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Review Oseltamivir View Oseltamivir Adverse Event Reports: patient, 43 years of age, was diagnosed with evidence based treatment, vasculitis, mycobacterium fortuitum infection, bronchopulmonary aspergillosis a

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Showing 1-25 of 390 

Respiratory Failure, Hallucination, Visual, Haemoptysis, Neutropenic Sepsis, H1n1 Influenza, Renal Failure, Cardio-respiratory Arrest, Bronchopulmonary Aspergillosis, Liver Injury (8409950-2)
on May 30, 2012 Male patient from UNITED KINGDOM , 43 years of age, was diagnosed with and was treated with Oseltamivir(View Usage). Patient experienced the following unwanted or unexpected effects: respiratory failure, hallucination, visual, haemoptysis, neutropenic sepsis, h1n1 influenza, renal failure, cardio-respiratory arrest, bronchopulmonary aspergillosis, liver injury. Oseltamivir dosage: N/A.
Patient was taking other medications: Patient was hospitalized.

Vomiting, Ear Pain, Nausea, Otitis Media (8398603-5)
Patient was taking Oseltamivir (View Usage). Patient had the following side effects: vomiting, ear pain, nausea (nausea Questions), otitis media on May 21, 2012 from UNITED STATES Additional patient health information: Female patient , 47 years of age, was diagnosed with
  • influenza
and. Oseltamivir dosage: N/A. Patient was hospitalized.

Maternal Exposure During Pregnancy, Abortion Spontaneous (8367748-8)
Adverse event was reported on May 15, 2012 by a Female patient taking Oseltamivir (View Usage) (Dosage: N/A) was diagnosed with
  • h1n1 influenza
  • respiratory disorder
and. Location: GERMANY , 24 years of age, After Oseltamivir was administered, patient had the following side effects: maternal exposure during pregnancy, abortion spontaneous.
Patient was taking other medications:

Placental Necrosis, Pregnancy (8361330-4)
on Apr 12, 2012 Female patient from TAIWAN, PROVINCE OF CHINA , 23 years of age, was diagnosed with
  • h1n1 influenza
and was treated with Oseltamivir (View Usage). Patient experienced the following unwanted or unexpected effects: placental necrosis, pregnancy (pregnancy Questions). Oseltamivir dosage: N/A.
Patient was taking other medications:


Maternal Exposure During Pregnancy, Abortion Induced (8250107-6)
on Mar 13, 2012 Female patient from UNITED STATES , 23 years of age, was diagnosed with
  • h1n1 influenza
and was treated with Oseltamivir Phosphate(View Usage). Patient had the following side effects: maternal exposure during pregnancy, abortion induced. Oseltamivir Phosphate dosage: 75 Mg, Twice Per Day, Oral.
Patient was taking other medications:

Muscle Spasms (8240265-1)
Patient was taking Oseltamivir (View Usage). After Oseltamivir was administered, patient had the following side effects: muscle spasms on Mar 28, 2012 from UNITED STATES Additional patient health information: Male patient , 32 years of age, weighting 266.0 lb, was diagnosed with
  • influenza
and. Oseltamivir dosage: N/A.

International Normalised Ratio Increased (8225910-9)
Adverse event was reported on Mar 08, 2012 by a Female patient taking Oseltamivir (View Usage) (Dosage: 150 Mg/day For 5 Days) . Location: KOREA, REPUBLIC OF , 64 years of age, Patient experienced the following unwanted or unexpected effects: international normalised ratio increased.
Patient was taking other medications:

Influenza (8076250-2)
on Jan 18, 2012 Male patient from CAMBODIA , 28 years of age, weighting 103.6 lb, was treated with Oseltamivir (View Usage). Patient had the following side effects: influenza. Oseltamivir dosage: N/A.

Hallucination, Tremor (8012902-8)
on Dec 23, 2011 Male patient from UNITED STATES , 75 years of age, weighting 169.1 lb, was diagnosed with
  • antiviral prophylaxis
and was treated with Oseltamivir(View Usage). After Oseltamivir was administered, patient had the following side effects: hallucination, tremor. Oseltamivir dosage: 75 Mg Every Day Po.

Pregnancy (7899033-2)
Patient was taking Oseltamivir (View Usage). Patient experienced the following unwanted or unexpected effects: pregnancy (pregnancy Questions) on Oct 31, 2011 from TURKEY Additional patient health information: Female patient , 22 years of age, was diagnosed with
  • h1n1 influenza
and. Oseltamivir dosage: N/A.

Shock, Renal Impairment, Convulsion, Acidosis, Respiratory Failure, Coagulopathy, Hepatic Function Abnormal (7762258-0)
Adverse event was reported on Mar 15, 2011 by a Male patient taking Oseltamivir (View Usage) (Dosage: N/A) was diagnosed with
  • influenza
and. Location: TAIWAN, PROVINCE OF CHINA , child 3 years of age, Patient had the following side effects: shock, renal impairment, convulsion, acidosis, respiratory failure, coagulopathy, hepatic function abnormal.

Pneumonia, Pathogen Resistance (7762187-2)
on Jan 13, 2011 Female patient from TAIWAN, PROVINCE OF CHINA , 13 years of age, was diagnosed with
  • h1n1 influenza
and was treated with Oseltamivir (View Usage). After Oseltamivir was administered, patient had the following side effects: pneumonia (pneumonia Questions), pathogen resistance. Oseltamivir dosage: N/A. Patient was hospitalized.

Pathogen Resistance, Pneumonia (7762179-3)
on Jan 13, 2011 Female patient from TAIWAN, PROVINCE OF CHINA , child 3 years of age, was diagnosed with
  • h1n1 influenza
and was treated with Oseltamivir(View Usage). Patient experienced the following unwanted or unexpected effects: pathogen resistance, pneumonia (pneumonia Questions). Oseltamivir dosage: N/A. Patient was hospitalized.

Pathogen Resistance, Pneumonia (7762178-1)
Patient was taking Oseltamivir (View Usage). Patient had the following side effects: pathogen resistance, pneumonia (pneumonia Questions) on Jan 13, 2011 from TAIWAN, PROVINCE OF CHINA Additional patient health information: Male patient , 22 years of age, was diagnosed with
  • h1n1 influenza
and. Oseltamivir dosage: N/A. Patient was hospitalized.

Disseminated Tuberculosis, Hepatic Failure (7762159-8)
Adverse event was reported on Jan 17, 2011 by a Female patient taking Oseltamivir (View Usage) (Dosage: N/A) . Location: UNITED STATES , weighting 6.17 lb, After Oseltamivir was administered, patient had the following side effects: disseminated tuberculosis, hepatic failure.

Pathogen Resistance, Pneumonia (7762154-9)
on Jan 13, 2011 Female patient from TAIWAN, PROVINCE OF CHINA , child 6 years of age, was diagnosed with
  • h1n1 influenza
and was treated with Oseltamivir (View Usage). Patient experienced the following unwanted or unexpected effects: pathogen resistance, pneumonia (pneumonia Questions). Oseltamivir dosage: N/A. Patient was hospitalized.

Peritoneal Haemorrhage, Abdominal Compartment Syndrome (7762139-2)
on Jan 17, 2011 Female patient from UNITED STATES , weighting 7.05 lb, was treated with Oseltamivir(View Usage). Patient had the following side effects: peritoneal haemorrhage, abdominal compartment syndrome. Oseltamivir dosage: N/A.

Pneumonia, Pathogen Resistance (7762137-9)
Patient was taking Oseltamivir (View Usage). After Oseltamivir was administered, patient had the following side effects: pneumonia (pneumonia Questions), pathogen resistance on Jan 13, 2011 from TAIWAN, PROVINCE OF CHINA Additional patient health information: Male patient , 45 years of age, was diagnosed with
  • h1n1 influenza
and. Oseltamivir dosage: N/A. Patient was hospitalized.

Pneumonia, Pathogen Resistance (7762136-7)
Adverse event was reported on Jan 13, 2011 by a Female patient taking Oseltamivir (View Usage) (Dosage: N/A) was diagnosed with
  • h1n1 influenza
and. Location: TAIWAN, PROVINCE OF CHINA , child 12 years of age, Patient experienced the following unwanted or unexpected effects: pneumonia (pneumonia Questions), pathogen resistance. Patient was hospitalized.

Strabismus (7729982-7)
on Aug 26, 2011 Female patient from JAPAN , weighting 18.30 lb, was treated with Oseltamivir (View Usage). Patient had the following side effects: strabismus. Oseltamivir dosage: N/A.

Angioedema (7729882-2)
on Aug 26, 2011 Female patient from UNITED STATES , 46 years of age, weighting 302.0 lb, was diagnosed with
  • h1n1 influenza
and was treated with Oseltamivir(View Usage). After Oseltamivir was administered, patient had the following side effects: angioedema. Oseltamivir dosage: N/A.
Patient was taking other medications: Patient was hospitalized.

Maternal Exposure During Pregnancy, Cardiac Murmur (7724144-1)
Patient was taking Oseltamivir (View Usage). Patient experienced the following unwanted or unexpected effects: maternal exposure during pregnancy, cardiac murmur on Aug 19, 2011 from JAPAN Additional patient health information: Female patient , weighting 19.62 lb, . Oseltamivir dosage: N/A.
Patient was taking other medications:

Respiratory Distress, Pathogen Resistance (7718455-3)
Adverse event was reported on Aug 24, 2011 by a Female patient taking Oseltamivir (View Usage) (Dosage: N/A) was diagnosed with
  • h1n1 influenza
and. Location: NETHERLANDS , 59 years of age, Patient had the following side effects: respiratory distress, pathogen resistance.
Patient was taking other medications:

Angioedema (7709229-8)
on Aug 22, 2011 Female patient from UNITED STATES , 46 years of age, was diagnosed with
  • h1n1 influenza
and was treated with Oseltamivir (View Usage). After Oseltamivir was administered, patient had the following side effects: angioedema. Oseltamivir dosage: N/A.
Patient was taking other medications: Patient was hospitalized.

Pathogen Resistance (7703948-5)
on Aug 18, 2011 Female patient from THAILAND , 14 years of age, was diagnosed with
  • h1n1 influenza
and was treated with Oseltamivir(View Usage). Patient experienced the following unwanted or unexpected effects: pathogen resistance. Oseltamivir dosage: For 5 Days.. Patient was hospitalized.

Showing 1-25 of 390 


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Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL)

Patients may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012).

 

[Posted 07/11/2011]

 

AUDIENCE: Pediatrics, Pharmacy

ISSUE: Labeling changes are being made to Tamiflu oral suspension to reduce the possibility of prescribing and dosing confusion that can lead to medication errors.  The changes to the product label include:

  • A change in the concentration of Tamiflu from 12 mg/mL to 6 mg/mL. The lower concentration of Tamiflu is less likely to become frothy when shaken, which helps to ensure an accurate measurement. A change in the measurements of the oral dosing device from milligrams (mg = weight) to milliliters (mL = volume).
  • A change in the dosing table for Tamiflu to include a column for the volume (mL) based on the new 6 mg/mL concentration. Revised container labels and carton packaging. Revised compounding instructions for pharmacies to prepare a 6 mg/mL oral suspension from Tamiflu capsules in an emergency situation only if the commercially manufactured Tamiflu for oral suspension is unavailable.

BACKGROUND: Tamiflu is in a class of medications called neuraminidase inhibitors. These drugs work by stopping the spread of the influenza (flu) virus in the body. Genentech, the manufacturer of Tamiflu for oral suspension, plans to begin distribution of the new 6 mg/mL product in July 2011.  The company has instituted a voluntary Take Back Program for wholesale buyers, distributors and pharmacies to remove the 12 mg/mL product from the marketplace. The 12 mg/mL product will remain in the marketplace and in state or national stockpiles until current supplies expire.

RECOMMENDATION: It is important for healthcare professionals to be aware that a patient may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012). Steps should be taken to avoid the potential for a medication error due to confusion between the two concentrations. Prescribers should include the new concentration (6 mg/mL) and dose in milliliters on all prescriptions for Tamiflu for oral suspension.

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

 

 

[07/11/2011 – Drug Safety Communication - FDA]

[07/13/2011 - Consumer Update - FDA]

[12/11/09 - Tamiflu Information Page - FDA]

 

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Oseltamivir Adverse Reactions
Normal Newborn ( 69 Reports)
Pathogen Resistance ( 60 Reports)
Pneumonia ( 39 Reports) Pneumonia Questions
Respiratory Failure ( 34 Reports)
Acute Respiratory Distress Syndrome ( 27 Reports)
Pregnancy ( 26 Reports) Pregnancy Questions
Death ( 25 Reports)
Caesarean Section ( 21 Reports)
No Adverse Event ( 20 Reports)
Influenza ( 13 Reports)
Thrombocytopenia ( 12 Reports)
Delirium ( 11 Reports)
Leukopenia ( 10 Reports)
Abdominal Distension ( 9 Reports)
Influenza Like Illness ( 8 Reports)
Pyrexia ( 8 Reports)
Convulsion ( 7 Reports)
Periproctitis ( 7 Reports)
Septic Shock ( 7 Reports)
Alanine Aminotransferase Abnormal ( 6 Reports)
Aspartate Aminotransferase Abnormal ( 6 Reports)
Renal Impairment ( 6 Reports)
Sepsis ( 6 Reports) Sepsis Questions
Maternal Exposure During Pregnancy ( 5 Reports)
Neutropenia ( 5 Reports)
Pneumothorax ( 5 Reports)
Ventricular Septal Defect ( 5 Reports)
Abortion Spontaneous ( 4 Reports)
Acne Infantile ( 4 Reports)
Anaemia ( 4 Reports)

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