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Somatuline Side Effects

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Common Somatuline Side Effects

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

Diarrhoea (64)
Nausea (39)
Death (32)
Headache (31)
Abdominal Pain (29)
Cholelithiasis (29)
Condition Aggravated (26)
Vomiting (24)
Injection Site Pain (24)
Injection Site Nodule (22)
Asthenia (22)
Fatigue (21)
Weight Decreased (18)
Off Label Use (18)
Malaise (15)
Dyspnoea (15)
Abdominal Distension (14)
Flatulence (14)
Constipation (13)
Neoplasm Progression (12)

➢ 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.

Somatuline Side Effects Reported to FDA



Somatuline Side Effect Report#9991513
Atrial Fibrillation
This is a report of a 77-year-old male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: acromegaly, who was treated with Somatuline (dosage: 90 Mg, start time:
Jul 26, 2007), combined with: NA. and developed a serious reaction and side effect(s): Atrial Fibrillation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Somatuline treatment in male patients, resulting in Atrial Fibrillation side effect. The patient was hospitalized.
Somatuline Side Effect Report#9991506
Disease Progression
This report suggests a potential Somatuline Autogel 120mg Disease Progression side effect(s) that can have serious consequences. A 81-year-old male patient (weight: NA) from IL was diagnosed with the following symptoms/conditions: neuroendocrine tumour and used Somatuline Autogel 120mg (dosage: 120mg) starting 201105. After starting Somatuline Autogel 120mg the patient began experiencing various side effects, including: Disease ProgressionAdditional drugs used concurrently: NA. Although Somatuline Autogel 120mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Disease Progression, may still occur.
Somatuline Side Effect Report#9986190
Cerebral Haemorrhage
This Cerebral Haemorrhage problem was reported by a health professional from NL. A 63-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: carcinoid syndrome. On
Oct 18, 2011 this consumer started treatment with Somatuline Autosolution 120mg (dosage: 120 Mg). The following drugs were being taken at the same time:
  • Vitamin B (Not Reported)
When using Somatuline Autosolution 120mg, the patient experienced the following unwanted symptoms/side effects: Cerebral HaemorrhageAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cerebral Haemorrhage, may become evident only after a product is in use by the general population.
Somatuline Side Effect Report#9972776
This Death side effect was reported by a consumer or non-health professional from GB. A 69-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Somatuline Autogel 60mg (drug dosage: 60 Mg), which was initiated on NS. Concurrently used drugs: NA..After starting to take Somatuline Autogel 60mg the consumer reported adverse symptoms, such as: These side effects may potentially be related to Somatuline Autogel 60mg.
Somatuline Side Effect Report#9961373
This is a report of a 85-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Somatuline Autogel 60mg (dosage: Not Reported, 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 Somatuline Autogel 60mg treatment in male patients, resulting in Death side effect.
Somatuline Side Effect Report#9951806
Hip Arthroplasty
This report suggests a potential Somatuline 90 Mg Hip Arthroplasty side effect(s) that can have serious consequences. A 59-year-old male patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: acromegaly and used Somatuline 90 Mg (dosage: 90 Mg) starting
Nov 07, 2013. After starting Somatuline 90 Mg the patient began experiencing various side effects, including: Hip ArthroplastyAdditional drugs used concurrently: NA.The patient was hospitalized. Although Somatuline 90 Mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hip Arthroplasty, may still occur.
Somatuline Side Effect Report#9929098
Myocardial Infarction
This Myocardial Infarction problem was reported by a health professional from NL. A 63-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: acromegaly. On
Dec 09, 2009 this consumer started treatment with Somatuline Autosolution 120mg (dosage: 120 Mg). The following drugs were being taken at the same time: NA. When using Somatuline Autosolution 120mg, the patient experienced the following unwanted symptoms/side effects: Myocardial InfarctionThe 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 Myocardial Infarction, may become evident only after a product is in use by the general population.
Somatuline Side Effect Report#9922237
Rash
This Rash side effect was reported by a physician from SE. A 57-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Somatuline Pr 30mg (drug dosage: Not Reported), which was initiated on 201312. Concurrently used drugs: NA..After starting to take Somatuline Pr 30mg the consumer reported adverse symptoms, such as: RashThese side effects may potentially be related to Somatuline Pr 30mg.
Somatuline Side Effect Report#9916409
Pneumonia
This is a report of a 66-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: acromegaly,hypopituitarism, who was treated with Somatuline Depot Injection (120mg) (dosage: 120 Mg, start time:
Mar 21, 2012), combined with:
  • Synthroid (150 Mcg)
  • Bromocriptine (2.5 (not Reported))
  • Prednisone (1.5 Tablet)
  • Gemfibrozil
  • Metanx (3-35-2 Mg)
  • Mirapex
  • Zetia
  • Famotidine (Not Reported)
and developed a serious reaction and side effect(s): Pneumonia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Somatuline Depot Injection (120mg) treatment in female patients, resulting in Pneumonia side effect. The patient was hospitalized.
Somatuline Side Effect Report#9905240
This report suggests a potential Somatuline Autogel 120mg Death side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Somatuline Autogel 120mg (dosage: 120 Mg) starting NS. After starting Somatuline Autogel 120mg the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Somatuline Autogel 120mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Somatuline Side Effect Report#9899000
Cerebral Haemangioma
This Cerebral Haemangioma problem was reported by a health professional from Country Not Specified. A 57-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: acromegaly. On 2013 this consumer started treatment with Somatuline Depot Injection (120mg) (dosage: 90 Mg). The following drugs were being taken at the same time: NA. When using Somatuline Depot Injection (120mg), the patient experienced the following unwanted symptoms/side effects: Cerebral HaemangiomaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cerebral Haemangioma, may become evident only after a product is in use by the general population.
Somatuline Side Effect Report#9893745
Syncope
This Death side effect was reported by a consumer or non-health professional from Country Not Specified. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: carcinoid tumour.The patient was prescribed Somatuline Depot Injection (120mg) (drug dosage: 120mg), which was initiated on
Jun 26, 2010. Concurrently used drugs: NA..After starting to take Somatuline Depot Injection (120mg) the consumer reported adverse symptoms, such as: SyncopeThese side effects may potentially be related to Somatuline Depot Injection (120mg).
Somatuline Side Effect Report#9893739
Hypoglycaemic Coma, Hypoglycaemia
This is a report of a 58-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Somatuline L.p. 120mg (dosage: 120 Mg, start time: 201301), combined with:
  • Bisoprolol (2.5 Mg In The Morning)
  • Triatec (5 Mg In The Morning)
  • Lasilix
  • Diffuk
and developed a serious reaction and side effect(s): Hypoglycaemic Coma, Hypoglycaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Somatuline L.p. 120mg treatment in male patients, resulting in Hypoglycaemic Coma side effect. The patient was hospitalized.
Somatuline Side Effect Report#9890308
Syncope, Atrial Fibrillation
This report suggests a potential Somatuline La Syncope side effect(s) that can have serious consequences. A 77-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: neuroendocrine tumour and used Somatuline La (dosage: 60 Mg) starting
Dec 11, 2013. After starting Somatuline La the patient began experiencing various side effects, including: Syncope, Atrial FibrillationAdditional drugs used concurrently: NA. Although Somatuline La demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Syncope, may still occur.
Somatuline Side Effect Report#9890307
Eosinophilia, Interstitial Lung Disease
This Eosinophilia problem was reported by a health professional from FR. A 65-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: gastrointestinal haemorrhage,off label use. On
Jan 07, 2014 this consumer started treatment with Somatuline Lp 30mg (dosage: 30 Mg). The following drugs were being taken at the same time: NA. When using Somatuline Lp 30mg, the patient experienced the following unwanted symptoms/side effects: Eosinophilia, Interstitial Lung DiseaseThe 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 Eosinophilia, may become evident only after a product is in use by the general population.
Somatuline Side Effect Report#9881766
Dehydration
This Dehydration side effect was reported by a health professional from NL. A 64-year-old male patient (weight:NA) experienced the following symptoms/conditions: acromegaly.The patient was prescribed Somatuline Autosolution 120mg (drug dosage: 120mg), which was initiated on
May 31, 2011. Concurrently used drugs: NA..After starting to take Somatuline Autosolution 120mg the consumer reported adverse symptoms, such as: DehydrationThese side effects may potentially be related to Somatuline Autosolution 120mg. The patient was hospitalized.
Somatuline Side Effect Report#9880902
Adverse Event
This is a report of a 60-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: acromegaly, who was treated with Somatuline Autogel 120mg (dosage: 120 Mg, start time: NS), combined with:
  • Omeprazole (Not Reported)
  • Mesalazine (Not Reported)
and developed a serious reaction and side effect(s): Adverse Event after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Somatuline Autogel 120mg treatment in male patients, resulting in Adverse Event side effect.
Somatuline Side Effect Report#9866774
Decubitus Ulcer, Asthenia
This report suggests a potential Somatuline Autosolution 120mg Death side effect(s) that can have serious consequences. A 65-year-old male patient (weight: NA) from NL was diagnosed with the following symptoms/conditions: neuroendocrine tumour and used Somatuline Autosolution 120mg (dosage: 120mg) starting
Apr 26, 2013. After starting Somatuline Autosolution 120mg the patient began experiencing various side effects, including: Decubitus Ulcer, AstheniaAdditional drugs used concurrently: NA. Although Somatuline Autosolution 120mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Somatuline Side Effect Report#9866773
Depression
This Depression problem was reported by a physician from Country Not Specified. A 43-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: diarrhoea. On
Nov 22, 2011 this consumer started treatment with Somatuline Autogel Injectable 120mg (dosage: 120 Mg). The following drugs were being taken at the same time:
  • Mirtazapine (Not Reported)
  • Nexiam (Not Reported)
When using Somatuline Autogel Injectable 120mg, the patient experienced the following unwanted symptoms/side effects: DepressionThe 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 Depression, may become evident only after a product is in use by the general population.
Somatuline Side Effect Report#9860257
Adrenal Insufficiency, Chest Pain, Blood Cortisol Decreased, Affect Lability, Disturbance In Social Behaviour, Weight Increased, Alopecia, Weight Decreased, Asthenia
This Adrenal Insufficiency side effect was reported by a health professional from Country Not Specified. A 43-year-old female patient (weight:NA) experienced the following symptoms/conditions: acromegaly.The patient was prescribed Somatuline Depot Injection (90mg) (drug dosage: 90 Mg), which was initiated on
Jan 17, 2012. Concurrently used drugs: NA..After starting to take Somatuline Depot Injection (90mg) the consumer reported adverse symptoms, such as: Adrenal Insufficiency, Chest Pain, Blood Cortisol Decreased, Affect Lability, Disturbance In Social Behaviour, Weight Increased, Alopecia, Weight Decreased, AstheniaThese side effects may potentially be related to Somatuline Depot Injection (90mg).
Somatuline Side Effect Report#9851691
Stress Fracture
This is a report of a 60-year-old male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: blood growth hormone increased,off label use,diabetes mellitus, who was treated with Somatuline Depot Injection (90mg) (dosage: 90 Mg, start time: 201312), combined with: NA. and developed a serious reaction and side effect(s): Stress Fracture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Somatuline Depot Injection (90mg) treatment in male patients, resulting in Stress Fracture side effect.
Somatuline Side Effect Report#9846314
Pituitary Tumour Removal
This report suggests a potential Somatuline Autogel 90 Mg Pituitary Tumour Removal side effect(s) that can have serious consequences. A 68-year-old female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: acromegaly and used Somatuline Autogel 90 Mg (dosage: 90 Mg) starting 2003. After starting Somatuline Autogel 90 Mg the patient began experiencing various side effects, including: Pituitary Tumour RemovalAdditional drugs used concurrently:
  • Omeprazol
  • Metobeta
  • Candesartan
  • Tramal Long
The patient was hospitalized. Although Somatuline Autogel 90 Mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pituitary Tumour Removal, may still occur.
Somatuline Side Effect Report#9836510
Lung Cancer Metastatic, White Blood Cell Count Decreased, Injection Site Pain, Fatigue
This Lung Cancer Metastatic problem was reported by a health professional from Country Not Specified. A 72-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: acromegaly. On
May 13, 2013 this consumer started treatment with Somatuline Depot Injection (90mg) (dosage: 90 Mg). The following drugs were being taken at the same time:
  • Neupogen (Not Reported)
When using Somatuline Depot Injection (90mg), the patient experienced the following unwanted symptoms/side effects: Lung Cancer Metastatic, White Blood Cell Count Decreased, Injection Site Pain, FatigueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Lung Cancer Metastatic, may become evident only after a product is in use by the general population.
Somatuline Side Effect Report#9826254
Metastasis
This Metastasis side effect was reported by a physician from Country Not Specified. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: acromegaly,pituitary tumour.The patient was prescribed Somatuline Depot Injection (120mg) (drug dosage: 120 Mg), which was initiated on
May 02, 2012. Concurrently used drugs: NA..After starting to take Somatuline Depot Injection (120mg) the consumer reported adverse symptoms, such as: MetastasisThese side effects may potentially be related to Somatuline Depot Injection (120mg).
Somatuline Side Effect Report#9826252
Osteoarthritis, Hypoglycaemia
This is a report of a 64-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: acromegaly, who was treated with Somatuline Depot Injection (90mg) (dosage: 90 Mg, start time:
Sep 19, 2013), combined with: NA. and developed a serious reaction and side effect(s): Osteoarthritis, Hypoglycaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Somatuline Depot Injection (90mg) treatment in female patients, resulting in Osteoarthritis side effect. The patient was hospitalized.


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The appearance of Somatuline 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 Somatuline Side Effects for Women?

Women Side EffectsReports
Diarrhoea 29
Nausea 22
Abdominal Pain 19
Vomiting 16
Asthenia 13
Condition Aggravated 13
Death 13
Fatigue 13
Injection Site Nodule 13
Headache 12

What are common Somatuline Side Effects for Men?

Men Side EffectsReports
Diarrhoea 34
Cholelithiasis 25
Death 19
Headache 19
Nausea 17
Condition Aggravated 13
Injection Site Pain 11
Weight Decreased 11
Abdominal Distension 10
Off Label Use 10

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.

    Somatuline 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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    Somatuline Safety Alerts, Active Ingredients, Usage Information

    NDC15054-0060
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameSomatuline Depot
    Namelanreotide acetate
    Dosage FormINJECTION
    RouteSUBCUTANEOUS
    On market since20071114
    LabelerIpsen Biopharmaceuticals, Inc.
    Active Ingredient(s)LANREOTIDE ACETATE
    Strength(s)60
    Unit(s)mg/.2mL
    Pharma ClassSomatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]

    More About Somatuline

    Side Effects reported to FDA: 509

    Somatuline safety alerts: No

    Reported deaths: 22

    Reported hospitalizations: 117

    Latest Somatuline clinical trials

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