OMNIPAQUE - Side Effects Iohexol
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Risks Associated with Inadvertent Intrathecal Administration [ see Warnings and Precautions (5.1) ]
- Risks Associated with Inadvertent Parenteral Administration [ see Warnings and Precautions (5.2) ]
- Hypersensitivity Reactions [ see Warnings and Precautions (5.3) ]
- Contrast Induced Kidney Injury [ see Warnings and Precautions (5.4) ]
- Cardiovascular Adverse Reactions [ see Warnings and Precautions (5.5) ]
- Thromboembolic Events [ see Warnings and Precautions (5.6) ]
- Severe Cutaneous Reactions [ see Warnings and Precautions (5.11) ]
clinical trials experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Intrathecal Administration
Adults
In controlled clinical studies involving 1531 patients using OMNIPAQUE the following adverse reactions were reported: | ||
---|---|---|
System Organ Class | Adverse Reaction | Incidence |
Nervous System | Headaches | 18% |
Musculoskeletal and Connective Tissue | Pain including backache, neckache, stiffness and neuralgia | 8% |
Gastrointestinal System | Nausea | 6% |
Vomiting | 3% | |
Nervous System | Dizziness | 2% |
Other Reactions | Feeling of heaviness, hypotension, hypertonia, sensation of heat, sweating, vertigo, loss of appetite, drowsiness, hypertension, photophobia, tinnitus, neuralgia, paresthesia, difficulty in micturition, and neurological changes | <0.1% |
Pediatric Patients
In clinical studies involving 152 patients for pediatric myelography by lumbar puncture, adverse events following the use of OMNIPAQUE 180 were generally similar to those reported in adults. | |||
---|---|---|---|
Procedure | System Organ Class | Adverse Reaction | Incidence |
Myelography by Lumbar Puncture | Nervous System | Headache | 9% |
Gastrointestinal System | Vomiting | 6% | |
Musculoskeletal and Connective Tissue | Backache | 1.3% | |
Other Reactions All were transient and mild with no clinical sequelae. | Fever | <0.7% | |
Hives | |||
Stomachache | |||
Visual Hallucination | |||
Neurological Changes |
Intravascular Administration
Immediately following intravascular injection of contrast medium, a transient sensation of mild warmth is not unusual. Warmth is less frequent with OMNIPAQUE than with ionic contrast media.
Adults
In controlled clinical studies involving 1485 patients, the following adverse reactions occurred (Table 25):
System Organ Class | Adverse Reaction | Incidence |
---|---|---|
Cardiovascular System | Arrhythmias including PVCs and PACs (2%), | 2% |
Hypotension | 0.7% | |
Others including cardiac failure, asystole, bradycardia, tachycardia, and vasovagal reaction | ≤ 0.3% | |
Nervous System | Vertigo (including dizziness and lightheadedness) | 0.5% |
Pain | 3% | |
Vision Abnormalities (including blurred vision and photomas) | 2% | |
Taste Perversion | 1% | |
Other Reactions | Anxiety, fever, motor and speech dysfunction, convulsion, paresthesia, somnolence, stiff neck, hemiparesis, syncope, shivering, transient ischemic attack, cerebral infarction, and nystagmus | Individual incidence of 0.3% or less |
Respiratory System | Dyspnea, rhinitis, coughing, and laryngitis | Individual incidence of 0.2% or less |
Gastrointestinal System | Nausea | 2% |
Vomiting | 0.7% | |
Others including diarrhea, dyspepsia, cramp, and dry mouth | Individual incidence of less than 0.1%. | |
Skin and Subcutaneous Tissues | Urticaria | 0.3% |
Purpura | 0.1% | |
Abscess | 0.1% | |
Pruritus | 0.1% |
Pediatric Patients
In controlled clinical studies involving 391 patients for pediatric angiocardiography, urography, and CT head imaging, adverse reactions following the use of OMNIPAQUE 240, 300, and 350 were generally similar in quality and frequency to those reported in adults (Table 26):
System Organ Class | Adverse Reaction | Incidence |
---|---|---|
Cardiovascular System | Ventricular Tachycardia | 0.5% |
2:1 Heart Block | 0.5% | |
Hypertension | 0.3% | |
Anemia | 0.3% | |
General Disorders and Administration Site Conditions | Pain | 0.8% |
Fever | 0.5% | |
Nervous System | Convulsion | 0.3% |
Taste Abnormality | 0.5% | |
Respiratory System | Congestion | 0.3% |
Apnea | 0.3% | |
Gastrointestinal System | Nausea | 1% |
Vomiting | 2% | |
Endocrine System | Hypoglycemia | 0.3% |
Skin and Subcutaneous Tissue | Rash | 0.3% |
Oral Administration for Examination of the Gastrointestinal Tract
Adults
Nausea, vomiting, and diarrhea have been most frequently reported following orally administered undiluted OMNIPAQUE for radiographic examination of the gastrointestinal tract. In controlled clinical studies involving 54 adult patients for oral radiographic examination of the gastrointestinal tract using undiluted OMNIPAQUE 350 the following adverse reactions were reported (Table 27):
System Organ Class | Adverse Reaction | Incidence |
---|---|---|
Gastrointestinal System | Diarrhea | 42% |
Nausea | 15% | |
Vomiting | 11% | |
Abdominal Pain | 7% | |
Flatulence | 2% | |
Nervous System | Headache | 2% |
Pediatrics Patients (Oral and Rectal Administration)
In clinical studies involving 58 pediatric patients, the adverse reactions were found to mostly affect the gastrointestinal system with diarrhea (36%), vomiting (9%), nausea (5%) and abdominal pain (2%). However, fever (5%), hypotension (2%) and urticaria (2%) were also reported.
Oral Administration for CT of the Abdomen in Conjunction with Intravenous Administration
Adults
In a controlled clinical study involving 44 adult patients receiving oral administration of diluted OMNIPAQUE (4-9 mg iodine/mL) in conjunction with intravenously injected OMNIPAQUE 300 for CT examination of the abdomen, adverse reactions were limited to a single report of vomiting.
Pediatric Patients
In clinical studies involving 69 pediatric patients receiving oral administration of diluted OMNIPAQUE (9-29 mg iodine/mL) in conjunction with intravenously administered OMNIPAQUE 240 and OMNIPAQUE 300 for CT examination of the abdomen, adverse reactions were limited to a single report of vomiting (1.4%).
Body Cavity Use
Adults
In controlled clinical studies involving 285 adult patients for various body cavity examinations using OMNIPAQUE 240, 300 and 350, the most frequent adverse reactions were administration site reactions: pain 26% and swelling 22%, were exclusively reported for arthrography and were generally related to the procedure rather than the contrast medium. Patients also experienced heat (7%). All other adverse reaction occurred at a rate less than or equal to 1%.
Pediatric Patients
No adverse reactions associated with the use of OMNIPAQUE for VCU procedures were reported in 51 pediatric patients studied.
post-marketing experience
The following additional reactions listed by indication have been identified during post-approval use of OMNIPAQUE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General
Immune System Disorders: Hypersensitivity reactions, anaphylactic or anaphylactoid reactions, anaphylactic or anaphylactoid shock including life-threatening or fatal anaphylaxis.
General Disorders and Administration Site Conditions: Pyrexia, chills, pain and discomfort, asthenia, administration site conditions including extravasation.
Intrathecal Administration
Nervous System Disorders: Meningism, aseptic meningitis, seizures or status epilepticus, disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia.
Musculoskeletal and Connective Tissue Disorders: Pain, muscle spasms or spasticity.
Psychiatric Disorders: Confusional state, agitation, anxiety.
Eye Disorders: Transient visual impairment including cortical blindness.
Renal Reactions: Acute kidney injury.
Intravascular Administration
Cardiovascular Disorders: Severe cardiac complications (including cardiac arrest, cardiopulmonary arrest), shock, peripheral vasodilatation, palpitations, vasospasm including spasm of coronary arteries, myocardial infarction, syncope, cyanosis, pallor, flushing, chest pain.
Hemodynamic Reactions: Vasospasm and thrombophlebitis following intravenous injection.
Blood and Lymphatic System Disorders: Neutropenia.
Nervous System Disorders: Disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia.
Psychiatric Disorders: Confusional state, agitation.
Eye Disorders: Eye irritation or itchiness, periorbital edema, ocular or conjunctival hyperemia, lacrimation.
Renal Reactions: Acute kidney injury, toxic nephropathy (CIN), transient proteinuria, oliguria or anuria, increased serum creatinine.
Gastrointestinal Disorders: Abdominal pain, pancreatitis aggravated, salivary gland enlargement.
Endocrin e Reactions: Hyperthyroidism. Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and pediatric patients, including infants. Some patients were treated for hypothyroidism.
Respiratory; Thoracic, and Mediastinal Disorders: Respiratory distress, respiratory failure, pulmonary edema, bronchospasm, laryngospasm, throat irritation, throat tightness, laryngeal edema, wheezing, chest discomfort, asthmatic attack.
Skin and Subcutaneous Tissue Disorders: Contrast media reactions range from mild (e.g. pleomorphic rashes, drug eruption, erythema and skin discoloration, blisters, hyperhidrosis, angioedema, localized areas of edema) to severe: [e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), bullous or exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS)].
Oral Administration
Gastrointestinal Disorders: Dysphagia, abdominal pain.
Body Cavity Administration
Gastrointestinal Disorders: Pancreatitis.
Musculoskeletal and Connective Tissue Disorders: Arthritis (arthrography).
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