Common Mydocalm Side Effects


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

Toxicity To Various Agents (3)
Overdose (3)
Depression (2)
Death (1)
Dry Mouth (1)
Alanine Aminotransferase Increased (1)
Fall (1)
Gamma-glutamyltransferase Increased (1)
Fibroadenoma Of Breast (1)
Hypersomnia (1)
Dry Skin (1)
Rash (1)
Leukopenia (1)
Irritability (1)
Initial Insomnia (1)
Maternal Exposure During Pregnancy (1)
Nightmare (1)
Skin Lesion (1)
Pregnancy On Oral Contraceptive (1)
Impaired Healing (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.

Mydocalm Side Effects Reported to FDA



Mydocalm Side Effect Report#8408753-2
Fall, Impaired Healing, Gamma-glutamyltransferase Increased, Alanine Aminotransferase Increased, Leukopenia, Skin Lesion
This is a report of a male patient (weight: NA) from Germany, suffering from the following health symptoms/conditions: NA, who was treated with Mydocalm (dosage: 100 Mg, Tid, start time:
Jun 01, 2001), combined with:
  • Clobazam (10 Mg, Prn)
  • Pk-merz (300 Mg, Unk)
  • Lamictal (300 Mg, Unk)
  • Gilenya (0.5 Mg, Qd)
  • Ibuprofen (600 Mg, Prn)
  • Keppra (2000 Mg, Unk)
and developed a serious reaction and side effect(s): Fall, Impaired Healing, Gamma-glutamyltransferase Increased, Alanine Aminotransferase Increased, Leukopenia, Skin Lesion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mydocalm treatment in male patients, resulting in Fall side effect.
Mydocalm Side Effect Report#8348971-5
Toxicity To Various Agents, Overdose
This report suggests a potential Mydocalm Toxicity To Various Agents side effect(s) that can have serious consequences. A 20-year-old female patient (weight: NA) from Switzerland was diagnosed with the following symptoms/conditions: suicide attempt and used Mydocalm (dosage: Unk) starting NS. After starting Mydocalm the patient began experiencing various side effects, including: Toxicity To Various Agents, OverdoseAdditional drugs used concurrently:
  • Ibuprofen
  • Acetaminophen (Unk)
Although Mydocalm demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Toxicity To Various Agents, may still occur.
Mydocalm Side Effect Report#8348799-6
Overdose, Toxicity To Various Agents
This Overdose problem was reported by a health professional from Switzerland. A 14-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Mydocalm (dosage: NA). The following drugs were being taken at the same time:
  • Acetaminophen
When using Mydocalm, the patient experienced the following unwanted symptoms/side effects: Overdose, Toxicity To Various AgentsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Overdose, may become evident only after a product is in use by the general population.
Mydocalm Side Effect Report#8293832-3
Overdose, Toxicity To Various Agents
This Overdose side effect was reported by a health professional from Switzerland. A 20-year-old female patient (weight:NA) experienced the following symptoms/conditions: suicide attempt.The patient was prescribed Mydocalm (drug dosage: Unk), which was initiated on NS. Concurrently used drugs:
  • Acetaminophen (Unk)
.After starting to take Mydocalm the consumer reported adverse symptoms, such as: Overdose, Toxicity To Various AgentsThese side effects may potentially be related to Mydocalm.
Mydocalm Side Effect Report#8276179-0
Maternal Exposure During Pregnancy, Pregnancy On Oral Contraceptive
This is a report of a 23-year-old female patient (weight: NA) from Switzerland, suffering from the following health symptoms/conditions: NA, who was treated with Mydocalm /00293002/ (tolperisone Hydrochloride) (dosage: NA, start time:
Sep 07, 2011), combined with:
  • Belara (chlormadinone Acetate, Ethinylestradiol)
  • Spiricort (prednisolone)
  • Zaldiar (paracetamol, Tramadol Hydrochloride)
  • Tizanidine Hydrochloride (4 Mg, Bid, Transplacental)
  • Ketesse (dexketoprofen Trometamol)
  • Kenacort /00031901/ (triamcinolone)
  • Irfen (ibuprofen)
  • Tramadol Hydrohloride
and developed a serious reaction and side effect(s): Maternal Exposure During Pregnancy, Pregnancy On Oral Contraceptive after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mydocalm /00293002/ (tolperisone Hydrochloride) treatment in female patients, resulting in Maternal Exposure During Pregnancy side effect.
Mydocalm Side Effect Report#8229877-9
Fibroadenoma Of Breast
This report suggests a potential Mydocalm Fibroadenoma Of Breast side effect(s) that can have serious consequences. A 39-year-old female patient (weight: NA) from Germany was diagnosed with the following symptoms/conditions: muscle spasticity,relapsing-remitting multiple sclerosis,paraesthesia,affective disorder,basedow's disease,fatigue and used Mydocalm (dosage: NA) starting
Oct 25, 2011. After starting Mydocalm the patient began experiencing various side effects, including: Fibroadenoma Of BreastAdditional drugs used concurrently:
  • Tysabri
  • Lyrica
  • Citalopram Hydrobromide
  • Levothyroxine Sodium
  • Vigil
The patient was hospitalized. Although Mydocalm demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fibroadenoma Of Breast, may still occur.
Mydocalm Side Effect Report#8186817-9
Hepatic Failure
This Hepatic Failure problem was reported by a consumer or non-health professional from Romania. A 36-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 30, 2012 this consumer started treatment with Mydocalm (dosage: NA). The following drugs were being taken at the same time:
  • Lyrica
  • Yervoy
  • Oxycontin
  • Omez (1 Df:1 Tablet/day)
  • Medrol
When using Mydocalm, the patient experienced the following unwanted symptoms/side effects: Hepatic FailureAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatic Failure, may become evident only after a product is in use by the general population.
Mydocalm Side Effect Report#7938547-3
Dry Mouth, Nightmare, Vomiting, Hypersomnia, Initial Insomnia, Dry Skin, Irritability, Rash, Depression
This Dry Mouth side effect was reported by a physician from Poland. A 33-year-old female patient (weight:NA) experienced the following symptoms/conditions: neck pain.The patient was prescribed Mydocalm ^choay Labs.^ (drug dosage: NA), which was initiated on
Aug 22, 2011. Concurrently used drugs:
  • Varenicline Tartrate (0.5 Mg, Unk)
  • Yasmin (Unk)
  • Varenicline Tartrate (1 Mg, Unk)
.After starting to take Mydocalm ^choay Labs.^ the consumer reported adverse symptoms, such as: Dry Mouth, Nightmare, Vomiting, Hypersomnia, Initial Insomnia, Dry Skin, Irritability, Rash, DepressionThese side effects may potentially be related to Mydocalm ^choay Labs.^.
Mydocalm Side Effect Report#7795730-8
Depression
This is a report of a 28-year-old female patient (weight: NA) from Germany, suffering from the following health symptoms/conditions: NA, who was treated with Mydocalm (dosage: NA, start time:
Dec 02, 2008), combined with:
  • Amitryptilin
  • Humira
  • Daivobet
and developed a serious reaction and side effect(s): Depression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mydocalm treatment in female patients, resulting in Depression side effect. The patient was hospitalized.



The appearance of Mydocalm 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 Mydocalm Side Effects for Women?

Women Side Effects Reports
Overdose 3
Toxicity To Various Agents 3
Depression 2
Dry Mouth 1
Dry Skin 1
Fibroadenoma Of Breast 1
Hypersomnia 1
Initial Insomnia 1
Irritability 1
Maternal Exposure During Pregnancy 1

What are common Mydocalm Side Effects for Men?

Men Side Effects Reports
Alanine Aminotransferase Increased 1
Death 1
Fall 1
Gamma-glutamyltransferase Increased 1
Hepatic Failure 1
Impaired Healing 1
Leukopenia 1
Skin Lesion 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.

    Mydocalm 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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    More About Mydocalm

    Side Effects reported to FDA: 9

    Mydocalm safety alerts: No

    Reported deaths: 4

    Reported hospitalizations: 2

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