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Theraflu Side Effects

Common Theraflu Side Effects


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

Dyspnoea (19)
Off Label Use (18)
Dizziness (16)
Hypersensitivity (13)
Hallucination (12)
Blood Glucose Increased (11)
Malaise (10)
Swelling Face (9)
Therapeutic Response Unexpected (9)
Pneumonia (9)
Convulsion (8)
Pharyngeal Oedema (8)
Urticaria (8)
Vomiting (7)
Swelling (7)
Loss Of Consciousness (7)
Burns Second Degree (7)
Insomnia (6)
Rash (6)
Pain (6)

➢ 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.

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.

Theraflu Side Effects Reported to FDA

The following Theraflu 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 Theraflu 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.
Bronchitis
This is a report of a 49-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: nasopharyngitis, who was treated with Theraflu Nighttime Severe Cold Warming Syrup (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Bronchitis
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Theraflu Nighttime Severe Cold Warming Syrup treatment in female patients, resulting in bronchitis side effect.

Rocky Mountain Spotted Fever, Anaemia, Dehydration, Therapeutic Response Unexpected
This report suggests a potential Theraflu Flu And Sore Throat Rocky Mountain Spotted Fever, Anaemia, Dehydration, Therapeutic Response Unexpected side effect(s) that can have serious consequences. A 73-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: oropharyngeal pain,viral infection,off label use,cough,nasopharyngitis and used Theraflu Flu And Sore Throat (dosage: Unk, Unk) starting 2006. Soon after starting Theraflu Flu And Sore Throat the patient began experiencing various side effects, including:
  • Rocky Mountain Spotted Fever
  • Anaemia
  • Dehydration
  • Therapeutic Response Unexpected
Drugs used concurrently: NA.The patient was hospitalized. Although Theraflu Flu And Sore Throat demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as rocky mountain spotted fever, may still occur.

Fibromyalgia
This Fibromyalgia problem was reported by a consumer or non-health professional from US. A 77-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: oropharyngeal pain. On NS this consumer started treatment with Theraflu Flu And Sore Throat (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Theraflu Flu And Sore Throat, the patient experienced the following unwanted symptoms/side effects:
  • Fibromyalgia
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as fibromyalgia, may become evident only after a product is in use by the general population.

Pneumonia, Ageusia, Anosmia, Therapeutic Response Unexpected
This is a report of a 61-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: influenza,off label use and was treated with Theraflu Warming Relief Nighttime Multi-symptom Cold (dosage: 2 Df,3 Separate Doses) starting 201312. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Pneumonia
  • Ageusia
  • Anosmia
  • Therapeutic Response Unexpected
This opens a possibility that Theraflu Warming Relief Nighttime Multi-symptom Cold treatment could cause the above reactions, including pneumonia, and some male subjects may be more susceptible.


Coeliac Disease
A 46-year-old female patient (weight: NA) from US with the following symptoms/conditions: NA started Theraflu Nighttime Severe Cold + Cough treatment (dosage: Unk) on NS. Soon after starting Theraflu Nighttime Severe Cold + Cough treatment, the subject experienced various side effects, including:
  • Coeliac Disease
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Theraflu Nighttime Severe Cold + Cough.

Laryngeal Obstruction, Dysphagia
A 18-year-old female patient from PL (weight: NA) experienced symptoms, such as: NA and was treated with Theraflu Extragrip(dosage: Unk). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Laryngeal Obstruction
  • Dysphagia
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Theraflu Extragrip efficacy: NA.

Pharyngeal Oedema, Dysphagia, Dyspnoea, Insomnia, Epistaxis, Feeling Abnormal, Chest Pain, Choking Sensation
In this report, Theraflu Nighttime Severe Cold Warming Syrup was administered for the following condition: cough,oropharyngeal pain,pyrexia.A 18-year-old female consumer from US (weight: NA) started Theraflu Nighttime Severe Cold Warming Syrup treatment (dosage: Unk, Unk) on Oct 15, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Pharyngeal Oedema
  • Dysphagia
  • Dyspnoea
  • Insomnia
  • Epistaxis
  • Feeling Abnormal
  • Chest Pain
  • Choking Sensation
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Theraflu Nighttime Severe Cold Warming Syrup treatment could be related to the listed above side effect(s).

Breast Cancer, Thyroid Cancer, Skin Cancer, Therapeutic Response Unexpected
This is a report of the following Theraflu Nighttime Severe Cold + Cough side effect(s):
  • Breast Cancer
  • Thyroid Cancer
  • Skin Cancer
  • Therapeutic Response Unexpected
A 69-year-old male patient from US (weight: NA) presented with the following condition: bronchitis,off label use and received a treatment with Theraflu Nighttime Severe Cold + Cough (dosage: Unk, Unk) starting: NS.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Theraflu Nighttime Severe Cold + Cough treatment could be associated with the listed above side effect(s).

Pneumonia, Pharyngitis Streptococcal, Increased Upper Airway Secretion, Cough, Therapeutic Response Unexpected, Off Label Use
This Theraflu Daytime Severe Cold + Cough report was submitted by a 58-year-old male consumer from US (weight: NA). The patient was diagnosed with: bronchitis,nasopharyngitis and Theraflu Daytime Severe Cold + Cough was administered (dosage: Unk, Unk) starting: NS. The consumer developed a set of symptoms:
  • Pneumonia
  • Pharyngitis Streptococcal
  • Increased Upper Airway Secretion
  • Cough
  • Therapeutic Response Unexpected
  • Off Label Use
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Theraflu Daytime Severe Cold + Cough treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Dysuria
This is a report of a possible correlation between Theraflu Extragrip use and the following symptoms/side effect(s):
  • Dysuria
which could contribute to an assessment of Theraflu Extragrip risk profile.A male consumer from PL (weight: NA) was suffering from upper respiratory tract inflammation and was treated with Theraflu Extragrip (dosage: 1 Df, Tid) starting Oct 18, 2012.Other concurrent medications: NA.The patient was hospitalized.

Breast Cancer
A 70-year-old female patient from US (weight: NA) presented with the following symptoms: lymphadenopathy,influenza,migraine,hypertension and after a treatment with Theraflu Cold And Cough (dosage: 1 Df, Q6h Prn) experienced the following side effect(s):
  • Breast Cancer
The treatment was started on NS. Theraflu Cold And Cough was used in combination with the following drugs: NA.This report could alert potential Theraflu Cold And Cough consumers.

Hepatic Steatosis, Off Label Use, Therapeutic Response Unexpected
In this report, a 79-year-old male patient from US (weight: NA) was affected by a possible Theraflu Flu side effect.The patient was diagnosed with chest discomfort,nasopharyngitis,throat irritation. After a treatment with Theraflu Flu (dosage: Unk, 4 To 6 Hours, start date: NS), the patient experienced the following side effect(s):
  • Hepatic Steatosis
  • Off Label Use
  • Therapeutic Response Unexpected
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Theraflu Flu treatment.

Bronchitis, Pneumonia, Disease Recurrence, Off Label Use
This is a report of a 32-year-old female patient from US (weight: NA), who used Theraflu Flu (dosage: Unk, Unk) for a treatment of bronchitis,pneumonia. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Bronchitis
  • Pneumonia
  • Disease Recurrence
  • Off Label Use
The following drugs could possibly have interacted with the Theraflu Flu treatment NA.Taken together, these observations suggest that a Theraflu Flu treatment could be related to side effect(s), such as Bronchitis, Pneumonia, Disease Recurrence, Off Label Use.

Poisoning, Fall, Foaming At Mouth, Loss Of Consciousness, Cardiac Arrest, Brain Oedema
This poisoning side effect was reported by a consumer or non-health professional from TR. A 28-year-old male patient (weight:NA) experienced the following symptoms/conditions: influenza. The patient was prescribed Theraflu Forte (dosage: 2 Df, Once/single), which was started on 201112. Concurrently used drugs: NA. When starting to take Theraflu Forte the consumer reported the following symptoms:
  • Poisoning
  • Fall
  • Foaming At Mouth
  • Loss Of Consciousness
  • Cardiac Arrest
  • Brain Oedema
The patient was hospitalized. These side effects may potentially be related to Theraflu Forte.

Off Label Use
This is a Theraflu Vapor Patch side effect report of a 74-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: increased viscosity of nasal secretion, who was treated with Theraflu Vapor Patch (dosage:2 Df, Qd, start time: 201210), combined with: NA., and developed a serious reaction and a death side effect. The patient presented with:
  • Off Label Use
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Theraflu Vapor Patch treatment in male patients suffering from increased viscosity of nasal secretion, resulting in death.

Neoplasm Malignant
This report suggests a potential Theraflu Daytime neoplasm malignant side effect(s) that can have serious consequences. A 66-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): nasopharyngitis and used Theraflu Daytime (dosage: Unk, Once/single) starting NS. Soon after starting Theraflu Daytime the patient began experiencing various side effects, including:
  • Neoplasm Malignant
Drugs used concurrently:NA. Although Theraflu Daytime demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as neoplasm malignant, may still occur.

Hypertension
This hypertension problem was reported by a consumer or non-health professional from LB. A 40-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Theraflu Flu + Sore Throat (dosage: 1 Df, Qd). The following drugs/medications were being taken at the same time: NA. When commencing Theraflu Flu + Sore Throat, the patient experienced the following unwanted symptoms /side effects:
  • Hypertension
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as hypertension, may become evident only after a product is in use by the general population.


This is a Theraflu Flu side effect report of a 81-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: nasopharyngitis and was treated with Theraflu Flu (dosage: Unk, Unk) starting NS. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
    This opens a possibility that Theraflu Flu could cause death and that some male patients may be more susceptible.

    Respiratory Disorder, Parosmia, Pain, Off Label Use
    A 34-year-old male patient (weight: NA) from US with the following symptoms: influenza like illness,muscular weakness started Theraflu Flu And Sore Throat treatment (dosage: 1 Df, Qd) on NS. Soon after starting Theraflu Flu And Sore Throat treatment, the consumer experienced several side effects, including:
    • Respiratory Disorder
    • Parosmia
    • Pain
    • Off Label Use
    . Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Theraflu Flu And Sore Throat side effects, such as respiratory disorder.

    Bladder Cancer, Off Label Use
    This bladder cancer side effect was reported by a consumer or non-health professional from US. A 61-year-old male patient (weight:NA) experienced the following symptoms/conditions: insomnia.The patient was prescribed Theraflu Nighttime Severe Cold + Cough (dosage: 1 Df, Unk), which was started on NS. Concurrently used drugs: NA..When starting to take Theraflu Nighttime Severe Cold + Cough the consumer reported symptoms, such as:
    • Bladder Cancer
    • Off Label Use
    These side effects may potentially be related to Theraflu Nighttime Severe Cold + Cough.

    Secretion Discharge, Malaise, Cough, Increased Upper Airway Secretion, Breath Sounds Abnormal, Arthralgia, Back Pain
    This is a report of a 68-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Theraflu Nighttime Severe Cold + Cough (dosage: Unk, Unk, start time: 2011), combined with:
    • Theraflu Flu And Sore Throat (1 To 2 Tablespoons, Once A Day)
    • Excedrin Extra Strength (1 To 2 Df, Unk)
    • Excedrin Extra Strength
    and developed a serious reaction and side effect(s). The consumer presented with:
    • Secretion Discharge
    • Malaise
    • Cough
    • Increased Upper Airway Secretion
    • Breath Sounds Abnormal
    • Arthralgia
    • Back Pain
    which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Theraflu Nighttime Severe Cold + Cough treatment in female patients, resulting in secretion discharge side effect.

    Heart Rate Increased, Nasopharyngitis, Nasal Discomfort, Nasal Mucosal Disorder, Nasal Oedema
    This report suggests a potential Theraflu Flu Heart Rate Increased, Nasopharyngitis, Nasal Discomfort, Nasal Mucosal Disorder, Nasal Oedema side effect(s) that can have serious consequences. A 72-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Theraflu Flu (dosage: Unk, Unk) starting NS. Soon after starting Theraflu Flu the patient began experiencing various side effects, including:
    • Heart Rate Increased
    • Nasopharyngitis
    • Nasal Discomfort
    • Nasal Mucosal Disorder
    • Nasal Oedema
    Drugs used concurrently:
    • Questran (20 Mg, Unk)
    • Elderberry (1 Df, As Needed)
    The patient was hospitalized. Although Theraflu Flu demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as heart rate increased, may still occur.

    Hypoaesthesia, Dysarthria, Fall, Salivary Hypersecretion, Vertigo, Bladder Cancer, Blood Urine Present, Viral Infection, Sinus Congestion
    This Hypoaesthesia, Dysarthria, Fall, Salivary Hypersecretion, Vertigo, Bladder Cancer, Blood Urine Present, Viral Infection, Sinus Congestion problem was reported by a consumer or non-health professional from US. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: sinus disorder,influenza. On 201212 this consumer started treatment with Theraflu Sinus + Cold (dosage: 1 Pack Per Day). The following drugs were being taken at the same time: NA. When commencing Theraflu Sinus + Cold, the patient experienced the following unwanted symptoms/side effects:
    • Hypoaesthesia
    • Dysarthria
    • Fall
    • Salivary Hypersecretion
    • Vertigo
    • Bladder Cancer
    • Blood Urine Present
    • Viral Infection
    • Sinus Congestion
    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 hypoaesthesia, may become evident only after a product is in use by the general population.

    Diabetes Mellitus
    This is a report of a 54-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: nasopharyngitis,coronary artery disease,blood cholesterol increased and was treated with Theraflu Nighttime Severe Cold (dosage: 1 Packet As Needed) starting 1997. Concurrently used drugs:
    • Isosorbide
    • Crestor
    • Plavix
    • Aspirin (325 Mg, Unk)
    • Metoprolol Tartrate (50 Mg, Unk)
    • Losartan
    • Calcium
    • Vitamin D3 (1000 Iu, Unk)
    Soon after that, the consumer experienced the following side effects:
    • Diabetes Mellitus
    This opens a possibility that Theraflu Nighttime Severe Cold treatment could cause the above reactions, including diabetes mellitus, and some male subjects may be more susceptible.

    Ear Infection, Sinusitis, Nasopharyngitis
    A 54-year-old female patient (weight: NA) from US with the following symptoms/conditions: nasopharyngitis started Theraflu Nighttime Severe Cold And Cough treatment (dosage: Unk, Unk) on NS. Soon after starting Theraflu Nighttime Severe Cold And Cough treatment, the subject experienced various side effects, including:
    • Ear Infection
    • Sinusitis
    • Nasopharyngitis
    Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Theraflu Nighttime Severe Cold And Cough.

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    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.


    Discuss Theraflu Side Effects

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    Theraflu Safety Alerts, Active Ingredients, Usage Information

    NDC0043-0460
    TypeHUMAN OTC DRUG
    Proprietary NameTheraflu Warming Relief Nighttime Severe Cold And Cough
    NameAcetaminophen, Diphenhydramine HCl, Phenylepherine HCl
    Dosage FormSYRUP
    RouteORAL
    On market since20070504
    LabelerNovartis Consumer Health
    Active Ingredient(s)ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
    Strength(s)325; 12.5; 5
    Unit(s)mg/15mL; mg/15mL; mg/15mL
    Pharma Class

    More About Theraflu

    Side Effects reported to FDA: 186

    Theraflu safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 4

    Latest Theraflu clinical trials