PatientsVille.com Logo

Codeine Side Effects

PatientsVille

Common Codeine Side Effects


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

Toxicity To Various Agents (77)
Vomiting (51)
Nausea (42)
Overdose (33)
Completed Suicide (32)
Rash (27)
Abdominal Discomfort (22)
Death (21)
Pancreatitis Acute (18)
Pruritus (17)
Headache (16)
Cardiac Arrest (16)
Constipation (16)
Dizziness (16)
Serotonin Syndrome (15)
Accidental Overdose (15)
Respiratory Arrest (15)
Hypersensitivity (14)
Hallucination (13)
Dyspnoea (13)

➢ 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.

Codeine Side Effects Reported to FDA



Codeine Side Effect Report#9991535
Asthma
This is a report of a 75-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Codeine Sulfate (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Asthma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Codeine Sulfate treatment in female patients, resulting in Asthma side effect.
Codeine Side Effect Report#9989252
Dyspnoea, Rash
This report suggests a potential Codeine Sulfate Dyspnoea side effect(s) that can have serious consequences. A 26-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Codeine Sulfate (dosage: NA) starting NS. After starting Codeine Sulfate the patient began experiencing various side effects, including: Dyspnoea, RashAdditional drugs used concurrently: NA. Although Codeine Sulfate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dyspnoea, may still occur.
Codeine Side Effect Report#9961229
Abdominal Discomfort
This Abdominal Discomfort problem was reported by a consumer or non-health professional from US. A 88-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Codeine Sulfate (dosage: NA). The following drugs were being taken at the same time: NA. When using Codeine Sulfate, the patient experienced the following unwanted symptoms/side effects: Abdominal DiscomfortAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abdominal Discomfort, may become evident only after a product is in use by the general population.
Codeine Side Effect Report#9951178
Abdominal Pain Upper
This Abdominal Pain Upper side effect was reported by a consumer or non-health professional from US. A 78-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Codeine Sulfate (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Codeine Sulfate the consumer reported adverse symptoms, such as: Abdominal Pain UpperThese side effects may potentially be related to Codeine Sulfate.
Codeine Side Effect Report#9943054
Malaise, Rash
This is a report of a 56-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Codeine Sulfate (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Malaise, Rash after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Codeine Sulfate treatment in female patients, resulting in Malaise side effect.
Codeine Side Effect Report#9934070
Abdominal Discomfort
This report suggests a potential Codeine Sulfate Abdominal Discomfort side effect(s) that can have serious consequences. A 81-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Codeine Sulfate (dosage: NA) starting NS. After starting Codeine Sulfate the patient began experiencing various side effects, including: Abdominal DiscomfortAdditional drugs used concurrently: NA. Although Codeine Sulfate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Discomfort, may still occur.
Codeine Side Effect Report#9931934
Rash
This Rash problem was reported by a consumer or non-health professional from US. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Codeine Sulfate (dosage: NA). The following drugs were being taken at the same time: NA. When using Codeine Sulfate, the patient experienced the following unwanted symptoms/side effects: RashAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rash, may become evident only after a product is in use by the general population.
Codeine Side Effect Report#9931833
Nausea
This Nausea side effect was reported by a consumer or non-health professional from US. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Codeine Sulfate (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Codeine Sulfate the consumer reported adverse symptoms, such as: NauseaThese side effects may potentially be related to Codeine Sulfate.
Codeine Side Effect Report#9894937
Nausea
This is a report of a 87-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Codeine Sulfate (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Nausea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Codeine Sulfate treatment in female patients, resulting in Nausea side effect.
Codeine Side Effect Report#9894936
Constipation
This report suggests a potential Codeine Sulfate Constipation side effect(s) that can have serious consequences. A 87-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Codeine Sulfate (dosage: NA) starting NS. After starting Codeine Sulfate the patient began experiencing various side effects, including: ConstipationAdditional drugs used concurrently: NA. Although Codeine Sulfate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Constipation, may still occur.
Codeine Side Effect Report#9894528
Nausea, Vomiting
This Nausea problem was reported by a consumer or non-health professional from US. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Codeine Sulfate (dosage: NA). The following drugs were being taken at the same time: NA. When using Codeine Sulfate, the patient experienced the following unwanted symptoms/side effects: Nausea, VomitingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nausea, may become evident only after a product is in use by the general population.
Codeine Side Effect Report#9894195
Dizziness, Vomiting
This Dizziness side effect was reported by a consumer or non-health professional from US. A 78-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Codeine Sulfate (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Codeine Sulfate the consumer reported adverse symptoms, such as: Dizziness, VomitingThese side effects may potentially be related to Codeine Sulfate.
Codeine Side Effect Report#9894123
Nausea, Vomiting
This is a report of a 76-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Codeine Sulfate (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Nausea, Vomiting after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Codeine Sulfate treatment in female patients, resulting in Nausea side effect.
Codeine Side Effect Report#9893762
Nausea
This report suggests a potential Codeine Sulfate Nausea side effect(s) that can have serious consequences. A 88-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Codeine Sulfate (dosage: NA) starting NS. After starting Codeine Sulfate the patient began experiencing various side effects, including: NauseaAdditional drugs used concurrently: NA. Although Codeine Sulfate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nausea, may still occur.
Codeine Side Effect Report#9893703
Nausea
This Nausea problem was reported by a consumer or non-health professional from US. A 84-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Codeine Sulfate (dosage: NA). The following drugs were being taken at the same time: NA. When using Codeine Sulfate, the patient experienced the following unwanted symptoms/side effects: NauseaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nausea, may become evident only after a product is in use by the general population.
Codeine Side Effect Report#9869281
Toxic Epidermal Necrolysis, Oropharyngeal Pain, Erythema, Rash Maculo-papular
This Toxic Epidermal Necrolysis side effect was reported by a health professional from GB. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Codeine (drug dosage: Unk), which was initiated on
Apr 12, 2013. Concurrently used drugs:
  • Dexamethasone (4 Mg, Qd)
  • Diazepam (Think This Was Given Just Before Patient Was Admitted Due To The Skin Reaction)
  • Flucanazole (50 Mg, Qd)
  • Paracetamol (Unk)
  • Co-amoxiclav (500/125mg)
  • Omerprazole (Unk)
.After starting to take Codeine the consumer reported adverse symptoms, such as: Toxic Epidermal Necrolysis, Oropharyngeal Pain, Erythema, Rash Maculo-papularThese side effects may potentially be related to Codeine.
Codeine Side Effect Report#9863734
Dyspnoea
This is a report of a 69-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Codeine Sulfate (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Codeine Sulfate treatment in female patients, resulting in Dyspnoea side effect.
Codeine Side Effect Report#9856399
Unresponsive To Stimuli
This report suggests a potential Codeine Death side effect(s) that can have serious consequences. A 3-year-old patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: procedural pain and used Codeine (dosage: NA) starting NS. After starting Codeine the patient began experiencing various side effects, including: Unresponsive To StimuliAdditional drugs used concurrently: NA. Although Codeine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Codeine Side Effect Report#9856393
Unresponsive To Stimuli
This Death problem was reported by a health professional from Country Not Specified. A 12-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: procedural pain. On NS this consumer started treatment with Codeine (dosage: NA). The following drugs were being taken at the same time: NA. When using Codeine, the patient experienced the following unwanted symptoms/side effects: Unresponsive To StimuliAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Codeine Side Effect Report#9845337
Respiratory Arrest, Cardiac Arrest, Poisoning
This Respiratory Arrest side effect was reported by a pharmacist from US. A 32-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Codeine (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Cocaine
  • Heroin
  • Levamisole
  • Dextromethorphan
.After starting to take Codeine the consumer reported adverse symptoms, such as: Respiratory Arrest, Cardiac Arrest, PoisoningThese side effects may potentially be related to Codeine.
Codeine Side Effect Report#9831079
Toxicity To Various Agents
This is a report of a 51-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Codeine (dosage: NA, start time: NS), combined with:
  • Diphenhydramine
  • Heroine
and developed a serious reaction and side effect(s): Toxicity To Various Agents after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Codeine treatment in male patients, resulting in Toxicity To Various Agents side effect.
Codeine Side Effect Report#9829291
Toxicity To Various Agents
This report suggests a potential Codeine Toxicity To Various Agents side effect(s) that can have serious consequences. A 22-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Codeine (dosage: NA) starting NS. After starting Codeine the patient began experiencing various side effects, including: Toxicity To Various AgentsAdditional drugs used concurrently:
  • Diphenhydramine Hydrochloride
  • Heroin
  • Alprazolam
Although Codeine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Toxicity To Various Agents, may still occur.
Codeine Side Effect Report#9817961
Vomiting
This Vomiting problem was reported by a consumer or non-health professional from US. A 67-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Codeine Sulfate (dosage: NA). The following drugs were being taken at the same time: NA. When using Codeine Sulfate, the patient experienced the following unwanted symptoms/side effects: VomitingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Vomiting, may become evident only after a product is in use by the general population.
Codeine Side Effect Report#9817846
Nausea, Vomiting
This Nausea side effect was reported by a consumer or non-health professional from US. A 71-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Codeine Sulfate (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Codeine Sulfate the consumer reported adverse symptoms, such as: Nausea, VomitingThese side effects may potentially be related to Codeine Sulfate.
Codeine Side Effect Report#9815325
Toxicity To Various Agents
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 Codeine (dosage: NA, start time: NS), combined with:
  • Diphenhydramine
  • Diphenhydramine
  • Heroin
  • Cocaine
and developed a serious reaction and side effect(s): Toxicity To Various Agents after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Codeine treatment in male patients, resulting in Toxicity To Various Agents side effect.


1 of 26 


The appearance of Codeine 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 Codeine Side Effects for Women?

Women Side EffectsReports
Vomiting 35
Toxicity To Various Agents 34
Nausea 33
Completed Suicide 24
Abdominal Discomfort 22
Rash 17
Dizziness 13
Pruritus 13
Malaise 12
Headache 11

What are common Codeine Side Effects for Men?

Men Side EffectsReports
Toxicity To Various Agents 33
Overdose 17
Vomiting 16
Death 12
Constipation 10
Accidental Overdose 9
Rash 9
Coma 8
Hypotension 8
Nausea 8

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.

    Codeine 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 Codeine Side Effects

    Did You Have a Codeine Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Codeine for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Codeine Safety Alerts, Active Ingredients, Usage Information

    NDC0054-0243
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameCodeine sulfate
    Namecodeine sulfate
    Dosage FormTABLET
    RouteORAL
    On market since20091001
    LabelerRoxane Laboratories, Inc
    Active Ingredient(s)CODEINE SULFATE
    Strength(s)15
    Unit(s)mg/1
    Pharma ClassFull Opioid Agonists [MoA],Opioid Agonist [EPC]

    More About Codeine

    Side Effects reported to FDA: 644

    Codeine safety alerts: 2012 2007

    Reported deaths: 64

    Reported hospitalizations: 54

    Codeine Use in Certain Children After Tonsillectomy and/or Adenoidectomy: Drug Safety Communication - Risk of Rare, But Life-Threatening Adverse Events or Death

     

    [UPDATED 02/20/2013] FDA notified the public about new actions being taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy (surgery to remove the tonsils and/or adenoids). A new BOXED WARNING, FDA’s strongest warning, will be added to the drug label of codeine-containing products about the risk of codeine in post-operative pain management in children following tonsillectomy and/or adenoidectomy. A Contraindication, which is a formal means for FDA to make a strong recommendation against use of a drug in certain patients, will be added to restrict codeine from being used in this setting. The Warnings/Precautions, Pediatric Use, and Patient Counseling Information sections of the drug label will also be updated.

    Health care professionals should prescribe an alternate analgesic for post-operative pain control in children who are undergoing tonsillectomy and/or adenoidectomy. Codeine should not be used for pain in children following these procedures.

    For management of other types of pain in children, codeine should only be used if the benefits are anticipated to outweigh the risks. 

     

    [Posted 08/15/2012]

    AUDIENCE: Pediatricians, Surgery, Consumer

    ISSUE: The FDA is reviewing reports of children who developed serious adverse effects or died after taking codeine for pain relief after tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome. Recently, three pediatric deaths and one non-fatal but life-threatening case of respiratory depression were documented in the medical literature.

    These children (ages two to five) had evidence of an inherited (genetic) ability to convert codeine into life-threatening or fatal amounts of morphine in the body. All children had received doses of codeine that were within the typical dose range.

    BACKGROUND: When codeine is ingested, it is converted to morphine in the liver by an enzyme called cytochrome P450 2D6 (CYP2D6). Some people have DNA variations that make this enzyme more active, causing codeine to be converted to morphine faster and more completely than in other people. These “ultra-rapid metabolizers” are more likely to have higher than normal amounts of morphine in their blood after taking codeine. High levels of morphine can result in breathing difficulty, which may be fatal. Taking codeine after tonsillectomy and/or adenoidectomy may increase the risk for breathing problems and death in children who are “ultra-rapid metabolizers.” See the FDA Drug Safety Communication for additional information, including a Data Summary.

    RECOMMENDATION: Health care professionals should be aware of the risks of using codeine in children, particularly in those who have undergone tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome. If prescribing codeine-containing drugs, the lowest effective dose for the shortest period of time should be used on an as-needed basis (i.e., not scheduled around the clock).

    Parents and caregivers who observe unusual sleepiness, confusion, or difficult or noisy breathing in their child should seek medical attention immediately, as these are signs of overdose.


    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [02/20/2013 - Drug Safety Communication - FDA]
    [08/15/2012 - Drug Safety Communication - FDA] 
    [08/15/2012 - Consumer Update - FDA]
     

    Latest Codeine clinical trials