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Suboxone Side Effects

PatientsVille

Common Suboxone Side Effects


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

Insomnia (517)
Convulsion (455)
Depression (410)
Anxiety (373)
Suicidal Ideation (349)
Headache (346)
Nausea (339)
Vomiting (333)
Substance Abuse (326)
Pain (314)
Fatigue (242)
Hyperhidrosis (239)
Loss Of Consciousness (236)
Back Pain (222)
Off Label Use (219)
Underdose (211)
Constipation (208)
Condition Aggravated (198)
Dyspnoea (193)
Hallucination (191)

➢ 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.

Suboxone Side Effects Reported to FDA



Suboxone Side Effect Report#9997948
Depression
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 Suboxone (dosage: NA, start time: 2011), combined with:
  • Subutex
and developed a serious reaction and side effect(s): Depression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Suboxone treatment in female patients, resulting in Depression side effect. The patient was hospitalized.
Suboxone Side Effect Report#9997825
Convulsion, Vomiting
This report suggests a potential Suboxone Convulsion side effect(s) that can have serious consequences. A 30-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Suboxone (dosage: NA) starting 2002. After starting Suboxone the patient began experiencing various side effects, including: Convulsion, VomitingAdditional drugs used concurrently:
  • Buprenorphine
  • Xanax
  • Klonopin
Although Suboxone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Convulsion, may still occur.
Suboxone Side Effect Report#9997818
Irritability, Feeling Abnormal
This Irritability problem was reported by a consumer or non-health professional from US. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 2008 this consumer started treatment with Suboxone (dosage: NA). The following drugs were being taken at the same time:
  • Subutex 8 Mg
When using Suboxone, the patient experienced the following unwanted symptoms/side effects: Irritability, Feeling AbnormalAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Irritability, may become evident only after a product is in use by the general population.
Suboxone Side Effect Report#9997749
Dehydration, Migraine, Abdominal Discomfort
This Dehydration side effect was reported by a consumer or non-health professional from US. A 25-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Suboxone 8 Mg (drug dosage: NA), which was initiated on 2007. Concurrently used drugs:
  • Buprenorphine
.After starting to take Suboxone 8 Mg the consumer reported adverse symptoms, such as: Dehydration, Migraine, Abdominal DiscomfortThese side effects may potentially be related to Suboxone 8 Mg. The patient was hospitalized.
Suboxone Side Effect Report#9997563
Pharyngeal Oedema, Swelling Face
This is a report of a 24-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Suboxone (dosage: NA, start time: NS), combined with:
  • Subutex
and developed a serious reaction and side effect(s): Pharyngeal Oedema, Swelling Face after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Suboxone treatment in female patients, resulting in Pharyngeal Oedema side effect.
Suboxone Side Effect Report#9997557
Hallucination, Vomiting, Abdominal Pain Upper, Diarrhoea, Dyspnoea, Substance Abuse, Feeling Of Body Temperature Change
This report suggests a potential Suboxone 8 Mg Hallucination side effect(s) that can have serious consequences. A 39-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Suboxone 8 Mg (dosage: NA) starting 2011. After starting Suboxone 8 Mg the patient began experiencing various side effects, including: Hallucination, Vomiting, Abdominal Pain Upper, Diarrhoea, Dyspnoea, Substance Abuse, Feeling Of Body Temperature ChangeAdditional drugs used concurrently: NA. Although Suboxone 8 Mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hallucination, may still occur.
Suboxone Side Effect Report#9996738
Fall
This Fall problem was reported by a consumer or non-health professional from US. A 26-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Suboxone (dosage: NA). The following drugs were being taken at the same time:
  • Buprenorphine
When using Suboxone, the patient experienced the following unwanted symptoms/side effects: FallAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Fall, may become evident only after a product is in use by the general population.
Suboxone Side Effect Report#9996486
Foetal Exposure During Pregnancy
This Foetal Exposure During Pregnancy side effect was reported by a consumer or non-health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Suboxone (drug dosage: Film; Neonate Was Exposed To 2-8 Mg Daily Due To Mother^s Cutting Film Transplacental), which was initiated on 201206. Concurrently used drugs:
  • Buprenorphine (Mother Was Cutting The Tablet And Taking 2-8 Mg Daily, Transplacental)
  • Nicotine (1/3 Pack Daily, Transplacental)
  • Prenatal Vitamins (Dosing: 1 Tablet Daily, Transplacental)
.After starting to take Suboxone the consumer reported adverse symptoms, such as: Foetal Exposure During PregnancyThese side effects may potentially be related to Suboxone. The patient was hospitalized.
Suboxone Side Effect Report#9996450
Anxiety, Diarrhoea, Fatigue, Pain, Hepatic Enzyme Increased
This is a report of a 23-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Suboxone (dosage: (8 Mg, Suboxone Film Sublingual)?, start time:
Sep 20, 2013), combined with:
  • Buprenorphine
  • Paxil
  • Wellbutrin
and developed a serious reaction and side effect(s): Anxiety, Diarrhoea, Fatigue, Pain, Hepatic Enzyme Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Suboxone treatment in male patients, resulting in Anxiety side effect. The patient was hospitalized.
Suboxone Side Effect Report#9993790
Diabetes Mellitus, Genital Burning Sensation, Urine Abnormality
This report suggests a potential Suboxone Tablet Diabetes Mellitus side effect(s) that can have serious consequences. A 49-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Suboxone Tablet (dosage: In The Morning) starting
Sep 27, 2013. After starting Suboxone Tablet the patient began experiencing various side effects, including: Diabetes Mellitus, Genital Burning Sensation, Urine AbnormalityAdditional drugs used concurrently: NA.The patient was hospitalized. Although Suboxone Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diabetes Mellitus, may still occur.
Suboxone Side Effect Report#9993771
Off Label Use, Pancreatitis
This Off Label Use problem was reported by a consumer or non-health professional from US. A 25-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Feb 21, 2014 this consumer started treatment with Suboxone Film (dosage: Suboxone Film). The following drugs were being taken at the same time: NA. When using Suboxone Film, the patient experienced the following unwanted symptoms/side effects: Off Label Use, PancreatitisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Off Label Use, may become evident only after a product is in use by the general population.
Suboxone Side Effect Report#9987973
Maternal Exposure During Pregnancy, Intentional Underdose, Exposure Via Father, Uterine Contractions During Pregnancy, Abortion Spontaneous
This Maternal Exposure During Pregnancy side effect was reported by a consumer or non-health professional from US. A 38-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Suboxone Film (drug dosage: Suboxone Film), which was initiated on 201304. Concurrently used drugs: NA..After starting to take Suboxone Film the consumer reported adverse symptoms, such as: Maternal Exposure During Pregnancy, Intentional Underdose, Exposure Via Father, Uterine Contractions During Pregnancy, Abortion SpontaneousThese side effects may potentially be related to Suboxone Film.
Suboxone Side Effect Report#9987962
Unevaluable Event, Hypertension, Uterine Mass, Obstructive Airways Disorder, Dyspnoea, Asthma, Renal Disorder, Oral Candidiasis, Dysphagia
This is a report of a 60-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Suboxone Film (dosage: Suboxone Film, start time:
Nov 17, 2013), combined with: NA. and developed a serious reaction and side effect(s): Unevaluable Event, Hypertension, Uterine Mass, Obstructive Airways Disorder, Dyspnoea, Asthma, Renal Disorder, Oral Candidiasis, Dysphagia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Suboxone Film treatment in female patients, resulting in Unevaluable Event side effect. The patient was hospitalized.
Suboxone Side Effect Report#9976080
Maternal Exposure During Pregnancy, Abortion Spontaneous
This report suggests a potential Suboxone Tablet Maternal Exposure During Pregnancy side effect(s) that can have serious consequences. A 31-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Suboxone Tablet (dosage: NA) starting NS. After starting Suboxone Tablet the patient began experiencing various side effects, including: Maternal Exposure During Pregnancy, Abortion SpontaneousAdditional drugs used concurrently: NA. Although Suboxone Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Maternal Exposure During Pregnancy, may still occur.
Suboxone Side Effect Report#9976079
Rotator Cuff Syndrome, Road Traffic Accident, Tendon Rupture, Rib Fracture, Disability, Anxiety, Intentional Underdose
This Rotator Cuff Syndrome problem was reported by a consumer or non-health professional from US. A 54-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201309 this consumer started treatment with Suboxone Tablet (dosage: NA). The following drugs were being taken at the same time:
  • Suboxone Film (Suboxone Film)
  • Suboxone Film (Suboxone Film; Medicaly Tapered To 8 Mg/daily; Cutting The Film)
  • Suboxone Film (Suboxone Film; Prescribed 24 Mg/daily, Takes Less Than Prescribed (8 To 12 Mg Daily))
  • Suboxone Film
  • Clonazepam
  • Clonazepam
When using Suboxone Tablet, the patient experienced the following unwanted symptoms/side effects: Rotator Cuff Syndrome, Road Traffic Accident, Tendon Rupture, Rib Fracture, Disability, Anxiety, Intentional UnderdoseThe patient was hospitalized and became disabled.Although 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.
Suboxone Side Effect Report#9976075
Alcohol Abuse, Maternal Exposure During Pregnancy, Stress, Haemorrhage In Pregnancy, Abortion Spontaneous, Post Abortion Haemorrhage
This Alcohol Abuse side effect was reported by a consumer or non-health professional from US. A 27-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Suboxone Film (drug dosage: Suboxone Film), which was initiated on 201311. Concurrently used drugs: NA..After starting to take Suboxone Film the consumer reported adverse symptoms, such as: Alcohol Abuse, Maternal Exposure During Pregnancy, Stress, Haemorrhage In Pregnancy, Abortion Spontaneous, Post Abortion HaemorrhageThese side effects may potentially be related to Suboxone Film.
Suboxone Side Effect Report#9976066
Affective Disorder, Alcohol Abuse, Suicidal Ideation, Alcohol Poisoning
This is a report of a 28-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Suboxone Film (dosage: Suboxone Film, start time: NS), combined with:
  • Alcohol
and developed a serious reaction and side effect(s): Affective Disorder, Alcohol Abuse, Suicidal Ideation, Alcohol Poisoning after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Suboxone Film treatment in male patients, resulting in Affective Disorder side effect. The patient was hospitalized.
Suboxone Side Effect Report#9966952
Endocarditis
This report suggests a potential Suboxone Film Endocarditis side effect(s) that can have serious consequences. A 45-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Suboxone Film (dosage: Suboxone Film) starting 201309. After starting Suboxone Film the patient began experiencing various side effects, including: EndocarditisAdditional drugs used concurrently:
  • Heroin
  • Klonopin
  • Lexapro
The patient was hospitalized. Although Suboxone Film demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Endocarditis, may still occur.
Suboxone Side Effect Report#9935663
Suicidal Ideation, Dyspnoea, Chest Pain, Tremor, Insomnia, Vomiting, Abdominal Pain, Hyperhidrosis
This Suicidal Ideation problem was reported by a consumer or non-health professional from US. A 30-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201308 this consumer started treatment with Suboxone Film (dosage: Suboxone Film, Used For About 6 Months). The following drugs were being taken at the same time: NA. When using Suboxone Film, the patient experienced the following unwanted symptoms/side effects: Suicidal Ideation, Dyspnoea, Chest Pain, Tremor, Insomnia, Vomiting, Abdominal Pain, HyperhidrosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Suicidal Ideation, may become evident only after a product is in use by the general population.
Suboxone Side Effect Report#9935660
Anxiety, Hypertension, Type 2 Diabetes Mellitus, Arthropathy, Road Traffic Accident, Brain Injury, Concussion, Memory Impairment
This Anxiety side effect was reported by a consumer or non-health professional from US. A 40-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Suboxone Tablet (drug dosage: 1/2 Tablet Twice Daily), which was initiated on 2011. Concurrently used drugs:
  • Suboxone Film (Suboxone Film; 1/2 Strip Twice A Day)
  • Subutex (1/2 Tablet, Using Various Doses)
.After starting to take Suboxone Tablet the consumer reported adverse symptoms, such as: Anxiety, Hypertension, Type 2 Diabetes Mellitus, Arthropathy, Road Traffic Accident, Brain Injury, Concussion, Memory ImpairmentThese side effects may potentially be related to Suboxone Tablet. The patient was hospitalized.
Suboxone Side Effect Report#9935659
Substance Abuse, Road Traffic Accident, Facial Bones Fracture, Laceration, Concussion
This is a report of a 27-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Suboxone Film (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Substance Abuse, Road Traffic Accident, Facial Bones Fracture, Laceration, Concussion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Suboxone Film treatment in male patients, resulting in Substance Abuse side effect. The patient was hospitalized.
Suboxone Side Effect Report#9929929
Substance Abuse, Hypersensitivity, Nausea, Vomiting, Pulmonary Mass, Renal Mass, Pneumothorax
This report suggests a potential Suboxone Tablet Substance Abuse side effect(s) that can have serious consequences. A 34-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Suboxone Tablet (dosage: NA) starting 1990. After starting Suboxone Tablet the patient began experiencing various side effects, including: Substance Abuse, Hypersensitivity, Nausea, Vomiting, Pulmonary Mass, Renal Mass, PneumothoraxAdditional drugs used concurrently:
  • Suboxone Film
The patient was hospitalized. Although Suboxone Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Substance Abuse, may still occur.
Suboxone Side Effect Report#9929926
Hospitalisation
This Hospitalisation problem was reported by a pharmacist 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 Suboxone Film (dosage: NA). The following drugs were being taken at the same time: NA. When using Suboxone Film, the patient experienced the following unwanted symptoms/side effects: HospitalisationThe 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 Hospitalisation, may become evident only after a product is in use by the general population.
Suboxone Side Effect Report#9923947
Intentional Underdose, Chest Pain, Malaise
This Intentional Underdose side effect was reported by a consumer or non-health professional from US. A 41-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Suboxone Film (drug dosage: Suboxone Film), which was initiated on
Feb 14, 2014. Concurrently used drugs: NA..After starting to take Suboxone Film the consumer reported adverse symptoms, such as: Intentional Underdose, Chest Pain, MalaiseThese side effects may potentially be related to Suboxone Film.
Suboxone Side Effect Report#9921997
Peritonsillar Abscess, Subcutaneous Abscess, Abscess Rupture, Pain, Blood Pressure Increased
This is a report of a 40-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Suboxone (dosage: 8mg. Strips?1 1/2 Films Daily ?12mg Daily ?once Daily ?bilingually, start time: 201312), combined with:
  • Advair
  • Proair
and developed a serious reaction and side effect(s): Peritonsillar Abscess, Subcutaneous Abscess, Abscess Rupture, Pain, Blood Pressure Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Suboxone treatment in male patients, resulting in Peritonsillar Abscess side effect.


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The appearance of Suboxone 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.

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What are common Suboxone Side Effects for Women?

Women Side EffectsReports
Convulsion 247
Insomnia 246
Nausea 204
Depression 197
Headache 197
Vomiting 192
Anxiety 182
Substance Abuse 159
Pain 153
Exposure During Pregnancy 148

What are common Suboxone Side Effects for Men?

Men Side EffectsReports
Insomnia 271
Depression 213
Convulsion 205
Suicidal Ideation 205
Anxiety 191
Substance Abuse 165
Pain 161
Headache 149
Vomiting 140
Hyperhidrosis 136

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.

    Suboxone 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 Suboxone Side Effects

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    How Effective is Suboxone for You?

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    Suboxone Safety Alerts, Active Ingredients, Usage Information

    NDC12496-1202
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameSuboxone buprenorphine hydrochloride, naloxone hydrochloride
    NameFILM, SOLUBLE
    Dosage FormSUBLINGUAL
    Route20100913
    On market sinceReckitt Benckiser Pharmaceuticals Inc
    LabelerBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
    Active Ingredient(s)2; .5
    Strength(s)mg/1; mg/1
    Unit(s)Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonist
    Pharma Class

    More About Suboxone

    Side Effects reported to FDA: 4865

    Suboxone safety alerts: No

    Reported deaths: 259

    Reported hospitalizations: 1923

    Latest Suboxone clinical trials