Suboxone side effects - from FDA reports


In this review, we analyze Suboxone side effects by the time on the drug, gender and age of the people who have side effects while taking Suboxone. The review is based on 15,491 people who have side effects while taking the drug from FDA, and is updated regularly.

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Suboxone

Suboxone has active ingredients of buprenorphine hydrochloride; naloxone hydrochloride. It is often used in opiate withdrawal. (latest outcomes from Suboxone 17,552 users)


On Aug, 07, 2018

15,491 people who take Suboxone are studied.


Number of reports submitted per year:

Suboxone side effects.

Most common side effects over time *:

< 1 month:
  • Vomiting
  • Substance abuse
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Drug withdrawal syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation)
  • Accidental exposure
  • Tremor (trembling or shaking movements in one or more parts of your body)
  • Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body)
  • Foetal exposure during pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect)
  • Drug exposure during pregnancy
  • Urticaria (rash of round, red welts on the skin that itch intensely)
1 - 6 months:
  • Foetal exposure during pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect)
  • Drug exposure during pregnancy
  • Maternal exposure during pregnancy (use of substance during pregnancy)
  • Vomiting
  • Drug withdrawal syndrome neonatal (prenatal nas is caused by discontinuation of drugs taken by the pregnant mother)
  • Premature baby
  • Drug withdrawal syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation)
  • Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body)
  • Low birth weight baby
  • Jaundice neonatal (yellowing of skin in neonate)
6 - 12 months:
  • Drug exposure during pregnancy
  • Premature baby
  • Foetal exposure during pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect)
  • Vomiting
  • Weight decreased
  • Drug withdrawal syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation)
  • Drug withdrawal syndrome neonatal (prenatal nas is caused by discontinuation of drugs taken by the pregnant mother)
  • Maternal exposure during pregnancy (use of substance during pregnancy)
  • Abortion spontaneous (naturally occurring miscarriage)
  • Pain
1 - 2 years:
  • Foetal exposure during pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect)
  • Vomiting
  • Drug exposure during pregnancy
  • Drug withdrawal syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation)
  • Pain
  • Pregnancy
  • Substance abuse
  • Agitation (state of anxiety or nervous excitement)
  • Abortion induced (medically referred abortion)
  • Abortion spontaneous (naturally occurring miscarriage)
2 - 5 years:
  • Vomiting
  • Drug withdrawal syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation)
  • Substance abuse
  • Withdrawal syndrome (a discontinuation syndrome is a set of symptoms occurred due to discontinuation of substance)
  • Death
  • Pneumonia
  • Weight decreased
  • Abortion spontaneous (naturally occurring miscarriage)
  • Maternal exposure during pregnancy (use of substance during pregnancy)
  • Premature labour
5 - 10 years:
  • Aggression
  • Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body)
  • Malaise (a feeling of general discomfort or uneasiness)
  • Migraine (headache)
  • Substance abuse
  • Urticaria (rash of round, red welts on the skin that itch intensely)
  • Vomiting
  • Abdominal discomfort
  • Leukopenia (less number of white blood cells in blood)
  • Pain
10+ years:
  • Depression
  • Limb injury
  • Pain
  • Pulmonary fibrosis (formation or development of excess fibrous connective tissue (fibrosis) in the lungs)
  • Road traffic accident
  • Seizure (abnormal excessive or synchronous neuronal activity in the brain)
  • Spinal column stenosis (narrowing of spinal column)
  • Thinking abnormal
not specified:
  • Vomiting
  • Substance abuse
  • Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body)
  • Suicidal ideation
  • Death
  • Pain
  • Drug exposure during pregnancy
  • Drug withdrawal syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation)
  • Therapeutic response unexpected
  • Weight decreased

Most common side effects by gender *:

female:
  • Vomiting
  • Drug exposure during pregnancy
  • Maternal exposure during pregnancy (use of substance during pregnancy)
  • Substance abuse
  • Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body)
  • Abortion spontaneous (naturally occurring miscarriage)
  • Drug withdrawal syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation)
  • Suicidal ideation
  • Pain
  • Anxiety
male:
  • Substance abuse
  • Vomiting
  • Suicidal ideation
  • Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body)
  • Drug withdrawal syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation)
  • Death
  • Weight decreased
  • Pain
  • Foetal exposure during pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect)
  • Overdose

Most common side effects by age *:

0-1:
  • Premature baby
  • Foetal exposure during pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect)
  • Low birth weight baby
  • Jaundice neonatal (yellowing of skin in neonate)
  • Drug exposure during pregnancy
  • Drug withdrawal syndrome neonatal (prenatal nas is caused by discontinuation of drugs taken by the pregnant mother)
  • Vomiting
  • Accidental exposure
  • Respiratory disorder neonatal (disease of respiratory organs in a month old baby)
  • Neonatal respiratory distress syndrome (a serious medical condition where a newborn baby's lungs cannot provide their body with enough oxygen)
2-9:
  • Accidental exposure
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Vomiting
  • Accidental drug intake by child
  • Drug exposure during pregnancy
  • Respiratory rate decreased (less breathing rate/min)
  • Foetal exposure during pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect)
  • Lethargy (tiredness)
  • Respiratory depression (respiration has a rate below 12 breaths)
  • Abnormal behaviour
10-19:
  • Death
  • Substance abuse
  • Overdose
  • Vomiting
  • Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body)
  • Suicidal ideation
  • Depression
  • Drug exposure during pregnancy
  • Loss of consciousness
  • Pre-eclampsia (high blood pressure and significant amounts of protein in the urine of a pregnant woman)
20-29:
  • Substance abuse
  • Vomiting
  • Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body)
  • Drug exposure during pregnancy
  • Suicidal ideation
  • Abortion spontaneous (naturally occurring miscarriage)
  • Maternal exposure during pregnancy (use of substance during pregnancy)
  • Weight decreased
  • Drug withdrawal syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation)
  • Overdose
30-39:
  • Vomiting
  • Substance abuse
  • Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body)
  • Maternal exposure during pregnancy (use of substance during pregnancy)
  • Drug withdrawal syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation)
  • Pain
  • Abortion spontaneous (naturally occurring miscarriage)
  • Suicidal ideation
  • Depression
  • Premature delivery
40-49:
  • Vomiting
  • Substance abuse
  • Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body)
  • Drug withdrawal syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation)
  • Suicidal ideation
  • Anxiety
  • Pain
  • Asthenia (weakness)
  • Myocardial infarction (destruction of heart tissue resulting from obstruction of the blood supply to the heart muscle)
  • Weight increased
50-59:
  • Vomiting
  • Anxiety
  • Suicidal ideation
  • Substance abuse
  • Depression
  • Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body)
  • Weight decreased
  • Drug withdrawal syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation)
  • Pain
  • Back pain
60+:
  • Vomiting
  • Drug withdrawal syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation)
  • Pain
  • Weight increased
  • Suicidal ideation
  • Insomnia (sleeplessness)
  • Loss of consciousness
  • Tremor (trembling or shaking movements in one or more parts of your body)
  • Substance abuse
  • Anxiety

* Approximation only. Some reports may have incomplete information.

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Want to find out more about the FDA reports used in the study? You can request them from FDA.

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On eHealthMe, Suboxone (buprenorphine hydrochloride; naloxone hydrochloride) is often used to treat drug dependence. Find out below the conditions the drugs are used for and how effective they are.

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