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Abreva Side Effects

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Common Abreva Side Effects


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

Oral Herpes (841)
Herpes Simplex (563)
Condition Aggravated (355)
Swelling Face (202)
Product Quality Issue (192)
Application Site Pain (172)
Lip Swelling (151)
Application Site Irritation (145)
Hypersensitivity (132)
Application Site Erythema (127)
Application Site Swelling (110)
Cheilitis (72)
Application Site Reaction (71)
Application Site Scab (61)
Application Site Scar (56)
Lip Pain (54)
Burning Sensation (47)
Lip Dry (47)
Chapped Lips (46)
Application Site Pruritus (40)

➢ 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.

Abreva Side Effects Reported to FDA



Abreva Side Effect Report#9841930
Application Site Infection, Application Site Inflammation
This is a report of a 55-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: oral herpes, who was treated with Abreva (dosage: NA, start time:
Jan 20, 2014), combined with: NA. and developed a serious reaction and side effect(s): Application Site Infection, Application Site Inflammation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Abreva treatment in female patients, resulting in Application Site Infection side effect.
Abreva Side Effect Report#9652578
Abscess, Oral Herpes, Condition Aggravated
This report suggests a potential Abreva Abscess side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: oral herpes and used Abreva (dosage: NA) starting
Oct 18, 2013. After starting Abreva the patient began experiencing various side effects, including: Abscess, Oral Herpes, Condition AggravatedAdditional drugs used concurrently: NA. Although Abreva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abscess, may still occur.
Abreva Side Effect Report#9546446
Oral Herpes, Condition Aggravated, Application Site Pain, Application Site Pain
This Oral Herpes problem was reported by a consumer or non-health professional from US. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: oral herpes. On
Jul 17, 2013 this consumer started treatment with Abreva (dosage: NA). The following drugs were being taken at the same time: NA. When using Abreva, the patient experienced the following unwanted symptoms/side effects: Oral Herpes, Condition Aggravated, Application Site Pain, Application Site PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Oral Herpes, may become evident only after a product is in use by the general population.
Abreva Side Effect Report#9546441
Oral Discomfort, Application Site Irritation, Condition Aggravated, Application Site Pain
This Oral Discomfort side effect was reported by a consumer or non-health professional from US. A 26-year-old female patient (weight:NA) experienced the following symptoms/conditions: oral herpes.The patient was prescribed Abreva (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Abreva the consumer reported adverse symptoms, such as: Oral Discomfort, Application Site Irritation, Condition Aggravated, Application Site PainThese side effects may potentially be related to Abreva.
Abreva Side Effect Report#9546440
Oral Herpes, Ill-defined Disorder
This is a report of a 51-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: oral herpes, who was treated with Abreva (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Oral Herpes, Ill-defined Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Abreva treatment in female patients, resulting in Oral Herpes side effect.
Abreva Side Effect Report#9546437
Oral Herpes, Condition Aggravated
This report suggests a potential Abreva Oral Herpes side effect(s) that can have serious consequences. A 69-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: oral herpes and used Abreva (dosage: NA) starting NS. After starting Abreva the patient began experiencing various side effects, including: Oral Herpes, Condition AggravatedAdditional drugs used concurrently: NA. Although Abreva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Oral Herpes, may still occur.
Abreva Side Effect Report#9546436
Product Quality Issue
This Product Quality Issue problem was reported by a consumer or non-health professional from US. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: oral herpes. On
Jul 15, 2013 this consumer started treatment with Abreva (dosage: NA). The following drugs were being taken at the same time: NA. When using Abreva, the patient experienced the following unwanted symptoms/side effects: Product Quality IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Product Quality Issue, may become evident only after a product is in use by the general population.
Abreva Side Effect Report#9546435
Application Site Warmth, Oral Herpes, Application Site Pain, Condition Aggravated
This Application Site Warmth side effect was reported by a consumer or non-health professional from US. A 26-year-old female patient (weight:NA) experienced the following symptoms/conditions: oral herpes.The patient was prescribed Abreva (drug dosage: NA), which was initiated on
Jul 10, 2013. Concurrently used drugs: NA..After starting to take Abreva the consumer reported adverse symptoms, such as: Application Site Warmth, Oral Herpes, Application Site Pain, Condition AggravatedThese side effects may potentially be related to Abreva.
Abreva Side Effect Report#9546433
Product Quality Issue
This is a report of a 85-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: oral herpes, who was treated with Abreva (dosage: NA, start time: 201307), combined with: NA. and developed a serious reaction and side effect(s): Product Quality Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Abreva treatment in male patients, resulting in Product Quality Issue side effect.
Abreva Side Effect Report#9546431
Application Site Pain, Off Label Use
This report suggests a potential Abreva Application Site Pain side effect(s) that can have serious consequences. A 73-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: dermatitis and used Abreva (dosage: NA) starting
Jul 15, 2013. After starting Abreva the patient began experiencing various side effects, including: Application Site Pain, Off Label UseAdditional drugs used concurrently: NA. Although Abreva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Application Site Pain, may still occur.
Abreva Side Effect Report#9546430
Application Site Scab, Oral Herpes, Condition Aggravated
This Application Site Scab problem was reported by a consumer or non-health professional from US. A 26-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: oral herpes. On
Jul 05, 2013 this consumer started treatment with Abreva (dosage: NA). The following drugs were being taken at the same time: NA. When using Abreva, the patient experienced the following unwanted symptoms/side effects: Application Site Scab, Oral Herpes, Condition AggravatedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Application Site Scab, may become evident only after a product is in use by the general population.
Abreva Side Effect Report#9546429
Oral Herpes, Condition Aggravated
This Oral Herpes side effect was reported by a consumer or non-health professional from US. A 16-year-old female patient (weight:NA) experienced the following symptoms/conditions: oral herpes.The patient was prescribed Abreva (drug dosage: NA), which was initiated on 201202. Concurrently used drugs: NA..After starting to take Abreva the consumer reported adverse symptoms, such as: Oral Herpes, Condition AggravatedThese side effects may potentially be related to Abreva.
Abreva Side Effect Report#9546428
Nonspecific Reaction, Application Site Pain
This is a report of a 32-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: oral herpes, who was treated with Abreva (dosage: NA, start time: 201307), combined with: NA. and developed a serious reaction and side effect(s): Nonspecific Reaction, Application Site Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Abreva treatment in female patients, resulting in Nonspecific Reaction side effect.
Abreva Side Effect Report#9546426
Hypersensitivity, Application Site Paraesthesia, Application Site Swelling, Lip Disorder, Application Site Pruritus, Application Site Pain, Paraesthesia Oral
This report suggests a potential Abreva Hypersensitivity side effect(s) that can have serious consequences. A 31-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: oral herpes and used Abreva (dosage: NA) starting
Jul 12, 2013. After starting Abreva the patient began experiencing various side effects, including: Hypersensitivity, Application Site Paraesthesia, Application Site Swelling, Lip Disorder, Application Site Pruritus, Application Site Pain, Paraesthesia OralAdditional drugs used concurrently: NA. Although Abreva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypersensitivity, may still occur.
Abreva Side Effect Report#9546425
Application Site Reaction, Application Site Hyperaesthesia, Product Quality Issue
This Application Site Reaction problem was reported by a consumer or non-health professional from US. A 80-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: sensitivity of teeth. On 201306 this consumer started treatment with Abreva (dosage: NA). The following drugs were being taken at the same time: NA. When using Abreva, the patient experienced the following unwanted symptoms/side effects: Application Site Reaction, Application Site Hyperaesthesia, Product Quality IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Application Site Reaction, may become evident only after a product is in use by the general population.
Abreva Side Effect Report#9546422
Application Site Swelling, Application Site Pain
This Application Site Swelling side effect was reported by a consumer or non-health professional from US. A 41-year-old female patient (weight:NA) experienced the following symptoms/conditions: oral herpes.The patient was prescribed Abreva (drug dosage: NA), which was initiated on
Jul 04, 2013. Concurrently used drugs: NA..After starting to take Abreva the consumer reported adverse symptoms, such as: Application Site Swelling, Application Site PainThese side effects may potentially be related to Abreva.
Abreva Side Effect Report#9546412
Chapped Lips, Cheilitis, Erythema, Condition Aggravated, Application Site Irritation, Application Site Pain, Application Site Reaction, Cheilitis
This is a report of a 27-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: chapped lips, who was treated with Abreva (dosage: NA, start time:
Jun 30, 2013), combined with: NA. and developed a serious reaction and side effect(s): Chapped Lips, Cheilitis, Erythema, Condition Aggravated, Application Site Irritation, Application Site Pain, Application Site Reaction, Cheilitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Abreva treatment in female patients, resulting in Chapped Lips side effect.
Abreva Side Effect Report#9546410
Oral Herpes, Condition Aggravated, Application Site Scar, Application Site Pruritus, Application Site Pain, Application Site Pain, Application Site Reaction
This report suggests a potential Abreva Oral Herpes side effect(s) that can have serious consequences. A 45-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: oral herpes and used Abreva (dosage: NA) starting NS. After starting Abreva the patient began experiencing various side effects, including: Oral Herpes, Condition Aggravated, Application Site Scar, Application Site Pruritus, Application Site Pain, Application Site Pain, Application Site ReactionAdditional drugs used concurrently: NA. Although Abreva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Oral Herpes, may still occur.
Abreva Side Effect Report#9546409
Lip Swelling, Oral Herpes, Condition Aggravated
This Lip Swelling problem was reported by a consumer or non-health professional from US. A 19-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: oral herpes. On
Jul 07, 2013 this consumer started treatment with Abreva (dosage: NA). The following drugs were being taken at the same time: NA. When using Abreva, the patient experienced the following unwanted symptoms/side effects: Lip Swelling, Oral Herpes, Condition AggravatedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Lip Swelling, may become evident only after a product is in use by the general population.
Abreva Side Effect Report#9546406
Oral Herpes, Condition Aggravated, Application Site Haemorrhage, Application Site Pain
This Oral Herpes side effect was reported by a consumer or non-health professional from US. A 74-year-old female patient (weight:NA) experienced the following symptoms/conditions: oral herpes.The patient was prescribed Abreva (drug dosage: NA), which was initiated on
Jul 01, 2013. Concurrently used drugs: NA..After starting to take Abreva the consumer reported adverse symptoms, such as: Oral Herpes, Condition Aggravated, Application Site Haemorrhage, Application Site PainThese side effects may potentially be related to Abreva.
Abreva Side Effect Report#9546404
Oral Herpes, Condition Aggravated, Hypersensitivity
This is a report of a 28-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: oral herpes, who was treated with Abreva (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Oral Herpes, Condition Aggravated, Hypersensitivity after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Abreva treatment in female patients, resulting in Oral Herpes side effect.
Abreva Side Effect Report#9546403
Oral Herpes, Condition Aggravated
This report suggests a potential Abreva Oral Herpes side effect(s) that can have serious consequences. A 26-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: oral herpes and used Abreva (dosage: NA) starting NS. After starting Abreva the patient began experiencing various side effects, including: Oral Herpes, Condition AggravatedAdditional drugs used concurrently: NA. Although Abreva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Oral Herpes, may still occur.
Abreva Side Effect Report#9546400
Hypersensitivity, Urticaria, Blister, Burning Sensation, Formication, Erythema, Feeling Hot, Flushing
This Hypersensitivity problem was reported by a consumer or non-health professional from US. A 47-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: oral herpes. On
Jun 13, 2013 this consumer started treatment with Abreva (dosage: NA). The following drugs were being taken at the same time:
  • Prednisone
  • Cetirizine
When using Abreva, the patient experienced the following unwanted symptoms/side effects: Hypersensitivity, Urticaria, Blister, Burning Sensation, Formication, Erythema, Feeling Hot, FlushingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypersensitivity, may become evident only after a product is in use by the general population.
Abreva Side Effect Report#9546397
Product Quality Issue
This Product Quality Issue side effect was reported by a consumer or non-health professional from US. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: oral herpes.The patient was prescribed Abreva (drug dosage: NA), which was initiated on
Jun 24, 2013. Concurrently used drugs: NA..After starting to take Abreva the consumer reported adverse symptoms, such as: Product Quality IssueThese side effects may potentially be related to Abreva.
Abreva Side Effect Report#9546396
Application Site Pain, Application Site Pain
This is a report of a 63-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: oral herpes, who was treated with Abreva (dosage: NA, start time:
Jun 28, 2013), combined with: NA. and developed a serious reaction and side effect(s): Application Site Pain, Application Site Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Abreva treatment in male patients, resulting in Application Site Pain side effect.


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The appearance of Abreva 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.

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.

    Abreva 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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    Abreva Safety Alerts, Active Ingredients, Usage Information

    NDC0135-0200
    TypeHUMAN OTC DRUG
    Proprietary NameABREVA
    Namedocosanol
    Dosage FormCREAM
    RouteTOPICAL
    On market since20100319
    LabelerGlaxoSmithKline Consumer Healthcare LP
    Active Ingredient(s)DOCOSANOL
    Strength(s)100
    Unit(s)mg/g
    Pharma Class

    More About Abreva

    Side Effects reported to FDA: 2472

    Abreva safety alerts: No

    Reported hospitalizations: 2

    Latest Abreva clinical trials

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