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Review Prohance View Prohance Adverse Event Reports: patient, weighting 154.3 lb, was diagnosed with renal mass, liver disorder, neck pain, nuclear magnetic resonance imaging abdominal, renal scan, osteo

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Showing 1-25 of 271 

Nephrogenic Systemic Fibrosis (8426142-1)
on Jun 06, 2012 Male patient from UNITED STATES , weighting 154.3 lb, was diagnosed with
  • renal mass
and was treated with Prohance(View Usage). Patient experienced the following unwanted or unexpected effects: nephrogenic systemic fibrosis. Prohance dosage: N/A.
Patient was taking other medications:

Musculoskeletal Stiffness, Pain, Anxiety, Arthralgia, Skin Hypopigmentation, Skin Fibrosis, Fatigue, Hypoaesthesia, Injury (8388096-6)
Patient was taking Prohance (View Usage). Patient had the following side effects: musculoskeletal stiffness, pain (pain Questions), anxiety (anxiety Questions), arthralgia, skin hypopigmentation, skin fibrosis, fatigue, hypoaesthesia, injury on May 18, 2012 from UNITED STATES Additional patient health information: Male patient , 57 years of age, weighting 170.0 lb, was diagnosed with
  • nuclear magnetic resonance imaging
and. Prohance dosage: N/A.
Patient was taking other medications:

Bone Pain, Musculoskeletal Chest Pain (8356008-7)
Adverse event was reported on May 11, 2012 by a Male patient taking Prohance (View Usage) (Dosage: N/A) was diagnosed with
  • nuclear magnetic resonance imaging
  • computerised tomogram
and. Location: UNITED STATES , 47 years of age, weighting 140.0 lb, After Prohance was administered, patient had the following side effects: bone pain, musculoskeletal chest pain.
Patient was taking other medications:

Shock (8353947-8)
on May 09, 2012 Male patient from JAPAN , 68 years of age, was diagnosed with
  • nuclear magnetic resonance imaging
  • metastasis
and was treated with Prohance (View Usage). Patient experienced the following unwanted or unexpected effects: shock. Prohance dosage: N/A.


Joint Stiffness, Joint Range Of Motion Decreased, Oedema Peripheral, Pruritus, Anxiety, Myalgia, Atrophy, Joint Contracture, Skin Tightness (8351034-6)
on May 04, 2012 Female patient from UNITED STATES , 31 years of age, weighting 131.8 lb, was diagnosed with
  • nuclear magnetic resonance imaging
and was treated with Prohance(View Usage). Patient had the following side effects: joint stiffness, joint range of motion decreased, oedema peripheral, pruritus, anxiety (anxiety Questions), myalgia, atrophy, joint contracture, skin tightness. Prohance dosage: N/A.
Patient was taking other medications:

Circulatory Collapse, Dyspnoea (8345078-8)
Patient was taking Prohance (View Usage). After Prohance was administered, patient had the following side effects: circulatory collapse, dyspnoea on Apr 30, 2012 from GERMANY Additional patient health information: Female patient , 62 years of age, was diagnosed with
  • nuclear magnetic resonance imaging
and. Prohance dosage: N/A. Patient was hospitalized.

Metastasis, Shock (8315380-4)
Adverse event was reported on Apr 20, 2012 by a Female patient taking Prohance (View Usage) (Dosage: N/A) was diagnosed with
  • diagnostic procedure
  • metastasis
and. Location: JAPAN , 68 years of age, Patient experienced the following unwanted or unexpected effects: metastasis, shock.

Shock (8293745-7)
on Apr 11, 2012 Male patient from JAPAN , 72 years of age, was diagnosed with
  • nuclear magnetic resonance imaging
  • metastases to central nervous system
  • lung neoplasm malignant
and was treated with Prohance (View Usage). Patient had the following side effects: shock. Prohance dosage: N/A. Patient was hospitalized.

Anaphylactoid Reaction, Shock (8266090-3)
on Apr 02, 2012 Female patient from JAPAN , 71 years of age, weighting 116.8 lb, was diagnosed with
  • diagnostic procedure
  • metastases to central nervous system
and was treated with Prohance(View Usage). After Prohance was administered, patient had the following side effects: anaphylactoid reaction, shock. Prohance dosage: N/A.

Shock (8266019-8)
Patient was taking Prohance (View Usage). Patient experienced the following unwanted or unexpected effects: shock on Apr 02, 2012 from JAPAN Additional patient health information: Male patient , weighting 158.7 lb, was diagnosed with
  • diagnostic procedure
  • brain cancer metastatic
and. Prohance dosage: N/A.

Dizziness, Shock, Nausea (8265052-X)
Adverse event was reported on Mar 29, 2012 by a Female patient taking Prohance (View Usage) (Dosage: N/A) was diagnosed with
  • nuclear magnetic resonance imaging
  • ovarian neoplasm
and. Location: JAPAN , 84 years of age, weighting 112.4 lb, Patient had the following side effects: dizziness (dizziness Questions), shock, nausea (nausea Questions). Patient was hospitalized.

Arrhythmia, Dyspnoea, Neurogenic Shock (8247535-1)
on Mar 26, 2012 Male patient from CANADA , 54 years of age, weighting 198.4 lb, was treated with Prohance (View Usage). After Prohance was administered, patient had the following side effects: arrhythmia (arrhythmia Questions), dyspnoea, neurogenic shock. Prohance dosage: N/A.

Mobility Decreased, Deformity, Oedema Peripheral, Nephrogenic Systemic Fibrosis, Pain, Scar (8221122-3)
on Mar 14, 2012 Male patient from UNITED STATES , weighting 163.8 lb, was diagnosed with
  • imaging procedure
and was treated with Prohance(View Usage). Patient experienced the following unwanted or unexpected effects: mobility decreased, deformity, oedema peripheral, nephrogenic systemic fibrosis, pain (pain Questions), scar (scar Questions). Prohance dosage: N/A.
Patient was taking other medications:

Nephrogenic Systemic Fibrosis, Skin Discolouration, Mobility Decreased, Oedema Peripheral, Pain In Extremity, Localised Oedema, Injury, Pruritus, Skin Induration (8217940-8)
Patient was taking Prohance (View Usage). Patient had the following side effects: nephrogenic systemic fibrosis, skin discolouration, mobility decreased, oedema peripheral, pain in extremity, localised oedema, injury, pruritus, skin induration on Mar 12, 2012 from UNITED STATES Additional patient health information: Female patient , 53 years of age, weighting 253.0 lb, was diagnosed with
  • nuclear magnetic resonance imaging
and. Prohance dosage: N/A.
Patient was taking other medications:

Blood Pressure Decreased, Loss Of Consciousness, Oxygen Saturation Decreased (8179299-4)
Adverse event was reported on Feb 28, 2012 by a Female patient taking Prohance (View Usage) (Dosage: N/A) was diagnosed with
  • diagnostic procedure
and. Location: JAPAN , 84 years of age, After Prohance was administered, patient had the following side effects: blood pressure decreased, loss of consciousness, oxygen saturation decreased. Patient was hospitalized.

Shock (8178350-5)
on Feb 24, 2012 Male patient from JAPAN , 63 years of age, weighting 167.6 lb, was diagnosed with
  • brain cancer metastatic
  • hypertension
and was treated with Prohance (View Usage). Patient experienced the following unwanted or unexpected effects: shock. Prohance dosage: N/A.
Patient was taking other medications: Patient was hospitalized.

Anaphylactic Shock (8170015-9)
on Sep 06, 2011 Female patient from UNITED STATES , 68 years of age, weighting 160.9 lb, was diagnosed with and was treated with Prohance(View Usage). Patient had the following side effects: anaphylactic shock. Prohance dosage: 20ml Once Intravenous (not Otherwise Specified).

Anaphylactic Reaction (8170014-7)
Patient was taking Prohance (View Usage). After Prohance was administered, patient had the following side effects: anaphylactic reaction on May 05, 2011 from UNITED STATES Additional patient health information: Female patient , 62 years of age, was diagnosed with
  • mass
  • nuclear magnetic resonance imaging
and. Prohance dosage: 15ml Once Intravenous (not Otherwise Specified). Patient was hospitalized.

Hypersensitivity (8170005-6)
Adverse event was reported on Mar 16, 2011 by a Female patient taking Prohance (View Usage) (Dosage: 10ml Once Intravenous (not Otherwise Specified)) was diagnosed with and. Location: UNITED STATES , 44 years of age, Patient experienced the following unwanted or unexpected effects: hypersensitivity.

Convulsion, Chest Pain, Dyspnoea (8169962-3)
on Apr 07, 2011 Female patient from UNITED STATES , 49 years of age, was diagnosed with
  • mammogram abnormal
  • nuclear magnetic resonance imaging
and was treated with Prohance (View Usage). Patient had the following side effects: convulsion, chest pain (chest pain Questions), dyspnoea. Prohance dosage: 20ml Once Intravenous (not Otherwise Specified).

Blood Pressure Decreased (8169918-0)
on Mar 01, 2011 Male patient from UNITED STATES , 69 years of age, weighting 189.6 lb, was diagnosed with
  • variant creutzfeldt-jakob disease
  • nuclear magnetic resonance imaging
and was treated with Prohance(View Usage). After Prohance was administered, patient had the following side effects: blood pressure decreased. Prohance dosage: 20ml Once Intravenous (not Otherwise Specified).

Convulsion (8169917-9)
Patient was taking Prohance (View Usage). Patient experienced the following unwanted or unexpected effects: convulsion on Jan 26, 2011 from UNITED STATES Additional patient health information: Female patient , 57 years of age, weighting 180.8 lb, was diagnosed with
  • nuclear magnetic resonance imaging
and. Prohance dosage: 17ml Once Intravenous (not Otherwise Specified).
Patient was taking other medications:

Pruritus, Pharyngeal Oedema, Urticaria, Eyelid Oedema (8169892-7)
Adverse event was reported on Nov 19, 2010 by a Female patient taking Prohance (View Usage) (Dosage: 20ml Once Intravenous (not Otherwise Specified)) was diagnosed with
  • mass
  • nuclear magnetic resonance imaging
and. Location: UNITED STATES , 39 years of age, weighting 285.5 lb, Patient had the following side effects: pruritus, pharyngeal oedema, urticaria, eyelid oedema.

Unresponsive To Stimuli, Syncope, Feeling Hot (8169857-5)
on Sep 14, 2011 Female patient from UNITED STATES , 74 years of age, weighting 160.9 lb, was diagnosed with and was treated with Prohance (View Usage). After Prohance was administered, patient had the following side effects: unresponsive to stimuli, syncope, feeling hot. Prohance dosage: 15ml Once Intravenous (not Otherwise Specified). Patient was hospitalized.

Shock, Dizziness, Nausea (8158392-6)
on Feb 15, 2012 Female patient from JAPAN , 84 years of age, weighting 112.4 lb, was diagnosed with
  • nuclear magnetic resonance imaging
and was treated with Prohance(View Usage). Patient experienced the following unwanted or unexpected effects: shock, dizziness (dizziness Questions), nausea (nausea Questions). Prohance dosage: N/A. Patient was hospitalized.

Showing 1-25 of 271 


Prohance Forum

Prohance Adverse Effect Reports (FDA)

Enter Unusual Symptoms or Side Effects:

Prohance Information

Alternative PROHANCE Names:GADOTERID

Substance:GADOTERID

Prohance Dosage, Warnings, Usage.

Side Effects reported to FDA: 271. View FDA Adverse Reports

Prohance safety alerts: 2007 2006

Reported deaths: 26

Reported hospitalizations: 93

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Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI): Magnevist, MultiHance, Omniscan, OptiMARK, ProHance

Audience: Radiologists, Nephrologists, Dermatologists, other healthcare professionals

[UPDATED 09/28/2007] Manufacturers of Gadolinium-based contrast agents issued a Dear Healthcare Professional letter to inform healthcare professionals of the addition of a BOXED WARNING and revisions to the WARNING section of the prescribing information for Gadolinium-based contrast agents as listed above used in Magnetic Resonance Imaging (MRI).

[Posted 05/23/2007] FDA notified healthcare professionals of the Agency's request for the addition of a boxed warning and new warnings about the risk of nephrogenic systemic fibrosis (NSF) to the full prescribing information for all gadolinium-based contrast agents (GBCAs). The new prescribing information FDA is requesting highlights and describes the risk for NSF following exposure to a GBCA in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2) and patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period. Healthcare professionals should avoid the use of a GBCA in these patients unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging.

[September 2007 - Letter - Bayer, GE-Healthcare, BRACCO, and MALLINCKRODT]
[May 2007 - Magnevist label - Bayer Healthcare Pharmaceuticals]
[May 2007 - MultiHance label - Bracco Diagnostics Inc.]
[September 2007 - Omniscan label - GE Healthcare]
[May 2007 - OptiMARK label - Mallinckrodt Inc.]
[May 2007 - ProHance label - Bracco Diagnostics, Inc.]

 

[May 23, 2007 - News Release - FDA]
[May 23, 2007 - Information for Healthcare Professionals - FDA]
[May 23, 2007 - Q&A - FDA]

 

Previous MedWatch Alerts:

[June 08, 2006]

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Prohance Adverse Reactions
Nephrogenic Systemic Fibrosis ( 43 Reports)
Dyspnoea ( 40 Reports)
Hypersensitivity ( 26 Reports)
Pain ( 25 Reports) Pain Questions
Shock ( 25 Reports)
Loss Of Consciousness ( 20 Reports)
Anaphylactic Shock ( 18 Reports)
Urticaria ( 18 Reports)
Anaphylactic Reaction ( 16 Reports)
Nausea ( 15 Reports) Nausea Questions
Pruritus ( 15 Reports)
Anaphylactoid Reaction ( 14 Reports)
Anxiety ( 14 Reports) Anxiety Questions
Convulsion ( 14 Reports)
Mobility Decreased ( 14 Reports)
Cough ( 13 Reports)
Fibrosis ( 11 Reports)
Skin Induration ( 11 Reports)
Dizziness ( 10 Reports) Dizziness Questions
Erythema ( 10 Reports)
Musculoskeletal Stiffness ( 10 Reports)
Blood Pressure Decreased ( 9 Reports)
Depressed Level Of Consciousness ( 9 Reports)
Circulatory Collapse ( 8 Reports)
Deformity ( 8 Reports)
Emotional Distress ( 8 Reports)
Oedema Peripheral ( 8 Reports)
Pharyngeal Oedema ( 8 Reports)
Respiratory Arrest ( 8 Reports)
Skin Fibrosis ( 8 Reports)

side effects
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