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Opana Side Effects

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Common Opana Side Effects


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

Nausea (50)
Vomiting (49)
Overdose (47)
Accidental Death (45)
Withdrawal Syndrome (37)
Diarrhoea (31)
Thrombotic Thrombocytopenic Purpura (31)
Headache (31)
Malaise (30)
Feeling Abnormal (30)
Abdominal Pain Upper (29)
Dizziness (27)
Insomnia (25)
Abdominal Discomfort (25)
Renal Failure Acute (25)
Constipation (23)
Unresponsive To Stimuli (22)
Dyspnoea (21)
Pain (20)
Toxicity To Various Agents (20)

➢ 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.

Opana Side Effects Reported to FDA



Opana Side Effect Report#9931891
Refusal Of Treatment By Patient, Thrombotic Thrombocytopenic Purpura, Haemoglobin Decreased, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Pancreatitis, Hepatitis C, Headache, Blood Lactate Dehydrogenase Increased
This is a report of a 26-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: NA, who was treated with Opana (dosage: Df, start time: NS), combined with:
  • 9-tetrahydrocannabinol (Df)
  • Opioids (Df)
  • Oxycodone (Df)
and developed a serious reaction and side effect(s): Refusal Of Treatment By Patient, Thrombotic Thrombocytopenic Purpura, Haemoglobin Decreased, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Pancreatitis, Hepatitis C, Headache, Blood Lactate Dehydrogenase Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Opana treatment in female patients, resulting in Refusal Of Treatment By Patient side effect. The patient was hospitalized.
Opana Side Effect Report#9882991
Microangiopathic Haemolytic Anaemia, Thrombotic Thrombocytopenic Purpura, Hepatitis C, Oedema Peripheral
This report suggests a potential Opana Er Microangiopathic Haemolytic Anaemia 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 Opana Er (dosage: NA) starting NS. After starting Opana Er the patient began experiencing various side effects, including: Microangiopathic Haemolytic Anaemia, Thrombotic Thrombocytopenic Purpura, Hepatitis C, Oedema PeripheralAdditional drugs used concurrently: NA.The patient was hospitalized. Although Opana Er demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Microangiopathic Haemolytic Anaemia, may still occur.
Opana Side Effect Report#9882033
Weight Increased, Insomnia, Dysphagia, Fatigue, Skin Disorder, Skin Irritation
This Weight Increased problem was reported by a consumer or non-health professional from US. A 52-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: back pain,breakthrough pain. On 2012 this consumer started treatment with Opana Er (dosage: 80 Mg, 2 In 1 D, Oral). The following drugs were being taken at the same time: NA. When using Opana Er, the patient experienced the following unwanted symptoms/side effects: Weight Increased, Insomnia, Dysphagia, Fatigue, Skin Disorder, Skin IrritationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Weight Increased, may become evident only after a product is in use by the general population.
Opana Side Effect Report#9866910
Tinnitus, Headache, Dizziness, Somnolence, Anxiety, Depression, Crying, Cold Sweat, Nausea
This Tinnitus side effect was reported by a consumer or non-health professional from US. A 50-year-old female patient (weight:NA) experienced the following symptoms/conditions: pain.The patient was prescribed Opana Er (drug dosage: NA), which was initiated on
Jan 24, 2014. Concurrently used drugs: NA..After starting to take Opana Er the consumer reported adverse symptoms, such as: Tinnitus, Headache, Dizziness, Somnolence, Anxiety, Depression, Crying, Cold Sweat, NauseaThese side effects may potentially be related to Opana Er.
Opana Side Effect Report#9804607
Fall
This is a report of a 53-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: fibromyalgia,arthralgia,rotator cuff syndrome, who was treated with Opana Er 20mg (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Fall after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Opana Er 20mg treatment in female patients, resulting in Fall side effect.
Opana Side Effect Report#9790084
Product Substitution Issue
This report suggests a potential Opana Er Product Substitution Issue side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pain and used Opana Er (dosage: Abt 2010 Originally) starting 2010. After starting Opana Er the patient began experiencing various side effects, including: Product Substitution IssueAdditional drugs used concurrently: NA. Although Opana Er demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Product Substitution Issue, may still occur.
Opana Side Effect Report#9779221
False Positive Investigation Result
This False Positive Investigation Result problem was reported by a consumer or non-health professional from US. A 47-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pain,cough,diabetes mellitus,hypertension,blood cholesterol increased,hiatus hernia,breakthrough pain. On 2008 this consumer started treatment with Opana Er 40mg (dosage: NA). The following drugs were being taken at the same time:
  • Tussionex (Unk)
  • Metformin Hydrochloride Tablets (Unk)
  • Lisinopril Tablets (Unk)
  • Simvastatin (Unk)
  • Protonix (Unk)
  • Hydrocodone/acetaminophen (10/325 Mg)
When using Opana Er 40mg, the patient experienced the following unwanted symptoms/side effects: False Positive Investigation ResultAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as False Positive Investigation Result, may become evident only after a product is in use by the general population.
Opana Side Effect Report#9779217
Upper Respiratory Tract Infection, Tooth Abscess
This Upper Respiratory Tract Infection side effect was reported by a pharmacist from US. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Opana Er 15 Mg (drug dosage: NA), which was initiated on 201308. Concurrently used drugs: NA..After starting to take Opana Er 15 Mg the consumer reported adverse symptoms, such as: Upper Respiratory Tract Infection, Tooth AbscessThese side effects may potentially be related to Opana Er 15 Mg.
Opana Side Effect Report#9779216
Influenza
This is a report of a 63-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Opana Er 40mg (dosage: NA, start time: 2012), combined with: NA. and developed a serious reaction and side effect(s): Influenza after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Opana Er 40mg treatment in female patients, resulting in Influenza side effect.
Opana Side Effect Report#9779214
Fall, Sciatica
This report suggests a potential Opana Er 40mg Fall side effect(s) that can have serious consequences. A 52-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pain and used Opana Er 40mg (dosage: NA) starting NS. After starting Opana Er 40mg the patient began experiencing various side effects, including: Fall, SciaticaAdditional drugs used concurrently: NA. Although Opana Er 40mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fall, may still occur.
Opana Side Effect Report#9779213
Extra Dose Administered
This Extra Dose Administered problem was reported by a pharmacist from US. A 33-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Nov 06, 2013 this consumer started treatment with Opana Er 30mg (dosage: NA). The following drugs were being taken at the same time:
  • Dilaudid (Unk)
When using Opana Er 30mg, the patient experienced the following unwanted symptoms/side effects: Extra Dose AdministeredAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Extra Dose Administered, may become evident only after a product is in use by the general population.
Opana Side Effect Report#9779212
Cystitis
This Cystitis side effect was reported by a pharmacist from US. A 32-year-old male patient (weight:NA) experienced the following symptoms/conditions: back pain.The patient was prescribed Opana Er 30mg (drug dosage: NA), which was initiated on 201211. Concurrently used drugs: NA..After starting to take Opana Er 30mg the consumer reported adverse symptoms, such as: CystitisThese side effects may potentially be related to Opana Er 30mg.
Opana Side Effect Report#9779209
Withdrawal Syndrome
This is a report of a 36-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Opana Er (dosage: NA, start time:
Dec 28, 2012), combined with: NA. and developed a serious reaction and side effect(s): Withdrawal Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Opana Er treatment in male patients, resulting in Withdrawal Syndrome side effect.
Opana Side Effect Report#9779178
Somnambulism
This report suggests a potential Opana Er 5mg Somnambulism side effect(s) that can have serious consequences. A 51-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pain and used Opana Er 5mg (dosage: NA) starting NS. After starting Opana Er 5mg the patient began experiencing various side effects, including: SomnambulismAdditional drugs used concurrently: NA. Although Opana Er 5mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Somnambulism, may still occur.
Opana Side Effect Report#9779174
Hypertension
This Hypertension problem was reported by a consumer or non-health professional from US. A 51-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pain. On 2009 this consumer started treatment with Opana Er 40mg (dosage: NA). The following drugs were being taken at the same time: NA. When using Opana Er 40mg, the patient experienced the following unwanted symptoms/side effects: HypertensionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypertension, may become evident only after a product is in use by the general population.
Opana Side Effect Report#9779172
Renal Cyst Infection, Oropharyngeal Pain, Dysphonia
This Renal Cyst Infection side effect was reported by a consumer or non-health professional from US. A 52-year-old male patient (weight:NA) experienced the following symptoms/conditions: pain,congenital cystic kidney disease,ankylosing spondylitis.The patient was prescribed Opana Er 30mg (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Opana Er 30mg the consumer reported adverse symptoms, such as: Renal Cyst Infection, Oropharyngeal Pain, DysphoniaThese side effects may potentially be related to Opana Er 30mg.
Opana Side Effect Report#9779171
Constipation
This is a report of a 64-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: pain, who was treated with Opana Er 40mg (dosage: NA, start time: 201209), combined with: NA. and developed a serious reaction and side effect(s): Constipation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Opana Er 40mg treatment in female patients, resulting in Constipation side effect.
Opana Side Effect Report#9779169
Panic Attack, Muscle Twitching, Insomnia, Pruritus, Dyspnoea, Palpitations, Anxiety, Heart Rate Increased
This report suggests a potential Opana Er 10mg Panic Attack side effect(s) that can have serious consequences. A 49-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: arthritis,neuralgia and used Opana Er 10mg (dosage: NA) starting
Sep 10, 2013. After starting Opana Er 10mg the patient began experiencing various side effects, including: Panic Attack, Muscle Twitching, Insomnia, Pruritus, Dyspnoea, Palpitations, Anxiety, Heart Rate IncreasedAdditional drugs used concurrently: NA. Although Opana Er 10mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Panic Attack, may still occur.
Opana Side Effect Report#9779168
Rotator Cuff Syndrome, Withdrawal Syndrome
This Rotator Cuff Syndrome problem was reported by a consumer or non-health professional from US. A 62-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: back disorder,rotator cuff syndrome. On 2012 this consumer started treatment with Opana Er (dosage: NA). The following drugs were being taken at the same time: NA. When using Opana Er, the patient experienced the following unwanted symptoms/side effects: Rotator Cuff Syndrome, Withdrawal SyndromeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rotator Cuff Syndrome, may become evident only after a product is in use by the general population.
Opana Side Effect Report#9779163
Alopecia, Eye Swelling, Joint Swelling
This Alopecia side effect was reported by a consumer or non-health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: pain.The patient was prescribed Opana Er 10mg (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Opana Er 10mg the consumer reported adverse symptoms, such as: Alopecia, Eye Swelling, Joint SwellingThese side effects may potentially be related to Opana Er 10mg.
Opana Side Effect Report#9779161
Nasopharyngitis
This is a report of a 61-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: pain, who was treated with Opana Er 40mg (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Nasopharyngitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Opana Er 40mg treatment in female patients, resulting in Nasopharyngitis side effect.
Opana Side Effect Report#9779160
Abdominal Distension, Abdominal Pain, Diarrhoea
This report suggests a potential Opana Er 10mg Abdominal Distension side effect(s) that can have serious consequences. A 53-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pain and used Opana Er 10mg (dosage: NA) starting
Dec 05, 2013. After starting Opana Er 10mg the patient began experiencing various side effects, including: Abdominal Distension, Abdominal Pain, DiarrhoeaAdditional drugs used concurrently:
  • Ms Contin
Although Opana Er 10mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Distension, may still occur.
Opana Side Effect Report#9779156
Hiatus Hernia
This Hiatus Hernia problem was reported by a pharmacist from US. A 44-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pain. On 2009 this consumer started treatment with Opana Er 40mg (dosage: NA). The following drugs were being taken at the same time: NA. When using Opana Er 40mg, the patient experienced the following unwanted symptoms/side effects: Hiatus HerniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hiatus Hernia, may become evident only after a product is in use by the general population.
Opana Side Effect Report#9779116
Vomiting
This Vomiting side effect was reported by a consumer or non-health professional from US. A male patient (weight:NA) experienced the following symptoms/conditions: pain.The patient was prescribed Opana Er 40mg (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Opana Er 40mg the consumer reported adverse symptoms, such as: VomitingThese side effects may potentially be related to Opana Er 40mg.
Opana Side Effect Report#9779113
Withdrawal Syndrome, Abdominal Pain Upper
This is a report of a 56-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: pain, who was treated with Opana Er 10mg (dosage: NA, start time: 201310), combined with:
  • Fentanyl (Unk)
and developed a serious reaction and side effect(s): Withdrawal Syndrome, Abdominal Pain Upper after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Opana Er 10mg treatment in male patients, resulting in Withdrawal Syndrome side effect.


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The appearance of Opana 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 Opana Side Effects for Women?

Women Side EffectsReports
Nausea 28
Vomiting 26
Headache 21
Feeling Abnormal 19
Thrombotic Thrombocytopenic Purpura 18
Dyspnoea 16
Malaise 16
Accidental Death 15
Dizziness 15
Renal Failure Acute 15

What are common Opana Side Effects for Men?

Men Side EffectsReports
Overdose 33
Accidental Death 30
Withdrawal Syndrome 27
Vomiting 23
Nausea 22
Diarrhoea 20
Abdominal Pain Upper 19
Abdominal Discomfort 18
Toxicity To Various Agents 18
Insomnia 16

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.

    Opana 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.

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    Opana Safety Alerts, Active Ingredients, Usage Information

    NDC16590-609
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameOPANA ER
    NameOXYMORPHONE HYDROCHLORIDE
    Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
    RouteORAL
    On market since20060622
    LabelerSTAT RX USA LLC
    Active Ingredient(s)OXYMORPHONE HYDROCHLORIDE
    Strength(s)40
    Unit(s)mg/1
    Pharma ClassFull Opioid Agonists [MoA],Opioid Agonist [EPC]

    More About Opana

    Side Effects reported to FDA: 755

    Opana safety alerts: No

    Reported deaths: 117

    Reported hospitalizations: 135

    Latest Opana clinical trials