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Index of reports
> Cases with Product Quality Issue (15)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Imitrex (Sumatriptan) where reactions include product quality issue. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Imitrex side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: female
Reactions: Product Quality Issue, Tinnitus, Injection Site Haemorrhage, Drug Ineffective, Injection Site Haematoma, Headache, Feeling Abnormal, Needle Issue
Drug(s) suspected as cause:
Imitrex
Indication: Migraine
Imitrex
Dosage: 6mg as required
Start date: 1993-01-01
Imitrex
Administration route: Oral
Indication: Migraine
Other drugs received by patient: Tenormin
Possible Imitrex 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 Imitrex side effects in 56 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-29
Patient: 56 year old male
Reactions: Product Quality Issue, Drug Ineffective, Injection Site Pain
Drug(s) suspected as cause:
Imitrex
Indication: Migraine
GSK Autoinjector
Indication: Migraine
Sumatriptan
Indication: Migraine
Possible Imitrex side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient: female
Reactions: Product Quality Issue, Injection Site Haematoma, Injection Site Pain, Injection Site Swelling
Drug(s) suspected as cause:
Imitrex
Dosage: .5ml unknown
Indication: Migraine
Sumatriptan Succinate
Possible Imitrex side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient: female
Reactions: Product Quality Issue, Drug Effect Decreased
Drug(s) suspected as cause:
Imitrex
Possible Imitrex side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient: female
Reactions: Product Quality Issue, Device Failure, Drug Ineffective, Injection Site Pain
Drug(s) suspected as cause:
Imitrex
Dosage: 1inj as required
Indication: Migraine
GSK Autoinjector
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Synthroid; Unspecified Medication; Unspecified Medication; Altace; Nexium; Vitamin TAB; Metoclopramide; Insulin; Clonopin; Crestor; Cytotec; Effexor; Reglan; Boniva; Imitrex; Zofran
Possible Imitrex side effects in
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient:
Reactions: Product Quality Issue, Injection Site Haematoma, Drug Ineffective, Expired Drug Administered, Injection Site Pain
Drug(s) suspected as cause:
Imitrex
Possible Imitrex side effects in 52 year old female
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient: 52 year old female
Reactions: Migraine, Product Quality Issue, Fatigue, Drug Ineffective, Nausea, Paraesthesia
Drug(s) suspected as cause:
Imitrex
Administration route: Oral
Indication: Migraine
Sumatriptan Succinate
Dosage: 6mg as required
Indication: Migraine
Start date: 2001-01-01
Other drugs received by patient: Aspirin; Estrace; Vitamin D; Vitamin B-12; B2
Possible Imitrex side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient: female
Reactions: Product Quality Issue, Drug Ineffective
Drug(s) suspected as cause:
GSK Autoinjector
Indication: Product Used FOR Unknown Indication
Imitrex
Dosage: 12mg unknown
Indication: Product Used FOR Unknown Indication
Start date: 2011-05-09
Possible Imitrex side effects in 47 year old female
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient: 47 year old female
Reactions: Product Quality Issue, Drug Ineffective
Drug(s) suspected as cause:
Imitrex
Other drugs received by patient: Lithium; Seroquel
Possible Imitrex side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient: female
Reactions: Product Quality Issue, Therapeutic Response Decreased, Headache
Drug(s) suspected as cause:
GSK Autoinjector
Indication: Migraine
Imitrex
Administration route: Oral
Imitrex
Indication: Migraine
Imitrex
Possible Imitrex side effects in 63 year old female
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient: 63 year old female
Reactions: Product Quality Issue, Drug Ineffective, Injection Site Pain
Drug(s) suspected as cause:
Imitrex
Dosage: 12mg as required
Indication: Migraine
Start date: 1992-01-01
Sumatriptan Succinate
Indication: Migraine
Other drugs received by patient: NO Concurrent Medication
Possible Imitrex side effects in 36 year old female
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient: 36 year old female
Reactions: Product Quality Issue, Drug Ineffective
Drug(s) suspected as cause:
Imitrex
Possible Imitrex side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient: female
Reactions: Product Quality Issue, Drug Dispensing Error
Drug(s) suspected as cause:
Imitrex
Dosage: 6mg as directed
Indication: Product Used FOR Unknown Indication
GSK Autoinjector
Possible Imitrex side effects in 65 year old female
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient: 65 year old female
Reactions: Product Quality Issue, Injection Site Swelling
Drug(s) suspected as cause:
Imitrex
Other drugs received by patient: Anti-Cholesterol Medication; Beta Blocker; Antidepressant; Muscle Relaxant
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