Common Biotene Side Effects


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

Oral Discomfort (5)
Throat Irritation (3)
Glossodynia (3)
Lip Pain (2)
Cheilitis (2)
Product Formulation Issue (2)
Dry Mouth (2)
Feeling Abnormal (2)
Product Taste Abnormal (2)
Thermal Burn (2)
Tremor (2)
Stomatitis (2)
Loss Of Consciousness (1)
Lip Swelling (1)
Lymphocyte Count Decreased (1)
Lip Dry (1)
Pain (1)
Peripheral Arterial Occlusive Disease (1)
Neutrophil Count Decreased (1)
Nausea (1)

➢ 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.

Biotene Side Effects Reported to FDA



Biotene Side Effect Report#9821558
Glossodynia, Oral Discomfort, Throat Irritation, Skin Exfoliation, Product Formulation Issue
This is a report of a 61-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: dry mouth, who was treated with Biotene (dosage: 1 Tbsp, 5xday, start time:
Nov 01, 2013), combined with: NA. and developed a serious reaction and side effect(s): Glossodynia, Oral Discomfort, Throat Irritation, Skin Exfoliation, Product Formulation Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Biotene treatment in female patients, resulting in Glossodynia side effect.
Biotene Side Effect Report#9805424
Oral Discomfort, Glossodynia, Throat Irritation
This report suggests a potential Biotene Oral Discomfort side effect(s) that can have serious consequences. A 60-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: dry mouth and used Biotene (dosage: NA) starting
Jan 06, 2014. After starting Biotene the patient began experiencing various side effects, including: Oral Discomfort, Glossodynia, Throat IrritationAdditional drugs used concurrently:
  • Synthroid
  • Avapro
  • Zegerid
  • Evoxac
  • Nefazodone
  • Clonazepam
  • Ambien Cr
  • Restasis
Although Biotene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Oral Discomfort, may still occur.
Biotene Side Effect Report#9748007
Loss Of Consciousness, Nausea, Chest Pain, Peripheral Arterial Occlusive Disease, Oral Discomfort, Oral Discomfort, Cheilitis, Lip Blister, Stomatitis
This Loss Of Consciousness problem was reported by a consumer or non-health professional from US. A 82-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Biotene Moisturizing Mouth Spray (dosage: NA). The following drugs were being taken at the same time:
  • Oral Moisturisers
  • Sodium Fluoride Toothpaste (sodium Fluoride)
  • Oral Moisturisers Spray
  • Sodium Fluoride Toothpaste (sodium Fluoride)
  • Oral Moisturisers Gum
  • Oxycodone Hydrochloride
  • Oxycodone
  • Indomethacin
When using Biotene Moisturizing Mouth Spray, the patient experienced the following unwanted symptoms/side effects: Loss Of Consciousness, Nausea, Chest Pain, Peripheral Arterial Occlusive Disease, Oral Discomfort, Oral Discomfort, Cheilitis, Lip Blister, StomatitisThe 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 Loss Of Consciousness, may become evident only after a product is in use by the general population.
Biotene Side Effect Report#9674631
Throat Irritation, Dysgeusia
This Throat Irritation side effect was reported by a consumer or non-health professional from US. A 73-year-old female patient (weight:NA) experienced the following symptoms/conditions: oral lichen planus.The patient was prescribed Biotene (drug dosage: NA), which was initiated on
Oct 16, 2013. Concurrently used drugs: NA..After starting to take Biotene the consumer reported adverse symptoms, such as: Throat Irritation, DysgeusiaThese side effects may potentially be related to Biotene.
Biotene Side Effect Report#9617198
Increased Viscosity Of Nasal Secretion, Sinusitis
This is a report of a 43-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Biotene Pbf (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Increased Viscosity Of Nasal Secretion, Sinusitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Biotene Pbf treatment in male patients, resulting in Increased Viscosity Of Nasal Secretion side effect.
Biotene Side Effect Report#9524960
Thermal Burn, Chemical Burn Of Gastrointestinal Tract, Pain, Dry Mouth, Lip Dry, Speech Disorder, Lip Pain, Skin Discolouration
This report suggests a potential Biotene Thermal Burn side effect(s) that can have serious consequences. A 57-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: dry mouth and used Biotene (dosage: Tablespoon As Needed.) starting
Sep 05, 2013. After starting Biotene the patient began experiencing various side effects, including: Thermal Burn, Chemical Burn Of Gastrointestinal Tract, Pain, Dry Mouth, Lip Dry, Speech Disorder, Lip Pain, Skin DiscolourationAdditional drugs used concurrently: NA. Although Biotene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Thermal Burn, may still occur.
Biotene Side Effect Report#9282769
Tremor, Tremor, Disturbance In Attention, Hypophagia, Somnolence, Feeling Abnormal
This Tremor problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Biotene (dosage: NA). The following drugs were being taken at the same time: NA. When using Biotene, the patient experienced the following unwanted symptoms/side effects: Tremor, Tremor, Disturbance In Attention, Hypophagia, Somnolence, Feeling AbnormalAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Tremor, may become evident only after a product is in use by the general population.
Biotene Side Effect Report#8131713-6
Leukopenia, Stomatitis, Pyrexia, Rash Maculo-papular, Lymphocyte Count Decreased, Neutrophil Count Decreased
This Leukopenia side effect was reported by a physician from United States. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Biotene (drug dosage: Unk), which was initiated on
May 25, 2011. Concurrently used drugs:
  • Erlotinib Hydrochloride (150 Mg, Uid/qd)
  • Erlotinib Hydrochloride (Unk)
  • Naproxen (aleve) (Unk)
  • Erlotinib Hydrochloride (50 Mg, Uid/qd)
  • Mk-2206 (45 Mg, Qod)
  • Mk-2206 (45 Mg, Qod)
  • Mk-2206 (15 Mg, Qod)
  • Mk-2206 (Unk)
.After starting to take Biotene the consumer reported adverse symptoms, such as: Leukopenia, Stomatitis, Pyrexia, Rash Maculo-papular, Lymphocyte Count Decreased, Neutrophil Count DecreasedThese side effects may potentially be related to Biotene. The patient was hospitalized.
Biotene Side Effect Report#8029879-1
Product Taste Abnormal, Urine Odour Abnormal, Stress, Oral Discomfort, Headache, Product Contamination, Anxiety, Fatigue, Dizziness
This is a report of a 68-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: dry mouth,dental disorder prophylaxis, who was treated with Biotene, Bio-active Enzyme System, Refreshes Without Burning (dosage: 1 Tablespoon Twice/day Have Used More Than 2 Years, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Product Taste Abnormal, Urine Odour Abnormal, Stress, Oral Discomfort, Headache, Product Contamination, Anxiety, Fatigue, Dizziness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Biotene, Bio-active Enzyme System, Refreshes Without Burning treatment in female patients, resulting in Product Taste Abnormal side effect.
Biotene Side Effect Report#7581313-1
Gingival Bleeding, Gastric Haemorrhage
This report suggests a potential Biotene Gingival Bleeding side effect(s) that can have serious consequences. A 40-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Biotene (dosage: 250mg Twice Per Day) starting
May 01, 2011. After starting Biotene the patient began experiencing various side effects, including: Gingival Bleeding, Gastric HaemorrhageAdditional drugs used concurrently:
  • Flonase (2puff Per Day)
  • Temovate
  • Zantac (2mg Twice Per Day)
  • Imitrex (1tab Cumulative Dose)
Although Biotene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gingival Bleeding, may still occur.
Biotene Side Effect Report#6595178-8
Ageusia, Anosmia, Condition Aggravated, Dry Mouth
This Ageusia problem was reported by a consumer or non-health professional from United States. A 81-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Biotene Original Toothpaste (glucose Oxidase, Lactoperoxide, Lysozyme (dosage: NA). The following drugs were being taken at the same time: NA. When using Biotene Original Toothpaste (glucose Oxidase, Lactoperoxide, Lysozyme, the patient experienced the following unwanted symptoms/side effects: Ageusia, Anosmia, Condition Aggravated, Dry MouthAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Ageusia, may become evident only after a product is in use by the general population.
Biotene Side Effect Report#5122149-0
Agitation, Contusion, Depressed Level Of Consciousness, Fall, Feeling Abnormal, Psychomotor Hyperactivity, Thinking Abnormal
This Agitation side effect was reported by a consumer or non-health professional from United States. A 43-year-old male patient (weight:NA) experienced the following symptoms/conditions: dry mouth.The patient was prescribed Biotene Oral Balance Dry Mouth Moisturizer (drug dosage: Squirt - 1 Teaspoon Once Daily Orally), which was initiated on
Jul 31, 2006. Concurrently used drugs:
  • Zyrtec
  • Remeron
.After starting to take Biotene Oral Balance Dry Mouth Moisturizer the consumer reported adverse symptoms, such as: Agitation, Contusion, Depressed Level Of Consciousness, Fall, Feeling Abnormal, Psychomotor Hyperactivity, Thinking AbnormalThese side effects may potentially be related to Biotene Oral Balance Dry Mouth Moisturizer.
Biotene Side Effect Report#10043206
Product Taste Abnormal, Glossodynia, Thermal Burn, Hypoaesthesia Oral, Lip Swelling, Product Formulation Issue, Cheilitis, Lip Disorder, Lip Pain
This is a report of a 77-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: dry mouth,sjogren^s syndrome, who was treated with Biotene Dry Mouth Oral Rinse (dosage: NA, start time:
Mar 24, 2014), combined with: NA. and developed a serious reaction and side effect(s): Product Taste Abnormal, Glossodynia, Thermal Burn, Hypoaesthesia Oral, Lip Swelling, Product Formulation Issue, Cheilitis, Lip Disorder, Lip Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Biotene Dry Mouth Oral Rinse treatment in female patients, resulting in Product Taste Abnormal side effect.



The appearance of Biotene 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 Biotene Side Effects for Women?

Women Side Effects Reports
Oral Discomfort 5
Glossodynia 3
Throat Irritation 3
Cheilitis 2
Lip Pain 2
Product Formulation Issue 2
Product Taste Abnormal 2
Stomatitis 2
Thermal Burn 2
Tremor 2

What are common Biotene Side Effects for Men?

Men Side Effects Reports
Ageusia 1
Agitation 1
Anosmia 1
Condition Aggravated 1
Contusion 1
Depressed Level Of Consciousness 1
Dry Mouth 1
Fall 1
Feeling Abnormal 1
Increased Viscosity Of Nasal Secretion 1

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.

    Biotene 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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    Biotene Safety Alerts, Active Ingredients, Usage Information

    NDC 0135-0487
    Type HUMAN OTC DRUG
    Proprietary Name BIOTENE Fresh Mint Original
    Name sodium monofluorophosphate
    Dosage Form PASTE
    Route ORAL
    On market since 20110418
    Labeler GlaxoSmithKline Consumer Healthcare LP
    Active Ingredient(s) SODIUM MONOFLUOROPHOSPHATE
    Strength(s) 1.4
    Unit(s) mg/g
    Pharma Class

    More About Biotene

    Side Effects reported to FDA: 13

    Biotene safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 1

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