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Index of reports
> Serious Reactions (42)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Promethazine serious reactions. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 42 Next >>
Possible Promethazine side effects in 57 year old female
Reported by a pharmacist from United States on 2012-08-24
Patient: 57 year old female
Reactions: Pain in Extremity, Muscle Rupture
Drug(s) suspected as cause:
Promethazine
Possible Promethazine side effects in female
Reported by a pharmacist from United States on 2012-08-23
Patient: female
Reactions: Fatigue, Somnolence
Drug(s) suspected as cause:
Temodar
Dosage: 240mg hs for 5 days po
Administration route: Oral
Indication: Malignant Melanoma
Start date: 2012-07-30
End date: 2012-08-21
Promethazine
Dosage: 25mg hs and q6hprn po
Administration route: Oral
Indication: Metastases To Lung
Possible Promethazine side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-21
Patient: male
Reactions: Neonatal Hypoxia, Foetal Exposure During Pregnancy, Toxicity To Various Agents
Adverse event resulted in: death
Drug(s) suspected as cause:
Methadone Hydrochloride
Promethazine
Possible Promethazine side effects in 47 year old female
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: 47 year old female, weighing 70.3 kg (154.7 pounds)
Reactions: Hypoaesthesia Oral, Rash Erythematous, Rash Pruritic
Drug(s) suspected as cause:
Promethazine
Dosage: 25 mg tablet 1 tablet every 8 h po
Administration route: Oral
Indication: Nausea
Start date: 2012-08-09
End date: 2012-08-09
Promethazine
Dosage: 25 mg tablet 1 tablet every 8 h po
Administration route: Oral
Indication: Gastroenteritis
Start date: 2012-08-09
End date: 2012-08-09
Possible Promethazine side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient:
Reactions: Scratch, White Blood Cell Count Decreased, Dyspnoea, Nausea, Drug Ineffective, Drug Hypersensitivity, Hyperhidrosis, Syncope, Middle Insomnia, RED Blood Cell Count Decreased, Injection Site Reaction, Dizziness, Unevaluable Event, Asthenia, Feeling Abnormal
Drug(s) suspected as cause:
Victrelis
Administration route: Oral
Copegus
Administration route: Oral
Promethazine
Peginterferon Alfa-2A
Possible Promethazine side effects in 70 year old female
Reported by a physician from United States on 2012-08-03
Patient: 70 year old female
Reactions: Hypersensitivity, Rash Pruritic
Drug(s) suspected as cause:
Lipitor
Dosage: (20 mg)
Indication: Product Used FOR Unknown Indication
Start date: 2003-05-27
Avandia
Dosage: 8 mg (4 mg, 2 in 1 d)
Indication: Product Used FOR Unknown Indication
Start date: 2002-10-08
Vesicare
Indication: Product Used FOR Unknown Indication
Pred-G
Indication: Product Used FOR Unknown Indication
Metfformin Hydrochloride
Dosage: 1000 mg (500 mg, 2 in 1 d)
Indication: Product Used FOR Unknown Indication
Start date: 2008-07-24
Daypro
Indication: Product Used FOR Unknown Indication
Hydromorphone HCL
Indication: Product Used FOR Unknown Indication
Allegra
Dosage: (60 mg)
Indication: Product Used FOR Unknown Indication
Vicodin
Indication: Product Used FOR Unknown Indication
Celebrex
Indication: Product Used FOR Unknown Indication
Pataday
Dosage: daily, ophthalmic
Indication: Product Used FOR Unknown Indication
Start date: 2010-11-02
Promethazine
Indication: Product Used FOR Unknown Indication
Systane (Rhinaris)
Indication: Product Used FOR Unknown Indication
Amaryl
Dosage: 8 mg (4 mg, 2 in 1 d)
Indication: Product Used FOR Unknown Indication
Start date: 2002-08-03
Promethazine
Dosage: (12.5 mg), oral
Administration route: Oral
Indication: Nausea
Start date: 2012-06-18
Mobic
Dosage: (7.5 mg)
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-18
Moxifloxacin HCL
Indication: Product Used FOR Unknown Indication
Oxycodone HCL
Indication: Product Used FOR Unknown Indication
Possible Promethazine side effects in 43 year old female
Reported by a physician from United States on 2012-07-24
Patient: 43 year old female
Reactions: Unresponsive To Stimuli, Convulsion
Drug(s) suspected as cause:
Promethazine
Dosage: unk
Indication: Product Used FOR Unknown Indication
Ethanol
Dosage: unk
Indication: Product Used FOR Unknown Indication
Heroin
Dosage: unk
Flumazenil
Dosage: unk
Indication: Overdose
Methadone Hydrochloride
Dosage: unk
Indication: Product Used FOR Unknown Indication
Possible Promethazine side effects in 52 year old female
Reported by a individual with unspecified qualification from United States on 2012-07-11
Patient: 52 year old female
Reactions: Weight Decreased, Vomiting, Nausea
Drug(s) suspected as cause:
Promethazine
Dosage: 25mg once daily po about 8 months ago
Administration route: Oral
Indication: Vomiting
Start date: 2012-01-17
End date: 2012-07-09
Prilosec
Dosage: 20mg once daily po about 8 months ago
Administration route: Oral
Indication: Vomiting
Start date: 2012-01-17
End date: 2012-07-09
Possible Promethazine side effects in 49 year old female
Reported by a consumer/non-health professional from United States on 2012-07-09
Patient: 49 year old female, weighing 98.9 kg (217.5 pounds)
Reactions: Grand MAL Convulsion, Drug Hypersensitivity, Sleep Apnoea Syndrome
Drug(s) suspected as cause:
Hydrocortisone 1%-P Cream
Dosage: ;bid;top
Administration route: Topical
Indication: Rash
Start date: 2005-01-01
End date: 2005-01-01
Hydrocortisone 1%-P Cream
Dosage: ;bid;top
Administration route: Topical
Indication: Fungal Infection
Start date: 2005-01-01
End date: 2005-01-01
Promethazine
Dosage: ;po
Administration route: Oral
Other drugs received by patient: Singulair; Thyroid Tablet; Lorazepam; Azithromycin; Seroquel
Possible Promethazine side effects in 80 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-19
Patient: 80 year old male
Reactions: Hypersensitivity, Drug Ineffective, Drug Interaction, Eczema, Constipation, Rash Pruritic, Psychiatric Symptom, Blood Cholesterol Increased, Rash Pustular, Dermatitis Atopic, Rash Papular, Cerebrovascular Accident, Ulcer, Eosinophilia, Mental Impairment, Pustular Psoriasis, Swelling, Insomnia, Infection
Drug(s) suspected as cause:
Lipitor
Indication: Product Used FOR Unknown Indication
Fucibet (Fucicort)
Dosage: 2 in 1 d
Indication: Product Used FOR Unknown Indication
Start date: 2009-12-30
End date: 2010-03-10
Bactroban
Dosage: 3 in 1 d
Indication: Skin Ulcer
Start date: 2010-03-10
End date: 2010-03-17
Omeprazole
Indication: Product Used FOR Unknown Indication
Prochlorperazine Maleate
Dosage: 3 in 1 d
Indication: Vertigo
Start date: 2007-01-01
Betnovate
Dosage: 2 in 1 d
Indication: Pruritus
Start date: 2007-01-01
Promethazine
Dosage: 1 dosage forms, 1 d
Indication: Product Used FOR Unknown Indication
Prochlorperazine
Indication: Vertigo
Possible Promethazine side effects in 49 year old female
Reported by a individual with unspecified qualification from United States on 2012-06-13
Patient: 49 year old female, weighing 98.9 kg (217.5 pounds)
Reactions: Grand MAL Convulsion, Rash Generalised, Drug Hypersensitivity
Drug(s) suspected as cause:
Promethazine
Dosage: po
Administration route: Oral
Hydrocortisone 1%-P Cream
Dosage: bid;top
Administration route: Topical
Indication: Fungal Infection
Start date: 2005-01-01
End date: 2005-01-01
Other drugs received by patient: Seroquel; Lorazepam; Azithromycin; Thyroid Tablet
Possible Promethazine side effects in 78 month old male
Reported by a health professional (non-physician/pharmacist) from China on 2012-05-11
Patient: 78 month old male, weighing 20.0 kg (44.0 pounds)
Reactions: Dyspnoea, Stridor, Heart Rate Increased, Depression, Laryngeal Oedema, Blood Pressure Decreased, Erythema, Oxygen Saturation Decreased
Drug(s) suspected as cause:
Atropine
Promethazine
Propofol
Indication: General Anaesthesia
Atracurium
Possible Promethazine side effects in 39 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-11
Patient: 39 year old female
Reactions: Urinary Tract Infection, Serotonin Syndrome
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Levothyroxine Sodium
Metformin HCL
Promethazine
Prochlorperazine
Amitriptyline HCL
Gabapentin
Pravastatin
Methadone HCL
Indication: Pain
Citalopram
Trimethoprim + Sulfamethoxazole
Indication: Dysuria
Buspirone HCL
Meclizine
Quetiapine Fumarate
Zonisamide
Possible Promethazine side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-10
Patient: female
Reactions: Cleft LIP, Limb Deformity, Cleft Palate, Maternal Drugs Affecting Foetus
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Depo-Provera
Dosage: trpl
Indication: Foetal Exposure During Pregnancy
Amoxicillin
Dosage: trpl
Indication: Foetal Exposure During Pregnancy
Promethazine
Dosage: trpl
Indication: Foetal Exposure During Pregnancy
Nasonex
Dosage: trpl
Indication: Foetal Exposure During Pregnancy
Topamax
Dosage: trpl
Indication: Foetal Exposure During Pregnancy
Tylenol W / Codeine
Dosage: trpl
Indication: Foetal Exposure During Pregnancy
Multi-Vitamins
Dosage: trpl
Indication: Foetal Exposure During Pregnancy
Possible Promethazine side effects in 78 month old male
Reported by a health professional (non-physician/pharmacist) from China on 2012-05-09
Patient: 78 month old male, weighing 20.0 kg (44.0 pounds)
Reactions: Dyspnoea, Stridor, Heart Rate Increased, Depression, Laryngeal Oedema, Blood Pressure Decreased, Erythema, Oxygen Saturation Decreased
Drug(s) suspected as cause:
Atropine
Propofol
Indication: Anaesthesia
Atracurium
Promethazine
Possible Promethazine side effects in female
Reported by a physician from United States on 2012-05-04
Patient: female, weighing 97.5 kg (214.5 pounds)
Reactions: Drug Dose Omission, Asthma, Scab, Orthostatic Hypotension, Headache, Fall, Chest Pain, Dizziness, Migraine, Dyspnoea, Drug Hypersensitivity, Supraventricular Tachycardia, Laceration, Impaired Healing, LOW Density Lipoprotein Increased, Hypertension, Sleep Apnoea Syndrome
Drug(s) suspected as cause:
Aspirin
Indication: Product Used FOR Unknown Indication
Topamax
Indication: Product Used FOR Unknown Indication
Vesicare
Indication: Product Used FOR Unknown Indication
Singulair
Indication: Product Used FOR Unknown Indication
Promethazine
Indication: Product Used FOR Unknown Indication
Methotrexate
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Tizanidine HCL
Indication: Product Used FOR Unknown Indication
Sulfasalazine
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Butalbital
Indication: Product Used FOR Unknown Indication
Remicade
Start date: 2011-01-01
Verapamil
Indication: Product Used FOR Unknown Indication
Neurontin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Folic Acid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Prozac
Indication: Product Used FOR Unknown Indication
Remicade
Indication: Rheumatoid Arthritis
Remicade
Dosage: loading dose
Start date: 2010-01-01
Darvon
Indication: Product Used FOR Unknown Indication
Fiorinal
Indication: Product Used FOR Unknown Indication
Enalapril Maleate
Indication: Product Used FOR Unknown Indication
Xanax
Indication: Product Used FOR Unknown Indication
Requip
Indication: Product Used FOR Unknown Indication
Voltaren
Administration route: Topical
Indication: Product Used FOR Unknown Indication
Lodine
Indication: Product Used FOR Unknown Indication
Soma
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Synthroid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Calcium and VIT D
Indication: Product Used FOR Unknown Indication
Hydrocodone Bitartrate and Ibuprofen
Indication: Product Used FOR Unknown Indication
Phenergan
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Methotrexate
Possible Promethazine side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-27
Patient: female, weighing 97.5 kg (214.5 pounds)
Reactions: Asthma, Migraine, Supraventricular Tachycardia, Laceration, Orthostatic Hypotension, Fall, Sleep Apnoea Syndrome, Hypertension
Drug(s) suspected as cause:
Remicade
Start date: 2011-01-01
Xanax
Indication: Product Used FOR Unknown Indication
Hydrocodone Bitartrate and Ibuprofen
Indication: Product Used FOR Unknown Indication
Remicade
Indication: Rheumatoid Arthritis
Tizanidine HCL
Indication: Product Used FOR Unknown Indication
Singulair
Indication: Product Used FOR Unknown Indication
Promethazine
Indication: Product Used FOR Unknown Indication
Sulfasalazine
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Phenergan
Indication: Product Used FOR Unknown Indication
Calcium and VIT D
Indication: Product Used FOR Unknown Indication
Synthroid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Vesicare
Indication: Product Used FOR Unknown Indication
Fiorinal
Indication: Product Used FOR Unknown Indication
Voltaren
Administration route: Topical
Indication: Product Used FOR Unknown Indication
Methotrexate
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Lodine
Indication: Product Used FOR Unknown Indication
Prozac
Indication: Product Used FOR Unknown Indication
Butalbital
Indication: Product Used FOR Unknown Indication
Remicade
Dosage: loading dose
Start date: 2010-01-01
Verapamil
Indication: Product Used FOR Unknown Indication
Aspirin
Indication: Product Used FOR Unknown Indication
Enalapril Maleate
Indication: Product Used FOR Unknown Indication
Darvon
Indication: Product Used FOR Unknown Indication
Requip
Indication: Product Used FOR Unknown Indication
Soma
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Neurontin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Topamax
Indication: Product Used FOR Unknown Indication
Folic Acid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Methotrexate
Possible Promethazine side effects in 33 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-27
Patient: 33 year old female, weighing 60.0 kg (132.0 pounds)
Reactions: Vomiting, Maternal Exposure During Pregnancy, Dyskinesia, Somnolence
Drug(s) suspected as cause:
Promethazine
Other drugs received by patient: Promethazine; Folic Acid
Possible Promethazine side effects in female
Reported by a individual with unspecified qualification from United States on 2012-04-13
Patient: female
Reactions: Scratch, White Blood Cell Count Decreased, Dyspnoea, Nausea, Drug Ineffective, Drug Hypersensitivity, Hyperhidrosis, Middle Insomnia, Syncope, RED Blood Cell Count Decreased, Injection Site Reaction, Dizziness, Unevaluable Event, Asthenia, Feeling Abnormal
Drug(s) suspected as cause:
Copegus
Indication: Hepatitis C
Start date: 2011-09-09
End date: 2012-02-17
Boceprevir
Indication: Hepatitis C
Start date: 2011-10-07
End date: 2011-11-30
Promethazine
Indication: Nausea
Peginterferon Alfa-2A
Indication: Hepatitis C
Start date: 2011-09-09
End date: 2012-02-17
Possible Promethazine side effects in male
Reported by a health professional (non-physician/pharmacist) from Hungary on 2012-03-22
Patient: male
Reactions: Foetal Exposure During Pregnancy, Anotia, Ventricular Septal Defect
Drug(s) suspected as cause:
Hydroxyethylrutosidea
Indication: Foetal Exposure During Pregnancy
Promethazine
Dosage: unk
Indication: Foetal Exposure During Pregnancy
Possible Promethazine side effects in
Reported by a consumer/non-health professional from United States on 2012-03-15
Patient:
Reactions: Ear Discomfort, Dyspnoea, Hyperacusis, Vomiting, Headache, Toxicity To Various Agents, Secretion Discharge, Barotrauma, Abdominal Pain Upper, Eye Pain, Abnormal Sensation in Eye, Dizziness, Tourette's Disorder, DRY Eye, Nervousness
Drug(s) suspected as cause:
Promethazine
Other drugs received by patient: Motrin
Possible Promethazine side effects in 35 year old female
Reported by a physician from United States on 2012-03-08
Patient: 35 year old female
Reactions: Death, Metabolic Acidosis, Cardio-Respiratory Arrest, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Coma, Prothrombin Time Prolonged, Suicidal Ideation
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Promethazine
Indication: Product Used FOR Unknown Indication
Acetaminophen
Meprobamate
Indication: Product Used FOR Unknown Indication
Venlafaxine
Indication: Product Used FOR Unknown Indication
Hydroxyzine
Indication: Product Used FOR Unknown Indication
Hydrocodone Bitartrate
Indication: Product Used FOR Unknown Indication
Clonazepam
Indication: Product Used FOR Unknown Indication
Carisoprodol
Indication: Product Used FOR Unknown Indication
Acetaminophen
Indication: Product Used FOR Unknown Indication
Topamax
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Ambien; Gabapentin
Possible Promethazine side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-07
Patient: female
Reactions: White Blood Cell Count Decreased, Scratch, Dyspnoea, Drug Ineffective, Drug Hypersensitivity, Hyperhidrosis, Fatigue, RED Blood Cell Count Decreased, Insomnia, Dizziness, Feeling Abnormal, Asthenia, Injection Site Infection, Infection
Drug(s) suspected as cause:
Promethazine
Dosage: 12.5 mg;unk;unk
Indication: Nausea
Victrelis
Dosage: ;unk;unk
Indication: Hepatitis C
Start date: 2011-10-07
End date: 2011-11-30
Pegasys
Dosage: ;unk;unk
Indication: Hepatitis C
Start date: 2011-09-09
End date: 2012-02-17
Ribavirin
Dosage: ;unk;unk
Indication: Hepatitis C
Start date: 2011-09-09
End date: 2012-02-17
Possible Promethazine side effects in
Reported by a consumer/non-health professional from Australia on 2012-03-02
Patient:
Reactions: Dizziness, Swollen Tongue, Headache, Tremor
Drug(s) suspected as cause:
Promethazine
Possible Promethazine side effects in 29 year old female
Reported by a consumer/non-health professional from United States on 2012-02-27
Patient: 29 year old female, weighing 68.0 kg (149.7 pounds)
Reactions: Burning Sensation, Hypoaesthesia, Paraesthesia
Drug(s) suspected as cause:
Promethazine
Dosage: one tablet
Administration route: Oral
Indication: Nausea
Start date: 2012-01-10
End date: 2012-01-11
Promethazine
Dosage: one tablet
Administration route: Oral
Indication: Vomiting
Start date: 2012-01-10
End date: 2012-01-11
Possible Promethazine side effects in 21 year old female
Reported by a consumer/non-health professional from United States on 2012-02-21
Patient: 21 year old female, weighing 54.4 kg (119.7 pounds)
Reactions: Anxiety, Panic Attack, Drug Ineffective, Nervous System Disorder, Depression, Intentional Self-Injury, Oculogyric Crisis, Suicidal Ideation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Promethazine
Possible Promethazine side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-14
Patient: female, weighing 74.8 kg (164.6 pounds)
Reactions: Nausea, Vomiting Projectile, Drug Ineffective, Headache, Aggression, Anger, Disturbance in Attention, Nervous System Disorder, Drug Administration Error, Memory Impairment
Drug(s) suspected as cause:
Pristiq
Indication: Insomnia
Xanax
Dosage: unk
Indication: Insomnia
Zofran
Indication: Nausea
Promethazine
Indication: Nausea
Fioricet
Dosage: unk
Administration route: Oral
Indication: Headache
Zofran
Dosage: unk
Indication: Vomiting Projectile
Pristiq
Dosage: 100 mg, daily
Indication: Stress AT Work
Start date: 2011-06-01
Promethazine
Dosage: unk
Indication: Vomiting Projectile
Lortab
Dosage: unk
Indication: Headache
Possible Promethazine side effects in male
Reported by a consumer/non-health professional from United States on 2012-02-14
Patient: male
Reactions: Multiple Drug Overdose, Oxygen Saturation Decreased
Adverse event resulted in: death
Drug(s) suspected as cause:
Fentanyl-100
Dosage: unk
Indication: Procedural Pain
Start date: 2011-11-28
Promethazine
Dosage: unk
Indication: Nausea
Start date: 2011-12-01
ALL Other Therapeutic Products
Dosage: unk
Start date: 2011-12-01
Demerol
Dosage: unk
Indication: Pain
Start date: 2011-12-01
Possible Promethazine side effects in 23 year old male
Reported by a health professional (non-physician/pharmacist) from Czech Republic on 2012-02-08
Patient: 23 year old male
Reactions: Drug Ineffective, Withdrawal Syndrome, Extrapyramidal Disorder, Delusion, Hypochondriasis
Drug(s) suspected as cause:
Risperidone
Dosage: 4 mg
Administration route: Oral
Methotrimeprazine
Indication: Schizophreniform Disorder
Zuclopenthixol
Indication: Schizophreniform Disorder
Risperidone
Indication: Schizophreniform Disorder
Promethazine
Indication: Schizophreniform Disorder
Biperiden Hydrochloride TAB
Indication: Extrapyramidal Disorder
Possible Promethazine side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-03
Patient: female, weighing 52.2 kg (114.8 pounds)
Reactions: Confusional State, Vomiting, Nightmare, Pruritus, Tinnitus, Swelling Face, Fear, Somnolence, Convulsion, Hallucinations, Mixed, Joint Swelling, Completed Suicide, Swelling, Coordination Abnormal
Drug(s) suspected as cause:
Promethazine
Other drugs received by patient: Tamoxifen Citrate
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