Common Optiray Side Effects


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

Dyspnoea (190)
Anaphylactic Shock (147)
Urticaria (141)
Pruritus (118)
Rash (80)
Nausea (80)
Sneezing (74)
Nephropathy Toxic (72)
Throat Irritation (66)
Loss Of Consciousness (65)
Shock (62)
Cough (61)
Erythema (57)
Blood Pressure Decreased (56)
Vomiting (49)
Chest Discomfort (47)
Cardio-respiratory Arrest (47)
Contrast Media Reaction (45)
Anaphylactic Reaction (42)
Oxygen Saturation Decreased (41)

➢ 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.

Optiray Side Effects Reported to FDA



Optiray Side Effect Report#9997236
Hypersensitivity, Urticaria
This is a report of a 74-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: computerised tomogram, who was treated with Optiray 350 (dosage: 128 Ml, Unk, start time:
Feb 18, 2014), combined with:
  • Kardegic (160 Mg, Unk)
and developed a serious reaction and side effect(s): Hypersensitivity, Urticaria after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Optiray 350 treatment in male patients, resulting in Hypersensitivity side effect.
Optiray Side Effect Report#9928939
Anaphylactic Shock
This report suggests a potential Optiray Anaphylactic Shock side effect(s) that can have serious consequences. A 52-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: arteriogram coronary and used Optiray (dosage: 57 Ml, Single) starting
Feb 06, 2014. After starting Optiray the patient began experiencing various side effects, including: Anaphylactic ShockAdditional drugs used concurrently:
  • Aspirin (100 Mg, Unk)
  • Sodium Rabeprazole (10 Mg, Unk)
  • Clopidogrel Sulfate (75 Mg, Unk)
  • Enalapril (2.5 Mg, Unk)
  • Rosuvastatin Calcium (5 Mg, Unk)
  • Carvedilol (2.5 Mg, Unk)
  • Lidocaine (Unk)
  • Heparin Sodium (Unk)
Although Optiray demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anaphylactic Shock, may still occur.
Optiray Side Effect Report#9919569
Throat Irritation, Dyspnoea, Throat Tightness, Cough
This Throat Irritation problem was reported by a consumer or non-health professional from DE. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: computerised tomogram. On
Feb 03, 2014 this consumer started treatment with Optiray 300 (dosage: 100 Ml, Single). The following drugs were being taken at the same time: NA. When using Optiray 300, the patient experienced the following unwanted symptoms/side effects: Throat Irritation, Dyspnoea, Throat Tightness, CoughAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Throat Irritation, may become evident only after a product is in use by the general population.
Optiray Side Effect Report#9908430
Blood Pressure Decreased, Rash
This Blood Pressure Decreased side effect was reported by a physician from JP. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: computerised tomogram.The patient was prescribed Optiray (drug dosage: 90 Ml, Single, 100 Ml Prefilled Syringe), which was initiated on
Feb 03, 2014. Concurrently used drugs: NA..After starting to take Optiray the consumer reported adverse symptoms, such as: Blood Pressure Decreased, RashThese side effects may potentially be related to Optiray.
Optiray Side Effect Report#9905815
Anaphylactic Shock
This is a report of a 80-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: computerised tomogram, who was treated with Optiray (dosage: 100 Ml, Single, start time:
Feb 03, 2014), combined with: NA. and developed a serious reaction and side effect(s): Anaphylactic Shock after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Optiray treatment in female patients, resulting in Anaphylactic Shock side effect. The patient was hospitalized.
Optiray Side Effect Report#9905790
Anaphylactic Shock
This report suggests a potential Optiray Anaphylactic Shock side effect(s) that can have serious consequences. A 74-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: computerised tomogram and used Optiray (dosage: 80 Ml, Single) starting
Feb 04, 2014. After starting Optiray the patient began experiencing various side effects, including: Anaphylactic ShockAdditional drugs used concurrently: NA.The patient was hospitalized. Although Optiray demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anaphylactic Shock, may still occur.
Optiray Side Effect Report#9897699
Swollen Tongue, Lip Swelling, Periorbital Oedema, Tremor, Headache, Pruritus, Emotional Distress
This Swollen Tongue problem was reported by a consumer or non-health professional from IE. A 38-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: computerised tomogram. On
Feb 06, 2014 this consumer started treatment with Optiray 300 (dosage: 90 Ml, Single). The following drugs were being taken at the same time: NA. When using Optiray 300, the patient experienced the following unwanted symptoms/side effects: Swollen Tongue, Lip Swelling, Periorbital Oedema, Tremor, Headache, Pruritus, Emotional DistressThe 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 Swollen Tongue, may become evident only after a product is in use by the general population.
Optiray Side Effect Report#9889315
Cerebrovascular Accident
This Cerebrovascular Accident side effect was reported by a health professional from ES. A 49-year-old male patient (weight:NA) experienced the following symptoms/conditions: angiogram pulmonary.The patient was prescribed Optiray 350 (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Blood, Whole (3 Units)
  • Tranexamic Acid C
.After starting to take Optiray 350 the consumer reported adverse symptoms, such as: Cerebrovascular AccidentThese side effects may potentially be related to Optiray 350. The patient was hospitalized.
Optiray Side Effect Report#9887404
Hypersensitivity, Periorbital Oedema, Urticaria, Paraesthesia Oral, Pruritus
This is a report of a 51-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: computerised tomogram, who was treated with Optiray (dosage: NA, start time:
Feb 04, 2014), combined with: NA. and developed a serious reaction and side effect(s): Hypersensitivity, Periorbital Oedema, Urticaria, Paraesthesia Oral, Pruritus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Optiray treatment in female patients, resulting in Hypersensitivity side effect.
Optiray Side Effect Report#9852317
Anaphylactic Shock
This report suggests a potential Optiray Anaphylactic Shock side effect(s) that can have serious consequences. A 71-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: computerised tomogram abdomen and used Optiray (dosage: 37.5 Ml, Single) starting
Jan 16, 2014. After starting Optiray the patient began experiencing various side effects, including: Anaphylactic ShockAdditional drugs used concurrently: NA. Although Optiray demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anaphylactic Shock, may still occur.
Optiray Side Effect Report#9845155
Bronchospasm, Laryngospasm, Pruritus
This Bronchospasm problem was reported by a pharmacist from PR. A 29-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: computerised tomogram. On
Jan 06, 2014 this consumer started treatment with Optiray (dosage: 125 Ml, Single, 2.5 Ml/hr). The following drugs were being taken at the same time: NA. When using Optiray, the patient experienced the following unwanted symptoms/side effects: Bronchospasm, Laryngospasm, PruritusAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bronchospasm, may become evident only after a product is in use by the general population.
Optiray Side Effect Report#9822006
Haematemesis, Oropharyngeal Pain, Headache, Nausea, Dizziness
This Haematemesis side effect was reported by a health professional from GB. A 43-year-old male patient (weight:NA) experienced the following symptoms/conditions: computerised tomogram.The patient was prescribed Optiray 300 (drug dosage: 71 Ml, Single), which was initiated on
Jan 08, 2014. Concurrently used drugs: NA..After starting to take Optiray 300 the consumer reported adverse symptoms, such as: Haematemesis, Oropharyngeal Pain, Headache, Nausea, DizzinessThese side effects may potentially be related to Optiray 300.
Optiray Side Effect Report#9809387
Eye Swelling, Eye Pruritus
This is a report of a 33-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: computerised tomogram, who was treated with Optiray (dosage: 90 Ml, Single, start time:
Oct 25, 2013), combined with: NA. and developed a serious reaction and side effect(s): Eye Swelling, Eye Pruritus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Optiray treatment in female patients, resulting in Eye Swelling side effect.
Optiray Side Effect Report#9809386
Throat Irritation, Urticaria
This report suggests a potential Optiray Throat Irritation side effect(s) that can have serious consequences. A 24-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: computerised tomogram and used Optiray (dosage: 100 Ml, Single) starting
Nov 14, 2013. After starting Optiray the patient began experiencing various side effects, including: Throat Irritation, UrticariaAdditional drugs used concurrently: NA. Although Optiray demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Throat Irritation, may still occur.
Optiray Side Effect Report#9809384
Throat Irritation, Dyspnoea
This Throat Irritation problem was reported by a health professional from US. A 62-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: computerised tomogram. On
Dec 16, 2013 this consumer started treatment with Optiray (dosage: 100 Ml, Single). The following drugs were being taken at the same time: NA. When using Optiray, the patient experienced the following unwanted symptoms/side effects: Throat Irritation, DyspnoeaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Throat Irritation, may become evident only after a product is in use by the general population.
Optiray Side Effect Report#9809382
Oral Pruritus, Nasal Congestion
This Oral Pruritus side effect was reported by a health professional from US. A 24-year-old female patient (weight:NA) experienced the following symptoms/conditions: computerised tomogram.The patient was prescribed Optiray (drug dosage: 90 Ml, Single), which was initiated on
Sep 25, 2013. Concurrently used drugs: NA..After starting to take Optiray the consumer reported adverse symptoms, such as: Oral Pruritus, Nasal CongestionThese side effects may potentially be related to Optiray.
Optiray Side Effect Report#9809381
Chest Pain, Throat Irritation, Pruritus
This is a report of a 45-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: computerised tomogram, who was treated with Optiray (dosage: 75 Ml, Single, start time:
Nov 25, 2013), combined with: NA. and developed a serious reaction and side effect(s): Chest Pain, Throat Irritation, Pruritus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Optiray treatment in female patients, resulting in Chest Pain side effect.
Optiray Side Effect Report#9809380
Tremor, Blood Pressure Increased, Urticaria
This report suggests a potential Optiray Tremor side effect(s) that can have serious consequences. A 70-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: computerised tomogram and used Optiray (dosage: 100 Ml, Single) starting
Nov 15, 2013. After starting Optiray the patient began experiencing various side effects, including: Tremor, Blood Pressure Increased, UrticariaAdditional drugs used concurrently: NA. Although Optiray demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tremor, may still occur.
Optiray Side Effect Report#9809379
Panic Attack
This Panic Attack problem was reported by a health professional from US. A 34-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 25, 2013 this consumer started treatment with Optiray (dosage: 100 Ml, 2.0ml/sec). The following drugs were being taken at the same time: NA. When using Optiray, the patient experienced the following unwanted symptoms/side effects: Panic AttackAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Panic Attack, may become evident only after a product is in use by the general population.
Optiray Side Effect Report#9809363
Rash, Urticaria
This Rash side effect was reported by a health professional from US. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: computerised tomogram.The patient was prescribed Optiray (drug dosage: 100 Ml, Single), which was initiated on
Oct 14, 2013. Concurrently used drugs: NA..After starting to take Optiray the consumer reported adverse symptoms, such as: Rash, UrticariaThese side effects may potentially be related to Optiray.
Optiray Side Effect Report#9809362
Hypoaesthesia Oral
This is a report of a 41-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: computerised tomogram head, who was treated with Optiray (dosage: 75 Ml, Single, start time:
Oct 11, 2013), combined with: NA. and developed a serious reaction and side effect(s): Hypoaesthesia Oral after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Optiray treatment in female patients, resulting in Hypoaesthesia Oral side effect.
Optiray Side Effect Report#9809361
Rhinorrhoea, Pharyngeal Oedema
This report suggests a potential Optiray Rhinorrhoea side effect(s) that can have serious consequences. A 66-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: computerised tomogram and used Optiray (dosage: 50 Ml, Single) starting
Sep 20, 2013. After starting Optiray the patient began experiencing various side effects, including: Rhinorrhoea, Pharyngeal OedemaAdditional drugs used concurrently: NA. Although Optiray demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rhinorrhoea, may still occur.
Optiray Side Effect Report#9809360
Oral Pruritus
This Oral Pruritus problem was reported by a health professional from US. A 45-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: computerised tomogram. On
Oct 07, 2013 this consumer started treatment with Optiray (dosage: 125 Ml, Single). The following drugs were being taken at the same time: NA. When using Optiray, the patient experienced the following unwanted symptoms/side effects: Oral PruritusAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Oral Pruritus, may become evident only after a product is in use by the general population.
Optiray Side Effect Report#9809359
Rash
This Rash side effect was reported by a health professional from US. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: computerised tomogram.The patient was prescribed Optiray (drug dosage: 95 Ml, Single), which was initiated on
Sep 30, 2013. Concurrently used drugs: NA..After starting to take Optiray the consumer reported adverse symptoms, such as: RashThese side effects may potentially be related to Optiray.
Optiray Side Effect Report#9809358
Anaphylactoid Reaction
This is a report of a 45-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: computerised tomogram abdomen, who was treated with Optiray (dosage: 92 Ml, Single, start time:
Oct 16, 2013), combined with: NA. and developed a serious reaction and side effect(s): Anaphylactoid Reaction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Optiray treatment in female patients, resulting in Anaphylactoid Reaction side effect.


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The appearance of Optiray 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.

What are common Optiray Side Effects for Women?

Women Side Effects Reports
Dyspnoea 115
Urticaria 83
Pruritus 74
Anaphylactic Shock 63
Rash 51
Throat Irritation 47
Sneezing 45
Nausea 42
Erythema 36
Loss Of Consciousness 35

What are common Optiray Side Effects for Men?

Men Side Effects Reports
Anaphylactic Shock 83
Dyspnoea 72
Urticaria 55
Pruritus 42
Nausea 38
Nephropathy Toxic 35
Loss Of Consciousness 29
Rash 29
Shock 28
Cough 27

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.

    Optiray 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.

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    Optiray Safety Alerts, Active Ingredients, Usage Information

    NDC 0019-1323
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Optiray Pharmacy Bulk Package - 320
    Name Ioversol
    Dosage Form INJECTION
    Route INTRA-ARTERIAL; INTRAVENOUS
    On market since 20111017
    Labeler Mallinckrodt Inc.
    Active Ingredient(s) IOVERSOL
    Strength(s) 678
    Unit(s) mg/mL
    Pharma Class Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]

    Optiray Dosage, Warnings, Usage.

    Side Effects reported to FDA: 1219

    Optiray safety alerts: No

    Reported deaths: 36

    Reported hospitalizations: 139

    Latest Optiray clinical trials