old female patient from GB (weight: NA) presented with the following condition: plasma cell myeloma and received a treatment with Dexamethasone (dosage: NA) starting: Nov 12, 2012.The following concurrently used drugs could have generated interactions:
  • Revlimid
  • Aspirine
  • Paracetamol
  • Imodium
The patient was hospitalized.This report suggests that a Dexamethasone treatment could be associated with the listed above side effect(s).

Confusional State, Respiratory Tract Infection, Neurological Symptom, Progressive Multifocal Leukoencephalopathy
This Dexamethasone report was submitted by a 76-year-old male consumer from BE (weight: NA). The patient was diagnosed with: plasmacytoma and Dexamethasone was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Confusional State
  • Respiratory Tract Infection
  • Neurological Symptom
  • Progressive Multifocal Leukoencephalopathy
Other drugs used simultaneously:
  • Bortezomib
Those unexpected symptoms could be linked to a Dexamethasone treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Pseudomonas Infection, Phaehyphomycosis
This is a report of a possible correlation between Dexamethasone use and the following symptoms/side effect(s):
  • Pseudomonas Infection
  • Phaehyphomycosis
which could contribute to an assessment of Dexamethasone risk profile.A 28-year-old male consumer from JP (weight: NA) was suffering from histiocytosis haematophagic and was treated with Dexamethasone (dosage: Daily Dose 16.5 Mg, Unk) starting NS.Other concurrent medications:
  • Cyclosporine (Daily Dose 120 Mg, Unk)
  • Etoposide (One Time Dose 240 Mg / 2 Week, Unk)
The patient was hospitalized.

Hypertension, Fall, Pathological Fracture, Peripheral Nerve Palsy
A 58-year-old male patient from US (weight: NA) presented with the following symptoms: plasma cell myeloma and after a treatment with Dexamethasone (dosage: NA) experienced the following side effect(s):
  • Hypertension
  • Fall
  • Pathological Fracture
  • Peripheral Nerve Palsy
The treatment was started on Nov 12, 2013. Dexamethasone was used in combination with the following drugs:
  • Arry-520
  • Bortezomib
  • Protonix
  • Acyclovir
  • Oxycodone
  • Acetaminophen-hydrocodone
  • Prednisone
  • Crestor
The patient was hospitalized.This report could alert potential Dexamethasone consumers.

Posterior Reversible Encephalopathy Syndrome, Headache, Vomiting, Blood Pressure Increased, Somnolence
In this report, a 10-year-old female patient from JP (weight: NA) was affected by a possible Dexamethasone side effect.The patient was diagnosed with t-cell type acute leukaemia. After a treatment with Dexamethasone (dosage: 10 Mg/m2, Daily, start date: NS), the patient experienced the following side effect(s):
  • Posterior Reversible Encephalopathy Syndrome
  • Headache
  • Vomiting
  • Blood Pressure Increased
  • Somnolence
The following simultaneously used drugs could have led to this reaction:
  • Vincristine (1.5 Mg/m2, Unk)
  • Cytarabine (30 Mg, Once/single)
  • Methotrexate (12 Mg, Unk)
  • Prednisolone (10 Mg, Unk)
  • Daunorubicin (30 Mg/m2, Every Week)
  • Asparaginase (5000 Iu/m2, Unk)
The findings here stress that side effects should be taken into consideration when evaluating a Dexamethasone treatment.

Metabolic Disorder, Blood Lactic Acid Increased, Hyperglycaemia, Blood Glucose Increased
This is a report of a 54-year-old male patient from US (weight: NA), who used Dexamethasone (dosage: NA) for a treatment of antiemetic supportive care. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Metabolic Disorder
  • Blood Lactic Acid Increased
  • Hyperglycaemia
  • Blood Glucose Increased
The following drugs could possibly have interacted with the Dexamethasone treatment
  • 5-fluorouracil
  • Leucovorin Calcium
  • Oxaliplatin
  • Dextrose
The patient was hospitalized.Taken together, these observations suggest that a Dexamethasone treatment could be related to side effect(s), such as Metabolic Disorder, Blood Lactic Acid Increased, Hyperglycaemia, Blood Glucose Increased.

Exposure During Pregnancy
This exposure during pregnancy side effect was reported by a physician from US. A 28-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Dexamethasone (dosage: NA), which was started on NS. Concurrently used drugs: NA. When starting to take Dexamethasone the consumer reported the following symptoms:
  • Exposure During Pregnancy
These side effects may potentially be related to Dexamethasone.

Haemoglobin Decreased, Neutrophil Count Decreased, Platelet Count Decreased, White Blood Cell Count Decreased
This is a Dexamethasone side effect report of a 81-year-old male patient (weight:NA) from GB, suffering from the following symptoms/conditions: plasma cell myeloma, who was treated with Dexamethasone (dosage:NA, start time: 201401), combined with:
  • Revlimid
  • Cyclophosphamide
  • Acyclovir
  • Allopurinol
  • Azithromycin
  • Dalteparin
  • Domperidone
  • Mesna
, and developed a serious reaction and a haemoglobin decreased side effect. The patient presented with:
  • Haemoglobin Decreased
  • Neutrophil Count Decreased
  • Platelet Count Decreased
  • White Blood Cell Count Decreased
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Dexamethasone treatment in male patients suffering from plasma cell myeloma, resulting in haemoglobin decreased.

Acute Febrile Neutrophilic Dermatosis, Pyrexia, Erythema, Skin Plaque, Rash, Feeling Hot
This report suggests a potential Dexamethasone acute febrile neutrophilic dermatosis side effect(s) that can have serious consequences. A 60-year-old female patient from JP (weight:NA) was diagnosed with the following health condition(s): plasma cell myeloma and used Dexamethasone (dosage: NA) starting 201111. Soon after starting Dexamethasone the patient began experiencing various side effects, including:
  • Acute Febrile Neutrophilic Dermatosis
  • Pyrexia
  • Erythema
  • Skin Plaque
  • Rash
  • Feeling Hot
Drugs used concurrently:
  • Zoledronic Acid
  • Allopurinol
  • Itraconazole
  • Rabeprazole
  • Tosufloxacin Tosilate
  • Lenalidomide
Although Dexamethasone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as acute febrile neutrophilic dermatosis, may still occur.

Anaphylactic Reaction
This anaphylactic reaction problem was reported by a consumer or non-health professional from US. A 54-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): swollen tongue.On Apr 09, 2013 a consumer started treatment with Dexamethasone (dosage: Unk). The following drugs/medications were being taken at the same time:
  • Ondansetron Hydrochloride (8 Mg, Prn (24 Mg))
  • Acetaminophen (325-650 Mg)
  • Miralax (17 G, Unk)
  • Cetuximab (912 Mg, Every Week)
  • Fentanyl (100 Microgram, 1 In 72 Hour)
  • Morphine (Unk)
  • Nystatin (Unk)
  • Ranitidine (150 Mg, Unk)
When commencing Dexamethasone, the patient experienced the following unwanted symptoms /side effects:
  • Anaphylactic Reaction
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as anaphylactic reaction, may become evident only after a product is in use by the general population.

Castleman^s Disease, Off Label Use
This is a Dexamethasone side effect report of a 65-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: castleman^s disease and was treated with Dexamethasone (dosage: Dosage/interval: 1 Cyclical) starting NS. Concurrently used drugs:
  • Doxorubicin Hydrochloride (Dosage/interval: 1 Cyclical)
  • Rituximab (Dosage/interval: 1 Cyclical)
  • Cyclophosphamide (Dosage/interval: 1 Cyclical)
  • Vincristine Sulfate (Dosage/interval: 1 Cyclical)
  • Prednisone (Dosage/interval: 1 Cyclical)
  • Cytarabine (Dosage/interval: 1 Cyclical)
  • Cisplatin (Dosage/interval: 1 Cyclical)
Soon after that, the consumer experienced the following of symptoms:
  • Castleman^s Disease
  • Off Label Use
This opens a possibility that Dexamethasone could cause castleman^s disease and that some male patients may be more susceptible.

Respiratory Failure, Angioedema, Condition Aggravated
A 58-year-old female patient (weight: NA) from US with the following symptoms: angioedema started Dexamethasone treatment (dosage: NA) on NS. Soon after starting Dexamethasone treatment, the consumer experienced several side effects, including:
  • Respiratory Failure
  • Angioedema
  • Condition Aggravated
. Concurrently used drugs:
  • Famotidine
  • Diphenhydramine
  • Epinephrine
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Dexamethasone side effects, such as respiratory failure.

Hypoxia, Tachypnoea, Dehydration, Listless, Hypotension, Pulse Absent, Cardio-respiratory Arrest, Respiratory Distress, Vomiting
This hypoxia side effect was reported by a consumer or non-health professional from US. A 4.-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Dexamethasone (dosage: NA), which was started on NS. Concurrently used drugs:
  • Mercaptopurine
  • Methotrexate
  • Sulfamethoxazole/trimethoprim
  • Albuterol
  • Fansoprazole
  • Polyethylene Glycol
.When starting to take Dexamethasone the consumer reported symptoms, such as:
  • Hypoxia
  • Tachypnoea
  • Dehydration
  • Listless
  • Hypotension
  • Pulse Absent
  • Cardio-respiratory Arrest
  • Respiratory Distress
  • Vomiting
These side effects may potentially be related to Dexamethasone. The patient was hospitalized.

Hepatic Function Abnormal
This is a report of a 79-year-old patient (weight: NA) from US, suffering from the following symptoms/conditions: plasma cell myeloma, who was treated with Dexamethasone (dosage: 20 Mg, On Days 1,2,4,5,8,9,11,12 Every 21 Days, start time: Jun 11, 2013), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Hepatic Function Abnormal
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dexamethasone treatment in patients, resulting in death side effect. The patient was hospitalized.

Mania
This report suggests a potential Dexamethasone Mania side effect(s) that can have serious consequences. A 17-year-old male patient (weight: NA) from IE was diagnosed with the following symptoms/conditions: acute lymphocytic leukaemia and used Dexamethasone (dosage: 10 Mg, Qd) starting NS. Soon after starting Dexamethasone the patient began experiencing various side effects, including:
  • Mania
Drugs used concurrently: NA.The patient was hospitalized. Although Dexamethasone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as mania, may still occur.

Melaena
This Melaena problem was reported by a physician from IT. A 76-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: plasma cell myeloma. On Nov 25, 2013 this consumer started treatment with Dexamethasone (dosage: NA). The following drugs were being taken at the same time:
  • Revlimid
When commencing Dexamethasone, the patient experienced the following unwanted symptoms/side effects:
  • Melaena
The 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 melaena, may become evident only after a product is in use by the general population.

Haemoglobin Decreased, Neutrophil Count Decreased, Platelet Count Decreased, White Blood Cell Count Decreased
This is a report of a 81-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: plasma cell myeloma and was treated with Dexamethasone Tablets Bp 2.0mg (dosage: 10 Mg, Day 1,4,17,20) starting Jan 23, 2014. Concurrently used drugs:
  • Cyclophosphamide (200 Mg, Qw (day 1,8,15,22))
  • Revlimid (10 Mg, 21/28 Days)
  • Acyclovir (200 Mg, Tid)
  • Allopurinol (300 Mg, Qd)
  • Azithromycin (500 Mg, Qd)
  • Dalteparin Sodium (1000iu, Qd)
  • Domperidone (500 Mg, Tid)
  • Mesna (400 Mg, Qd)
Soon after that, the consumer experienced the following side effects:
  • Haemoglobin Decreased
  • Neutrophil Count Decreased
  • Platelet Count Decreased
  • White Blood Cell Count Decreased
This opens a possibility that Dexamethasone Tablets Bp 2.0mg treatment could cause the above reactions, including haemoglobin decreased, and some male subjects may be more susceptible.

Septic Shock, Acute Respiratory Distress Syndrome, Pneumocystis Jirovecii Pneumonia, Bacillus Test Positive, Laboratory Test Abnormal, Respiratory Syncytial Virus Test Positive, Continuous Haemodiafiltration, Pseudomonas Test Positive, Multi-organ Failure
A 3.-year-old male patient (weight: NA) from US with the following symptoms/conditions: NA started Dexamethasone treatment (dosage: NA) on NS. Soon after starting Dexamethasone treatment, the subject experienced various side effects, including:
  • Septic Shock
  • Acute Respiratory Distress Syndrome
  • Pneumocystis Jirovecii Pneumonia
  • Bacillus Test Positive
  • Laboratory Test Abnormal
  • Respiratory Syncytial Virus Test Positive
  • Continuous Haemodiafiltration
  • Pseudomonas Test Positive
  • Multi-organ Failure
Concurrently used drugs:
  • Doxorubicin Hydrochloride
  • Methotrexate
  • Vincristine Sulfate
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Dexamethasone.

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Top 10 Dexa Side Effects for Women

Women Side EffectsReports
Dyspnoea 102
Nausea 70
Pyrexia 70
Thrombocytopenia 69
Pneumonia 67
Diarrhoea 65
Neutropenia 57
Febrile Neutropenia 54
Vomiting 52
Pain 45

Top 10 Dexa Side Effects for Men

Men Side EffectsReports
Pneumonia 84
Pyrexia 71
Thrombocytopenia 59
Diarrhoea 58
Anaemia 57
Neutropenia 57
Sepsis 57
Febrile Neutropenia 51
Death 50
Asthenia 49

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


    Discuss Dexa Side Effects

    Did You Have a Dexa Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Dexa for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Dexa Safety Alerts, Active Ingredients, Usage Information

    NDC0054-3176
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameDexamethasone Intensol
    NameDexamethasone Intensol
    Dosage FormSOLUTION, CONCENTRATE
    RouteORAL
    On market since19830901
    LabelerRoxane Laboratories, Inc
    Active Ingredient(s)DEXAMETHASONE
    Strength(s)1
    Unit(s)mg/mL
    Pharma ClassCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

    More About Dexa

    Side Effects reported to FDA: 3572

    Dexa safety alerts: 2010

    Reported deaths: 637

    Reported hospitalizations: 1505

    Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose Vial: Recall due to Particulates in Product

    [Posted 12/24/2010]

    AUDIENCE: Risk Managers, Pharmacists

    ISSUE: American Regent and FDA notified healthcare professionals of the nationwide recall of  specific lots of Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL, 30 mL Multiple Dose Vial because some vials of these lots either contain particulates or have the potential to form particulates prior to their respective expiration dates.
     
    BACKGROUND: This voluntary recall was initiated December 20, 2010 because some vials of these lots either contain particulates or have the potential to form particulates prior to their respective expiration dates. American Regent is undertaking this recall in consideration of the potential for safety issues if these lots of product are administered to patients.

    RECOMMENDATION: The recalled lots are listed in the firm's press release below. Hospitals, infusion centers, clinics and other healthcare facilities should not use the drug product with these lot numbers for patient care and should immediately quarantine any product for return. As stated in the Dexamethasone Sodium Phosphate Injection, USP Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”

     

    [12/24/2010 - Firm Press Release - American Regent]

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