Common Calpol Side Effects


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

Accidental Overdose (4)
Urticaria (4)
Flushing (4)
Mouth Ulceration (3)
Coeliac Disease (3)
Back Pain (2)
Bronchospasm (2)
Diabetes Mellitus (2)
Laryngeal Oedema (2)
Epilepsy (1)
Diarrhoea (1)
Death (1)
Feeling Abnormal (1)
Delirium (1)
Pyrexia (1)
Scratch (1)
Screaming (1)
Lip Swelling (1)
Insomnia (1)
Hepatic Failure (1)

➢ 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.

Calpol Side Effects Reported to FDA



Calpol Side Effect Report#9880445
Coeliac Disease
This is a report of a 3-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Calpol Sugar Free Infant Suspension (dosage: NA, start time: 2011), combined with: NA. and developed a serious reaction and side effect(s): Coeliac Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Calpol Sugar Free Infant Suspension treatment in female patients, resulting in Coeliac Disease side effect.
Calpol Side Effect Report#9861351
Product Container Issue
This report suggests a potential Calpol Infant Suspension Product Container Issue side effect(s) that can have serious consequences. A 3-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: accidental exposure to product and used Calpol Infant Suspension (dosage: Half The Bottle) starting NS. After starting Calpol Infant Suspension the patient began experiencing various side effects, including: Product Container IssueAdditional drugs used concurrently: NA.The patient was hospitalized. Although Calpol Infant Suspension demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Product Container Issue, may still occur.
Calpol Side Effect Report#9399038
Delirium, Confusional State, Pyrexia, Sudden Onset Of Sleep
This Delirium problem was reported by a consumer or non-health professional from GB. A 4-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: pyrexia. On NS this consumer started treatment with Calpol (dosage: NA). The following drugs were being taken at the same time:
  • Nurofen
When using Calpol, the patient experienced the following unwanted symptoms/side effects: Delirium, Confusional State, Pyrexia, Sudden Onset Of SleepAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Delirium, may become evident only after a product is in use by the general population.
Calpol Side Effect Report#9392278
Accidental Exposure To Product, Overdose
This Accidental Exposure To Product side effect was reported by a consumer or non-health professional from IE. A 2.-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Calpol (drug dosage: NA), which was initiated on
May 09, 2013. Concurrently used drugs: NA..After starting to take Calpol the consumer reported adverse symptoms, such as: Accidental Exposure To Product, OverdoseThese side effects may potentially be related to Calpol. The patient was hospitalized.
Calpol Side Effect Report#9146302
Accidental Overdose, No Adverse Event
This is a report of a 4-year-old male patient (weight: NA) from IE, suffering from the following health symptoms/conditions: irritability,pyrexia, who was treated with Calpol (dosage: 240 Mg, 4 Times Per Day, start time:
Feb 02, 2013), combined with: NA. and developed a serious reaction and side effect(s): Accidental Overdose, No Adverse Event after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Calpol treatment in male patients, resulting in Accidental Overdose side effect. The patient was hospitalized.
Calpol Side Effect Report#9054158
Psychomotor Hyperactivity
This report suggests a potential Calpol Psychomotor Hyperactivity side effect(s) that can have serious consequences. A 8-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Calpol (dosage: NA) starting NS. After starting Calpol the patient began experiencing various side effects, including: Psychomotor HyperactivityAdditional drugs used concurrently: NA. Although Calpol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Psychomotor Hyperactivity, may still occur.
Calpol Side Effect Report#9009900
Coeliac Disease
This Coeliac Disease problem was reported by a consumer or non-health professional from GB. A 7-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Calpol (dosage: NA). The following drugs were being taken at the same time: NA. When using Calpol, the patient experienced the following unwanted symptoms/side effects: Coeliac DiseaseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Coeliac Disease, may become evident only after a product is in use by the general population.
Calpol Side Effect Report#9007181
Anaphylactic Reaction
This Anaphylactic Reaction side effect was reported by a physician from GB. A 10-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Calpol Sixplus (drug dosage: NA), which was initiated on
Dec 27, 2012. Concurrently used drugs: NA..After starting to take Calpol Sixplus the consumer reported adverse symptoms, such as: Anaphylactic ReactionThese side effects may potentially be related to Calpol Sixplus.
Calpol Side Effect Report#8985223
Unresponsive To Stimuli, Body Temperature Increased, Pallor, Flushing, Therapeutic Response Decreased
This is a report of a 4-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Calpol (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Unresponsive To Stimuli, Body Temperature Increased, Pallor, Flushing, Therapeutic Response Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Calpol treatment in female patients, resulting in Unresponsive To Stimuli side effect.
Calpol Side Effect Report#8968203
Wheezing, Vomiting, Feeling Abnormal
This report suggests a potential Calpol Wheezing side effect(s) that can have serious consequences. A 3-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Calpol (dosage: NA) starting NS. After starting Calpol the patient began experiencing various side effects, including: Wheezing, Vomiting, Feeling AbnormalAdditional drugs used concurrently: NA.The patient was hospitalized. Although Calpol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Wheezing, may still occur.
Calpol Side Effect Report#8913770
Accidental Overdose
This Accidental Overdose problem was reported by a consumer or non-health professional from GB. A 3-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: accidental exposure to product. On NS this consumer started treatment with Calpol (dosage: NA). The following drugs were being taken at the same time: NA. When using Calpol, the patient experienced the following unwanted symptoms/side effects: Accidental OverdoseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Accidental Overdose, may become evident only after a product is in use by the general population.
Calpol Side Effect Report#8903345
Nephrotic Syndrome
This Nephrotic Syndrome side effect was reported by a consumer or non-health professional from GB. A 3-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Calpol (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Calpol the consumer reported adverse symptoms, such as: Nephrotic SyndromeThese side effects may potentially be related to Calpol.
Calpol Side Effect Report#8839568
Hepatic Failure, Accidental Overdose
This is a report of a female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: accidental exposure to product, who was treated with Calpol Infant Suspension (dosage: Whole Bottle Of 120mg/5ml Suspension (strawberry Flavour), start time:
Oct 07, 2012), combined with: NA. and developed a serious reaction and side effect(s): Hepatic Failure, Accidental Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Calpol Infant Suspension treatment in female patients, resulting in Hepatic Failure side effect. The patient was hospitalized.
Calpol Side Effect Report#8833111
Asthma, Scratch, Insomnia, Screaming
This report suggests a potential Calpol Asthma side effect(s) that can have serious consequences. A 4-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: pain and used Calpol (dosage: NA) starting NS. After starting Calpol the patient began experiencing various side effects, including: Asthma, Scratch, Insomnia, ScreamingAdditional drugs used concurrently: NA.The patient was hospitalized. Although Calpol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Asthma, may still occur.
Calpol Side Effect Report#7373726-8
Diarrhoea, Accidental Overdose
This Diarrhoea problem was reported by a consumer or non-health professional from United Kingdom. A 2-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Calpol Infant Suspension (dosage: NA). The following drugs were being taken at the same time: NA. When using Calpol Infant Suspension, the patient experienced the following unwanted symptoms/side effects: Diarrhoea, Accidental OverdoseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Diarrhoea, may become evident only after a product is in use by the general population.
Calpol Side Effect Report#6410556-5
Back Pain, Diabetes Mellitus
This Back Pain side effect was reported by a consumer or non-health professional from United Kingdom. A 12-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Calpol Six Plus Sugar Free/color Free (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Insulin
.After starting to take Calpol Six Plus Sugar Free/color Free the consumer reported adverse symptoms, such as: Back Pain, Diabetes MellitusThese side effects may potentially be related to Calpol Six Plus Sugar Free/color Free.
Calpol Side Effect Report#6379866-4
Back Pain, Diabetes Mellitus
This is a report of a 12-year-old male patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: NA, who was treated with Calpol Paediatric Suspension Sugar Free (dosage: NA, start time: NS), combined with:
  • Insulin
and developed a serious reaction and side effect(s): Back Pain, Diabetes Mellitus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Calpol Paediatric Suspension Sugar Free treatment in male patients, resulting in Back Pain side effect.
Calpol Side Effect Report#6290966-X
This report suggests a potential Calpol Six Plus Death side effect(s) that can have serious consequences. A 79-year-old male patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: NA and used Calpol Six Plus (dosage: NA) starting NS. After starting Calpol Six Plus the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Calpol Six Plus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Calpol Side Effect Report#5992668-3
Coeliac Disease, Malaise
This Coeliac Disease problem was reported by a consumer or non-health professional from United Kingdom. A 2-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Calpol Infant Suspension (dosage: NA). The following drugs were being taken at the same time: NA. When using Calpol Infant Suspension, the patient experienced the following unwanted symptoms/side effects: Coeliac Disease, MalaiseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Coeliac Disease, may become evident only after a product is in use by the general population.
Calpol Side Effect Report#5915652-4
Epilepsy
This Epilepsy side effect was reported by a consumer or non-health professional from United Kingdom. A 6-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Calpol Six Plus Fastmelt (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Calpol Six Plus Fastmelt the consumer reported adverse symptoms, such as: EpilepsyThese side effects may potentially be related to Calpol Six Plus Fastmelt.
Calpol Side Effect Report#5372144-1
Cough, Lip Swelling, Obstructive Airways Disorder, Oedema Peripheral, Pruritus, Urticaria
This is a report of a female patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: preoperative care, who was treated with Calpol (dosage: NA, start time:
May 27, 2007), combined with: NA. and developed a serious reaction and side effect(s): Cough, Lip Swelling, Obstructive Airways Disorder, Oedema Peripheral, Pruritus, Urticaria after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Calpol treatment in female patients, resulting in Cough side effect.
Calpol Side Effect Report#5362256-0
Bronchospasm, Flushing, Laryngeal Oedema, Mouth Ulceration, Urticaria
This report suggests a potential Calpol Bronchospasm side effect(s) that can have serious consequences. A 56-year-old female patient (weight: NA) from India was diagnosed with the following symptoms/conditions: headache and used Calpol (dosage: 2tab Per Day) starting
May 15, 2007. After starting Calpol the patient began experiencing various side effects, including: Bronchospasm, Flushing, Laryngeal Oedema, Mouth Ulceration, UrticariaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Calpol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bronchospasm, may still occur.
Calpol Side Effect Report#5342227-0
Bronchospasm, Flushing, Laryngeal Oedema, Mouth Ulceration, Urticaria
This Bronchospasm problem was reported by a physician from India. A 56-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: headache. On
May 15, 2007 this consumer started treatment with Calpol (dosage: 2tab Per Day). The following drugs were being taken at the same time: NA. When using Calpol, the patient experienced the following unwanted symptoms/side effects: Bronchospasm, Flushing, Laryngeal Oedema, Mouth Ulceration, UrticariaThe 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 Bronchospasm, may become evident only after a product is in use by the general population.
Calpol Side Effect Report#5335012-7
Flushing, Mouth Ulceration, Urticaria
This Flushing side effect was reported by a physician from India. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: headache.The patient was prescribed Calpol (drug dosage: 2tab Per Day), which was initiated on
May 15, 2007. Concurrently used drugs: NA..After starting to take Calpol the consumer reported adverse symptoms, such as: Flushing, Mouth Ulceration, UrticariaThese side effects may potentially be related to Calpol. The patient was hospitalized.



The appearance of Calpol 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 Calpol Side Effects for Women?

Women Side Effects Reports
Flushing 4
Urticaria 4
Mouth Ulceration 3
Accidental Overdose 2
Bronchospasm 2
Coeliac Disease 2
Laryngeal Oedema 2
Accidental Exposure To Product 1
Anaphylactic Reaction 1
Body Temperature Increased 1

What are common Calpol Side Effects for Men?

Men Side Effects Reports
Accidental Overdose 2
Back Pain 2
Diabetes Mellitus 2
Asthma 1
Coeliac Disease 1
Confusional State 1
Death 1
Delirium 1
Epilepsy 1
Insomnia 1

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.

    Calpol 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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    Calpol Safety Alerts, Active Ingredients, Usage Information

    More About Calpol

    Side Effects reported to FDA: 24

    Calpol safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 7

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