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Tice Side Effects

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Common Tice Side Effects


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

Pyrexia (28)
Haematuria (14)
Chills (13)
Bovine Tuberculosis (13)
Dysuria (8)
Disseminated Tuberculosis (7)
Influenza Like Illness (7)
Bladder Cancer Recurrent (7)
Urinary Tract Infection (7)
Night Sweats (7)
Atrial Fibrillation (6)
Arthralgia (6)
Nausea (5)
Multi-organ Failure (5)
Weight Decreased (5)
Headache (5)
Reiter's Syndrome (5)
No Adverse Event (5)
Sepsis (5)
Tuberculosis (5)

➢ 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.

Tice Side Effects Reported to FDA



Tice Side Effect Report#9918058
Body Temperature Increased, Blood Urine Present
This is a report of a 70-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: prophylaxis, who was treated with Tice Bcg Live (dosage: Unk, start time:
Feb 11, 2014), combined with: NA. and developed a serious reaction and side effect(s): Body Temperature Increased, Blood Urine Present after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tice Bcg Live treatment in male patients, resulting in Body Temperature Increased side effect.
Tice Side Effect Report#9807369
Injection Site Swelling, Product Quality Issue, Accidental Exposure To Product, Injury Associated With Device
This report suggests a potential Tice Bcg Live Injection Site Swelling side effect(s) that can have serious consequences. A 27-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: prophylaxis and used Tice Bcg Live (dosage: Unk) starting
Dec 11, 2013. After starting Tice Bcg Live the patient began experiencing various side effects, including: Injection Site Swelling, Product Quality Issue, Accidental Exposure To Product, Injury Associated With DeviceAdditional drugs used concurrently:
  • Lisinopril (Unk)
Although Tice Bcg Live demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Injection Site Swelling, may still occur.
Tice Side Effect Report#9803186
Atrial Fibrillation, Blood Urine Present, Brain Hypoxia, Hypoxia
This Atrial Fibrillation problem was reported by a health professional from US. A 70-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: bladder irrigation. On
Nov 21, 2014 this consumer started treatment with Tice Bcg (dosage: NA). The following drugs were being taken at the same time: NA. When using Tice Bcg, the patient experienced the following unwanted symptoms/side effects: Atrial Fibrillation, Blood Urine Present, Brain Hypoxia, HypoxiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Atrial Fibrillation, may become evident only after a product is in use by the general population.
Tice Side Effect Report#9788012
Abasia, Muscular Weakness
This Abasia side effect was reported by a pharmacist from US. A 86-year-old female patient (weight:NA) experienced the following symptoms/conditions: bladder cancer.The patient was prescribed Tice Bcg (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Tice Bcg the consumer reported adverse symptoms, such as: Abasia, Muscular WeaknessThese side effects may potentially be related to Tice Bcg.
Tice Side Effect Report#9784617
Osteomyelitis
This is a report of a 76-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: bladder cancer, who was treated with Tice Bcg Live (dosage: 6 Weekly Cycles Of Bcg, start time: 1991), combined with: NA. and developed a serious reaction and side effect(s): Osteomyelitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tice Bcg Live treatment in male patients, resulting in Osteomyelitis side effect.
Tice Side Effect Report#9717151
Sepsis
This report suggests a potential Tice Bcg Live Sepsis side effect(s) that can have serious consequences. A 47-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: bladder cancer and used Tice Bcg Live (dosage: 1 Vial) starting
Nov 12, 2013. After starting Tice Bcg Live the patient began experiencing various side effects, including: SepsisAdditional drugs used concurrently:
  • Hydrochlorothiazide
  • Tramadol Hydrochloride
The patient was hospitalized. Although Tice Bcg Live demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Sepsis, may still occur.
Tice Side Effect Report#9715777
Loss Of Consciousness, Prostate Cancer, Organic Erectile Dysfunction, Hypertonic Bladder, Bladder Disorder, Urinary Tract Infection, Haematuria, Influenza Like Illness, Bladder Outlet Obstruction
This Loss Of Consciousness problem was reported by a health professional from US. A 85-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: bladder cancer. On
Nov 19, 2013 this consumer started treatment with Tice Bcg Live (dosage: Unk). The following drugs were being taken at the same time: NA. When using Tice Bcg Live, the patient experienced the following unwanted symptoms/side effects: Loss Of Consciousness, Prostate Cancer, Organic Erectile Dysfunction, Hypertonic Bladder, Bladder Disorder, Urinary Tract Infection, Haematuria, Influenza Like Illness, Bladder Outlet ObstructionAlthough 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.
Tice Side Effect Report#9715756
Sepsis
This Sepsis side effect was reported by a physician from US. A 62-year-old male patient (weight:NA) experienced the following symptoms/conditions: bladder cancer.The patient was prescribed Tice Bcg Live (drug dosage: Unk), which was initiated on
Nov 04, 2013. Concurrently used drugs: NA..After starting to take Tice Bcg Live the consumer reported adverse symptoms, such as: SepsisThese side effects may potentially be related to Tice Bcg Live. The patient was hospitalized.
Tice Side Effect Report#9706255
Adverse Reaction, Dysuria, Pyrexia, Haematuria, Chills
This is a report of a 55-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: bladder cancer, who was treated with Tice Bcg Live (dosage: Unk, start time:
Nov 08, 2013), combined with: NA. and developed a serious reaction and side effect(s): Adverse Reaction, Dysuria, Pyrexia, Haematuria, Chills after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tice Bcg Live treatment in male patients, resulting in Adverse Reaction side effect.
Tice Side Effect Report#9659261
Fall, Dialysis, Head Injury, Delusion, Hallucination, Blood Creatinine Increased, Renal Failure, Dialysis, Speech Disorder
This report suggests a potential Tice Bcg Live Fall side effect(s) that can have serious consequences. A 68-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: bladder cancer and used Tice Bcg Live (dosage: Unk) starting 201301. After starting Tice Bcg Live the patient began experiencing various side effects, including: Fall, Dialysis, Head Injury, Delusion, Hallucination, Blood Creatinine Increased, Renal Failure, Dialysis, Speech DisorderAdditional drugs used concurrently: NA.The patient was hospitalized. Although Tice Bcg Live demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fall, may still occur.
Tice Side Effect Report#9644144
Urinary Tract Infection
This Urinary Tract Infection problem was reported by a physician from US. A 74-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: bladder cancer. On
Oct 02, 2013 this consumer started treatment with Tice Bcg Live (dosage: NA). The following drugs were being taken at the same time:
  • Aspirin
  • Crestor
  • Aleve
  • Align
  • Atenolol
  • Furosemide
  • Nystatin
  • Pantoprazole
When using Tice Bcg Live, the patient experienced the following unwanted symptoms/side effects: Urinary Tract InfectionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Urinary Tract Infection, may become evident only after a product is in use by the general population.
Tice Side Effect Report#9634042
Haemorrhage Urinary Tract, Haematuria, Pyrexia, Blood Urine Present, Emotional Disorder, Crying, Influenza Like Illness, Bladder Irritation, Arthralgia
This Haemorrhage Urinary Tract side effect was reported by a consumer or non-health professional from US. A 66-year-old male patient (weight:NA) experienced the following symptoms/conditions: bladder cancer.The patient was prescribed Tice Bcg Live (drug dosage: Unk), which was initiated on
Sep 09, 2013. Concurrently used drugs: NA..After starting to take Tice Bcg Live the consumer reported adverse symptoms, such as: Haemorrhage Urinary Tract, Haematuria, Pyrexia, Blood Urine Present, Emotional Disorder, Crying, Influenza Like Illness, Bladder Irritation, ArthralgiaThese side effects may potentially be related to Tice Bcg Live.
Tice Side Effect Report#9631177
Penile Haemorrhage, Catheter Site Haemorrhage
This is a report of a 64-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Tice Bcg Live (bcg Live) Powder For Instillation Fluid (dosage: Powder For Instillation Fluid, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Penile Haemorrhage, Catheter Site Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tice Bcg Live (bcg Live) Powder For Instillation Fluid treatment in male patients, resulting in Penile Haemorrhage side effect.
Tice Side Effect Report#9631166
Urinary Incontinence
This report suggests a potential Tice Bcg Live (bcg Live) Powder For Instillation Fluid Urinary Incontinence side effect(s) that can have serious consequences. A 65-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Tice Bcg Live (bcg Live) Powder For Instillation Fluid (dosage: NA) starting NS. After starting Tice Bcg Live (bcg Live) Powder For Instillation Fluid the patient began experiencing various side effects, including: Urinary IncontinenceAdditional drugs used concurrently: NA. Although Tice Bcg Live (bcg Live) Powder For Instillation Fluid demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Urinary Incontinence, may still occur.
Tice Side Effect Report#9631138
Bladder Spasm
This Bladder Spasm problem was reported by a consumer or non-health professional from US. A 56-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Tice Bcg Live (bcg Live) Powder For Instillation Fluid (dosage: Intravesical). The following drugs were being taken at the same time: NA. When using Tice Bcg Live (bcg Live) Powder For Instillation Fluid, the patient experienced the following unwanted symptoms/side effects: Bladder SpasmAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bladder Spasm, may become evident only after a product is in use by the general population.
Tice Side Effect Report#9564208
Osteomyelitis, Pneumonia
This Osteomyelitis side effect was reported by a physician from US. A 89-year-old male patient (weight:NA) experienced the following symptoms/conditions: bladder cancer.The patient was prescribed Tice Bcg Live (drug dosage: 50 Ml Once Weekly For 7 Weeks), which was initiated on
Feb 27, 2013. Concurrently used drugs: NA..After starting to take Tice Bcg Live the consumer reported adverse symptoms, such as: Osteomyelitis, PneumoniaThese side effects may potentially be related to Tice Bcg Live. The patient was hospitalized and became disabled.
Tice Side Effect Report#9460891
Hip Fracture, Treatment Failure
This is a report of a 95-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: bladder cancer, who was treated with Tice Bcg Live (dosage: 6 Week Cycle, start time: 2010), combined with: NA. and developed a serious reaction and side effect(s): Hip Fracture, Treatment Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tice Bcg Live treatment in female patients, resulting in Hip Fracture side effect. The patient was hospitalized and became disabled.
Tice Side Effect Report#9459093
Treatment Failure
This report suggests a potential Tice Bcg Live Treatment Failure side effect(s) that can have serious consequences. A 67-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: bladder cancer and used Tice Bcg Live (dosage: Unk) starting
Sep 15, 2006. After starting Tice Bcg Live the patient began experiencing various side effects, including: Treatment FailureAdditional drugs used concurrently: NA. Although Tice Bcg Live demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Treatment Failure, may still occur.
Tice Side Effect Report#9448060
Urinary Bladder Haemorrhage, Bladder Operation, Bladder Neoplasm Surgery, Bladder Neoplasm Surgery
This Urinary Bladder Haemorrhage problem was reported by a physician from US. A 69-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: bladder cancer. On NS this consumer started treatment with Tice Bcg Live (dosage: NA). The following drugs were being taken at the same time:
  • Lantus
  • Lipitor (Unk)
  • Advair (Unk)
  • Metoprolol (Unk)
  • Prilosec (Unk)
  • Imdur (Unk)
  • Ventolin (albuterol Sulfate) (Unk)
  • Prinivil (Unk)
When using Tice Bcg Live, the patient experienced the following unwanted symptoms/side effects: Urinary Bladder Haemorrhage, Bladder Operation, Bladder Neoplasm Surgery, Bladder Neoplasm SurgeryThe 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 Urinary Bladder Haemorrhage, may become evident only after a product is in use by the general population.
Tice Side Effect Report#9439103
Device Issue, Device Infusion Issue, No Adverse Event
This Device Issue side effect was reported by a health professional from US. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: bladder cancer.The patient was prescribed Tice Bcg Live (drug dosage: 1 Standard Dose), which was initiated on
Jul 02, 2013. Concurrently used drugs:
  • Sodium Chloride
.After starting to take Tice Bcg Live the consumer reported adverse symptoms, such as: Device Issue, Device Infusion Issue, No Adverse EventThese side effects may potentially be related to Tice Bcg Live.
Tice Side Effect Report#9438820
Bursitis, Off Label Use
This is a report of a 78-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: bladder cancer, who was treated with Tice Bcg Live (dosage: 1 Vial Of Tice Bcg Suspended In 50 Ml Saline, Administered Intravesically, Once A Week For 6 Weeks, start time:
Jun 22, 2013), combined with: NA. and developed a serious reaction and side effect(s): Bursitis, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tice Bcg Live treatment in male patients, resulting in Bursitis side effect.
Tice Side Effect Report#9378995
Tuberculin Test Positive
This report suggests a potential Tice Bcg Live Tuberculin Test Positive side effect(s) that can have serious consequences. A 66-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: bladder cancer and used Tice Bcg Live (dosage: Unk (strength: 50 Mg)) starting
Sep 17, 2002. After starting Tice Bcg Live the patient began experiencing various side effects, including: Tuberculin Test PositiveAdditional drugs used concurrently: NA. Although Tice Bcg Live demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tuberculin Test Positive, may still occur.
Tice Side Effect Report#9373453
Bacterial Test Positive, Bladder Granuloma, Bladder Injury, Dysuria
This Bacterial Test Positive problem was reported by a physician from US. A 66-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: bladder cancer. On
Jun 17, 2013 this consumer started treatment with Tice Bcg Live (dosage: Unk). The following drugs were being taken at the same time:
  • Isoniazid (Unk)
  • Rifampin (Unk)
  • Lovenox (500 Mg, Unk)
When using Tice Bcg Live, the patient experienced the following unwanted symptoms/side effects: Bacterial Test Positive, Bladder Granuloma, Bladder Injury, DysuriaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bacterial Test Positive, may become evident only after a product is in use by the general population.
Tice Side Effect Report#9352545
Bovine Tuberculosis
This Bovine Tuberculosis side effect was reported by a health professional from US. A 78-year-old male patient (weight:NA) experienced the following symptoms/conditions: bladder cancer stage 0, with cancer in situ.The patient was prescribed Tice Bcg Live (drug dosage: 15 Weekly Intravesical Bcg Instillations), which was initiated on NS. Concurrently used drugs: NA..After starting to take Tice Bcg Live the consumer reported adverse symptoms, such as: Bovine TuberculosisThese side effects may potentially be related to Tice Bcg Live. The patient was hospitalized.
Tice Side Effect Report#9335925
Alveolitis Allergic
This is a report of a 80-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: bladder transitional cell carcinoma, who was treated with Tice Bcg Live (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Alveolitis Allergic after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tice Bcg Live treatment in male patients, resulting in Alveolitis Allergic side effect. The patient was hospitalized.


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The appearance of Tice 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.

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.

    Tice 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 Tice Side Effects

    Did You Have a Tice Side Effect?

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    How Effective is Tice for You?

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

    NDC0052-0602
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameTICE BCG
    NameBACILLUS CALMETTE-GUERIN
    Dosage FormPOWDER, FOR SUSPENSION
    RouteINTRAVESICAL
    On market since19900824
    LabelerOrganon USA Inc.
    Active Ingredient(s)BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN
    Strength(s)50
    Unit(s)mg/50mL
    Pharma ClassLive Attenuated Bacillus Calmette-Guerin Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Att

    More About Tice

    Side Effects reported to FDA: 161

    Tice safety alerts: 2012 2009 2000

    Reported deaths: 16

    Reported hospitalizations: 67

    Avastin (bevacizumab): Counterfeit Product - FDA Issues Letters to 19 Medical Practices

    [Posted 02/14/2012]

    AUDIENCE: Oncology, Pharmacy, Patient

    ISSUE: The FDA is warning healthcare professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin, manufactured by Roche and does not contain the medicine's active ingredient, bevacizumab, which my have resulted in patients not receiving needed therapy. 19 medical practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products. 

    BACKGROUND: Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors' offices. Roche is the company that manufactures Avastin approved for marketing outside of the United States. Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:

    • are labeled with Roche as the manufacturer
    • display batch numbers that start with B6010, B6011 or B86017  

    The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials. FDA approved versions of these medicines are available in adequate supply to meet demand.

     
    RECOMMENDATION: Medical practices that have obtained products from Volunteer Distribution and QSP should stop using them and contact the FDA. These products should be retained and securely stored. To report suspect counterfeit products and other suspect products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions:

    Healthcare professionals and patients are encouraged to report adverse events related to the use of suspect injectable cancer medications 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


    [02/14/2012 - Counterfeit Version of Avastin in U.S. Distribution - FDA] 
    [02/14/2012 - Press Release disclaimer icon - Genentech]

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