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Dexa Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 2950 

Catatonia, Selective Mutism, Posture Abnormal, Psychotic Disorder, Muscle Rigidity, Neuroleptic Malignant Syndrome, Social Avoidant Behaviour, Abnormal Behaviour (8464852-0)
on May 31, 2012 Female from NIGERIA , 20 years of age, was diagnosed with
  • off label use
and was treated with Dexamethasone Sodium Phosphate. Directly after, patient experienced the unwanted or unexpected Dexa side effects: catatonia, selective mutism, posture abnormal, psychotic disorder, muscle rigidity, neuroleptic malignant syndrome, social avoidant behaviour, abnormal behaviour. Dexamethasone Sodium Phosphate dosage: 4 Mg, 1 In 1 D : 4 Mg, 2 In 1 D.

Diarrhoea (8464619-3)
Patient was taking Dexamethasone. Patient felt the following Dexa side effects: diarrhoea on Oct 10, 2011 from UNITED STATES Additional patient health information: Female , 61 years of age, . Dexamethasone dosage: N/A.

White Blood Cell Count Decreased (8463155-8)
Adverse event was reported on Nov 29, 2011 by a Female taking Dexamethasone (Dosage: N/A) . Location: UNITED STATES , 87 years of age, After Dexa was administered, patient encountered several Dexa side effects: white blood cell count decreased.
Multiple concurrent drugs taken:
  • Aredia
  • Aspirin
  • Revlimid (25 Mg, Qd X 21 D, Po; 25 Mg, Qd X 21 D, Po)
  • Levaquin
  • Multivitamins (multivitamins0
  • Coumadin
  • Mobic


Renal Failure Acute (8463153-4)
on Nov 14, 2011 Male from UNITED STATES , 57 years of age, weighting 197.1 lb, was treated with Dexamethasone. Directly after, patient experienced the unwanted or unexpected Dexa side effects: renal failure acute. Dexamethasone dosage: N/A.
Associated medications used:
  • Velcade
  • Revlimid (15 Mg, 1 In 1 D, Po ; 5 Mg, 1 In 1 D, Po)
  • Revlimid (15 Mg, 1 In 1 D, Po ; 5 Mg, 1 In 1 D, Po)
  • Kayexalate
  • Cytoxan
Patient was hospitalized.


Hypersensitivity, Rash Pruritic (8463127-3)
on Nov 30, 2011 Female from UNITED STATES , 74 years of age, was treated with Dexamethasone. Patient felt the following Dexa side effects: hypersensitivity, rash pruritic. Dexamethasone dosage: N/A.
Multiple prescriptions taken:
  • Metfformin Hydrochloride
  • Msm (methylsulfonylmethane)
  • Diovan
  • Atenolol
  • Metrazole (metronidazole)
  • Warfarin Sodium
  • Allopurinol
  • Omeprazole


Peripheral Arterial Occlusive Disease, Impaired Healing, Thrombosis, Acute Respiratory Failure, Haemorrhagic Anaemia (8462910-8)
Patient was taking Dexamethasone Sodium Phosphate. After Dexa was administered, patient encountered several Dexa side effects: peripheral arterial occlusive disease, impaired healing, thrombosis, acute respiratory failure, haemorrhagic anaemia on Jun 11, 2012 from GERMANY Additional patient health information: Male , weighting 238.1 lb, . Dexamethasone Sodium Phosphate dosage: N/A.
Multiple concurrent drugs taken:
  • Granisetron Hydrochloride
  • Fluorouracil
  • Irinotecan Hcl
  • Fluorouracil
  • Avastin
  • Leucovorin Calcium
  • Aspirin
Patient was hospitalized and became disabled.

Gastrointestinal Perforation, Circulatory Collapse, Acute Myocardial Infarction, Constipation (8462787-0)
Adverse event was reported on Jun 15, 2012 by a Male taking Dexamethasone Sodium Phosphate (Dosage: N/A) . Location: JAPAN , weighting 158.7 lb, Directly after, patient experienced the unwanted or unexpected Dexa side effects: gastrointestinal perforation, circulatory collapse, acute myocardial infarction, constipation.
Associated medications used:
  • Alimta


Haematotoxicity, Nephropathy Toxic (8461931-9)
on Jun 12, 2012 Male from SPAIN , 76 years of age, was diagnosed with
  • multiple myeloma
and was treated with Dexamethasone. Patient felt the following Dexa side effects: haematotoxicity, nephropathy toxic. Dexamethasone dosage: N/A.
Multiple prescriptions taken:
  • Revlimid (10 Milligram)
Patient was hospitalized.

Nausea, Multiple Myeloma, Dyspepsia (8461898-3)
on Jun 13, 2012 Female from SPAIN , 69 years of age, was diagnosed with
  • multiple myeloma
and was treated with Dexamethasone. After Dexa was administered, patient encountered several Dexa side effects: nausea, multiple myeloma, dyspepsia. Dexamethasone dosage: N/A.
Multiple concurrent drugs taken:
  • Revlimid (10 Milligram)


Skin Reaction, Toxicity To Various Agents, Neutropenia (8461896-X)
Patient was taking Dexamethasone. Directly after, patient experienced the unwanted or unexpected Dexa side effects: skin reaction, toxicity to various agents, neutropenia on Jun 13, 2012 from SPAIN Additional patient health information: Male , 61 years of age, was diagnosed with
  • multiple myeloma
and. Dexamethasone dosage: N/A.
Associated medications used:
  • Revlimid (10 Milligram)


Neuropathy Peripheral, Toxicity To Various Agents (8461864-8)
Adverse event was reported on Jun 13, 2012 by a Male taking Dexamethasone (Dosage: 3 Pulses) . Location: SPAIN , 64 years of age, Patient felt the following Dexa side effects: neuropathy peripheral, toxicity to various agents.
Multiple prescriptions taken:
  • Revlimid
  • Revlimid


Pulmonary Embolism, Toxicity To Various Agents (8461833-8)
on Jun 13, 2012 Male from SPAIN , 66 years of age, was treated with Dexamethasone. After Dexa was administered, patient encountered several Dexa side effects: pulmonary embolism, toxicity to various agents. Dexamethasone dosage: 3 Pulses.
Multiple concurrent drugs taken:
  • Revlimid
  • Revlimid


Thrombocytopenia, Toxicity To Various Agents, Adverse Event (8461832-6)
on Jun 13, 2012 Male from SPAIN , 69 years of age, was diagnosed with
  • multiple myeloma
and was treated with Dexamethasone. Directly after, patient experienced the unwanted or unexpected Dexa side effects: thrombocytopenia, toxicity to various agents, adverse event. Dexamethasone dosage: N/A.
Associated medications used:
  • Revlimid


Diabetes Mellitus (8461729-1)
Patient was taking Dexamethasone. Patient felt the following Dexa side effects: diabetes mellitus on Jun 20, 2012 from UNITED KINGDOM Additional patient health information: Female , 75 years of age, weighting 173.3 lb, . Dexamethasone dosage: 8 Mg, Unk.
Multiple prescriptions taken:
  • Antihypertensives
  • Denosumab (120 Mg, Q4wk)
  • Fluconazole (50 Mg, Unk)
  • Domperidone (20 Mg, Unk)
  • Ondansetron (8 Mg, Unk)
  • Difflam (10 Ml, Unk)
  • Ciprofloxacin (250 Mg, Unk)
  • Calcium Carbonate (10 Mug, Unk)
Patient was hospitalized.

Rash (8461699-6)
Adverse event was reported on Nov 23, 2011 by a Female taking Dexamethasone (Dosage: N/A) . Location: UNITED STATES , 73 years of age, After Dexa was administered, patient encountered several Dexa side effects: rash. Patient was hospitalized.

Full Blood Count Decreased (8461447-X)
on Sep 22, 2011 Male from UNITED STATES , 84 years of age, was treated with Dexamethasone. Directly after, patient experienced the unwanted or unexpected Dexa side effects: full blood count decreased. Dexamethasone dosage: N/A.
Associated medications used:
  • Revlimid (See Image: Oral)
  • Revlimid (See Image: Oral)
  • Revlimid (See Image: Oral)
  • Revlimid (See Image: Oral)
  • Revlimid (See Image: Oral)
  • Revlimid (See Image: Oral)
Patient was hospitalized.

Pulmonary Fibrosis (8461363-3)
on Jun 11, 2012 Female from GERMANY , 74 years of age, weighting 154.3 lb, was treated with Dexamethasone. Patient felt the following Dexa side effects: pulmonary fibrosis. Dexamethasone dosage: 24 Milligram.
Multiple prescriptions taken:
  • Vidaza (75 Milligram/sq. Meter)
  • Amlodipine (5 Milligram)
  • Eposartan (600 Milligram)
  • Levothyroxine Sodium (25 Microgram)
  • Metoprolol Tartrate
  • Pantoprazole (40 Milligram)
Patient was hospitalized.

Thrombosis, Pulmonary Embolism (8461220-2)
Patient was taking Dexamethasone. After Dexa was administered, patient encountered several Dexa side effects: thrombosis, pulmonary embolism on Oct 21, 2011 from UNITED STATES Additional patient health information: Female , 83 years of age, weighting 148.0 lb, . Dexamethasone dosage: N/A.
Multiple concurrent drugs taken:
  • Multivitamin
  • Aspirin
  • Lisinopril
  • Warfarin Sodium
  • Revlimid (25 Mg, 1 In 1 D, Po)
  • Amlodipine
Patient was hospitalized.

Febrile Neutropenia (8461208-1)
Adverse event was reported on Apr 14, 2011 by a Male taking Dexamethasone (Dosage: N/A) . Location: UNITED STATES , 65 years of age, weighting 187.4 lb, Directly after, patient experienced the unwanted or unexpected Dexa side effects: febrile neutropenia.
Associated medications used:
  • Lenalidomide (15 Mg, Daily, Po)
Patient was hospitalized.

Rash Papular, Blister, Rash Pruritic (8461195-6)
on Nov 09, 2011 Male from UNITED STATES , 80 years of age, weighting 179.7 lb, was treated with Dexamethasone. Patient felt the following Dexa side effects: rash papular, blister, rash pruritic. Dexamethasone dosage: N/A.
Multiple prescriptions taken:
  • Revlimid (25 Mg, 1 In 1 D, Po)
Patient was hospitalized.

Diarrhoea, Electrolyte Imbalance (8460629-0)
on Jun 14, 2012 Male from UNITED KINGDOM , 64 years of age, was diagnosed with
  • multiple myeloma
and was treated with Dexamethasone. After Dexa was administered, patient encountered several Dexa side effects: diarrhoea, electrolyte imbalance. Dexamethasone dosage: N/A.
Multiple concurrent drugs taken:
  • Fluconazole
  • Bendamustine Hydrochloride
  • Thalidomide
  • Cotrim
  • Lansoprazole
  • Acyclovir
  • Bendamustine Hydrochloride
  • Ondansetron


Presyncope, Viral Upper Respiratory Tract Infection, Oral Candidiasis (8460453-9)
Patient was taking Dexamethasone. Directly after, patient experienced the unwanted or unexpected Dexa side effects: presyncope, viral upper respiratory tract infection, oral candidiasis on Jun 19, 2012 from UNITED KINGDOM Additional patient health information: Female , 40 years of age, . Dexamethasone dosage: N/A.
Associated medications used:
  • Granulocyte Macrophage Csf Recombinant 21-r Modified
  • Temozolomide
  • Ima950
Patient was hospitalized.

Toxicity To Various Agents, Pulmonary Embolism (8460245-0)
Adverse event was reported on Jun 11, 2012 by a Male taking Dexamethasone (Dosage: N/A) . Location: SPAIN , 72 years of age, Patient felt the following Dexa side effects: toxicity to various agents, pulmonary embolism.
Multiple prescriptions taken:
  • Revlimid


Rash, Urticaria (8460143-2)
on Nov 30, 2011 Female from UNITED STATES , 85 years of age, was treated with Dexamethasone (dexamethasone). After Dexa was administered, patient encountered several Dexa side effects: rash, urticaria. Dexamethasone (dexamethasone) dosage: N/A.
Multiple concurrent drugs taken:
  • Revlimid (25 Mg, Q21 Days, Po)


Lung Infection, Thrombocytopenia (8459971-9)
on Jun 18, 2012 Female from GREECE , 64 years of age, weighting 158.7 lb, was treated with Dexamethasone. Directly after, patient experienced the unwanted or unexpected Dexa side effects: lung infection, thrombocytopenia. Dexamethasone dosage: 4 Mg, Unk.
Associated medications used:
  • Panitumumab (9 Mg/kg, Q3wk)
  • Capecitabine (2000 Mg/m2, Q3wk)
  • Eloxatin (130 Mg/m2, Q3wk)
  • Tenormin (50 Mg, Bid)
  • Digoxin (0.5 Mg, Unk)
  • Arixtra (2.5 Mg, Bid)
  • Zofran (8 Mg, Unk)
  • Fenistil (8 Mg, Unk)
Patient was hospitalized.

Showing 1-25 of 2950 

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Dexa Information

TOBRAMYCI

Active Ingredient: DEXAMETHA LISDEXAMF

More About Dexa

Side Effects reported to FDA: 2950. View Dexa Adverse Reports

Dexa safety alerts: 2010

Reported deaths: 510

Reported hospitalizations: 1175

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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