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Promethazine Side Effects

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Common Promethazine Side Effects


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

Poisoning (63)
Toxicity To Various Agents (47)
Pain (45)
Nausea (37)
Completed Suicide (36)
Cardiac Arrest (36)
Cholecystitis Chronic (36)
Respiratory Arrest (34)
Confusional State (33)
Anxiety (27)
Dyspnoea (24)
Vomiting (24)
Exposure Via Ingestion (23)
Cholelithiasis (21)
Convulsion (21)
Injury (20)
Gallbladder Disorder (19)
Abdominal Pain (19)
Death (19)
Pain In Extremity (18)

➢ 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.

Promethazine Side Effects Reported to FDA



Promethazine Side Effect Report#9909538
Injection Site Reaction
This is a report of a 29-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Promethazine (dosage: NA, start time: NS), combined with:
  • Zofran
  • Quetiapine
  • Citalopram
  • Loratadine
  • Tramadol
and developed a serious reaction and side effect(s): Injection Site Reaction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Promethazine treatment in male patients, resulting in Injection Site Reaction side effect.
Promethazine Side Effect Report#9885515
Toxicity To Various Agents, Exposure Via Ingestion
This report suggests a potential Promethazine Toxicity To Various Agents side effect(s) that can have serious consequences. A 47-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Promethazine (dosage: Df Oral) starting NS. After starting Promethazine the patient began experiencing various side effects, including: Toxicity To Various Agents, Exposure Via IngestionAdditional drugs used concurrently:
  • Methadone (Df)
  • Cocaine (Df)
  • Sertraline (Df)
Although Promethazine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Toxicity To Various Agents, may still occur.
Promethazine Side Effect Report#9885510
Toxicity To Various Agents
This Toxicity To Various Agents problem was reported by a health professional from US. A 47-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Promethazine (dosage: Df). The following drugs were being taken at the same time:
  • Methadone (Df)
When using Promethazine, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various AgentsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Promethazine Side Effect Report#9885502
Poisoning, Exposure Via Ingestion
This Poisoning side effect was reported by a pharmacist from US. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Promethazine (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Oxycodone
  • Diphenhydramine
  • Temazepam
.After starting to take Promethazine the consumer reported adverse symptoms, such as: Poisoning, Exposure Via IngestionThese side effects may potentially be related to Promethazine.
Promethazine Side Effect Report#9885492
Toxicity To Various Agents, Exposure Via Ingestion
This is a report of a 44-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Promethazine (dosage: Df, start time: NS), combined with:
  • Fentanyl
  • Phenobarbital (Df)
  • Diphenhydramine (Df)
  • Amitriptyline (Df)
  • Venlafaxine (Df)
and developed a serious reaction and side effect(s): Toxicity To Various Agents, Exposure Via Ingestion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Promethazine treatment in female patients, resulting in Toxicity To Various Agents side effect.
Promethazine Side Effect Report#9885487
Toxicity To Various Agents, Exposure Via Ingestion, Completed Suicide
This report suggests a potential Promethazine Toxicity To Various Agents side effect(s) that can have serious consequences. A 42-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Promethazine (dosage: Df) starting NS. After starting Promethazine the patient began experiencing various side effects, including: Toxicity To Various Agents, Exposure Via Ingestion, Completed SuicideAdditional drugs used concurrently:
  • Acetylsalicylate Sodium (Df)
  • Acetaminophen (Df)
Although Promethazine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Toxicity To Various Agents, may still occur.
Promethazine Side Effect Report#9885481
Toxicity To Various Agents
This Toxicity To Various Agents problem was reported by a pharmacist from US. A 41-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Promethazine (dosage: Df). The following drugs were being taken at the same time:
  • Methadone (Df)
  • Cocaine
When using Promethazine, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various AgentsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Promethazine Side Effect Report#9885478
Toxicity To Various Agents, Exposure Via Ingestion
This Toxicity To Various Agents side effect was reported by a pharmacist from US. A 40-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Promethazine (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Oxycodone
  • Butalbital
  • Cyclobenzaprine
  • Amitriptyline
.After starting to take Promethazine the consumer reported adverse symptoms, such as: Toxicity To Various Agents, Exposure Via IngestionThese side effects may potentially be related to Promethazine.
Promethazine Side Effect Report#9885471
Toxicity To Various Agents, Respiratory Arrest, Cardiac Arrest
This is a report of a 39-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Promethazine (dosage: Df Oral, start time: NS), combined with:
  • Methadone (Df Oral)
  • Morphine (Df Oral)
  • Memantine (Df Oral)
and developed a serious reaction and side effect(s): Toxicity To Various Agents, Respiratory Arrest, Cardiac Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Promethazine treatment in male patients, resulting in Toxicity To Various Agents side effect.
Promethazine Side Effect Report#9885466
Exposure Via Ingestion
This report suggests a potential Promethazine Exposure Via Ingestion side effect(s) that can have serious consequences. A 38-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Promethazine (dosage: NA) starting NS. After starting Promethazine the patient began experiencing various side effects, including: Exposure Via IngestionAdditional drugs used concurrently:
  • Oxycodone
  • Hydromorphine
Although Promethazine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Exposure Via Ingestion, may still occur.
Promethazine Side Effect Report#9885459
Toxicity To Various Agents
This Toxicity To Various Agents problem was reported by a pharmacist from US. A 37-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Promethazine (dosage: NA). The following drugs were being taken at the same time:
  • Methadone
  • Clonazepam
  • Cocaine
When using Promethazine, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various AgentsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Promethazine Side Effect Report#9885413
Poisoning
This Poisoning side effect was reported by a pharmacist from US. A 46-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Promethazine (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Heroin
  • Codeine
  • Quinine
.After starting to take Promethazine the consumer reported adverse symptoms, such as: PoisoningThese side effects may potentially be related to Promethazine.
Promethazine Side Effect Report#9885400
Poisoning
This is a report of a 48-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Promethazine (dosage: Df, start time: NS), combined with:
  • Heroin (Df)
  • Cyclobenzaprine (Df)
  • Ethanol (Df)
and developed a serious reaction and side effect(s): Poisoning after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Promethazine treatment in female patients, resulting in Poisoning side effect.
Promethazine Side Effect Report#9885391
Exposure Via Ingestion
This report suggests a potential Promethazine Exposure Via Ingestion side effect(s) that can have serious consequences. A 48-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Promethazine (dosage: Df) starting NS. After starting Promethazine the patient began experiencing various side effects, including: Exposure Via IngestionAdditional drugs used concurrently:
  • Cocaine (Df)
  • Methadone (Df)
  • Quinine (Df)
Although Promethazine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Exposure Via Ingestion, may still occur.
Promethazine Side Effect Report#9885382
Toxicity To Various Agents, Exposure Via Ingestion
This Toxicity To Various Agents problem was reported by a pharmacist from US. A 50-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Promethazine (dosage: Df Parenteral). The following drugs were being taken at the same time:
  • Heroin (Df Parenteral)
  • Methadone (Df Parenteral)
  • Cocaine (Df Parenteral)
  • Quetiapine (Df Parenteral)
  • Diphenhydramine (Dp Parenteral)
When using Promethazine, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various Agents, Exposure Via IngestionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Promethazine Side Effect Report#9885365
Poisoning, Exposure Via Ingestion
This Poisoning side effect was reported by a pharmacist from US. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Promethazine (drug dosage: Df Oral), which was initiated on NS. Concurrently used drugs:
  • Cocaine (Df Oral)
  • Meperidine (Df Oral)
  • Paroxetine
.After starting to take Promethazine the consumer reported adverse symptoms, such as: Poisoning, Exposure Via IngestionThese side effects may potentially be related to Promethazine.
Promethazine Side Effect Report#9885357
Poisoning
This is a report of a 64-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Promethazine (dosage: NA, start time: NS), combined with:
  • Heroin
  • Methadone
and developed a serious reaction and side effect(s): Poisoning after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Promethazine treatment in male patients, resulting in Poisoning side effect.
Promethazine Side Effect Report#9885172
Viral Infection, Nausea, Vomiting, Agitation, Unresponsive To Stimuli, Sinus Tachycardia, Bundle Branch Block Right, Bradyarrhythmia, Hyperkalaemia
This report suggests a potential Promethazine Viral Infection side effect(s) that can have serious consequences. A 21-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Promethazine (dosage: 2 Doses Adminstered, Each Dose Given Approximately 4 Hours Apart) starting 2012. After starting Promethazine the patient began experiencing various side effects, including: Viral Infection, Nausea, Vomiting, Agitation, Unresponsive To Stimuli, Sinus Tachycardia, Bundle Branch Block Right, Bradyarrhythmia, HyperkalaemiaAdditional drugs used concurrently:
  • Cocaine (Respiratory (inhalation))
The patient was hospitalized. Although Promethazine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Viral Infection, may still occur.
Promethazine Side Effect Report#9885024
Poisoning
This Poisoning problem was reported by a pharmacist from US. A 44-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Promethazine (dosage: Df). The following drugs were being taken at the same time:
  • Heroin (Df)
  • Cocaine (Df)
  • Trazodone (Df)
When using Promethazine, the patient experienced the following unwanted symptoms/side effects: PoisoningAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Poisoning, may become evident only after a product is in use by the general population.
Promethazine Side Effect Report#9885016
Poisoning
This Poisoning side effect was reported by a pharmacist from US. A 41-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Promethazine (drug dosage: Df), which was initiated on NS. Concurrently used drugs:
  • Heroin (Df)
  • Cocaine (Df)
  • Citalopram (Df)
  • Dextromethorphan (Df)
  • Quinine (Df)
.After starting to take Promethazine the consumer reported adverse symptoms, such as: PoisoningThese side effects may potentially be related to Promethazine.
Promethazine Side Effect Report#9885008
Poisoning
This is a report of a 41-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Promethazine (dosage: Df, start time: NS), combined with:
  • Heroin (Df)
  • Clonazepam (Df)
  • Metoclopramide (Df)
and developed a serious reaction and side effect(s): Poisoning after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Promethazine treatment in male patients, resulting in Poisoning side effect.
Promethazine Side Effect Report#9884993
Poisoning
This report suggests a potential Promethazine Poisoning side effect(s) that can have serious consequences. A 30-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Promethazine (dosage: NA) starting NS. After starting Promethazine the patient began experiencing various side effects, including: PoisoningAdditional drugs used concurrently:
  • Heroin
  • Cocaine
  • Pseudoephedrine
Although Promethazine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Poisoning, may still occur.
Promethazine Side Effect Report#9884974
Poisoning, Accidental Exposure To Product
This Poisoning problem was reported by a pharmacist from US. A 26-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Promethazine (dosage: NA). The following drugs were being taken at the same time:
  • Heroin
  • Diazepam
  • Cocaine
  • Clonazepam
  • Diphenhydramine
When using Promethazine, the patient experienced the following unwanted symptoms/side effects: Poisoning, Accidental Exposure To ProductAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Poisoning, may become evident only after a product is in use by the general population.
Promethazine Side Effect Report#9884958
Toxicity To Various Agents, Exposure Via Ingestion
This Toxicity To Various Agents side effect was reported by a pharmacist from US. A 30-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Promethazine (drug dosage: (df Oral) Unknwon Until Not Continuing?), which was initiated on NS. Concurrently used drugs:
  • Hydrocodone ((df Oral) Unknwon Until Not Continuing??)
  • Olanzapine ((df Oral) Unknwon Until Not Continuing??)
  • Citalopram ((df Oral) Unknwon Until Not Continuing?)
  • Alprazolam ((df Oral) Unknwon Until Not Continuing??)
.After starting to take Promethazine the consumer reported adverse symptoms, such as: Toxicity To Various Agents, Exposure Via IngestionThese side effects may potentially be related to Promethazine.
Promethazine Side Effect Report#9884949
Poisoning, Exposure Via Ingestion
This is a report of a 56-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Promethazine (dosage: Df, start time: NS), combined with:
  • Citalopram (Df)
  • Nortriptyline
  • Metoprolol (Df)
and developed a serious reaction and side effect(s): Poisoning, Exposure Via Ingestion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Promethazine treatment in male patients, resulting in Poisoning side effect.


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The appearance of Promethazine 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.

What are common Promethazine Side Effects for Women?

Women Side EffectsReports
Poisoning 39
Pain 38
Cholecystitis Chronic 36
Nausea 27
Toxicity To Various Agents 27
Anxiety 22
Completed Suicide 22
Cholelithiasis 21
Gallbladder Disorder 19
Injury 19

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.

    Promethazine 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 Promethazine Side Effects

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    How Effective is Promethazine for You?

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    Promethazine Safety Alerts, Active Ingredients, Usage Information

    NDC0115-1040
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NamePromethazine Hydrochloride
    NamePromethazine Hydrochloride
    Dosage FormTABLET
    RouteORAL
    On market since20080212
    LabelerGlobal Pharmaceuticals, Division of Impax Laboratories Inc.
    Active Ingredient(s)PROMETHAZINE HYDROCHLORIDE
    Strength(s)12.5
    Unit(s)mg/1
    Pharma ClassPhenothiazine [EPC],Phenothiazines [Chemical/Ingredient]

    More About Promethazine

    Side Effects reported to FDA: 644

    Promethazine safety alerts: 2009 2006 2005

    Reported deaths: 147

    Reported hospitalizations: 207

    Promethazine Hydrochloride Injection

    Audience: All healthcare professionals

    [Posted 09/16/2009] FDA notified healthcare professionals that a Boxed Warning is being added to the prescribing information for Promethazine Hydrochloride products, describing the risks of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine. The Boxed Warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular injection and that subcutaneous injection is contraindicated.

    Perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration of the drug may result in irritation and tissue damage. Healthcare professionals should be alert for signs and symptoms of potential tissue injury including burning or pain at the site of injection, phlebitis, swelling, and blistering.

    [09/16/2009 - Information for Healthcare Professionals - FDA]
    [09/16/2009 - News Release - FDA]

    Latest Promethazine clinical trials