Common Amitiza Side Effects


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

Dyspnoea (217)
Nausea (98)
Chest Discomfort (93)
Diarrhoea (66)
Chest Pain (65)
Dizziness (52)
Headache (40)
Abdominal Distension (32)
Cough (30)
Abdominal Pain (28)
Feeling Abnormal (26)
Vomiting (26)
Malaise (24)
Anxiety (24)
Palpitations (24)
Constipation (23)
Dehydration (22)
Asthenia (22)
Oedema Peripheral (20)
Syncope (18)

➢ 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.

Amitiza Side Effects Reported to FDA



Amitiza Side Effect Report#9955043
Chest Pain
This is a report of a 46-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: constipation, who was treated with Amitiza (dosage: 8 Mcg, Bid, start time:
Jan 21, 2014), combined with: NA. and developed a serious reaction and side effect(s): Chest Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amitiza treatment in female patients, resulting in Chest Pain side effect.
Amitiza Side Effect Report#9913150
Abdominal Pain, Abdominal Distension
This report suggests a potential Amitiza Abdominal Pain side effect(s) that can have serious consequences. A 65-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: constipation and used Amitiza (dosage: 24 Mcg?per Day Plus {180}?2 Daily?by Mouth) starting NS. After starting Amitiza the patient began experiencing various side effects, including: Abdominal Pain, Abdominal DistensionAdditional drugs used concurrently:
  • Florinef
  • Toprol
  • Xarelto
  • Miralax
  • Restoril
  • Vitamin D
Although Amitiza demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Pain, may still occur.
Amitiza Side Effect Report#9891658
Abdominal Pain
This Abdominal Pain problem was reported by a health professional from JP. A 54-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: constipation. On NS this consumer started treatment with Amitiza (dosage: 24 Mcg, Qd). The following drugs were being taken at the same time:
  • Sennoside (60 Mg, Qd)
  • Adjust-a (240 Mg, Qd)
When using Amitiza, the patient experienced the following unwanted symptoms/side effects: Abdominal PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abdominal Pain, may become evident only after a product is in use by the general population.
Amitiza Side Effect Report#9882730
Dyspnoea
This Dyspnoea side effect was reported by a physician from JP. A 40-year-old female patient (weight:NA) experienced the following symptoms/conditions: constipation.The patient was prescribed Amitiza (drug dosage: 24 Mcg, Bid), which was initiated on
Jan 27, 2014. Concurrently used drugs: NA..After starting to take Amitiza the consumer reported adverse symptoms, such as: DyspnoeaThese side effects may potentially be related to Amitiza.
Amitiza Side Effect Report#9864006
Dyspnoea
This is a report of a 46-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: constipation,depression, who was treated with Amitiza (dosage: 24 Mcg, Qd, start time:
Jan 10, 2014), combined with:
  • Cymbalta (20 Mg, Qd)
and developed a serious reaction and side effect(s): Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amitiza treatment in female patients, resulting in Dyspnoea side effect.
Amitiza Side Effect Report#9853238
Dyspnoea, Chest Pain
This report suggests a potential Amitiza Dyspnoea side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: constipation and used Amitiza (dosage: 24 Mcg, Bid) starting NS. After starting Amitiza the patient began experiencing various side effects, including: Dyspnoea, Chest PainAdditional drugs used concurrently:
  • Ganaton (50 Mg, Bid)
Although Amitiza demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dyspnoea, may still occur.
Amitiza Side Effect Report#9853237
Dyspnoea, Chest Pain, Abdominal Distension, Cold Sweat, Abdominal Pain, Vomiting, Urticaria, Rash
This Dyspnoea problem was reported by a pharmacist from JP. A 54-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: constipation,rheumatoid arthritis. On 199905 this consumer started treatment with Amitiza (dosage: 24 Mcg, Bid). The following drugs were being taken at the same time:
  • Rheumatrex (Unk, 8mg Per Week)
  • Foliamin (Unk)
  • Recalbon (Unk)
  • Enbrel (Unk)
When using Amitiza, the patient experienced the following unwanted symptoms/side effects: Dyspnoea, Chest Pain, Abdominal Distension, Cold Sweat, Abdominal Pain, Vomiting, Urticaria, RashAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dyspnoea, may become evident only after a product is in use by the general population.
Amitiza Side Effect Report#9831830
Dyspnoea, Palpitations, Diarrhoea, Abdominal Pain
This Dyspnoea side effect was reported by a physician from JP. A 80-year-old female patient (weight:NA) experienced the following symptoms/conditions: constipation,hypertension.The patient was prescribed Amitiza (drug dosage: 24 Mcg, Qd), which was initiated on
Jan 08, 2014. Concurrently used drugs:
  • Cardenalin (4 Mg, Qd)
  • Coniel (4 Mg, Qd)
  • Adalat (40 Mg, Bid)
  • Rize (20 Mg, Bid)
  • Amaryl (3 Mg, Bid)
  • Mevalotin (5 Mg, Qd)
  • Olmetec (20 Mg, Qd)
  • Equa (50 Mg, Qd)
.After starting to take Amitiza the consumer reported adverse symptoms, such as: Dyspnoea, Palpitations, Diarrhoea, Abdominal PainThese side effects may potentially be related to Amitiza.
Amitiza Side Effect Report#9831828
Haematemesis, Dyspnoea, Nausea, Off Label Use
This is a report of a 16-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: irritable bowel syndrome, who was treated with Amitiza (dosage: 2 Doses With Dinner, start time: 201401), combined with: NA. and developed a serious reaction and side effect(s): Haematemesis, Dyspnoea, Nausea, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amitiza treatment in male patients, resulting in Haematemesis side effect.
Amitiza Side Effect Report#9811224
Hypokalaemia, Cardiac Failure
This report suggests a potential Amitiza Hypokalaemia side effect(s) that can have serious consequences. A 85-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: constipation and used Amitiza (dosage: 24 Mcg, Bid) starting NS. After starting Amitiza the patient began experiencing various side effects, including: Hypokalaemia, Cardiac FailureAdditional drugs used concurrently:
  • Jun Cho To (Unk)
  • Amlodipine (2.5 Mg, Qd)
  • Imidapril Hydrochloride (5 Mg, Qd)
  • Hordazol (50 Mg, Bid)
Although Amitiza demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypokalaemia, may still occur.
Amitiza Side Effect Report#9785669
Hernia, Rectal Tenesmus, Paraesthesia, Weight Decreased, Hypersensitivity
This Hernia problem was reported by a consumer or non-health professional from US. A 76-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: constipation. On 2011 this consumer started treatment with Amitiza (dosage: 24 Mcg, Unk). The following drugs were being taken at the same time: NA. When using Amitiza, the patient experienced the following unwanted symptoms/side effects: Hernia, Rectal Tenesmus, Paraesthesia, Weight Decreased, HypersensitivityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hernia, may become evident only after a product is in use by the general population.
Amitiza Side Effect Report#9785396
Nausea, Headache, Diarrhoea, Joint Swelling, Swelling
This Nausea side effect was reported by a consumer or non-health professional from US. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: constipation.The patient was prescribed Amitiza Lobiprostone (drug dosage: 25 Mcg?1-tab-am?once?10 Pills), which was initiated on
Nov 05, 2013. Concurrently used drugs:
  • Celerrex
  • Chlorthaild
  • Synthroid
  • Q-var
  • Losartan
  • Cranberry
  • Vitamin C
.After starting to take Amitiza Lobiprostone the consumer reported adverse symptoms, such as: Nausea, Headache, Diarrhoea, Joint Swelling, SwellingThese side effects may potentially be related to Amitiza Lobiprostone.
Amitiza Side Effect Report#9778425
Transient Ischaemic Attack, Carotid Artery Stenosis, Subclavian Artery Stenosis
This is a report of a 73-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Amitiza (lubiprostone) (dosage: NA, start time: NS), combined with:
  • Aspirin (acetylsalytic Acid)
  • Lovastatin (lovastatin)
  • Levothroxine (levothyroxine)
and developed a serious reaction and side effect(s): Transient Ischaemic Attack, Carotid Artery Stenosis, Subclavian Artery Stenosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amitiza (lubiprostone) treatment in female patients, resulting in Transient Ischaemic Attack side effect. The patient was hospitalized.
Amitiza Side Effect Report#9767490
Dyspnoea, Nausea
This report suggests a potential Amitiza Dyspnoea side effect(s) that can have serious consequences. A 48-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: constipation and used Amitiza (dosage: 24 Mcg, Bid) starting 201006. After starting Amitiza the patient began experiencing various side effects, including: Dyspnoea, NauseaAdditional drugs used concurrently: NA. Although Amitiza demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dyspnoea, may still occur.
Amitiza Side Effect Report#9737457
Chest Discomfort, Abdominal Discomfort, Nausea
This Chest Discomfort problem was reported by a pharmacist from JP. A 81-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: constipation. On
Nov 23, 2013 this consumer started treatment with Amitiza (dosage: 24 Mcg, Qd). The following drugs were being taken at the same time:
  • Bayaspirin (Unk, Qd)
  • Alfarol (Unk, Qd)
  • Norvasc (Unk, Qd)
  • Avolve (Unk, Qd)
  • Pariet (Unk, Qd)
  • Sigmart (Unk, Qd)
  • Crestor (Unk, Qd)
When using Amitiza, the patient experienced the following unwanted symptoms/side effects: Chest Discomfort, Abdominal Discomfort, NauseaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Chest Discomfort, may become evident only after a product is in use by the general population.
Amitiza Side Effect Report#9731543
Dyspnoea
This Dyspnoea side effect was reported by a physician from JP. A 60-year-old female patient (weight:NA) experienced the following symptoms/conditions: constipation,hypertension,osteoporosis,hypercholesterolaemia.The patient was prescribed Amitiza (drug dosage: 24 Mcg, Qd), which was initiated on
Sep 28, 2013. Concurrently used drugs:
  • Amlodipine (2.5 Mg, Qd)
  • Evista (60 Mg, Qd)
  • Pravapeak (10 Mg, Qd)
.After starting to take Amitiza the consumer reported adverse symptoms, such as: DyspnoeaThese side effects may potentially be related to Amitiza.
Amitiza Side Effect Report#9724087
Dyspnoea
This is a report of a 39-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: constipation,gastrooesophageal reflux disease,depression, who was treated with Amitiza (dosage: 24 Mcg, Bid, start time:
Jun 29, 2013), combined with:
  • Nexium (20 Mg, Qd)
  • Anafranil (Unk)
  • Paxil (Unk)
  • Contomin (Unk)
and developed a serious reaction and side effect(s): Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amitiza treatment in female patients, resulting in Dyspnoea side effect.
Amitiza Side Effect Report#9705293
Dehydration, Constipation, Decreased Appetite, Nausea, Diarrhoea
This report suggests a potential Amitiza Dehydration side effect(s) that can have serious consequences. A 68-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: constipation and used Amitiza (dosage: 24 Mcg, Bid) starting
Oct 23, 2013. After starting Amitiza the patient began experiencing various side effects, including: Dehydration, Constipation, Decreased Appetite, Nausea, DiarrhoeaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Amitiza demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dehydration, may still occur.
Amitiza Side Effect Report#9688464
Dyspnoea, Diarrhoea, Cough
This Dyspnoea problem was reported by a physician from JP. A 66-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: constipation. On
Oct 12, 2013 this consumer started treatment with Amitiza (dosage: 24 Mcg, Qd). The following drugs were being taken at the same time: NA. When using Amitiza, the patient experienced the following unwanted symptoms/side effects: Dyspnoea, Diarrhoea, CoughAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dyspnoea, may become evident only after a product is in use by the general population.
Amitiza Side Effect Report#9687003
Haemorrhagic Erosive Gastritis, Oropharyngeal Discomfort, Decreased Appetite, Nausea, Abdominal Pain Upper
This Haemorrhagic Erosive Gastritis side effect was reported by a pharmacist from JP. A 74-year-old female patient (weight:NA) experienced the following symptoms/conditions: constipation,cerebral infarction,hypertension.The patient was prescribed Amitiza (drug dosage: 24 Mcg, Bid), which was initiated on
Sep 25, 2013. Concurrently used drugs:
  • Pletal (50 Mg, Bid)
  • Diovan (80 Mg, Qd)
  • Amlodipine (5 Mg, Qd)
  • Pursennid (24 Mg, Qd)
  • Magmitt (500 Mg, Tid)
  • Gaster (10 Mg, Bid)
  • Gaster (20 Mg, Bid)
  • Mucosta (100 Mg, Tid)
.After starting to take Amitiza the consumer reported adverse symptoms, such as: Haemorrhagic Erosive Gastritis, Oropharyngeal Discomfort, Decreased Appetite, Nausea, Abdominal Pain UpperThese side effects may potentially be related to Amitiza.
Amitiza Side Effect Report#9687000
Weight Decreased, Diarrhoea
This is a report of a 86-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: constipation, who was treated with Amitiza (dosage: 24 Mcg, Bid, start time:
Oct 02, 2013), combined with: NA. and developed a serious reaction and side effect(s): Weight Decreased, Diarrhoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amitiza treatment in female patients, resulting in Weight Decreased side effect.
Amitiza Side Effect Report#9669512
Abortion Spontaneous, Hormone Level Abnormal
This report suggests a potential Amitiza Abortion Spontaneous 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: irritable bowel syndrome and used Amitiza (dosage: 1 Pill) starting
Nov 10, 2011. After starting Amitiza the patient began experiencing various side effects, including: Abortion Spontaneous, Hormone Level AbnormalAdditional drugs used concurrently: NA. Although Amitiza demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abortion Spontaneous, may still occur.
Amitiza Side Effect Report#9666562
Blood Magnesium Decreased, Blood Potassium Decreased
This Blood Magnesium Decreased problem was reported by a consumer or non-health professional from US. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: irritable bowel syndrome. On 2010 this consumer started treatment with Amitiza (dosage: 24 Mcg, Bid). The following drugs were being taken at the same time:
  • Cardizem Cd
When using Amitiza, the patient experienced the following unwanted symptoms/side effects: Blood Magnesium Decreased, Blood Potassium DecreasedThe 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 Blood Magnesium Decreased, may become evident only after a product is in use by the general population.
Amitiza Side Effect Report#9666374
Pyrexia, Chest Pain, Dizziness, Diarrhoea
This Pyrexia side effect was reported by a consumer or non-health professional from US. A 33-year-old female patient (weight:NA) experienced the following symptoms/conditions: constipation.The patient was prescribed Amitiza (drug dosage: 24 Mcg, Bid), which was initiated on
Oct 07, 2013. Concurrently used drugs: NA..After starting to take Amitiza the consumer reported adverse symptoms, such as: Pyrexia, Chest Pain, Dizziness, DiarrhoeaThese side effects may potentially be related to Amitiza.
Amitiza Side Effect Report#9666356
Pneumonia, Hyponatraemia
This is a report of a 63-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: constipation, who was treated with Amitiza (dosage: 8 Mcg, Bid, start time:
Jan 25, 2013), combined with: NA. and developed a serious reaction and side effect(s): Pneumonia, Hyponatraemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amitiza treatment in female patients, resulting in Pneumonia side effect. The patient was hospitalized.


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The appearance of Amitiza 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 Amitiza Side Effects for Women?

Women Side Effects Reports
Dyspnoea 196
Nausea 90
Chest Discomfort 81
Chest Pain 59
Diarrhoea 58
Dizziness 49
Headache 36
Abdominal Distension 27
Cough 27
Feeling Abnormal 24

What are common Amitiza Side Effects for Men?

Men Side Effects Reports
Dyspnoea 20
Chest Discomfort 11
Dehydration 9
Diarrhoea 8
Nausea 8
Chest Pain 6
Abdominal Distension 5
Abdominal Pain 5
Weight Decreased 5
Colitis Ischaemic 4

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.

    Amitiza 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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    Amitiza Safety Alerts, Active Ingredients, Usage Information

    NDC 16590-622
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name AMITIZA
    Name LUBIPROSTONE
    Dosage Form CAPSULE, GELATIN COATED
    Route ORAL
    On market since 20060131
    Labeler STAT RX USA LLC
    Active Ingredient(s) LUBIPROSTONE
    Strength(s) 8
    Unit(s) ug/1
    Pharma Class Chloride Channel Activator [EPC],Chloride Channel Activators [MoA]

    Amitiza Dosage, Warnings, Usage.

    Side Effects reported to FDA: 560

    Amitiza safety alerts: No

    Reported deaths: 18

    Reported hospitalizations: 139

    Latest Amitiza clinical trials

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