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Theraflu Side Effects

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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.

Theraflu Side Effects Reported to FDA



Theraflu Side Effect Report#9993373
Bronchitis
This is a report of a 49-year-old female patient (weight: NA) from US, suffering from the following health 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): Bronchitis 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.
Theraflu Side Effect Report#9886637
Rocky Mountain Spotted Fever, Anaemia, Dehydration, Therapeutic Response Unexpected
This report suggests a potential Theraflu Flu And Sore Throat Rocky Mountain Spotted Fever 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. After starting Theraflu Flu And Sore Throat the patient began experiencing various side effects, including: Rocky Mountain Spotted Fever, Anaemia, Dehydration, Therapeutic Response UnexpectedAdditional 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.
Theraflu Side Effect Report#9886636
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 using Theraflu Flu And Sore Throat, the patient experienced the following unwanted symptoms/side effects: FibromyalgiaAlthough 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.
Theraflu Side Effect Report#9871064
Pneumonia, Ageusia, Anosmia, Therapeutic Response Unexpected
This Pneumonia 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: influenza,off label use.The patient was prescribed Theraflu Warming Relief Nighttime Multi-symptom Cold (drug dosage: 2 Df,3 Separate Doses), which was initiated on 201312. Concurrently used drugs: NA..After starting to take Theraflu Warming Relief Nighttime Multi-symptom Cold the consumer reported adverse symptoms, such as: Pneumonia, Ageusia, Anosmia, Therapeutic Response UnexpectedThese side effects may potentially be related to Theraflu Warming Relief Nighttime Multi-symptom Cold.
Theraflu Side Effect Report#9758414
Coeliac Disease
This is a report of a 46-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Theraflu Nighttime Severe Cold + Cough (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Coeliac Disease 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 Coeliac Disease side effect.
Theraflu Side Effect Report#9730006
Laryngeal Obstruction, Dysphagia
This report suggests a potential Theraflu Extragrip Laryngeal Obstruction side effect(s) that can have serious consequences. A 18-year-old female patient (weight: NA) from PL was diagnosed with the following symptoms/conditions: NA and used Theraflu Extragrip (dosage: Unk) starting NS. After starting Theraflu Extragrip the patient began experiencing various side effects, including: Laryngeal Obstruction, DysphagiaAdditional drugs used concurrently: NA. Although Theraflu Extragrip demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Laryngeal Obstruction, may still occur.
Theraflu Side Effect Report#9643809
Pharyngeal Oedema, Dysphagia, Dyspnoea, Insomnia, Epistaxis, Feeling Abnormal, Chest Pain, Choking Sensation
This Pharyngeal Oedema problem was reported by a consumer or non-health professional from US. A 18-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: cough,oropharyngeal pain,pyrexia. On
Oct 15, 2013 this consumer started treatment with Theraflu Nighttime Severe Cold Warming Syrup (dosage: Unk, Unk). The following drugs were being taken at the same time: NA. When using Theraflu Nighttime Severe Cold Warming Syrup, the patient experienced the following unwanted symptoms/side effects: Pharyngeal Oedema, Dysphagia, Dyspnoea, Insomnia, Epistaxis, Feeling Abnormal, Chest Pain, Choking SensationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pharyngeal Oedema, may become evident only after a product is in use by the general population.
Theraflu Side Effect Report#9597068
Breast Cancer, Thyroid Cancer, Skin Cancer, Therapeutic Response Unexpected
This Breast Cancer side effect was reported by a consumer or non-health professional from US. A 69-year-old male patient (weight:NA) experienced the following symptoms/conditions: bronchitis,off label use.The patient was prescribed Theraflu Nighttime Severe Cold + Cough (drug dosage: Unk, Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Theraflu Nighttime Severe Cold + Cough the consumer reported adverse symptoms, such as: Breast Cancer, Thyroid Cancer, Skin Cancer, Therapeutic Response UnexpectedThese side effects may potentially be related to Theraflu Nighttime Severe Cold + Cough.
Theraflu Side Effect Report#9322516
Pneumonia, Pharyngitis Streptococcal, Increased Upper Airway Secretion, Cough, Therapeutic Response Unexpected, Off Label Use
This is a report of a 58-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: bronchitis,nasopharyngitis, who was treated with Theraflu Daytime Severe Cold + Cough (dosage: Unk, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Pneumonia, Pharyngitis Streptococcal, Increased Upper Airway Secretion, Cough, Therapeutic Response Unexpected, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Theraflu Daytime Severe Cold + Cough treatment in male patients, resulting in Pneumonia side effect.
Theraflu Side Effect Report#9261786
Dysuria
This report suggests a potential Theraflu Extragrip Dysuria side effect(s) that can have serious consequences. A male patient (weight: NA) from PL was diagnosed with the following symptoms/conditions: upper respiratory tract inflammation and used Theraflu Extragrip (dosage: 1 Df, Tid) starting
Oct 18, 2012. After starting Theraflu Extragrip the patient began experiencing various side effects, including: DysuriaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Theraflu Extragrip demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dysuria, may still occur.
Theraflu Side Effect Report#9239366
Breast Cancer
This Breast Cancer problem was reported by a consumer or non-health professional from US. A 70-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: lymphadenopathy,influenza,migraine,hypertension. On NS this consumer started treatment with Theraflu Cold And Cough (dosage: 1 Df, Q6h Prn). The following drugs were being taken at the same time: NA. When using Theraflu Cold And Cough, the patient experienced the following unwanted symptoms/side effects: Breast CancerAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Breast Cancer, may become evident only after a product is in use by the general population.
Theraflu Side Effect Report#9218205
Hepatic Steatosis, Off Label Use, Therapeutic Response Unexpected
This Hepatic Steatosis side effect was reported by a consumer or non-health professional from US. A 79-year-old male patient (weight:NA) experienced the following symptoms/conditions: chest discomfort,nasopharyngitis,throat irritation.The patient was prescribed Theraflu Flu (drug dosage: Unk, 4 To 6 Hours), which was initiated on NS. Concurrently used drugs: NA..After starting to take Theraflu Flu the consumer reported adverse symptoms, such as: Hepatic Steatosis, Off Label Use, Therapeutic Response UnexpectedThese side effects may potentially be related to Theraflu Flu.
Theraflu Side Effect Report#9214853
Bronchitis, Pneumonia, Disease Recurrence, Off Label Use
This is a report of a 32-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: bronchitis,pneumonia, who was treated with Theraflu Flu (dosage: Unk, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Bronchitis, Pneumonia, Disease Recurrence, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Theraflu Flu treatment in female patients, resulting in Bronchitis side effect.
Theraflu Side Effect Report#9193985
Poisoning, Fall, Foaming At Mouth, Loss Of Consciousness, Cardiac Arrest, Brain Oedema
This report suggests a potential Theraflu Forte Poisoning side effect(s) that can have serious consequences. A 28-year-old male patient (weight: NA) from TR was diagnosed with the following symptoms/conditions: influenza and used Theraflu Forte (dosage: 2 Df, Once/single) starting 201112. After starting Theraflu Forte the patient began experiencing various side effects, including: Poisoning, Fall, Foaming At Mouth, Loss Of Consciousness, Cardiac Arrest, Brain OedemaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Theraflu Forte demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Poisoning, may still occur.
Theraflu Side Effect Report#9188829
Off Label Use
This Death problem was reported by a consumer or non-health professional from US. A 74-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: increased viscosity of nasal secretion. On 201210 this consumer started treatment with Theraflu Vapor Patch (dosage: 2 Df, Qd). The following drugs were being taken at the same time: NA. When using Theraflu Vapor Patch, the patient experienced the following unwanted symptoms/side effects: Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Theraflu Side Effect Report#9158495
Neoplasm Malignant
This Neoplasm Malignant side effect was reported by a consumer or non-health professional from US. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: nasopharyngitis.The patient was prescribed Theraflu Daytime (drug dosage: Unk, Once/single), which was initiated on NS. Concurrently used drugs: NA..After starting to take Theraflu Daytime the consumer reported adverse symptoms, such as: Neoplasm MalignantThese side effects may potentially be related to Theraflu Daytime.
Theraflu Side Effect Report#9147869
Hypertension
This is a report of a 40-year-old male patient (weight: NA) from LB, suffering from the following health symptoms/conditions: NA, who was treated with Theraflu Flu + Sore Throat (dosage: 1 Df, Qd, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Hypertension after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Theraflu Flu + Sore Throat treatment in male patients, resulting in Hypertension side effect.
Theraflu Side Effect Report#9141008
This report suggests a potential Theraflu Flu Death side effect(s) that can have serious consequences. A 81-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: nasopharyngitis and used Theraflu Flu (dosage: Unk, Unk) starting NS. After starting Theraflu Flu the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Theraflu Flu demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Theraflu Side Effect Report#9137600
Respiratory Disorder, Parosmia, Pain, Off Label Use
This Respiratory Disorder problem was reported by a consumer or non-health professional from US. A 34-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: influenza like illness,muscular weakness. On NS this consumer started treatment with Theraflu Flu And Sore Throat (dosage: 1 Df, Qd). The following drugs were being taken at the same time: NA. When using Theraflu Flu And Sore Throat, the patient experienced the following unwanted symptoms/side effects: Respiratory Disorder, Parosmia, Pain, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Respiratory Disorder, may become evident only after a product is in use by the general population.
Theraflu Side Effect Report#9119342
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 (drug dosage: 1 Df, Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Theraflu Nighttime Severe Cold + Cough the consumer reported adverse symptoms, such as: Bladder Cancer, Off Label UseThese side effects may potentially be related to Theraflu Nighttime Severe Cold + Cough.
Theraflu Side Effect Report#9105227
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 health 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): Secretion Discharge, Malaise, Cough, Increased Upper Airway Secretion, Breath Sounds Abnormal, Arthralgia, Back Pain 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.
Theraflu Side Effect Report#9065374
Heart Rate Increased, Nasopharyngitis, Nasal Discomfort, Nasal Mucosal Disorder, Nasal Oedema
This report suggests a potential Theraflu Flu Heart Rate Increased 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. After starting Theraflu Flu the patient began experiencing various side effects, including: Heart Rate Increased, Nasopharyngitis, Nasal Discomfort, Nasal Mucosal Disorder, Nasal OedemaAdditional 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.
Theraflu Side Effect Report#9003359
Hypoaesthesia, Dysarthria, Fall, Salivary Hypersecretion, Vertigo, Bladder Cancer, Blood Urine Present, Viral Infection, Sinus Congestion
This Hypoaesthesia 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 using 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 CongestionThe 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.
Theraflu Side Effect Report#8960408
Diabetes Mellitus
This Diabetes Mellitus side effect was reported by a consumer or non-health professional from US. A 54-year-old male patient (weight:NA) experienced the following symptoms/conditions: nasopharyngitis,coronary artery disease,blood cholesterol increased.The patient was prescribed Theraflu Nighttime Severe Cold (drug dosage: 1 Packet As Needed), which was initiated on 1997. Concurrently used drugs:
  • Isosorbide
  • Crestor
  • Plavix
  • Aspirin (325 Mg, Unk)
  • Metoprolol Tartrate (50 Mg, Unk)
  • Losartan
  • Calcium
  • Vitamin D3 (1000 Iu, Unk)
.After starting to take Theraflu Nighttime Severe Cold the consumer reported adverse symptoms, such as: Diabetes MellitusThese side effects may potentially be related to Theraflu Nighttime Severe Cold.
Theraflu Side Effect Report#8960400
Ear Infection, Sinusitis, Nasopharyngitis
This is a report of a 54-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: nasopharyngitis, who was treated with Theraflu Nighttime Severe Cold And Cough (dosage: Unk, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Ear Infection, Sinusitis, Nasopharyngitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Theraflu Nighttime Severe Cold And Cough treatment in female patients, resulting in Ear Infection side effect.


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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.

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.

    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.

    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