Common Vivitrol Side Effects


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

Injection Site Pain (29)
Injection Site Reaction (29)
Injection Site Induration (20)
Death (20)
Injection Site Abscess (18)
Injection Site Mass (17)
Nausea (17)
Injection Site Erythema (13)
Injection Site Necrosis (13)
Alcohol Use (11)
Dizziness (11)
Pain (11)
Fall (11)
Injection Site Swelling (11)
Overdose (10)
Injection Site Nodule (9)
Anxiety (9)
Fatigue (8)
Injection Site Pruritus (8)
Vomiting (8)

➢ 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.

Vivitrol Side Effects Reported to FDA



Vivitrol Side Effect Report#9745465
Pain, Vomiting, Frequent Bowel Movements, Haematemesis, Skin Burning Sensation, Injection Site Reaction, Injection Site Mass, Injection Site Swelling
This is a report of a 55-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Vivitrol (dosage: NA, start time:
Nov 11, 2013), combined with:
  • Suboxone (buprenorphine Hydrochloride, Naloxone Hydrochloride)
  • Tramadol
  • Provigil (modafinil)
  • Clonidine
  • Xanax (alprazolam)
  • Omeprazole
  • Zofran (ondansetron)
and developed a serious reaction and side effect(s): Pain, Vomiting, Frequent Bowel Movements, Haematemesis, Skin Burning Sensation, Injection Site Reaction, Injection Site Mass, Injection Site Swelling after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vivitrol treatment in male patients, resulting in Pain side effect. The patient was hospitalized.
Vivitrol Side Effect Report#9701917
This report suggests a potential Vivitrol Death side effect(s) that can have serious consequences. A 29-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Vivitrol (dosage: 380 Mg, Qmo, Intramuscular) starting NS. After starting Vivitrol the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Vivitrol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Vivitrol Side Effect Report#9685232
This Death problem was reported by a pharmacist from US. A 29-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 14, 2013 this consumer started treatment with Vivitrol (dosage: NA). The following drugs were being taken at the same time: NA. When using Vivitrol, the patient experienced the following unwanted symptoms/side effects:Although 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.
Vivitrol Side Effect Report#9678241
Investigation
This Investigation side effect was reported by a consumer or non-health professional from US. A 22-year-old male patient (weight:NA) experienced the following symptoms/conditions: alcoholism.The patient was prescribed Vivitrol (drug dosage: 380 Mg, Qmo, Intramuscular), which was initiated on NS. Concurrently used drugs: NA..After starting to take Vivitrol the consumer reported adverse symptoms, such as: InvestigationThese side effects may potentially be related to Vivitrol. The patient was hospitalized.
Vivitrol Side Effect Report#9676406
This is a report of a 21-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: alcoholism, who was treated with Vivitrol (vivitrol_nda) Injection, 380mg (dosage: NA, start time:
Dec 20, 2012), combined with: NA. and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vivitrol (vivitrol_nda) Injection, 380mg treatment in male patients, resulting in Death side effect.
Vivitrol Side Effect Report#9676362
Transient Ischaemic Attack
This report suggests a potential Vivitrol Transient Ischaemic Attack side effect(s) that can have serious consequences. A 61-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: alcoholism and used Vivitrol (dosage: NA) starting
Oct 02, 2013. After starting Vivitrol the patient began experiencing various side effects, including: Transient Ischaemic AttackAdditional drugs used concurrently: NA.The patient was hospitalized. Although Vivitrol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Transient Ischaemic Attack, may still occur.
Vivitrol Side Effect Report#9659817
This Death problem was reported by a health professional from US. A 31-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Vivitrol (vivitrol_nda) Injection, 380mg (dosage: NA). The following drugs were being taken at the same time: NA. When using Vivitrol (vivitrol_nda) Injection, 380mg, the patient experienced the following unwanted symptoms/side effects:Although 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.
Vivitrol Side Effect Report#9659784
Overdose, Product Quality Issue
This Overdose side effect was reported by a health professional from US. A 25-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Vivitrol (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Vivitrol the consumer reported adverse symptoms, such as: Overdose, Product Quality IssueThese side effects may potentially be related to Vivitrol.
Vivitrol Side Effect Report#9659729
Surgery, Joint Injury
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 Vivitrol (vivitol_nda) Injection, 380mg (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Surgery, Joint Injury after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vivitrol (vivitol_nda) Injection, 380mg treatment in male patients, resulting in Surgery side effect.
Vivitrol Side Effect Report#9630682
Overdose, Product Quality Issue
This report suggests a potential Vivitrol Overdose side effect(s) that can have serious consequences. A 24-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Vivitrol (dosage: NA) starting
Apr 04, 2013. After starting Vivitrol the patient began experiencing various side effects, including: Overdose, Product Quality IssueAdditional drugs used concurrently: NA. Although Vivitrol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Overdose, may still occur.
Vivitrol Side Effect Report#9630669
Surgery, Cerebrovascular Accident
This Surgery problem was reported by a health professional from US. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: alcoholism. On
Jun 15, 2013 this consumer started treatment with Vivitrol (dosage: Qmo). The following drugs were being taken at the same time: NA. When using Vivitrol, the patient experienced the following unwanted symptoms/side effects: Surgery, Cerebrovascular AccidentThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Surgery, may become evident only after a product is in use by the general population.
Vivitrol Side Effect Report#9612022
This Death side effect was reported by a consumer or non-health professional from US. A 32-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Vivitrol (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Vivitrol the consumer reported adverse symptoms, such as: These side effects may potentially be related to Vivitrol.
Vivitrol Side Effect Report#9593080
Drowning
This is a report of a 22-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Vivitrol (dosage: Qmo, start time:
Aug 31, 2012), combined with:
  • Abilify (aripiprazole)
and developed a serious reaction and side effect(s): Drowning after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vivitrol treatment in male patients, resulting in Drowning side effect.
Vivitrol Side Effect Report#9592490
Injection Site Pain, Injection Site Swelling, Injection Site Mass, Injury, Haematoma, Medical Device Complication
This report suggests a potential Vivitrol Injection Site Pain side effect(s) that can have serious consequences. A 56-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: alcohol abuse and used Vivitrol (dosage: NA) starting
Apr 24, 2013. After starting Vivitrol the patient began experiencing various side effects, including: Injection Site Pain, Injection Site Swelling, Injection Site Mass, Injury, Haematoma, Medical Device ComplicationAdditional drugs used concurrently:
  • Lamictal
  • Wellbutrin Sr
  • Ambien
Although Vivitrol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Injection Site Pain, may still occur.
Vivitrol Side Effect Report#9539294
Ovarian Cyst
This Ovarian Cyst problem was reported by a consumer or non-health professional from US. A 34-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Aug 20, 2013 this consumer started treatment with Vivitrol (dosage: NA). The following drugs were being taken at the same time: NA. When using Vivitrol, the patient experienced the following unwanted symptoms/side effects: Ovarian CystAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Ovarian Cyst, may become evident only after a product is in use by the general population.
Vivitrol Side Effect Report#9539288
Overdose
This Overdose side effect was reported by a consumer or non-health professional from Country Not Specified. A 56-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Vivitrol (vivitrol_nda) Injection, 380mg (drug dosage: 380 Mg, Qmo, Intramuscular), which was initiated on
Aug 14, 2013. Concurrently used drugs: NA..After starting to take Vivitrol (vivitrol_nda) Injection, 380mg the consumer reported adverse symptoms, such as: OverdoseThese side effects may potentially be related to Vivitrol (vivitrol_nda) Injection, 380mg.
Vivitrol Side Effect Report#9518655
Injection Site Mass, Injection Site Reaction, Injection Site Induration, Injection Site Erythema, Injection Site Warmth, Injection Site Pain, Injection Site Discolouration
This is a report of a 44-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: alcoholism, who was treated with Vivitrol (vivitrol_nda) Injection, 380mg (dosage: NA, start time:
Jul 09, 2013), combined with:
  • Beyaz (calcium Levomefolate, Drospirenone, Ethinylestradiol Betadex Clathrate)
  • Lexapro (escitalopram Oxalate)
  • Trazodone (trazodone Hydrochloride)
  • Vitamins Nos (vitamins Nos)
  • Tramadol (tramadol)
  • Loryna (drospirenone And Ethinylestradiol)
and developed a serious reaction and side effect(s): Injection Site Mass, Injection Site Reaction, Injection Site Induration, Injection Site Erythema, Injection Site Warmth, Injection Site Pain, Injection Site Discolouration after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vivitrol (vivitrol_nda) Injection, 380mg treatment in female patients, resulting in Injection Site Mass side effect.
Vivitrol Side Effect Report#9518640
Injection Site Reaction, Injection Site Infection, Arthropod Bite, Injection Site Irritation, Injection Site Mass, Injection Site Erythema, Injection Site Warmth, Injection Site Inflammation, Injection Site Pain
This report suggests a potential Vivitrol (vivitrol_nda) Injection, 380mg Injection Site Reaction side effect(s) that can have serious consequences. A 46-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: alcoholism and used Vivitrol (vivitrol_nda) Injection, 380mg (dosage: NA) starting
Jul 29, 2013. After starting Vivitrol (vivitrol_nda) Injection, 380mg the patient began experiencing various side effects, including: Injection Site Reaction, Injection Site Infection, Arthropod Bite, Injection Site Irritation, Injection Site Mass, Injection Site Erythema, Injection Site Warmth, Injection Site Inflammation, Injection Site PainAdditional drugs used concurrently: NA. Although Vivitrol (vivitrol_nda) Injection, 380mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Injection Site Reaction, may still occur.
Vivitrol Side Effect Report#9498891
This Death problem was reported by a physician from US. A 27-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: alcoholism. On
Apr 17, 2013 this consumer started treatment with Vivitrol (dosage: Qmo). The following drugs were being taken at the same time: NA. When using Vivitrol, the patient experienced the following unwanted symptoms/side effects:Although 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.
Vivitrol Side Effect Report#9485999
Disease Complication
This Disease Complication side effect was reported by a health professional from US. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: alcoholism.The patient was prescribed Vivitrol (vivitrol_nda) Injection, 380 Mg (drug dosage: NA), which was initiated on
Apr 02, 2013. Concurrently used drugs:
  • Zithromax (azithromycin)
  • Risperdal (risperidone)
  • Fluoxetine (fluoxetine Hydrochloride)
  • Omeprazole (omeprazole)
  • Metoprolol Tartrate (metoprolol Tartrate)
  • Furosemide (furosemide)
.After starting to take Vivitrol (vivitrol_nda) Injection, 380 Mg the consumer reported adverse symptoms, such as: Disease ComplicationThese side effects may potentially be related to Vivitrol (vivitrol_nda) Injection, 380 Mg.
Vivitrol Side Effect Report#9468586
Subdural Haematoma, Alcohol Use, Alcoholism, Fall, Product Quality Issue
This is a report of a 58-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: alcoholism, who was treated with Vivitrol (vivitrol_nda) Injection, 380 Mg (dosage: Qmo, start time:
May 31, 2012), combined with: NA. and developed a serious reaction and side effect(s): Subdural Haematoma, Alcohol Use, Alcoholism, Fall, Product Quality Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vivitrol (vivitrol_nda) Injection, 380 Mg treatment in male patients, resulting in Subdural Haematoma side effect. The patient was hospitalized.
Vivitrol Side Effect Report#9468577
Injection Site Abscess, Injection Site Reaction, Injection Site Cellulitis
This report suggests a potential Vivitrol Injection Site Abscess side effect(s) that can have serious consequences. A 23-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Vivitrol (dosage: NA) starting NS. After starting Vivitrol the patient began experiencing various side effects, including: Injection Site Abscess, Injection Site Reaction, Injection Site CellulitisAdditional drugs used concurrently: NA. Although Vivitrol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Injection Site Abscess, may still occur.
Vivitrol Side Effect Report#9434489
Alcohol Poisoning
This Alcohol Poisoning problem was reported by a physician from US. A 44-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: alcoholism. On NS this consumer started treatment with Vivitrol (dosage: NA). The following drugs were being taken at the same time: NA. When using Vivitrol, the patient experienced the following unwanted symptoms/side effects: Alcohol PoisoningAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Alcohol Poisoning, may become evident only after a product is in use by the general population.
Vivitrol Side Effect Report#9432315
Overdose
This Overdose side effect was reported by a health professional from US. A 41-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Vivitrol (vivitrol_nda) Injection, 380mg (drug dosage: NA), which was initiated on
Jun 11, 2013. Concurrently used drugs:
  • Gabapentin (gabapentin)
  • Valacyclovir Hcl (valacyclovir Hydrochloride)
  • Ibuprofen (ibuprofen)
  • Paxil (paroxetine Hydrochloride)
.After starting to take Vivitrol (vivitrol_nda) Injection, 380mg the consumer reported adverse symptoms, such as: OverdoseThese side effects may potentially be related to Vivitrol (vivitrol_nda) Injection, 380mg. The patient was hospitalized.
Vivitrol Side Effect Report#9416860
This is a report of a 24-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Vivitrol (dosage: 380 Mg, Qmo, Im, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Vivitrol treatment in male patients, resulting in Death side effect.


1 of 11 


The appearance of Vivitrol 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 Vivitrol Side Effects for Women?

Women Side Effects Reports
Injection Site Reaction 21
Injection Site Induration 15
Injection Site Pain 15
Injection Site Mass 14
Injection Site Abscess 13
Injection Site Necrosis 13
Injection Site Erythema 11
Injection Site Swelling 9
Nausea 8
Abscess 7

What are common Vivitrol Side Effects for Men?

Men Side Effects Reports
Death 15
Injection Site Pain 13
Alcohol Use 9
Nausea 9
Injection Site Reaction 8
Dyspnoea 7
Fall 7
Depression 6
Dizziness 6
Pancreatitis 6

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.

    Vivitrol 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 Vivitrol Side Effects

    Did You Have a Vivitrol Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Vivitrol for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Vivitrol Safety Alerts, Active Ingredients, Usage Information

    Vivitrol Dosage, Warnings, Usage.

    Side Effects reported to FDA: 256

    Vivitrol safety alerts: 2010 2008

    Reported deaths: 78

    Reported hospitalizations: 149

    Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients

    Audience: Substance Abuse healthcare providers, patients

    [Posted 05/04/2010] Alkermes and FDA notified healthcare professionals and patients of an update to the Warnings, Information for Patients, and Dosage and Administration sections of the Prescribing Information to strengthen language regarding the risk of injection site reactions based on postmarketing reports that had been received prior to June 2009.

    FDA requires that a Medication Guide, which communicates this and other important information about treatment be provided to all patients. Healthcare professionals should also counsel patients about the risks and benefits of Vivitrol before an initial prescription, including those risks and benefits set forth in the new Medication Guide and Prescribing Information, and should ensure that patients understand these risks.

    [05/04/2010 - Dear Healthcare Professional Letter - Alkermes]
    [03/2010 - Prescribing Information - Alkermes]
    [12/2009 - Medication Guide - Alkermes]

    Latest Vivitrol clinical trials