Last updated on RxList: 4/1/2019
Gleolan Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/1/2019

Gleolan [aminolevulinic acid hydrochloride (ALA HCl)] is an optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. Common side effects of Gleolan include:

The recommended reconstituted oral dose of Gleolan is 20 mg/kg. Gleolan may interact with phototoxic drugs such as St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines, and topical preparations containing ALA. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Gleolan; it is unknown how it would affect a fetus. It is unknown if Gleolan passes into breast milk. Consult your doctor before breastfeeding.

Our Gleolan [aminolevulinic acid hydrochloride (ALA HCl)] for Oral Solution 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.


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Gleolan Consumer Information

Signs of an allergic reaction may include: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Your caregivers will watch you closely to make sure you do not have an allergic reaction, and to treat a reaction if it does occur.

Many side effects can occur up to 6 weeks after you took aminolevulinic acid. Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • skin redness or swelling, raised red areas;
  • skin rash, itching, or blistering;
  • a seizure;
  • chills; or
  • trouble speaking or understanding what is said to you.

Common side effects may include:

  • nausea, vomiting, diarrhea; or
  • abnormal liver function tests (for up to 6 weeks after taking aminolevulinic acid).

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.

Read the entire detailed patient monograph for Gleolan (Aminolevulinic Acid Hydrochloride (ALA HCl) Solution)


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Gleolan Professional Information


Clinical Trial 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.

The safety of Gleolan is supported by data from 5 open label clinical studies, which included 527 patients with glioma who received ALA HCl. Adverse reactions that occurred in > 1% of patients in the week following surgery were pyrexia, hypotension, nausea, and vomiting. Adverse reactions occurring in the first 6 weeks after surgery in < 1% of patients were: chills, photosensitivity reaction, solar dermatitis, hypotension, abnormal liver function test, and diarrhea. One patient experienced respiratory failure due to drug overdose [see OVERDOSE].

Neurologic Events

Nervous system disorders occurred in 29% of patients within the first week after surgery. Events occurring in > 1% of patients included aphasia (8%), hemiparesis (7.8%), hemianopsia (3.2%), headache (2.7%), seizure (1.9%), hemiplegia (1.9%), monoparesis (1.3%) and hypoesthesia (1.1%). Brain edema occurred in < 1 % of patients in the first 6 weeks after surgery. In a randomized clinical trial (Study 3), the numbers of serious neurologic adverse events in the post operative period were higher in patients randomized to ALA fluorescence arm compared to the control arm. An imbalance was notable for the adverse events aphasia, ataxia, convulsion and hemianopsia, and is likely related to the higher amount of brain resection performed in the ALA arm. At longer follow up periods, the numbers between the two arms appeared similar [see Clinical Trials].

Elevated Liver Enzymes

Worsening of ≥ 2 Common Toxicity Criteria (CTC) grades in alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) occurred in (15.8% and 11.6%, respectively) within the first week after surgery. Absolute levels ranged from 2 times to greater than 10 times the upper limit of normal (ULN) for each parameter. At 6 weeks, ALT remained elevated in 2.9% of patients (range 2 to greater than 5 × ULN), and GGT was elevated in 7.5% of patients (range 2 to greater than 10 × ULN). No cases of liver failure occurred.

Post Marketing Experience

The following adverse reactions are among those that have been identified during post-approval use of Gleolan outside of the United States. 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 Disorders: anaphylactic shock, angioedema, drug eruption, urticaria, erythema.

Metabolism and Nutrition Disorders: metabolic acidosis.

Read the entire FDA prescribing information for Gleolan (Aminolevulinic Acid Hydrochloride (ALA HCl) Solution)

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

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