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Propylene Glycol Side Effects

Common Propylene Glycol Side Effects



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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.

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.

Propylene Glycol Side Effects Reported to FDA

The following Propylene Glycol 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.


The appearance of Propylene Glycol 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.
Eye Injury, Corneal Abrasion
This is a report of a 63-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Propylene Glycol (dosage: (ophthalmic), start time: 2012), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Eye Injury
  • Corneal Abrasion
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Propylene Glycol treatment in female patients, resulting in eye injury side effect.

Eye Injury, Injury Corneal
This report suggests a potential Propylene Glycol Eye Injury, Injury Corneal side effect(s) that can have serious consequences. A 63-year-old female patient (weight: NA) from UNITED STATES was diagnosed with the following symptoms/conditions: NA and used Propylene Glycol (dosage: NA) starting Jan 01, 2012. Soon after starting Propylene Glycol the patient began experiencing various side effects, including:
  • Eye Injury
  • Injury Corneal
Drugs used concurrently: NA. Although Propylene Glycol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as eye injury, may still occur.

Medical Device Complication, Uterine Perforation
This Medical Device Complication, Uterine Perforation problem was reported by a consumer or non-health professional from UNITED STATES. A 32-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Oct 24, 2011 this consumer started treatment with Propylene Glycol (dosage: NA). The following drugs were being taken at the same time:
  • Protonix
  • Advair Diskus 100/50
  • Mirena (Levonorgestrel Daily Intra-uterine)
  • Mirena (Levonorgestrel Daily Intra-uterine)
  • Azelex
  • Rhinocort
When commencing Propylene Glycol, the patient experienced the following unwanted symptoms/side effects:
  • Medical Device Complication
  • Uterine Perforation
The 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 medical device complication, may become evident only after a product is in use by the general population.

Reaction To Preservatives
This is a report of a 67-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: dry eye,eye inflammation and was treated with Propylene Glycol (dosage: NA) starting Mar 07, 2011. Concurrently used drugs:
  • Lotemax
Soon after that, the consumer experienced the following side effects:
  • Reaction To Preservatives
This opens a possibility that Propylene Glycol treatment could cause the above reactions, including reaction to preservatives, and some female subjects may be more susceptible.


Renal Failure, Lactic Acidosis, Renal Tubular Necrosis, Accidental Overdose, Hypotension
A 50-year-old male patient (weight: NA) from UNITED STATES with the following symptoms/conditions: NA started Propylene Glycol treatment (dosage: 2 Mg/min During 10 Hours) on NS. Soon after starting Propylene Glycol treatment, the subject experienced various side effects, including:
  • Renal Failure
  • Lactic Acidosis
  • Renal Tubular Necrosis
  • Accidental Overdose
  • Hypotension
Concurrently used drugs:
  • Lorazepam (2 Mg/min During 10 Hours)
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Propylene Glycol.

Dyspnoea, Balance Disorder, Headache
A male patient from UNITED STATES (weight: NA) experienced symptoms, such as: NA and was treated with Propylene Glycol(dosage: Two Doses). The treatment was initiated on Jan 06, 2012. After that a consumer reported the following side effect(s):
  • Dyspnoea
  • Balance Disorder
  • Headache
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Propylene Glycol efficacy:
  • Bisoprolol Fumarate (6.25)
  • Rebif
  • Aspirin
  • Tramadol Hcl (4-6 Times)
  • Soma (Every Evening)


Muscle Contractions Involuntary, Bipolar Disorder, Cystitis Interstitial, Restless Legs Syndrome, Tachycardia, Heart Rate Irregular, Dyspnoea Exertional, Serotonin Syndrome, Bladder Disorder
In this report, Propylene Glycol was administered for the following condition: NA.A 53-year-old female consumer from UNITED STATES (weight: NA) started Propylene Glycol treatment (dosage: NA) on Jan 01, 2008.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Muscle Contractions Involuntary
  • Bipolar Disorder
  • Cystitis Interstitial
  • Restless Legs Syndrome
  • Tachycardia
  • Heart Rate Irregular
  • Dyspnoea Exertional
  • Serotonin Syndrome
  • Bladder Disorder
A possible interaction with other drugs could have contributed to this reaction:
  • Armitex Sq
  • Clobax
  • Align
  • Cymbalta (60)
  • Losartan Potassium
  • Elmiron
  • Rustasus (0.5 Cc Bid)
  • Seroquel
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Propylene Glycol treatment could be related to the listed above side effect(s).

Increased Upper Airway Secretion, Odynophagia
This is a report of the following Propylene Glycol side effect(s):
  • Increased Upper Airway Secretion
  • Odynophagia
A 88-year-old female patient from UNITED STATES (weight: NA) presented with the following condition: dry eye and received a treatment with Propylene Glycol (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions:
  • Restasis (Unk)
  • Thera Tears
  • Tears Naturale
This report suggests that a Propylene Glycol treatment could be associated with the listed above side effect(s).

Blood Urine Present, Dermatitis, Feeling Of Body Temperature Change, Gingival Infection, Immunosuppression, Solvent Sensitivity
This Propylene Glycol report was submitted by a 56-year-old male consumer from UNITED STATES (weight: NA). The patient was diagnosed with: NA and Propylene Glycol was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Blood Urine Present
  • Dermatitis
  • Feeling Of Body Temperature Change
  • Gingival Infection
  • Immunosuppression
  • Solvent Sensitivity
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Propylene Glycol treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.



Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


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    Propylene Glycol Safety Alerts, Active Ingredients, Usage Information

    More About Propylene glycol

    Side Effects reported to FDA: 9

    Propylene Glycol safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 3

    Latest Propylene Glycol clinical trials

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