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Constipation (79)
Severe Edema In The Legs (55)
Fatigue (50)
Headache (50)
Abdomen (42)
Hypertension (30)
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Suboxone Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 3411 

Back Pain, Adrenal Mass, Hormone Level Abnormal, Underdose, Neck Pain, Substance Abuse, Constipation, Pulmonary Mass (8443162-1)
on Jun 05, 2012 Female from UNITED STATES , 24 years of age, was treated with Suboxone. Directly after, patient experienced the unwanted or unexpected Suboxone side effects: back pain, adrenal mass, hormone level abnormal, underdose, neck pain, substance abuse, constipation, pulmonary mass. Suboxone dosage: Dosing Details Not Provided. Patient was hospitalized.

Alcohol Abuse, Poor Quality Sleep, Substance Abuse, Hepatitis C, Diarrhoea, Hepatic Cirrhosis, Vomiting (8443161-X)
Patient was taking Suboxone. Patient felt the following Suboxone side effects: alcohol abuse, poor quality sleep, substance abuse, hepatitis c, diarrhoea, hepatic cirrhosis, vomiting on Jun 07, 2012 from UNITED STATES Additional patient health information: Male , 54 years of age, . Suboxone dosage: N/A.

Oedema Peripheral, Abasia, Chest Pain, Pulmonary Embolism (8443157-8)
Adverse event was reported on Jun 08, 2012 by a Female taking Suboxone (Dosage: N/A) . Location: UNITED STATES , 38 years of age, After Suboxone was administered, patient encountered several Suboxone side effects: oedema peripheral, abasia, chest pain, pulmonary embolism. Patient was hospitalized.

Nausea, Pain In Extremity, Arthropathy, Laryngitis, Therapeutic Response Decreased (8438427-3)
on Jun 05, 2012 Female from UNITED STATES , 52 years of age, was treated with Suboxone. Directly after, patient experienced the unwanted or unexpected Suboxone side effects: nausea, pain in extremity, arthropathy, laryngitis, therapeutic response decreased. Suboxone dosage: N/A. Patient was hospitalized.


Vasculitis, Eye Pain, Intraocular Pressure Increased, Migraine, Brain Neoplasm, Transient Ischaemic Attack, Anxiety, Glaucoma, Condition Aggravated (8438424-8)
on Jun 05, 2012 Female from UNITED STATES , 55 years of age, was treated with Suboxone. Patient felt the following Suboxone side effects: vasculitis, eye pain, intraocular pressure increased, migraine, brain neoplasm, transient ischaemic attack, anxiety, glaucoma, condition aggravated. Suboxone dosage: N/A.

Hepatic Neoplasm Malignant (8438422-4)
Patient was taking Suboxone. After Suboxone was administered, patient encountered several Suboxone side effects: hepatic neoplasm malignant on Jun 06, 2012 from UNITED STATES Additional patient health information: Male , 61 years of age, . Suboxone dosage: N/A.

Malabsorption, Product Formulation Issue, Swollen Tongue, Fluid Intake Reduced, Oral Pain, Hypophagia, Stomatitis (8435054-9)
Adverse event was reported on Jun 08, 2012 by a Male taking Suboxone (Dosage: 8/2mg 2x Day Sl) was diagnosed with
  • substance abuse
and. Location: UNITED STATES , 33 years of age, weighting 282.0 lb, Directly after, patient experienced the unwanted or unexpected Suboxone side effects: malabsorption, product formulation issue, swollen tongue, fluid intake reduced, oral pain, hypophagia, stomatitis.

Abnormal Behaviour, Overdose (8434368-6)
on Jun 04, 2012 Male from UNITED STATES , 48 years of age, was treated with Suboxone. Patient felt the following Suboxone side effects: abnormal behaviour, overdose. Suboxone dosage: N/A. Patient was hospitalized.

Maternal Exposure During Pregnancy, Suppressed Lactation, Substance Abuse, Premature Delivery (8430785-9)
on Jun 01, 2012 Female from UNITED STATES , 37 years of age, was treated with Suboxone. After Suboxone was administered, patient encountered several Suboxone side effects: maternal exposure during pregnancy, suppressed lactation, substance abuse, premature delivery. Suboxone dosage: N/A.
Multiple concurrent drugs taken:
  • Methadone Hcl
  • Buprenorphine


Activities Of Daily Living Impaired, Somnolence, Depression, Malaise, Suicidal Ideation (8430783-5)
Patient was taking Suboxone. Directly after, patient experienced the unwanted or unexpected Suboxone side effects: activities of daily living impaired, somnolence, depression, malaise, suicidal ideation on Jun 01, 2012 from UNITED STATES Additional patient health information: Female , 31 years of age, . Suboxone dosage: N/A.

Depression, Fatigue, Nervous System Disorder (8430779-3)
Adverse event was reported on Jun 04, 2012 by a Male taking Suboxone (Dosage: N/A) . Location: UNITED STATES , 62 years of age, Patient felt the following Suboxone side effects: depression, fatigue, nervous system disorder.

Maternal Exposure During Pregnancy, Abortion Spontaneous (8430775-6)
on Jun 05, 2012 Female from UNITED STATES , 32 years of age, was treated with Suboxone. After Suboxone was administered, patient encountered several Suboxone side effects: maternal exposure during pregnancy, abortion spontaneous. Suboxone dosage: N/A.
Multiple concurrent drugs taken:
  • Buprenorphine


Overdose, Dyspnoea, Gun Shot Wound, Local Swelling (8430772-0)
on Jun 04, 2012 Female from UNITED STATES , 29 years of age, was treated with Suboxone. Directly after, patient experienced the unwanted or unexpected Suboxone side effects: overdose, dyspnoea, gun shot wound, local swelling. Suboxone dosage: N/A.
Associated medications used:
  • Oxycontin (120 Tablets)


Pneumonia, Abdominal Pain Upper (8423991-0)
Patient was taking Suboxone. Patient felt the following Suboxone side effects: pneumonia, abdominal pain upper on May 31, 2012 from UNITED STATES Additional patient health information: Female , 53 years of age, . Suboxone dosage: N/A. Patient was hospitalized.

Infection, Nausea, Incision Site Oedema, Foot Fracture, Pain In Extremity, Thrombosis, Oedema Peripheral (8423990-9)
Adverse event was reported on May 31, 2012 by a Female taking Suboxone (Dosage: N/A) . Location: UNITED STATES , 34 years of age, After Suboxone was administered, patient encountered several Suboxone side effects: infection, nausea, incision site oedema, foot fracture, pain in extremity, thrombosis, oedema peripheral. Patient was hospitalized.

Insomnia, Depression, Dehydration (8423988-0)
on May 31, 2012 Female from UNITED STATES , 25 years of age, was treated with Suboxone. Directly after, patient experienced the unwanted or unexpected Suboxone side effects: insomnia, depression, dehydration. Suboxone dosage: N/A. Patient was hospitalized.

Balance Disorder, Road Traffic Accident, Impaired Work Ability, Anxiety, Depression, Coma, Hypertension, Headache, Amnesia (8420426-9)
on May 29, 2012 Male from UNITED STATES , 37 years of age, was treated with Suboxone. Patient felt the following Suboxone side effects: balance disorder, road traffic accident, impaired work ability, anxiety, depression, coma, hypertension, headache, amnesia. Suboxone dosage: N/A.
Multiple prescriptions taken:
  • Motrin
  • Nexium
Patient was hospitalized and became disabled.

Feeding Disorder Neonatal, Cleft Palate, Foetal Exposure During Pregnancy (8417642-9)
Patient was taking Suboxone. After Suboxone was administered, patient encountered several Suboxone side effects: feeding disorder neonatal, cleft palate, foetal exposure during pregnancy on May 30, 2012 from UNITED STATES Additional patient health information: Male , weighting 7.05 lb, . Suboxone dosage: 8 Mg Daily.
Multiple concurrent drugs taken:
  • Nicotine (Dosing Details Not Provided)
  • Buprenorphine (16 Mg Daily)


Therapeutic Response Decreased, Maternal Exposure During Pregnancy, Hyperhidrosis, Parosmia, Dizziness, Apathy, Migraine, Photopsia (8417640-5)
Adverse event was reported on May 29, 2012 by a Female taking Suboxone (Dosage: Dosing Details Not Provided) . Location: UNITED STATES , 24 years of age, Directly after, patient experienced the unwanted or unexpected Suboxone side effects: therapeutic response decreased, maternal exposure during pregnancy, hyperhidrosis, parosmia, dizziness, apathy, migraine, photopsia.

Burning Sensation, Musculoskeletal Stiffness (8409236-6)
on May 25, 2012 Female from UNITED STATES , 63 years of age, was treated with Suboxone. Patient felt the following Suboxone side effects: burning sensation, musculoskeletal stiffness. Suboxone dosage: N/A. Patient was hospitalized.

Emotional Disorder, Suicidal Ideation, Mood Altered, Weight Increased, Ovarian Cyst, Depression, Feeling Of Body Temperature Change, Ovarian Enlargement, Blood Cholesterol Abnormal (8404836-1)
on May 23, 2012 Female from UNITED STATES , 27 years of age, was treated with Suboxone. After Suboxone was administered, patient encountered several Suboxone side effects: emotional disorder, suicidal ideation, mood altered, weight increased, ovarian cyst, depression, feeling of body temperature change, ovarian enlargement, blood cholesterol abnormal. Suboxone dosage: N/A.

Toxicity To Various Agents, Pneumonia Staphylococcal, Loss Of Consciousness, Bronchopneumonia, Respiratory Failure, Cardiac Arrest, Bladder Dilatation (8404835-X)
Patient was taking Suboxone. Directly after, patient experienced the unwanted or unexpected Suboxone side effects: toxicity to various agents, pneumonia staphylococcal, loss of consciousness, bronchopneumonia, respiratory failure, cardiac arrest, bladder dilatation on May 24, 2012 from UNITED STATES Additional patient health information: Male , weighting 22.27 lb, . Suboxone dosage: N/A.

Skin Ulcer, Off Label Use (8404831-2)
Adverse event was reported on May 24, 2012 by a Female taking Suboxone (Dosage: N/A) was diagnosed with
  • pain
and. Location: UNITED STATES , 79 years of age, Patient felt the following Suboxone side effects: skin ulcer, off label use. Patient was hospitalized.

Pyrexia, Sleep Disorder, Chronic Obstructive Pulmonary Disease, Vomiting, Coma, Suicidal Ideation, Feeling Hot, Dyspnoea, Haematemesis (8400815-9)
on May 24, 2012 Female from UNITED STATES , 48 years of age, was treated with Suboxone. After Suboxone was administered, patient encountered several Suboxone side effects: pyrexia, sleep disorder, chronic obstructive pulmonary disease, vomiting, coma, suicidal ideation, feeling hot, dyspnoea, haematemesis. Suboxone dosage: One 8 Mg Tablet Only. Patient was hospitalized.

Abdominal Pain Upper, Fear, Anxiety, Nausea, Self-injurious Ideation, Feeling Abnormal, Panic Attack, Bipolar I Disorder (8397215-7)
on May 22, 2012 Female from UNITED STATES , 53 years of age, was treated with Suboxone. Directly after, patient experienced the unwanted or unexpected Suboxone side effects: abdominal pain upper, fear, anxiety, nausea, self-injurious ideation, feeling abnormal, panic attack, bipolar i disorder. Suboxone dosage: N/A. Patient was hospitalized.

Showing 1-25 of 3411 

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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 Information

Alternative SUBOXONE Names:BUPRENORP

Active Ingredient: BUPRENORP

More About Suboxone

Side Effects reported to FDA: 3411. View Suboxone Adverse Reports

Suboxone safety alerts: No

Reported deaths: 162

Reported hospitalizations: 1512

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