DaTscan Side Effects Center

Last updated on RxList: 11/11/2022
DaTscan Side Effects Center

What Is DaTscan?

DaTscan (Ioflupane I 123 Injection) is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). In these patients, DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson's disease, multiple system atrophy and progressive supranuclear palsy). DaTscan is an adjunct to other diagnostic evaluations.

What Are Side Effects of DaTscan?

DaTscan may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • itching, and
  • skin redness

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of DaTscan include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for DaTscan

The dose of DaTscan is 2.5 mL of sterile solution for intravenous injection in a single-use vial [74 MBq (2 mCi)/mL at calibration time].

What Drugs, Substances, or Supplements Interact with DaTscan?

DaTscan may interact with:

  • amoxapine,
  • amphetamine,
  • benztropine,
  • bupropion,
  • buspirone,
  • cocaine,
  • mazindol,
  • methamphetamine,
  • methylphenidate,
  • norephedrine,
  • phentermine,
  • phenylpropanolamine,
  • selegiline,
  • sertraline,
  • citalopram and paroxetine

Tell your doctor all medications and supplements you use.

DaTscan During Pregnancy and Breastfeeding

During pregnancy, DaTscan should be used only if needed. Any radiopharmaceutical, including DaTscan, may cause fetal harm. DaTscan is not recommended for use while breastfeeding.

Additional Information

Our DaTscan (Ioflupane I 123 Injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Parkinson's disease is only seen in people of advanced age. See Answer
DaTscan Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives, itching, skin redness; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

  • pain, swelling, burning, or irritation around the IV needle;
  • headache;
  • dizziness, spinning sensation;
  • dry mouth; or
  • nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Dementia, Alzheimer's Disease, and Aging Brains See Slideshow
DaTscan Professional Information

SIDE EFFECTS

The following clinically significant adverse reaction is described elsewhere in the labeling:

  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of DATSCAN cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data from clinical trials reflect exposure to DATSCAN in 942 subjects with a mean age of 66 years (range 25 years to 90 years). Among these subjects, 42% were female and 99% White. Subjects received 88 MBq to 287 MBq (2 mCi to 8 mCi) [median 173 MBq (4.7 mCi)] intravenously as a single dose. The recommended dose of DATSCAN is 111 MBq to 185 MBq (3 mCi to 5 mCi) [see DOSAGE AND ADMINISTRATION].

The following adverse reactions were reported at a rate of 1% or less: headache, nausea, vertigo, dry mouth, and dizziness.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of DATSCAN. 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.

Immune system disorders: Hypersensitivity, including dyspnea, edema, rash, erythema, and pruritus

General disorders and administration site conditions: Injection site pain

DRUG INTERACTIONS

Ioflupane I 123 binds to the dopamine transporter [see CLINICAL PHARMACOLOGY]. Drugs that bind to the dopamine transporter with high affinity may interfere with the image obtained following DATSCAN administration. These potentially interfering drugs consist of: amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil, norephedrine, phentermine, phenylpropanolamine, selegiline, and sertraline. Selective serotonin reuptake inhibitors (paroxetine and citalopram) may increase or decrease ioflupane binding to the dopamine transporter. Whether discontinuation of these drugs prior to DATSCAN administration may minimize the interference with a DATSCAN image is unknown.

The impact of dopamine agonists and antagonists upon DATSCAN imaging results has not been established.

Read the entire FDA prescribing information for DaTscan (Ioflupane I123 Injection)

© DaTscan Patient Information is supplied by Cerner Multum, Inc. and DaTscan Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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