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Primatene Side Effects

Common Primatene Side Effects


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

Dyspnoea (15)
Chest Pain (14)
Asthma (12)
Dizziness (9)
Heart Rate Increased (7)
Lung Disorder (6)
Anxiety (6)
Headache (6)
Nervousness (5)
Vomiting (5)
Nausea (5)
Condition Aggravated (5)
Feeling Abnormal (4)
Blood Pressure Increased (4)
Malaise (4)
Overdose (4)
Throat Irritation (4)
Pharyngolaryngeal Pain (4)
Respiratory Tract Irritation (3)
Treatment Noncompliance (3)

➢ 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.

Primatene Side Effects Reported to FDA

The following Primatene 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 Primatene 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.
Blood Pressure Increased
This is a report of a 54-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: dyspnoea,hypertension, who was treated with Primatene (dosage: 25/400mg,every 4-6 Hours, start time: Feb 02, 2013), combined with:
  • Ramipril (Unk,1x/day)
  • Metoprolol Tartrate (Unk,2x/day)
  • Plavix (Unk,1x/day)
  • Pravastatin (Unk,1x/day)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Blood Pressure Increased
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Primatene treatment in male patients, resulting in apparent death side effect.

Nervousness, Feeling Abnormal, Dizziness, Pre-existing Condition Improved, Therapeutic Response Unexpected, Cellulitis, Osteomyelitis, Oedema, Fluid Retention
This report suggests a potential Primatene Nervousness, Feeling Abnormal, Dizziness, Pre-existing Condition Improved, Therapeutic Response Unexpected, Cellulitis, Osteomyelitis, Oedema, Fluid Retention side effect(s) that can have serious consequences. A 43-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: asthma and used Primatene (dosage: 1-2 Tablets Four Times A Day) starting 1975. Soon after starting Primatene the patient began experiencing various side effects, including:
  • Nervousness
  • Feeling Abnormal
  • Dizziness
  • Pre-existing Condition Improved
  • Therapeutic Response Unexpected
  • Cellulitis
  • Osteomyelitis
  • Oedema
  • Fluid Retention
Drugs used concurrently: NA.The patient was hospitalized. Although Primatene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as nervousness, may still occur.

Asthma, Dyspnoea, Lung Disorder
This Asthma, Dyspnoea, Lung Disorder problem was reported by a consumer or non-health professional from US. A 50-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: asthma. On 2011 this consumer started treatment with Primatene (dosage: Unk). The following drugs were being taken at the same time:
  • Albuterol (Unk,two Puffs)
When commencing Primatene, the patient experienced the following unwanted symptoms/side effects:
  • Asthma
  • Dyspnoea
  • Lung Disorder
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 asthma, may become evident only after a product is in use by the general population.

Asthma
This is a report of a female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: asthma and was treated with Primatene Mist (dosage: 25/400 Mg (two 12.5mg/200mg), 6x/day) starting Apr 28, 2012. Concurrently used drugs:
  • Insulin (Unk)
Soon after that, the consumer experienced the following side effects:
  • Asthma
This opens a possibility that Primatene Mist treatment could cause the above reactions, including asthma, and some female subjects may be more susceptible.


Asthma
A female patient (weight: NA) from UNITED STATES with the following symptoms/conditions: asthma started Primatene Mist treatment (dosage: 25/400 Mg (two 12.5mg/200mg), 6x/day) on Apr 28, 2012. Soon after starting Primatene Mist treatment, the subject experienced various side effects, including:
  • Asthma
Concurrently used drugs:
  • Insulin (Unk)
This finding indicates that some female patients could be more vulnerable to Primatene Mist.

Sinusitis, Chronic Obstructive Pulmonary Disease, Pharyngeal Disorder, Malaise
A 51-year-old male patient from UNITED STATES (weight: NA) experienced symptoms, such as: NA and was treated with Primatene Mist(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Sinusitis
  • Chronic Obstructive Pulmonary Disease
  • Pharyngeal Disorder
  • Malaise
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Primatene Mist efficacy:
  • Symbicort (160/4.5 Mcg 2 Puffs Twice A Day)


Chest Pain, Pulmonary Embolism, Dyspnoea, Injury, Deep Vein Thrombosis, Anxiety, Traumatic Lung Injury
In this report, Primatene Mist was administered for the following condition: NA.A 18-year-old female consumer from UNITED STATES (weight: NA) started Primatene Mist treatment (dosage: Unk) on Mar 22, 2008.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Chest Pain
  • Pulmonary Embolism
  • Dyspnoea
  • Injury
  • Deep Vein Thrombosis
  • Anxiety
  • Traumatic Lung Injury
A possible interaction with other drugs could have contributed to this reaction:
  • Yaz (Unk)
  • Yaz
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 Primatene Mist treatment could be related to the listed above side effect(s).

Heart Rate Increased, Chest Pain, Dizziness, Cerebral Thrombosis, Dyspnoea
This is a report of the following Primatene Mist side effect(s):
  • Heart Rate Increased
  • Chest Pain
  • Dizziness
  • Cerebral Thrombosis
  • Dyspnoea
A 70-year-old male patient from UNITED STATES (weight: NA) presented with the following condition: asthma and received a treatment with Primatene Mist (dosage: 2 Puffs/day, Inhalation) starting: NS.The following concurrently used drugs could have generated interactions: NA.The patient was hospitalized.This report suggests that a Primatene Mist treatment could be associated with the listed above side effect(s).

Anxiety, Pulmonary Embolism, Chest Pain, Fear Of Disease, Gallbladder Disorder, Dyspnoea, Emotional Distress
This Primatene Mist report was submitted by a 18-year-old female consumer from UNITED STATES (weight: NA). The patient was diagnosed with: NA and Primatene Mist was administered (dosage: Unk) starting: Mar 22, 2008. The consumer developed a set of symptoms:
  • Anxiety
  • Pulmonary Embolism
  • Chest Pain
  • Fear Of Disease
  • Gallbladder Disorder
  • Dyspnoea
  • Emotional Distress
Other drugs used simultaneously:
  • Yaz (Unk)
  • Yaz
The patient was hospitalized.Those unexpected symptoms could be linked to a Primatene Mist treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Dyspnoea, Wheezing
This is a report of a possible correlation between Primatene Mist use and the following symptoms/side effect(s):
  • Dyspnoea
  • Wheezing
which could contribute to an assessment of Primatene Mist risk profile.A male consumer from UNITED STATES (weight: NA) was suffering from asthma,wheezing and was treated with Primatene Mist (dosage: NA) starting Jan 01, 2012.Other concurrent medications: NA.

Dyspnoea, No Therapeutic Response, Atrial Fibrillation, Tachycardia, Pneumonia Primary Atypical, Asthma
A 57-year-old male patient from UNITED STATES (weight: NA) presented with the following symptoms: asthma and after a treatment with Primatene Mist (dosage: 0.22 Mg) experienced the following side effect(s):
  • Dyspnoea
  • No Therapeutic Response
  • Atrial Fibrillation
  • Tachycardia
  • Pneumonia Primary Atypical
  • Asthma
The treatment was started on Nov 19, 2011. Primatene Mist was used in combination with the following drugs: NA.The patient was hospitalized.This report could alert potential Primatene Mist consumers.

Dyspnoea, Product Quality Issue
In this report, a 50-year-old male patient from UNITED STATES (weight: NA) was affected by a possible Primatene Mist side effect.The patient was diagnosed with NA. After a treatment with Primatene Mist (dosage: NA, start date: Jan 01, 2010), the patient experienced the following side effect(s):
  • Dyspnoea
  • Product Quality Issue
The following simultaneously used drugs could have led to this reaction:
  • Nebulizer Treatment
  • Advair Diskus 100/50 (1puff Twice Per Day)
The findings here stress that side effects should be taken into consideration when evaluating a Primatene Mist treatment.

Feeling Abnormal, Product Quality Issue, Dyspnoea
This is a report of a 51-year-old male patient from UNITED STATES (weight: NA), who used Primatene Mist (dosage: NA) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Feeling Abnormal
  • Product Quality Issue
  • Dyspnoea
The following drugs could possibly have interacted with the Primatene Mist treatment
  • Lisinopril
  • Advair Diskus 100/50 (1puff Per Day)
  • Effexor
Taken together, these observations suggest that a Primatene Mist treatment could be related to side effect(s), such as Feeling Abnormal, Product Quality Issue, Dyspnoea.

Dyspnoea, Oxygen Saturation Decreased
This dyspnoea side effect was reported by a consumer or non-health professional from UNITED STATES. A male patient (weight:NA) experienced the following symptoms/conditions: dyspnoea. The patient was prescribed Primatene Mist (dosage: Inhale Use Then In One Min. Then In 3 Hrs Nasal), which was started on Jul 25, 2011. Concurrently used drugs: NA. When starting to take Primatene Mist the consumer reported the following symptoms:
  • Dyspnoea
  • Oxygen Saturation Decreased
The patient was hospitalized. These side effects may potentially be related to Primatene Mist.

Dyspnoea
This is a Primatene Mist side effect report of a 47-year-old male patient (weight:NA) from UNITED STATES, suffering from the following symptoms/conditions: NA, who was treated with Primatene Mist (dosage:As Required, start time: NS), combined with:
  • Symbicort (160/4.5 Mcg,two Puffs Two Times A Day)
, and developed a serious reaction and a dyspnoea side effect. The patient presented with:
  • Dyspnoea
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Primatene Mist treatment in male patients suffering from NA, resulting in dyspnoea.

Dyspnoea, Condition Aggravated, Oxygen Saturation Decreased
This report suggests a potential Primatene Mist dyspnoea side effect(s) that can have serious consequences. A 81-year-old male patient from UNITED STATES (weight:NA) was diagnosed with the following health condition(s): NA and used Primatene Mist (dosage: NA) starting Jul 24, 2011. Soon after starting Primatene Mist the patient began experiencing various side effects, including:
  • Dyspnoea
  • Condition Aggravated
  • Oxygen Saturation Decreased
Drugs used concurrently:NA. The patient was hospitalized. Although Primatene Mist demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as dyspnoea, may still occur.

Asthma, Condition Aggravated, Nausea, Rhinitis Allergic, Vomiting
This asthma problem was reported by a consumer or non-health professional from UNITED STATES. A 41-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): asthma.On May 17, 2010 a consumer started treatment with Primatene Mist (dosage: NA). The following drugs/medications were being taken at the same time: NA. When commencing Primatene Mist, the patient experienced the following unwanted symptoms /side effects:
  • Asthma
  • Condition Aggravated
  • Nausea
  • Rhinitis Allergic
  • Vomiting
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as asthma, may become evident only after a product is in use by the general population.

Asthma, Condition Aggravated, Nausea, Pyrexia, Restlessness, Rhinitis Allergic, Sputum Discoloured, Vomiting
This is a Primatene Mist side effect report of a 41-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: asthma and was treated with Primatene Mist (dosage: Previous User) starting May 17, 2010. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Asthma
  • Condition Aggravated
  • Nausea
  • Pyrexia
  • Restlessness
  • Rhinitis Allergic
  • Sputum Discoloured
  • Vomiting
This opens a possibility that Primatene Mist could cause asthma and that some female patients may be more susceptible.

Asthma, Economic Problem, Treatment Noncompliance
A 61-year-old male patient (weight: NA) from UNITED STATES with the following symptoms: eagle barrett syndrome started Primatene Mist treatment (dosage: Oral) on NS. Soon after starting Primatene Mist treatment, the consumer experienced several side effects, including:
  • Asthma
  • Economic Problem
  • Treatment Noncompliance
. Concurrently used drugs:
  • Albuterol -the Old One- (Oral)
This finding indicates that some patients can be more vulnerable to developing Primatene Mist side effects, such as asthma.

Cerebrovascular Accident
This cerebrovascular accident side effect was reported by a consumer or non-health professional from UNITED STATES. A 37-year-old male patient (weight:NA) experienced the following symptoms/conditions: asthma.The patient was prescribed Primatene Mist (dosage: NA), which was started on Jul 01, 2008. Concurrently used drugs: NA..When starting to take Primatene Mist the consumer reported symptoms, such as:
  • Cerebrovascular Accident
These side effects may potentially be related to Primatene Mist.

Asthma
This is a report of a 40-year-old female patient (weight: NA) from UNITED STATES, suffering from the following symptoms/conditions: dyspnoea, who was treated with Primatene Mist (dosage: 1 Inhalation X 1, Inhalation, start time: Nov 11, 2007), combined with:
  • Albuterol
  • Oral Contraceptive Nos (oral Contraceptive Nos)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Asthma
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Primatene Mist treatment in female patients, resulting in asthma side effect.

Glossodynia, Headache, Nasal Discomfort
This report suggests a potential Primatene Mist Glossodynia, Headache, Nasal Discomfort side effect(s) that can have serious consequences. A 64-year-old female patient (weight: NA) from UNITED STATES was diagnosed with the following symptoms/conditions: asthma and used Primatene Mist (dosage: ^1 Inhalation X 1^, Inhalation) starting Jan 01, 2008. Soon after starting Primatene Mist the patient began experiencing various side effects, including:
  • Glossodynia
  • Headache
  • Nasal Discomfort
Drugs used concurrently:
  • Thyroid Tab
Although Primatene Mist demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as glossodynia, may still occur.

Diarrhoea
This Diarrhoea problem was reported by a consumer or non-health professional from UNITED STATES. A 50-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chest discomfort. On Feb 05, 2008 this consumer started treatment with Primatene Mist (dosage: ^ 1 Puff 2 Times In One Day^, Inhalation). The following drugs were being taken at the same time:
  • Mucinex
When commencing Primatene Mist, the patient experienced the following unwanted symptoms/side effects:
  • Diarrhoea
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as diarrhoea, may become evident only after a product is in use by the general population.

Glossodynia
This is a report of a 66-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: asthma and was treated with Primatene Mist (dosage: One Inhalation, One Time, Inhalation) starting Feb 18, 2008. Concurrently used drugs:
  • Lisinopril
  • Singulair
Soon after that, the consumer experienced the following side effects:
  • Glossodynia
This opens a possibility that Primatene Mist treatment could cause the above reactions, including glossodynia, and some female subjects may be more susceptible.

No Therapeutic Response
A 22-year-old female patient (weight: NA) from UNITED STATES with the following symptoms/conditions: asthma started Primatene Mist treatment (dosage: 2 Acutations As Needed) on NS. Soon after starting Primatene Mist treatment, the subject experienced various side effects, including:
  • No Therapeutic Response
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Primatene Mist.

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Top 10 Primatene Side Effects for Women

Women Side EffectsReports
Asthma 7
Chest Pain 6
Vomiting 5
Heart Rate Increased 4
Nausea 4
Anxiety 3
Blood Pressure Increased 3
Condition Aggravated 3
Dizziness 3
Dyspnoea 3

Top 10 Primatene Side Effects for Men

Men Side EffectsReports
Dyspnoea 12
Chest Pain 8
Dizziness 6
Lung Disorder 5
Asthma 4
Heart Rate Increased 3
Overdose 3
Anxiety 2
Cerebrovascular Accident 2
Cough 2

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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    Primatene Safety Alerts, Active Ingredients, Usage Information

    NDC0573-2952
    TypeHUMAN OTC DRUG
    Proprietary NamePRIMATENE ephedrine hcl, guaifenesin
    NameTABLET
    Dosage FormORAL
    Route20040106
    On market sincePfizer Consumer Healthcare
    LabelerEPHEDRINE HYDROCHLORIDE; GUAIFENESIN
    Active Ingredient(s)12.5; 200
    Strength(s)mg/1; mg/1
    Unit(s)
    Pharma Class

    More About Primatene

    Side Effects reported to FDA: 110

    Primatene safety alerts: No

    Reported deaths: 5

    Reported hospitalizations: 19

    Latest Primatene clinical trials