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Treximet (Sumatriptan / Naproxen) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Treximet (Sumatriptan / Naproxen) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (53)
Disability (2)

Reports by Reaction Type

Drug Ineffective (8)Product Quality Issue (7)Migraine (6)Anxiety (6)Feeling Abnormal (6)Dizziness (4)Chest Discomfort (4)Nausea (4)Sensation of Heaviness (4)Asthma (3)Nonspecific Reaction (3)Malaise (3)

Below are a few examples of reports where side effects / adverse reactions may be related to Treximet (Sumatriptan / Naproxen). For a complete list or a specific selection of reports, please use the links above.

Possible Treximet side effects in

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient:

Reactions: Anxiety, Flushing, Drug Ineffective, Incorrect Dose Administered, Feeling Abnormal

Drug(s) suspected as cause:
Relpax
    Dosage: 20 mg, unk

Treximet
    Dosage: unk



Possible Treximet side effects in female

Reported by a physician from United States on 2012-08-03

Patient: female, weighing 100.0 kg (220.0 pounds)

Reactions: Chest Discomfort, Pain in Extremity, Drug Ineffective, Musculoskeletal Pain, Sensation of Heaviness, Feeling Abnormal

Drug(s) suspected as cause:
Relpax
    Dosage: 40 mg, daily
    Indication: Migraine
    Start date: 2012-05-24
    End date: 2012-05-24

Treximet
    Dosage: unk

Maxalt
    Dosage: unk

Other drugs received by patient: Klonopin; Seroquel



Possible Treximet side effects in female

Reported by a physician from United States on 2012-08-03

Patient: female, weighing 100.0 kg (220.0 pounds)

Reactions: Migraine, Chest Discomfort, Pain in Extremity, Sensation of Heaviness, Musculoskeletal Pain, Feeling Abnormal

Drug(s) suspected as cause:
Maxalt
    Dosage: unk

Relpax
    Dosage: 40 mg, daily
    Indication: Migraine
    Start date: 2012-05-24
    End date: 2012-05-24

Treximet
    Dosage: unk

Relpax
    Dosage: 40 mg, daily
    Start date: 2012-05-31
    End date: 2012-06-01

Other drugs received by patient: Klonopin; Seroquel



Possible Treximet side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 69 year old female

Reactions: Performance Status Decreased, Movement Disorder, Product Quality Issue, Pain in Extremity, Nausea, Swollen Tongue, Somnolence, Paraesthesia, Fatigue, Palpitations, Oedema Peripheral, Feeling Drunk, Asthenia, Influenza Like Illness

Drug(s) suspected as cause:
Imitrex
    Administration route: Oral
    Indication: Migraine

Treximet
    Administration route: Oral
    Indication: Migraine

Imitrex

Other drugs received by patient: Pravastatin; Protonix; Synthroid; Tricor; Aspirin



Possible Treximet side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient:

Reactions: Gastrointestinal Haemorrhage

Drug(s) suspected as cause:
Treximet



Possible Treximet side effects in 50 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-02

Patient: 50 year old female, weighing 95.0 kg (209.0 pounds)

Reactions: Nephrolithiasis, Pyrexia, Hypertension, Kidney Infection

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: Iron; Omeprazole; Unspecified Medication; Lisinopril and Hydrochlorothiazide; Ativan; Cranberry Fruit; ST. Johns Wort; Butalbital; Vitamin TAB; Vitamin B-12; Multi-Vitamins



Possible Treximet side effects in 17 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 17 year old female

Reactions: Wrong Technique in Drug Usage Process, Nausea

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: Multi-Vitamin; Prozac



Possible Treximet side effects in 42 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 42 year old female

Reactions: Oesophageal Pain

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: Nexium; Synthroid



Possible Treximet side effects in 37 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 37 year old female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: Nasonex



Possible Treximet side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: female

Reactions: Drug Effect Decreased

Drug(s) suspected as cause:
Treximet
    Indication: Product Used FOR Unknown Indication

Sumatriptan
    Indication: Product Used FOR Unknown Indication



Possible Treximet side effects in 47 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 47 year old female

Reactions: Drug Ineffective, Heart Rate Increased, Expired Drug Administered

Drug(s) suspected as cause:
Ibuprofen
    Administration route: Oral
    Indication: Headache
    Start date: 2011-01-01

Treximet
    Administration route: Oral
    Indication: Migraine
    Start date: 2011-01-01
    End date: 2012-03-24

Other drugs received by patient: Ibuprofen



Possible Treximet side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-13

Patient: 47 year old female, weighing 79.5 kg (174.9 pounds)

Reactions: Eyelid Oedema, Skin Discolouration

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: NO Concurrent Medication



Possible Treximet side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: male

Reactions: Weight Decreased, Vomiting, Malaise, Diarrhoea

Drug(s) suspected as cause:
Treximet



Possible Treximet side effects in

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient:

Reactions: Malaise, Drug Ineffective

Drug(s) suspected as cause:
Treximet



Possible Treximet side effects in 68 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 68 year old female

Reactions: Dysarthria, Drug Screen Positive, Hypersomnia

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: Methadone HCL



Possible Treximet side effects in 29 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-13

Patient: 29 year old female

Reactions: Dyspnoea, Chest Discomfort, Malaise, Paraesthesia

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: Fluoxetine



Possible Treximet side effects in 37 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 37 year old female

Reactions: Product Quality Issue, Drug Ineffective, Temperature Intolerance

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: Topamax; Ranitidine; Savella



Possible Treximet side effects in female

Reported by a physician from United States on 2012-06-13

Patient: female

Reactions: Overdose

Drug(s) suspected as cause:
Treximet



Possible Treximet side effects in 22 year old male

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 22 year old male

Reactions: Drug Screen Positive

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: Methadone HCL



Possible Treximet side effects in 33 year old male

Reported by a lawyer from United States on 2012-06-13

Patient: 33 year old male

Reactions: Drug Screen False Positive

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: Zyban; Depakote; Zofran



Possible Treximet side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: female

Reactions: Product Quality Issue, Muscular Weakness, Somnolence

Drug(s) suspected as cause:
Treximet



Possible Treximet side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 55 year old female

Reactions: Chest Discomfort, Fatigue, Sensation of Heaviness, Feeling Abnormal, Asthenia, Eructation

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: Medrol; Acetaminophen



Possible Treximet side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 54 year old female

Reactions: Product Quality Issue, Blood Pressure Increased, Anxiety, Dizziness, Condition Aggravated, Feeling Abnormal

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: Potassium CL; Lorazepam; Pancrease Mt16; Imitrex; Synthroid; Phillips Gel Caps; Nodoz; Pepcid AC



Possible Treximet side effects in 41 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 41 year old female

Reactions: Abdominal Discomfort

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: Vitamin TAB



Possible Treximet side effects in 32 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 32 year old female

Reactions: Sensation of Heaviness, Dizziness

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: Amoxicillin



Possible Treximet side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: male

Reactions: Wrong Technique in Drug Usage Process

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: NO Concurrent Medication



Possible Treximet side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: female

Reactions: Feeling Cold

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: Omeprazole; Klonopin; Albuterol; Vicodin; Estradiol; Avonex; Dextromethorphan Hydrobromide; Namenda; Zyprexa; Levothyroxine Sodium; Paroxetine



Possible Treximet side effects in 27 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 27 year old female

Reactions: Dizziness

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: NO Concurrent Medication



Possible Treximet side effects in 43 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 43 year old female

Reactions: Fatigue, Dissociation, Hangover

Drug(s) suspected as cause:
Treximet

Other drugs received by patient: NO Concurrent Medication



Possible Treximet side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: female

Reactions: Anxiety, Vomiting, Tremor

Drug(s) suspected as cause:
Treximet

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